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Sample records for previously irradiated patients

  1. Pregnancy hemoperitoneum and placenta percreta in a patient with previous pelvic irradiation and ovarian failure

    SciTech Connect

    Pridjian, G.; Rich, N.E.; Montag, A.G. )

    1990-05-01

    Placenta percreta in a patient with previous pelvic irradiation has never been described. Reported is a case of placenta percreta with hemoperitoneum associated with a second-trimester incomplete abortion in a patient with previous pelvic irradiation and ovarian failure.

  2. Thyroid abnormalities in patients previously treated with irradiation for acne vulgaris

    SciTech Connect

    Thomson, D.B.; Grammes, C.F.; Starkey, R.H.; Monsaert, R.P.; Sunderlin, F.S.

    1984-01-01

    Of 1,203 patients who received radiation treatment for acne vulgaris between 1940 and 1968, 302 patients were recalled and examined, 121 at Geisinger Medical Center and the remainder by their local physicians. Radiation records were reviewed on all patients. Lead-rubber and cones had been used as shielding. Mean age at the time of exposure was 21 years and mean total exposure was 692 R. Palpable nodular thyroid disease was found in eight patients (2.6%). Of these, thyroid carcinoma was detected in two patients (0.66%). Although the number of patients examined was small, the incidence of carcinomas was unexpectedly high. We conclude that follow-up examination is worthwhile for patients previously treated by irradiation for acne vulgaris.

  3. Thyroid abnormalities in patients previously treated with irradiation for acne vulgaris

    SciTech Connect

    Thomson, D.B.; Grammes, C.F.; Starkey, R.H.; Monsaert, R.P.; Sunderlin, F.S.

    1984-01-01

    Of 1203 patients who received radiation treatment for acne vulgaris between 1940 and 1968, 302 were recalled and examined, 121 at Geisinger Medical Center and the remainder by their local physicians. Radiation records were reviewed on all patients. Lead-rubber and cones had been used as shielding. Mean age at the time of exposure was 21 years and mean total exposure was 692 R. Palpable nodular thyroid disease was found in eight patients (2.6%). Of these, thyroid carcinoma was detected in two patients (0.66%). Although the number of patients examined was small, the incidence of carcinomas was unexpectedly high. The authors conclude that follow-up examination is worthwhile for patients previously treated by irradiation for acne vulgaris.

  4. Rhabdomyosarcoma Arising in a Previously Irradiated Field: An Analysis of 43 Patients

    SciTech Connect

    Dang, Nguyen D.; Teh, Bin S.; Paulino, Arnold C.

    2013-03-01

    Patients with soft tissue sarcomas that arise from previously irradiated fields have traditionally been reported to have a poor prognosis. In this report, we examined the characteristics and outcomes of patients who developed a rhabdomyosarcoma in a previously irradiated field (RMS-RIF); we hypothesize that these patients should have a better outcome compared to other postradiation soft tissue sarcomas as these tumors are chemosensitive and radiosensitive. A PubMed search of the literature from 1961-2010 yielded 33 studies with data for patients with RMS-RIF. The study included 43 patients with a median age of 6.5 years at the time of radiation therapy (RT) for the initial tumor. The median RT dose was 48 Gy. The median latency period, the time from RT to development of RMS-RIF, was 8 years. The 3-year overall survival for RMS-RIF was 42%. The 3-year overall survival was 66% for patients receiving chemotherapy and local treatment (surgery and/or RT) compared to 29% for those who had systemic treatment only or local treatment only (P=.049). Other factors associated with increased 3-year overall survival included retinoblastoma initial diagnosis (P<.001), age ≤18 years at diagnosis of RMS-RIF (P=.003), favorable site (P=.008), and stage 1 disease (P=.002). Age at time of RMS-RIF, retinoblastoma initial tumor, favorable site, stage 1 disease, and use of both systemic and local treatment were found to be favorable prognostic factors for 3-year overall survival.

  5. Low dose reirradiation in combination with hyperthermia: a palliative treatment for patients with breast cancer recurring in previously irradiated areas.

    PubMed

    van der Zee, J; Treurniet-Donker, A D; The, S K; Helle, P A; Seldenrath, J J; Meerwaldt, J H; Wijnmaalen, A J; van den Berg, A P; van Rhoon, G C; Broekmeyer-Reurink, M P

    1988-12-01

    Ninety-seven patients with breast cancer recurring in a previously irradiated area (mean dose 44 Gy) were reirradiated in combination with hyperthermia and had evaluable tumor responses. In the reirradiation series, radiotherapy was given twice weekly in most patients, with a fraction size varying from 200 to 400 cGy, the total dose varying from 8 to 32 Gy. Hyperthermia was given following the radiotherapy fractions. The combined treatment resulted in 35% complete and 55% partial responses. Duration of response was median 4 months for partial response and 26 months for complete response, respectively. The median survival time for all patients was 12 months. Acute skin reaction was mild, with more than moderate erythema in only 14/97 patients. Thermal burns occurred in 44/97 patients, generally at sites where pain sensation was decreased, and therefore they did not cause much inconvenience. In the 19 patients who survived more than 2 years, no late radiation damage was observed. When patients who received a "high dose" (greater than 29 Gy and hyperthermia) were compared with those who received a "low dose" (less than 29 Gy and hyperthermia), a higher complete response rate was observed in the high dose group (58% vs. 24%), whereas no difference in acute toxicity was found. We conclude that reirradiation with 8 x 4 Gy in combination with hyperthermia twice weekly is a safe, effective and well tolerated method for palliative treatment of patients with breast cancer recurring in previously irradiated areas.

  6. Preoperative hyperfractionated chemoradiation for locally recurrent rectal cancer in patients previously irradiated to the pelvis: A multicentric phase II study

    SciTech Connect

    Valentini, Vincenzo . E-mail: vvalentini@rm.unicatt.it; Morganti, Alessio G.; Gambacorta, M. Antonietta; Mohiuddin, Mohammed; Doglietto, G. Battista; Coco, Claudio; De Paoli, Antonino; Rossi, Carlo; Di Russo, Annamaria; Valvo, Francesca; Bolzicco, Giampaolo; Dalla Palma, Maurizio

    2006-03-15

    Purpose: The combination of irradiation and total mesorectal excision for rectal carcinoma has significantly lowered the incidence of local recurrence. However, a new problem is represented by the patient with locally recurrent cancer who has received previous irradiation to the pelvis. In these patients, local recurrence is very often not easily resectable and reirradiation is expected to be associated with a high risk of late toxicity. The aim of this multicenter phase II study is to evaluate the response rate, resectability rate, local control, and treatment-related toxicity of preoperative hyperfractionated chemoradiation for locally recurrent rectal cancer in patients previously irradiated to the pelvis. Methods and Materials: Patients with histologically proven pelvic recurrence of rectal carcinoma, with the absence of extrapelvic disease or bony involvement and previous pelvic irradiation with doses {<=}55 Gy; age {>=}18 years; performance status (PS) (Karnofsky) {>=}60, and who gave institutional review board-approved written informed consent were treated by preoperative chemoradiation. Radiotherapy was delivered to a planning target volume (PTV2) including the gross tumor volume (GTV) plus a 4-cm margin, with a dose of 30 Gy (1.2 Gy twice daily with a minimum 6-h interval). A boost was delivered, with the same fractionation schedule, to a PTV1 including the GTV plus a 2-cm margin (10.8 Gy). During the radiation treatment, concurrent chemotherapy was delivered (5-fluorouracil, protracted intravenous infusion, 225 mg/m{sup 2}/day, 7 days per week). Four to 6 weeks after the end of chemoradiation, patients were evaluated for tumor resectability, and, when feasible, surgical resection of recurrence was performed between 6-8 weeks from the end of chemoradiation. Adjuvant chemotherapy was prescribed to all patients, using Raltitrexed, 3 mg/square meter (sm), every 3 weeks, for a total of 5 cycles. Patients were staged using the computed tomography (CT)-based F

  7. A Pilot Study of Hypofractionated Stereotactic Radiation Therapy and Sunitinib in Previously Irradiated Patients With Recurrent High-Grade Glioma

    SciTech Connect

    Wuthrick, Evan J.; Curran, Walter J.; Camphausen, Kevin; Lin, Alexander; Glass, Jon; Evans, James; Andrews, David W.; Axelrod, Rita; Shi, Wenyin; Werner-Wasik, Maria; Haacke, E. Mark; Hillman, Gilda G.; Dicker, Adam P.

    2014-10-01

    Purpose/Objective(s): Angiogenic blockade with irradiation may enhance the therapeutic ratio of radiation therapy (RT) through vascular normalization. We sought to determine the safety and toxicity profile of continuous daily-dosed sunitinib when combined with hypofractionated stereotactic RT (fSRT) for recurrent high-grade gliomas (rHGG). Methods and Materials: Eligible patients had malignant high-grade glioma that recurred or progressed after primary surgery and RT. All patients received a minimum of a 10-day course of fSRT, had World Health Organization performance status of 0 to 1, and a life expectancy of >3 months. During fSRT, sunitinib was administered at 37.5 mg daily. The primary endpoint was acute toxicity, and response was assessed via serial magnetic resonance imaging. Results: Eleven patients with rHGG were enrolled. The fSRT doses delivered ranged from 30 to 42 Gy in 2.5- to 3.75-Gy fractions. The median follow-up time was 40 months. Common acute toxicities included hematologic disorders, fatigue, hypertension, and elevated liver transaminases. Sunitinib and fSRT were well tolerated. One grade 4 mucositis toxicity occurred, and no grade 4 or 5 hypertensive events or intracerebral hemorrhages occurred. One patient had a nearly complete response, and 4 patients had stable disease for >9 months. Two patients (18%) remain alive and progression-free >3 years from enrollment. The 6-month progression-free survival was 45%. Conclusions: Sunitinib at a daily dose of 37.5 mg given concurrently with hypofractionated stereotactic reirradiation for rHGG yields acceptable toxicities and an encouraging 6-month progression-free survival.

  8. Histologic changes in previously irradiated thyroid glands

    SciTech Connect

    Valdiserri, R.O.; Borochovitz, D.

    1980-03-01

    Thyroid tissue from 90 patients with a history of therapeutic irradiation to the head and neck in childhood and adolescence was examined microscopically. In addition to the well-known observation that these individuals have an increased incidence of primary thyroid carcinoma, it was also demonstrated that they have an increased incidence of benign histologic changes. These changes represent a spectrum from nonspecific hyperplastic lesions to benign neoplasis and thyroidltis.

  9. Squamous cell carcinoma arising in previously burned or irradiated skin

    SciTech Connect

    Edwards, M.J.; Hirsch, R.M.; Broadwater, J.R.; Netscher, D.T.; Ames, F.C.

    1989-01-01

    Squamous cell carcinoma (SCC) arising in previously burned or irradiated skin was reviewed in 66 patients treated between 1944 and 1986. Healing of the initial injury was complicated in 70% of patients. Mean interval from initial injury to diagnosis of SCC was 37 years. The overwhelming majority of patients presented with a chronic intractable ulcer in previously injured skin. The regional relapse rate after surgical excision was very high, 58% of all patients. Predominant patterns of recurrence were in local skin and regional lymph nodes (93% of recurrences). Survival rates at 5, 10, and 20 years were 52%, 34%, and 23%, respectively. Five-year survival rates in previously burned and irradiated patients were not significantly different (53% and 50%, respectively). This review, one of the largest reported series, better defines SCC arising in previously burned or irradiated skin as a locally aggressive disease that is distinct from SCC arising in sunlight-damaged skin. An increased awareness of the significance of chronic ulceration in scar tissue may allow earlier diagnosis. Regional disease control and survival depend on surgical resection of all known disease and may require radical lymph node dissection or amputation.

  10. A Prospective Phase 2 Trial of Reirradiation With Stereotactic Body Radiation Therapy Plus Cetuximab in Patients With Previously Irradiated Recurrent Squamous Cell Carcinoma of the Head and Neck

    SciTech Connect

    Vargo, John A.; Ferris, Robert L.; Ohr, James; Clump, David A.; Davis, Kara S.; Duvvuri, Umamaheswar; Kim, Seungwon; Johnson, Jonas T.; Bauman, Julie E.; Gibson, Michael K.; Branstetter, Barton F.; Heron, Dwight E.

    2015-03-01

    Purpose: Salvage options for unresectable locally recurrent, previously irradiated squamous cell carcinoma of the head and neck (rSCCHN) are limited. Although the addition of reirradiation may improve outcomes compared to chemotherapy alone, significant toxicities limit salvage reirradiation strategies, leading to suboptimal outcomes. We therefore designed a phase 2 protocol to evaluate the efficacy of stereotactic body radiation therapy (SBRT) plus cetuximab for rSCCHN. Methods and Materials: From July 2007 to March 2013, 50 patients >18 years of age with inoperable locoregionally confined rSCCHN within a previously irradiated field receiving ≥60 Gy, with a Zubrod performance status of 0 to 2, and normal hepatic and renal function were enrolled. Patients received concurrent cetuximab (400 mg/m{sup 2} on day −7 and then 250 mg/m{sup 2} on days 0 and +8) plus SBRT (40-44 Gy in 5 fractions on alternating days over 1-2 weeks). Primary endpoints were 1-year locoregional progression-free survival and National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 graded toxicity. Results: Median follow-up for surviving patients was 18 months (range: 10-70). The 1-year local PFS rate was 60% (95% confidence interval [CI]: 44%-75%), locoregional PFS was 37% (95% CI: 23%-53%), distant PFS was 71% (95% CI: 54%-85%), and PFS was 33% (95% CI: 20%-49%). The median overall survival was 10 months (95% CI: 7-16), with a 1-year overall survival of 40% (95% CI: 26%-54%). At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression. Acute and late grade 3 toxicity was observed in 6% of patients respectively. Conclusions: SBRT with concurrent cetuximab appears to be a safe salvage treatment for rSCCHN of short overall treatment time.

  11. No Salvage Using High-Dose Chemotherapy Plus/Minus Reirradiation for Relapsing Previously Irradiated Medulloblastoma

    SciTech Connect

    Massimino, Maura Gandola, Lorenza; Spreafico, Filippo; Biassoni, Veronica; Luksch, Roberto; Collini, Paola; Solero, Carlo N.; Simonetti, Fabio; Pignoli, Emanuele; Cefalo, Graziella; Poggi, Geraldina; Modena, Piergiorgio Ph.D.; Mariani, Luigi; Potepan, Paolo; Podda, Marta; Casanova, Michela; Pecori, Emilia; Acerno, Stefania; Ferrari, Andrea; Terenziani, Monica

    2009-04-01

    Purpose: Myeloablative regimens were frequently used for medulloblastoma relapsing after craniospinal irradiation (CSI): in 1997-2002, we used repeated surgery, standard-dose and myeloablative chemotherapy, and reirradiation. Methods and Materials: In 10 patients, reinduction included sequential high-dose etoposide, high-dose cyclophosphamide/vincristine, and high-dose carboplatin/vincristine, then two myeloablative courses with high-dose thiotepa ({+-} carboplatin); 6 other patients received two of four courses of cisplatin/etoposide. Hematopoietic precursor mobilization followed high-dose etoposide or high-dose cyclophosphamide or cisplatin/etoposide therapy. After the overall chemotherapy program, reirradiation was prescribed when possible. Results: Seventeen patients were treated: previous treatment included CSI of 19.5-36 Gy with posterior fossa/tumor boost and chemotherapy in 16 patients. Fifteen patients were in their first and 2 in their second and third relapses, respectively. First progression-free survival had lasted a median of 26 months. Relapse sites included leptomeninges in 9 patients, spine in 4 patients, posterior fossa in 3 patients, and brain in 1 patient. Three patients underwent complete resection of recurrence, and 10 underwent reirradiation. Twelve of 14 patients with assessable tumor had an objective response after reinduction; 2 experienced progression and were not given the myeloablative courses. Remission lasted a median of 16 months. Additional relapses appeared in 13 patients continuing the treatment. Fifteen patients died of progression and 1 died of pneumonia 13 months after relapse. The only survivor at 93 months had a single spinal metastasis that was excised and irradiated. Survival for the series as a whole was 11-93 months, with a median of 41 months. Conclusions: Despite responses being obtained and ample use of surgery and reirradiation, second-line therapy with myeloablative schedules was not curative, barring a few

  12. Adenoid cystic carcinoma of the nasopharynx after previous adenoid irradiation

    SciTech Connect

    Sofferman, R.A.; Heisse, J.W. Jr.

    1985-04-01

    In 1978, Pratt challenged the otolaryngology community to identify an incidence of malignancy in individuals who have previously received radium therapy to the nasopharyngeal lymphoid tissues. This case report is a direct response to that quest and presents a well documented adenoid cystic carcinoma evolving 23 years after radium applicator treatment to the fossa of Rosenmuller. Although a cause-and-effect relationship cannot be scientifically proven, the case history raises several important questions concerning the stimulating effects of radiation on the later onset of frank malignancy.

  13. Stereotactic Radiosurgery for Treatment of Spinal Metastases Recurring in Close Proximity to Previously Irradiated Spinal Cord

    SciTech Connect

    Choi, Clara Y.H.; Adler, John R.; Gibbs, Iris C.; Chang, Steven D.; Jackson, Paul S.; Minn, A. Yuriko; Lieberson, Robert E.; Soltys, Scott G.

    2010-10-01

    Purpose: As the spinal cord tolerance often precludes reirradiation with conventional techniques, local recurrence within a previously irradiated field presents a treatment challenge. Methods and Materials: We retrospectively reviewed 51 lesions in 42 patients treated from 2002 to 2008 whose spinal metastases recurred in a previous radiation field (median previous spinal cord dose of 40 Gy) and were subsequently treated with stereotactic radiosurgery (SRS). Results: SRS was delivered to a median marginal dose of 20 Gy (range, 10-30 Gy) in 1-5 fractions (median, 2), targeting a median tumor volume of 10.3 cm{sup 3} (range, 0.2-128.6 cm{sup 3}). Converting the SRS regimens with the linear quadratic model ({alpha}/{beta} = 3), the median spinal cord maximum single-session equivalent dose (SSED) was 12.1 Gy{sub 3} (range, 4.7-19.3 Gy{sub 3}). With a median follow-up of 7 months (range, 2-47 months), the Kaplan-Meier local control and overall survival rates at 6/12 months were 87%/73% and 81%/68%, respectively. A time to retreatment of {<=}12 months and the combination of time to retreatment of {<=}12 months with an SSED of <15 Gy{sub 10} were significant predictors of local failure on univariate and multivariate analyses. In patients with a retreatment interval of <12 months, 6/12 month local control rates were 88%/58%, with a SSED of >15 Gy{sub 10}, compared to 45%/0% with <15 Gy{sub 10}, respectively. One patient (2%) experienced Grade 4 neurotoxicity. Conclusion: SRS is safe and effective in the treatment of spinal metastases recurring in previously irradiated fields. Tumor recurrence within 12 months may correlate with biologic aggressiveness and require higher SRS doses (SSED >15 Gy{sub 10}). Further research is needed to define the partial volume retreatment tolerance of the spinal cord and the optimal target dose.

  14. Malignant tumor formation at the site of previously irradiated acanthomatous epulides in four dogs

    SciTech Connect

    Thrall, D.E.; Goldschmidt, M.H.; Biery, D.N.

    1981-01-15

    The radiation response of acanthomatous epulis in 32 dogs was good, with an estimated median survival time of 21 months. Of the 32 patients, 14 have died. In 4 of those 14, malignant tumors developed at the site of the acanthomatous epulis. The tumors were of epithelial origin in 3 patients and of mesenchymal origin in 1 patient. Possibilities explaining the appearance of the malignancies included spontaneous malignant transformation, radiation induction of neoplasms, and radiation induction of malignant transformation. This uncommon complication was not considered contradictory to radiotherapy of acanthomatous epulides, because of their excellent response to irradiation and the long latent period between irradiation and appearance of the malignant tumor.

  15. Statin-induced myopathy in a patient with previous poliomyelitis.

    PubMed

    Martikainen, Mika H; Gardberg, Maria; Kohonen, Ia; Lähdesmäki, Janne

    2013-11-01

    This report describes a patient with a history of poliomyelitis who developed new, progressive symptoms of muscle fatigue and weakness, suggestive of postpoliomyelitis syndrome. However, comprehensive investigations led to the diagnosis of statin-induced myopathy as the cause of the patient's symptoms. This case highlights the possibility of statin-induced myopathy in patients with a history of poliomyelitis and the differential diagnosis between postpoliomyelitis syndrome and statin-induced myopathy in these patients. The possibility of statin-induced myopathy should be considered when patients with previous poliomyelitis who take statin medication develop symptoms suggestive of postpoliomyelitis syndrome.

  16. Detection of previous neutron irradiation and reprocessing of uranium materials for nuclear forensic purposes.

    PubMed

    Varga, Zsolt; Surányi, Gergely

    2009-04-01

    The paper describes novel analytical methods developed for the detection of previous neutron irradiation and reprocessing of illicit nuclear materials, which is an important characteristic of nuclear materials of unknown origin in nuclear forensics. Alpha spectrometry and inductively coupled plasma sector-field mass spectrometry (ICP-SFMS) using solution nebulization and direct, quasi-non-destructive laser ablation as sample introduction were applied for the measurement of trace-level (232)U, (236)U and plutonium isotopes deriving from previous neutron irradiation of uranium-containing nuclear materials. The measured radionuclides and isotope ratios give important information on the raw material used for fuel production and enable confirm the supposed provenance of illicit nuclear material. PMID:19179085

  17. Myelopathy in a previously asymptomatic HIV-1-infected patient.

    PubMed

    Eyer-Silva, W A; Auto, I; Pinto, J F; Morais-de-Sá, C A

    2001-01-01

    A wide variety of disorders of diverse pathogenic mechanisms can trigger spinal cord dysfunction in HIV-1-infected patients. The most common such condition is HIV-1-associated myelopathy (HM) which characteristically complicates advanced HIV-1 disease in patients with low CD4 cell counts and previous AIDS-defining diagnoses. We describe an unusual presentation of HM in a previously asymptomatic patient with a relatively preserved CD4 cell count (458 cells/mm3) who was even unaware of his serological status. The patient presented with a clinically severe, slowly progressive myelopathy and could not walk unassisted. Significant neurological improvement could be obtained as rapidly as within 4 weeks after the institution of an antiretroviral combination of only two nucleoside analog HIV-1 reverse transcriptase inhibitors (zidovudine and didanosine). An HIV-1 protease inhibitor was also prescribed at that point but could only be added to intensify the regimen 3 months later, when significant neurological improvement had already been recorded. We also review the disorders reported to derange spinal cord function in previously asymptomatic HIV-1-infected patients.

  18. Rosiglitazone and Myocardial Infarction in Patients Previously Prescribed Metformin

    PubMed Central

    Dormuth, Colin R.; Maclure, Malcolm; Carney, Greg; Schneeweiss, Sebastian; Bassett, Ken; Wright, James M.

    2009-01-01

    Objective Rosiglitazone was found associated with approximately a 43% increase in risk of acute myocardial infarction (AMI) in a two meta-analyses of clinical trials. Our objective is to estimate the magnitude of the association in real-world patients previously treated with metformin. Research Design and Methods We conducted a nested case control study in British Columbia using health care databases on 4.3 million people. Our cohort consisted of 158,578 patients with Type 2 diabetes who used metformin as first-line drug treatment. We matched 2,244 cases of myocardial infarction (AMI) with up to 4 controls. Conditional logistic regression models were used to estimate matched odds ratios for AMI associated with treatment with rosiglitazone, pioglitazone and sulfonylureas. Results In our cohort of prior metformin users, adding rosiglitazone for up to 6 months was not associated with an increased risk of AMI compared to adding a sulfonylurea (odds ratio [OR] 1.38; 95% confidence interval [CI], 0.91–2.10), or compared to adding pioglitazone (OR for rosi versus pio 1.41; 95% CI, 0.74–2.66). There were also no significant differences between rosiglitazone, pioglitazone and sulfonylureas for longer durations of treatment. Though not significantly different from sulfonylureas, there was a transient increase in AMI risk associated with the first 6 months of treatment with a glitazone compared to not using the treatment (OR 1.53; 95% CI, 1.13–2.07) Conclusions In our British Columbia cohort of patients who received metformin as first-line pharmacotherapy for Type 2 diabetes mellitus, further treatment with rosiglitazone did not increase the risk of AMI compared to patients who were treated with pioglitazone or a sulfonylurea. Though not statistically significantly different compared from each other, an increased risk of AMI observed after starting rosiglitazone or sulfonylureas is a matter of concern that requires more research. PMID:19562036

  19. Computerized implantology for the irradiated patient.

    PubMed

    Horowitz, Andrew; Orentlicher, Gary; Goldsmith, Douglas

    2009-03-01

    Reconstruction of the irradiated head and neck cancer patient continues to be a challenge. Conventional prosthodontics can be very unpredictable and difficult in these patients. Implant-supported fixed prostheses are good alternatives. It is well-accepted that maxillofacial surgery for the irradiated head and neck cancer patients should be performed in an atraumatic fashion to minimize postoperative complications. We propose the use of computer generated surgical guides and flapless surgery for the placement of dental implants in the irradiated head and neck cancer patient. With these techniques, implants can be placed in an atraumatic, predictable, and accurate manner, according to a prosthetically driven treatment plan.

  20. Impaired lipid clearance in patients with previous acute pancreatitis.

    PubMed Central

    Guzmán, S; Nervi, F; Llanos, O; León, P; Valdivieso, V

    1985-01-01

    Fasting serum triglycerides were measured in 52 patients who had sustained an attack of pancreatitis (gall stone related 33, alcoholism six) at least six months earlier. Several patients (23%) had raised fasting serum triglycerides, with a type IV phenotype in all but one patient. The 40 patients with normal fasting serum triglycerides received an oral load of 100 g sunflower oil to compare their clearance of dietary triglycerides with that of a control group of 54 subjects. The clearance of ingested triglycerides was significantly impaired in the patients - irrespective of the presumed aetiological factor, or clinical condition associated with pancreatitis - compared with the clearance in controls. A triglyceride tolerance test is the only way to detect those patients in whom a future attack of pancreatitis may be precipitated by a diet rich in fat, or endogenous over production of triglycerides as after an alcoholic debauch. PMID:4029716

  1. Total knee arthroplasty in patients with a previous patellectomy.

    PubMed

    Maslow, Jed; Zuckerman, Joseph D; Immerman, Igor

    2013-01-01

    Post-patellectomy patients represent a specific subgroup of patients that may develop arthritis and persistent knee pain and potentially require treatment with total knee arthroplasty. This article reviews the treatment and functional outcomes following total knee arthroplasty in patients with prior patellectomy. A case report is presented as an example of the clinical management of a post-patellectomy patient with significant knee pain and disability treated with total knee arthroplasty. Emphasis will be placed in decision- making, specifically with the use of a posterior stabilized implant. In addition, postoperative strengthening of the quadriceps is essential to compensate for the lack of the patella and increase the success of total knee arthroplasty in this subgroup of patients. PMID:24151951

  2. Cutaneous protothecosis in a patient with previously undiagnosed HIV infection.

    PubMed

    Fong, Kenneth; Tee, Shang-Ian; Ho, Madeline S L; Pan, Jiun Yit

    2015-08-01

    Protothecosis is an uncommon condition resulting from infection by achlorophyllous algae of the Prototheca species. Immunocompromised individuals are generally most susceptible to protothecal infection and tend to develop severe and disseminated disease. However, the association between protothecosis and HIV-induced immunosuppression is not clear, with only a handful of cases having been described to date. Here we report a case of cutaneous protothecosis in a Chinese man with previously undiagnosed HIV infection that responded well to oral itraconazole. PMID:24592936

  3. New strategies for osteoporosis patients previously managed with strontium ranelate.

    PubMed

    Vestergaard, Peter

    2014-12-01

    The aim of this article is to describe potential alternatives to patients no longer eligible for management with strontium ranelate for osteoporosis according to the recommendations by the European Medicines Agency. A systematic search of Pubmed was done for papers on fracture efficacy of various treatments for osteoporosis, and potential harms especially in terms of cardiovascular events and stroke. The results showed that drugs more efficacious in terms of relative risk reduction of fractures than strontium ranelate were alendronate, risedronate, zoledronate, and denosumab. Raloxifene, as for strontium, may be associated with an increased risk of deep venous thromboembolism and fatal stroke. In terms of cardiovascular events special attention may be given to calcium supplements. Thus, patients at risk of stroke and ischemic cardiac events such as acute myocardial infarction should not use strontium ranelate. Ideally more efficacious drugs in terms of fracture reduction should be used such as alendronate, risedronate, zoledronate or denosumab. Raloxifene may pose a special problem as this too may be associated with an increased risk of fatal strokes. Other less-potent drugs in terms of fracture reduction should only be used if no alternatives are available (ibandronate, pamidronate, clodronate). Parathyroid hormone or analogs may be used for a limited time interval in specially selected patients and needs to be followed up with antiresorptive treatment to prevent loss of the bone gained. However, it should be remembered that no head-to-head comparison studies exist. PMID:25435924

  4. A technique to re-establish dose distributions for previously treated brain cancer patients in external beam radiotherapy

    SciTech Connect

    Yue, Ning J.; Knisely, Jonathan; Studholme, Colin; Chen Zhe; Bond, James E.; Nath, Ravinder

    2004-03-31

    Tumor recurrences or new tumors may develop after irradiation of local lesion(s) in the brain, and additional radiotherapy treatments are often needed for previously treated patients. It is critical to re-establish the dose distributions delivered during the previous treatment in the current patient geometry, so that the previous dose distributions can be accurately taken into consideration in the design of the current treatment plan. The difficulty in re-establishing the previous treatment dose distributions in the current patient geometry arises from the fact that the patient position at the time of reirradiation is different from that at the previous treatment session. Simple re-entry of the previous isocenter coordinates, gantry, and couch and collimator angles into the new treatment plan would result in incorrect beam orientations relative to the new patient anatomy, and therefore incorrect display of the previous dose distributions on the current patient anatomy. To address this issue, a method has been developed so that the previous dose distributions can be accurately re-established in the framework of the current brain treatment. The method involves 3 matrix transformations: (1) transformation of beams from machine coordinate system to patient coordinate system in the previous treatment; (2) transformation of beams from patient coordinate system in the previous treatment to patient coordinate system in the current treatment; and (3) transformation of beams from patient coordinate system in the current treatment to machine coordinate system. The transformation matrices used in the second transformation are determined by registration using a mutual information-based algorithm with which the old and new computed tomography (CT) scan sets are registered automatically without human interpretation. A series of transformation matrices are derived to calculate the isocenter coordinates, the gantry, couch, and collimator angles of the beams for the previous

  5. Volatile evolution induced by energetic He++ ions in a polyurethane and the effects of previous gamma irradiation

    NASA Astrophysics Data System (ADS)

    Murphy, J. J.; Wetteland, C. J.

    2005-07-01

    Irradiation of polymer samples using an accelerated beam of He++ ions passed through a 10 μm thick window of havar foil, has been performed. Such an irradiation simulates the effects of large α radiation doses, on a vastly reduced time-scale. The experimental set up was designed to allow analysis of volatiles evolved from the irradiated samples by means of a residual gas analyser (RGA). This was located in close proximity to the sample chamber. A radiation study on a poly(urethane) materials using an RGA to analyse volatiles indicated the dominant degradation products to be H2, CO and CO2. A series of polyurethane samples previously conditioned by γ irradiation to between 1 and 5 MGy were irradiated in the ion beam. Identification of differences in trends in the rates of volatile evolution between these samples indicated the precise vacuum conditions at the time of irradiation had a major influence. There was also an indication that the surface of the sample had a small effect on rates of volatile evolution. Comparative plots of CO and CO2 evolution for series of 5 × 1 MGy irradiations indicated variations in behaviour between samples with different γ doses. Evolution during the first 1 MGy was inhibited for the unirradiated sample, the extent of inhibition diminished with increasing γ dose and was no longer evident in a sample with 1.5 MGy γ dose. H2 does not show an equivalent inhibition. Evidence for a low dose crosslinking reaction is put forward as the reason for the inhibition. Chemical reaction mechanisms are postulated and used to explain the differences in behaviour observed between CO/CO2 and H2.

  6. A Feasibility Study on Adaptive 18F-FDG-guided Radiotherapy for Recurrent and Second Primary Head and Neck Cancer in the Previously Irradiated Territory.

    ClinicalTrials.gov

    2015-11-30

    Recurrent and Second Primary Squamous Cell Carcinoma of the Oral Cavity in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.; Recurrent and Second Primary Squamous Cell Carcinoma of the Oropharynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.; Recurrent and Second Primary Squamous Cell Carcinoma of the Hypopharynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.; Recurrent and Second Primary Squamous Cell Carcinoma of the Larynx in the Previously Irradiated Territory in Case of Primary Unresectable Tumor.

  7. Obstetric outcome of patients with more than one previous cesarean section.

    PubMed

    Novas, J; Myers, S A; Gleicher, N

    1989-02-01

    Records of patients with more than one previous cesarean section were reviewed for a 1-year period. Of 69 such pregnancies, 36 underwent trial of labor in concurrence with an ongoing departmental cesarean section reduction initiative; 80% culminated in vaginal delivery. Twenty of these 69 patients had three or more previous cesarean sections; 9 underwent trial of labor, with 8 subsequent vaginal deliveries. The vaginal delivery rate after more than one previous cesarean section was no different from that of patients with only one previous cesarean section. We conclude that trial of labor in patients with more than one previous cesarean section did not result in a deleterious outcome. Our findings suggest that a trial of labor after more than one previous cesarean section delivery can safely be allowed. Guidelines can be identical to those already established for patients with only one previous cesarean section.

  8. External Dacryocystorhinostomy: Characteristics and Surgical Outcomes in Patients with and without Previous Dacryocystitis.

    PubMed

    Rabina, Gilad; Golan, Shani; Neudorfer, Meira; Leibovitch, Igal

    2013-01-01

    Objective. To compare pre- and postoperative characteristics and surgical success rates of patients with and without previous episodes of dacryocystitis, who underwent external dacryocystorhinostomy (DCR) for nasolacrimal duct obstruction (NLDO). Methods. The medical files of all patients who underwent external DCR between 2006 and 2011 in our institution were reviewed. The retrieved data of patients with and without previous episodes of dacryocystitis were compared. Surgical success was determined by postoperative followup of at least 6 months. Results. A total of 185 patients with NLDO underwent external DCR of whom 152 (100 females and 52 males, mean age 67 ± 15 years) met the inclusion criteria. Sixty had previous episodes of dacryocystitis and 92 did not. Left-side obstruction was more common than right-side obstruction among patients with previous episodes of dacryocystitis (48.3% versus 31.7%, resp., P = 0.031). Glaucoma patients were significantly more likely to develop dacryocystitis than patients without glaucoma (P = 0.002). The success rate of external DCR was 94.4% for patients with previous episodes of dacryocystitis and 86.7% for patients without (P = 0.337). Conclusions. The surgical outcomes of external DCR in patients with or without a previous episode of dacryocystitis were similar. Patients with glaucoma and NLDO had a significantly higher risk of developing dacryocystitis. PMID:24455195

  9. External Dacryocystorhinostomy: Characteristics and Surgical Outcomes in Patients with and without Previous Dacryocystitis

    PubMed Central

    Rabina, Gilad; Golan, Shani; Neudorfer, Meira; Leibovitch, Igal

    2013-01-01

    Objective. To compare pre- and postoperative characteristics and surgical success rates of patients with and without previous episodes of dacryocystitis, who underwent external dacryocystorhinostomy (DCR) for nasolacrimal duct obstruction (NLDO). Methods. The medical files of all patients who underwent external DCR between 2006 and 2011 in our institution were reviewed. The retrieved data of patients with and without previous episodes of dacryocystitis were compared. Surgical success was determined by postoperative followup of at least 6 months. Results. A total of 185 patients with NLDO underwent external DCR of whom 152 (100 females and 52 males, mean age 67 ± 15 years) met the inclusion criteria. Sixty had previous episodes of dacryocystitis and 92 did not. Left-side obstruction was more common than right-side obstruction among patients with previous episodes of dacryocystitis (48.3% versus 31.7%, resp., P = 0.031). Glaucoma patients were significantly more likely to develop dacryocystitis than patients without glaucoma (P = 0.002). The success rate of external DCR was 94.4% for patients with previous episodes of dacryocystitis and 86.7% for patients without (P = 0.337). Conclusions. The surgical outcomes of external DCR in patients with or without a previous episode of dacryocystitis were similar. Patients with glaucoma and NLDO had a significantly higher risk of developing dacryocystitis. PMID:24455195

  10. FDA Approval: Ibrutinib for Patients with Previously Treated Mantle Cell Lymphoma and Previously Treated Chronic Lymphocytic Leukemia.

    PubMed

    de Claro, R Angelo; McGinn, Karen M; Verdun, Nicole; Lee, Shwu-Luan; Chiu, Haw-Jyh; Saber, Haleh; Brower, Margaret E; Chang, C J George; Pfuma, Elimika; Habtemariam, Bahru; Bullock, Julie; Wang, Yun; Nie, Lei; Chen, Xiao-Hong; Lu, Donghao Robert; Al-Hakim, Ali; Kane, Robert C; Kaminskas, Edvardas; Justice, Robert; Farrell, Ann T; Pazdur, Richard

    2015-08-15

    On November 13, 2013, the FDA granted accelerated approval to ibrutinib (IMBRUVICA capsules; Pharmacyclics, Inc.) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. On February 12, 2014, the FDA granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Ibrutinib is a first-in-class Bruton's tyrosine kinase (BTK) inhibitor that received all four expedited programs of the FDA: Fast-Track designation, Breakthrough Therapy designation, Priority Review, and Accelerated Approval. Both approvals were based on overall response rate (ORR) and duration of response (DOR) in single-arm clinical trials in patients with prior treatment. In MCL (N = 111), the complete and partial response rates were 17.1% and 48.6%, respectively, for an ORR of 65.8% [95% confidence interval (CI), 56.2%-74.5%]. The median DOR was 17.5 months (95% CI, 15.8-not reached). In CLL (N = 48), the ORR was 58.3% (95% CI, 43.2%-72.4%), and the DOR ranged from 5.6 to 24.2 months. The most common adverse reactions (≥ 30% in either trial) were thrombocytopenia, diarrhea, neutropenia, bruising, upper respiratory tract infection, anemia, fatigue, musculoskeletal pain, peripheral edema, and nausea.

  11. Identification of multidrug resistance in previously treated tuberculosis patients: a mixed methods study in Cambodia

    PubMed Central

    Royce, S; Khann, S; Yadav, RP; Mao, ET; Cattamanchi, A; Sam, S; Handley, MA

    2014-01-01

    SUMMARY Setting Previously treated tuberculosis (TB) patients are a priority for drug susceptibility testing (DST) to identify cases with multidrug resistance (MDR). In Cambodia, a recent study found that only one-third of smear-positive previously treated patients had DST results. Objective To quantify the gaps in detecting MDR in previously treated TB patients in Cambodia, and describe health workers’ perspectives on barriers, facilitators and potential interventions. Design We analyzed case notifications in Cambodia (2004–2012) and conducted semi-structured interviews with key stakeholders Results The proportion of previously treated notifications varied significantly across provinces 2010–12, in the context of longer term trends of decreasing relapse and increasing “other” retreatment notifications. Correct classification of patients’ TB treatment history and ensuring specimens from previously-treated patients are collected and reach the laboratory could nearly double the number of detected MDR-TB cases. Identified barriers include patients’ reluctance to disclose and staff difficulty eliciting treatment history, partly due to availability of streptomycin only in hospitals. Facilitators include trained health workers, collection of sputum for DST even if previously treated patients are not taking streptomycin, streamlining sputum transportation and promptly reporting results. Conclusion Improved monitoring, supportive supervision, and correctly classifying previously treated patients are essential for improving detection of MDR-TB. PMID:25299861

  12. Retrograde Intrarenal Surgery in Patients Who Previously Underwent Open Renal Stone Surgery

    PubMed Central

    Alkan, Erdal; Saribacak, Ali; Ozkanli, Ahmet Oguz; Başar, Mehmet Murad; Acar, Oguz; Balbay, Mevlana Derya

    2015-01-01

    Purpose. To ascertain whether retrograde intrarenal surgery (RIRS) is as effective in patients treated previously with open renal stone surgery (ORSS) on the same kidney as in patients with no previous ORSS. Methods. There were 32 patients with renal stones who had previous ORSS and were treated with RIRS in the study group (Group 1). A total of 38 patients with renal stones who had no previous ORSS and were treated with RIRS were selected as the control group (Group 2). Recorded data regarding preoperative characteristics of the patients, stone properties, surgical parameters, outcomes, SFRs (no fragments or small fragments <4 mm), and complications between groups were compared. Results. Mean age, mean BMI, mean hospital stay, and mean operative time were not statistically different between groups. Mean stone size (10.1 ± 5.6 versus 10.3 ± 4.2; p = 0.551) and mean stone burden (25.4 ± 14.7 versus 23.5 ± 9.9; p = 0.504) were also similar between groups. After the second procedures, SFRs were 100% and 95% in groups 1 and 2, respectively (p = 0.496). No major perioperative complications were seen. Conclusion. RIRS can be safely and effectively performed with acceptable complication rates in patients treated previously with ORSS as in patients with no previous ORSS. PMID:26357570

  13. Safety and efficacy of velaglucerase alfa in Gaucher disease type 1 patients previously treated with imiglucerase.

    PubMed

    Zimran, Ari; Pastores, Gregory M; Tylki-Szymanska, Anna; Hughes, Derralynn A; Elstein, Deborah; Mardach, Rebecca; Eng, Christine; Smith, Laurie; Heisel-Kurth, Margaret; Charrow, Joel; Harmatz, Paul; Fernhoff, Paul; Rhead, William; Longo, Nicola; Giraldo, Pilar; Ruiz, Juan A; Zahrieh, David; Crombez, Eric; Grabowski, Gregory A

    2013-03-01

    Velaglucerase alfa is a glucocerebrosidase produced by gene activation technology in a human fibroblast cell line (HT-1080), and it is indicated as an enzyme replacement therapy (ERT) for the treatment of Gaucher disease type 1 (GD1). This multicenter, open-label, 12-month study examined the safety and efficacy of velaglucerase alfa in patients with GD1 previously receiving imiglucerase. Eligible patients, ≥2 years old and clinically stable on imiglucerase therapy, were switched to velaglucerase alfa at a dose equal to their prior imiglucerase dose. Infusion durations were 1 hr every other week. Forty patients received velaglucerase alfa (18 male, 22 female; four previously splenectomized; age range 9-71 years). Velaglucerase alfa was generally well tolerated with most adverse events (AEs) of mild or moderate severity. The three most frequently reported AEs were headache (12 of 40 patients), arthralgia (9 of 40 patients), and nasopharyngitis (8 of 40 patients). No patients developed antibodies to velaglucerase alfa. There was one serious AE considered treatment-related: a grade 2 anaphylactoid reaction within 30 min of the first infusion. The patient withdrew; this was the only AE-related withdrawal. Hemoglobin concentrations, platelet counts, and spleen and liver volumes remained stable through 12 months. In conclusion, adult and pediatric patients with GD1, previously treated with imiglucerase, successfully transitioned to velaglucerase alfa, which was generally well tolerated and demonstrated efficacy over 12 months' treatment consistent with that observed in the velaglucerase alfa phase 3 clinical trial program. PMID:23339116

  14. GaAs 904-nm laser irradiation improves myofiber mass recovery during regeneration of skeletal muscle previously damaged by crotoxin.

    PubMed

    Silva, Lucila H; Silva, Meiricris T; Gutierrez, Rita M; Conte, Talita C; Toledo, Cláudio A; Aoki, Marcelo S; Liebano, Richard E; Miyabara, Elen H

    2012-09-01

    This work investigated the effect of gallium arsenide (GaAs) irradiation (power: 5 mW; intensity: 77.14 mW/cm(2), spot: 0.07 cm(2)) on regenerating skeletal muscles damaged by crotoxin (CTX). Male C57Bl6 mice were divided into six groups (n = 5 each): control, treated only with laser at doses of 1.5 J or 3 J, CTX-injured and, CTX-injured and treated with laser at doses of 1.5 J or 3 J. The injured groups received a CTX injection into the tibialis anterior (TA) muscle. After 3 days, TA muscles were submitted to GaAs irradiation at doses of 1.5 or 3 J (once a day, during 5 days) and were killed on the eighth day. Muscle histological sections were stained with hematoxylin and eosin (H&E) in order to determine the myofiber cross-sectional area (CSA), the previously injured muscle area (PIMA) and the area density of connective tissue. The gene expression of MyoD and myogenin was detected by real-time PCR. GaAs laser at a dose of 3 J, but not 1.5 J, significantly increased the CSA of regenerating myofibers and reduced the PIMA and the area density of intramuscular connective tissue of CTX-injured muscles. MyoD gene expression increased in the injured group treated with GaAs laser at a dose of 1.5 J. The CTX-injured, 3-J GaAs laser-treated, and the CTX-injured and treated with 3-J laser groups showed an increase in myogenin gene expression when compared to the control group. Our results suggest that GaAs laser treatment at a dose of 3 J improves skeletal muscle regeneration by accelerating the recovery of myofiber mass.

  15. Trial of labor in previous cesarean section patients, excluding classical cesarean sections.

    PubMed

    Stovall, T G; Shaver, D C; Solomon, S K; Anderson, G D

    1987-11-01

    The American College of Obstetricians and Gynecologists has supported the concept of a trial of labor in patients with a previous lower uterine transverse cesarean section, and its safety is generally accepted. The purpose of this report was to present the results of a year-long, prospective study in which the indications for trial of labor were liberalized. Only patients with a previous classical incision or "T" incision on the uterus were excluded. Two hundred seventy-two patients elected to undergo a trial of labor. Vaginal delivery occurred in 216 patients (76.5%). Oxytocin was used as needed, and epidural anesthesia was used in all patients who requested it. One uterine rupture occurred in a patient with a single lower transverse scar. The results of this study suggest that a trial of labor is a safe alternative for patients with a previous single or multiple lower uterine transverse incision or a lower uterine vertical incision. In addition, the use of epidural anesthesia and oxytocin appears safe in patients undergoing a trial of labor. PMID:3658277

  16. Outcomes of Cardiac Surgery in Patients With Previous Solid Organ Transplantation (Kidney, Liver, and Pancreas).

    PubMed

    Vargo, Patrick R; Schiltz, Nicholas K; Johnston, Douglas R; Smedira, Nicholas G; Moazami, Nader; Blackstone, Eugene H; Soltesz, Edward G

    2015-12-15

    A growing number of solid organ transplant survivors require surgery for cardiac disease. We examined the effect of having a previous transplant on outcomes after cardiac surgery in these patients from a population-based perspective. Of 1,709,735 patients who underwent coronary artery bypass grafting, valve, or thoracic aorta surgery from 2004 to 2008 in the Nationwide Inpatient Sample, 3,535 patients (0.21%) had a previous organ transplant (2,712 kidney, 738 liver, 300 pancreas). Multivariate logistic regression analysis and propensity score matching were used to determine the effect of a previous solid organ transplant on outcomes. In-hospital mortality rate was 7% for patients who underwent transplantation versus 4% for patients who did not undergo transplantation (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.16 to 2.38). Patients who underwent transplantation were at an increased risk for acute renal failure (OR 1.62, CI 1.36 to 1.94) and blood transfusions (OR 1.63, CI 1.36 to 1.95). Median length of stay was longer (10 vs 9 days), with greater median total charges ($111,362 vs $102,221; both p <0.001). Occurrence of stroke, gastrointestinal complication, infection, and pneumonia was similar between groups. In conclusion, previous solid organ transplantation is an incremental risk factor for postoperative mortality after cardiac surgery. Renal protective strategies and bleeding control should be stressed to mitigate complications.

  17. Dental implants in irradiated versus nonirradiated patients: A meta-analysis.

    PubMed

    Chrcanovic, Bruno Ramos; Albrektsson, Tomas; Wennerberg, Ann

    2016-03-01

    The purpose of the present meta-analysis was to test the null hypothesis of no difference in dental implant failure rates, postoperative infection, and marginal bone loss for patients being rehabilitated by dental implants and being previously irradiated in the head and neck region versus nonirradiated patients against the alternative hypothesis of a difference. The study suggests that irradiation negatively affects the survival of implants, as well as the difference in implant location (maxilla vs mandible), but there is no statistically significant difference in survival when implants are inserted before or after 12 months after radiotherapy. The study failed to support the effectiveness of hyperbaric oxygen therapy in irradiated patients. It was observed that there was a tendency of lower survival rates of implants inserted in the patients submitted to higher irradiation doses. The results should be interpreted with caution because of the presence of uncontrolled confounding factors in the included studies.

  18. Stereotactic Body Radiation Therapy for Patients With Lung Cancer Previously Treated With Thoracic Radiation

    SciTech Connect

    Kelly, Patrick; Balter, Peter A.; Rebueno, Neal; Sharp, Hadley J.; Liao Zhongxing; Komaki, Ritsuko; Chang, Joe Y.

    2010-12-01

    Purpose: Stereotactic body radiation therapy (SBRT) provides excellent local control with acceptable toxicity for patients with early-stage non-small cell lung cancer. However, the efficacy and safety of SBRT for patients previously given thoracic radiation therapy is not known. In this study, we retrospectively reviewed outcomes after SBRT for recurrent disease among patients previously given radiation therapy to the chest. Materials and Methods: A search of medical records for patients treated with SBRT to the thorax after prior fractionated radiation therapy to the chest at The University of Texas M. D. Anderson Cancer Center revealed 36 such cases. The median follow-up time after SBRT was 15 months. The endpoints analyzed were overall survival, local control, and the incidence and severity of treatment-related toxicity. Results: SBRT provided in-field local control for 92% of patients; at 2 years, the actuarial overall survival rate was 59%, and the actuarial progression-free survival rate was 26%, with the primary site of failure being intrathoracic relapse. Fifty percent of patients experienced worsening of dyspnea after SBRT, with 19% requiring oxygen supplementation; 30% of patients experienced chest wall pain and 8% Grade 3 esophagitis. No Grade 4 or 5 toxic effects were noted. Conclusions: SBRT can provide excellent in-field tumor control in patients who have received prior radiation therapy. Toxicity was significant but manageable. The high rate of intrathoracic failure indicates the need for further study to identify patients who would derive the most benefit from SBRT for this purpose.

  19. Re-treatment of patients with hepatitis C who failed to respond (nonresponders) to previous treatment.

    PubMed

    Sharvadze, L G; Gogichaishvili, Sh Sh; Sakandelidze, Ts G; Zhamutashvili, M T; Chkhartishvili, N I

    2009-01-01

    The aim of four-year follow up study was evaluation of re-treatment efficacy of antiviral therapy in patients with hepatitis C who failed to respond (non responders) to previous therapy. Study enrolled 29 patients, aged 21-59 with HCV infection (15 had HCV genotype 1, and 14 had HCV non-genotype1), who previously were treated with unmodified interferon alfa (conventional interferon) 2a or 2b 5 MIU TIW plus ribavirin (1000-1200 mg/day) and who failed under this therapy. Study subjects were randomized into two groups: in group I were included 17 patients--relapsers (patient in whom HCV RNA becomes undetectable on treatment and is undetectable at the end of therapy, but is detected again after discontinuation of treatment). Group II was composed of 12 patients: 4 were non responders (patient in whom HCV RNA levels remain stable on treatment), 4--partial responders (HCV RNA levels decline by >2 logs, but never become undetectable during treatment) and 4--breakthrough non responders (HCV RNA become undetectable during treatment, but before-treatment termination again become detectable). The diagnosis of HCV infection was made based on detection of HCV antibodies by ELISA and confirmed by RIBA. Detection of HCV RNA (qualitative) and HCV RNA Viral load--by Real time PCR technique (COBAS TaqMan Test). HCV genotypes were detected by INNO-Lipa method. In group I--rapid virological response (RVR) was observed in 10 (58%) patients, early viral response (EVR) in 12 patients (70%). Among them 9 (52%) patients remained HCV RNA undetectable by the end of treatment. After 6 months sustained viral response (SVR) was received in 7 (41%) patients from group I. In group II--RVR was observed in 5 (41%), EVR in 6 (50%) patients. Among them 5 (41%) patients remained HCV RNA undetectable by the end of treatment. After 6 months Sustained Viral Response was received in 3 (25%) patients. Re-treatment with pegylated interferon and ribavirin in patients with hepatitis C who failed to responds

  20. Trauma-Induced Alterations in Cognition and Arc Expression are Reduced by Previous Exposure to 56Fe Irradiation

    PubMed Central

    Rosi, Susanna; Belarbi, Karim; Ferguson, Ryan A.; Fishman, Kelly; Obenaus, Andre; Raber, Jacob; Fike, John R.

    2013-01-01

    Exposure to ionizing irradiation may affect brain functions directly, but may also change tissue sensitivity to a secondary insult such as trauma, stroke or degenerative disease. To determine if a low dose of particulate irradiation sensitizes the brain to a subsequent injury, C56BL6 mice were exposed to brain only irradiation with 0.5 Gy of 56Fe ions. Two months later, unilateral traumatic brain injury was induced using a controlled cortical impact system. Three weeks after trauma animals received multiple BrdU injections and 30 days later were tested for cognitive performance in the Morris water maze. All animals where able to locate the visible and hidden platform during training; however, treatment effects were seen when spatial memory retention was assessed in the probe trial (no platform). While sham and irradiated animals showed spatial memory retention, mice that received trauma alone did not. When trauma was preceded by irradiation, performance in the water maze was not different from sham-treated animals, suggesting that low dose irradiation had a protective effect in the context of a subsequent traumatic injury. Measures of hippocampal neurogenesis showed that combined injury did not induce any changes greater that those seen after trauma or radiation alone. After trauma there was a significant decrease in the percentage of neurons expressing the behaviorally-induced immediate early gene Arc in both hemispheres, without associated neuronal loss. After combined injury there were no differences relative to sham-treated mice. Our results suggest that combined injury resulted in decreased alterations of our endpoints compared to trauma alone. While the underlying mechanisms are not yet known, these results resemble a preconditioning, adaptive, or inducible-like protective response, where a sublethal or potentially injurious stimulus (i.e. irradiation) induces tolerance to a subsequent and potentially more damaging insult (trauma). PMID:21192069

  1. [Transradial percutaneous approach for cardiac catheterization in patients with previous brachial artery cutdown].

    PubMed

    Magariños, Eduardo; Solioz, Germán; Cermesoni, Gabriel; Koretzky, Martín; Carnevalini, Mariana; González, Daniel

    2013-01-01

    The percutaneous punction of the radial artery for catheterization procedures has gained acceptance lately. This was a consequence of achieving results similar to the femoral approach, with the benefits of a lower rate of complications and increased comfort for the patients post procedure. Recently it has gained an additional impulse with the better prognosis obtained in acute coronary syndromes. In this trial we have evaluated if the feasibility, results and advantages related with the use of the radial artery percutaneous approach to perform catheterization procedures, continues when used in patients who have had a previous brachial artery cutdown. Out of a total of 1356 percutaneous radial accesses, 53 were in patients with previous brachial artery cutdown. Through this access 71 catheterization procedures were performed, achieving access success in 96.2% (51/53) of the punctions. Once the access success was obtained, 93.6% (44/47) of the diagnostic procedures and 100% (24/24) of the therapeutics procedures were successful. During hospitalization, in this group of patients, no major adverse cardiac events occurred and there was a 1.4% (1/71) rate of minor events. At seven days follow up, no new complications were recorded. Although this is a small group, we believe that it is enough to show that percutaneous punctions of the radial artery to perform catheterization procedures, in patients with previous brachial artery cutdown, are feasible, allowing high access and procedure success rates, with a low frequency of complications.

  2. Endophthalmitis after tooth extraction in a patient with previous perforating eye injury.

    PubMed

    Ogurel, Tevfik; Onaran, Zafer; Ogurel, Reyhan; Örnek, Kemal

    2015-01-01

    The aim of this stuty is to describe a case of endophthalmitis after tooth extraction in a patient with previous perforating eye injury. 50 years old male patient attempted to our clinic with complaints of sudden severe pain, reduced vision, light sensitivity and redness in the right eye. The patient stated that severe pain in his eye began approximately 12 hours following tooth extraction. The patient's ocular examination revealed a visual acuity of hand motion in the right eye. Anterior segment examination of the right eye showed intense conjunctival hyperemia, chemosis, a fine keraticprespitat and corneal edema. Dental procedures of the patients who had recently underwent ocular surgery or trauma should be done in a more controlled manner under anti -infective therapy or should be postponed in elective procedures. PMID:26090030

  3. Transcaval TIPS in Patients with Failed Revision of Occluded Previous TIPS

    PubMed Central

    Kim, Yong Joo; Shin, Tae Beom; Park, Hyo Yong; Kim, Tae Hun; Kang, Duk Sik

    2001-01-01

    Objective To determine the feasibility of transcaval transjugular intrahepatic portosystemic shunt (TIPS) in patients with occluded previous TIPS. Materials and Methods Between February 1996 and December 2000 we performed five transcaval TIPS procedures in four patients with recurrent gastric cardiac variceal bleeding. All four had occluded TIPS, which was between the hepatic and portal vein. The interval between initial TIPS placement and revisional procedures with transcaval TIPS varied between three and 31 months; one patient underwent transcaval TIPS twice, with a 31-month interval. After revision of the occluded shunt failed, direct cavoportal puncture at the retrohepatic segment of the IVC was attempted. Results Transcaval TIPS placement was technically successful in all cases. In three, tractography revealed slight leakage of contrast materials into hepatic subcapsular or subdiaphragmatic pericaval space. There was no evidence of propagation of extravasated contrast materials through the retroperitoneal space or spillage into the peritoneal space. After the tract was dilated by a bare stent, no patient experienced trans-stent bleeding and no serious procedure-related complications occurred. After successful shunt creation, variceal bleeding ceased in all patients. Conclusion Transcaval TIPS placement is an effective and safe alternative treatment in patients with occluded previous TIPS and no hepatic veins suitable for new TIPS. PMID:11754327

  4. Reoperative Aortic Root Replacement in Patients with Previous Aortic Root or Aortic Valve Procedures

    PubMed Central

    Chong, Byung Kwon; Jung, Sung-Ho; Choo, Suk Jung; Chung, Cheol Hyun; Lee, Jae Won; Kim, Joon Bum

    2016-01-01

    Background Generalization of standardized surgical techniques to treat aortic valve (AV) and aortic root diseases has benefited large numbers of patients. As a consequence of the proliferation of patients receiving aortic root surgeries, surgeons are more frequently challenged by reoperative aortic root procedures. The aim of this study was to evaluate the outcomes of redo-aortic root replacement (ARR). Methods We retrospectively reviewed 66 patients (36 male; mean age, 44.5±9.5 years) who underwent redo-ARR following AV or aortic root procedures between April 1995 and June 2015. Results Emergency surgeries comprised 43.9% (n=29). Indications for the redo-ARR were aneurysm (n=12), pseudoaneurysm (n=1), or dissection (n=6) of the residual native aortic sinus in 19 patients (28.8%), native AV dysfunction in 8 patients (12.1%), structural dysfunction of an implanted bioprosthetic AV in 19 patients (28.8%), and infection of previously replaced AV or proximal aortic grafts in 30 patients (45.5%). There were 3 early deaths (4.5%). During follow-up (median, 54.65 months; quartile 1–3, 17.93 to 95.71 months), there were 14 late deaths (21.2%), and 9 valve-related complications including reoperation of the aortic root in 1 patient, infective endocarditis in 3 patients, and hemorrhagic events in 5 patients. Overall survival and event-free survival rates at 5 years were 81.5%±5.1% and 76.4%±5.4%, respectively. Conclusion Despite technical challenges and a high rate of emergency conditions in patients requiring redo-ARR, early and late outcomes were acceptable in these patients. PMID:27525233

  5. Current role of endovascular therapy in Marfan patients with previous aortic surgery

    PubMed Central

    Akin, Ibrahim; Kische, Stephan; Rehders, Tim C; Chatterjee, Tushar; Schneider, Henrik; Körber, Thomas; Nienaber, Christoph A; Ince, Hüseyin

    2008-01-01

    The Marfan syndrome is a heritable disorder of the connective tissue which affects the cardiovascular, ocular, and skeletal system. The cardiovascular manifestation with aortic root dilatation, aortic valve regurgitation, and aortic dissection has a prevalence of 60% to 90% and determines the premature death of these patients. Thirty-four percent of the patients with Marfan syndrome will have serious cardiovascular complications requiring surgery in the first 10 years after diagnosis. Before aortic surgery became available, the majority of the patients died by the age of 32 years. Introduction in the aortic surgery techniques caused an increase of the 10 year survival rate up to 97%. The purpose of this article is to give an overview about the feasibility and outcome of stent-graft placement in the descending thoracic aorta in Marfan patients with previous aortic surgery. PMID:18629349

  6. Infused vincristine and adriamycin with high dose methylprednisolone (VAMP) in advanced previously treated multiple myeloma patients.

    PubMed Central

    Forgeson, G. V.; Selby, P.; Lakhani, S.; Zulian, G.; Viner, C.; Maitland, J.; McElwain, T. J.

    1988-01-01

    Forty-five patients with relapsed or refractory multiple myeloma received continuous infusions of vincristine (0.4 mg total dose daily for 4 days) and adriamycin (9 mg m-2 daily for 4 days) with a high dose of methylprednisolone (1 g m-2 i.v. or p.o. daily by 1 h infusion), the VAMP regimen. Sixteen (36%) responded, with a median duration of remission of 11 months and median survival of 20 months. Major toxicities encountered were infective and cardiovascular. Two smaller groups of myeloma patients were treated with high dose methylprednisolone (HDMP) alone, or VAMP plus weekly low dose cyclophosphamide (Cyclo-VAMP). HDMP produced short responses in 25% of patients with less toxicity than VAMP. Cyclo-VAMP was used in a highly selected group of patients who had previously responded to high dose melphalan. It was well tolerated and produced responses in 61% of this group. PMID:3207601

  7. Parotid gland pathophysiology after mixed gamma and neutron irradiation of cancer patients

    SciTech Connect

    Anderson, M.W.; Izutsu, K.T.; Rice, J.C.

    1981-11-01

    Electrolyte and protein concentrations were measured in parotid saliva samples obtained from patients receiving localized, fractionated, neutron and gamma irradiation for the treatment of cancer. Salivary sodium chloride concentration increased transiently but then usually decreased to preirradiation values after 2 weeks of therapy. There were concurrent decreases in salivary flow rate, pH, and bicarbonate concentration. The decreases in sodium chloride concentration and flow rate are inconsistent with a previously suggested, irradiation-induced ductal sodium resorption defect. The findings contribute toward understanding how salivary gland physiology is altered in irradiation injury.

  8. Rate and Amplification of Drug Resistance among Previously-Treated Patients with Tuberculosis in Kampala, Uganda

    PubMed Central

    Temple, Beth; Ayakaka, Irene; Ogwang, Sam; Nabanjja, Helen; Kayes, Susan; Nakubulwa, Susan; Worodria, William; Levin, Jonathan; Joloba, Moses; Okwera, Alphonse; Eisenach, Kathleen D.; McNerney, Ruth; Elliott, Alison M.; Smith, Peter G.; Mugerwa, Roy D.; Ellner, Jerrold J.; Jones-López, Edward C.

    2010-01-01

    Background Drug-resistant Mycobacterium tuberculosis has emerged as a global threat. In resource-constrained settings, patients with a history of tuberculosis (TB) treatment may have drug-resistant disease and may experience poor outcomes. There is a need to measure the extent of and risk factors for drug resistance in such patients. Methods From July 2003 through November 2006, we enrolled 410 previously treated patients with TB in Kampala, Uganda. We measured the prevalence of resistance to first- and second-line drugs and analyzed risk factors associated with baseline and acquired drug resistance. Results The prevalence of multidrug-resistant TB was 12.7% (95% confidence interval [95% CI], 9.6%–16.3%). Resistance to second-line drugs was low. Factors associated with multidrug-resistant TB at enrollment included a history of treatment failure (odds ratio, 23.6; 95% CI, 7.7–72.4), multiple previous TB episodes (odds ratio, 15.6; 95% CI, 5.0–49.1), and cavities present on chest radiograph (odds ratio, 5.9; 95% CI, 1.2–29.5). Among a cohort of 250 patients, 5.2% (95% CI, 2.8%–8.7%) were infected with M. tuberculosis that developed additional drug resistance. Amplification of drug resistance was associated with existing drug resistance at baseline (P<.01) and delayed sputum culture conversion (P<.01). Conclusions The burden of drug resistance in previously treated patients with TB in Uganda is sizeable, and the risk of generating additional drug resistance is significant. There is an urgent need to improve the treatment for such patients in low-income countries. PMID:18808360

  9. Improved cycle outcomes after laparoscopic ovarian diathermy in hyper-responder patients with previous ART failure.

    PubMed

    Pabuccu, Recai; Pabuccu, Emre Goksan; Gursoy, Asli Yarci; Caglar, Gamze Sinem; Yilmaz, Muserref Banu; Ozdegirmenci, Ozlem

    2014-01-01

    Excessive response to ovarian stimulation is common among hyper-responder patients undergoing assisted reproductive technology (ART). Cycle cancellations and severe ovarian hyperstimulation syndrome (OHSS) are all detrimental consequences observed within this cohort and several approaches have been proposed to enhance outcomes. The current study is designed to evaluate whether laparoscopic ovarian diathermy (LOD) improves ART outcomes and pregnancy rates by reducing Anti-mullerian hormone (AMH) levels in a group of patients who had a history of recurrent ART failure and high response. A total of 40 hyper-responder patients with history of previous ART failure were included. Group I consisted of 22 patients that underwent LOD prior to ART. Group II consisted of 18 patients that underwent only ART. Cycle outcomes of groups were compared. Following LOD, significant reduction in AMH levels were detected in group I (4.75 ng/mL to 2.25 ng/mL). Clinical pregnancies were similar among groups (40% versus 27.8% p = 0.65). There was no cycle cancellation in Group I, whereas there were three cycle cancellations observed due to OHSS in Group II. Our results indicate that LOD might offer enhanced fertility outcomes and may reduce the likelihood of cycle cancellations in hyper-responders with previous ART failures.

  10. Inguinal endometriosis in a patient without a previous history of gynecologic surgery

    PubMed Central

    Kim, Da Hee; Kim, Min Jung; Park, Jong Taek; Lee, Ji Hyun

    2014-01-01

    Endometriosis, defined as growth of endometrial stroma and glands outside the uterine cavity, is a chronic and recurrent disease that affects patients' quality of life. Ectopic endometrial tissue can proliferate at any location in the body, but the pelvic organs and peritoneum are the most frequent implantation sites. Among extrapelvic endometriosis, inguinal endometriosis is a very rare gynecologic condition usually associated with previous pelvic surgery. Endometriosis should be preoperatively distinguished from other inguinal masses using computed tomography, magnetic resonance imaging, or ultrasonography. Here, we report a case of right inguinal endometriosis in a patient with no previous history of gynecologic surgery; in addition, we have provided a brief review of relevant literature. PMID:24678494

  11. Dubowitz syndrome: review of 141 cases including 36 previously unreported patients.

    PubMed

    Tsukahara, M; Opitz, J M

    1996-05-01

    We review clinical information on 141 individuals with Dubowitz syndrome, 105 reported since 1965, and 36 previously unreported. We define the Dubowitz syndrome phenotype on the basis of clinical descriptions. The facial appearance is characteristic and present in most patients with Dubowitz syndrome. The phenotypic spectrum is quite variable and ranges from normal growth and head circumference with mild psychomotor retardation and lack of eczema to a condition of severe growth retardation, mental retardation, microcephaly, and eczema. Overall, the condition may involve the cutaneous, ocular, dental, digestive, musculoskeletal, urogenital, cardiovascular, neurological, hematological, and immune systems. Characteristic behavior patterns which have not been cited previously are present in our cases; most patients are hyperactive, shy, hate crowds, and like music, rhythm, and vibrations from music speakers, tape recorders, or transmitted through floors. Dubowitz syndrome is an autosomal recessive disorder with possibly increased frequency of parental consanguinity. Heterogeneity cannot be excluded at this time. PMID:8723121

  12. Automatic treatment planning implementation using a database of previously treated patients

    NASA Astrophysics Data System (ADS)

    Moore, J. A.; Evans, K.; Yang, W.; Herman, J.; McNutt, T.

    2014-03-01

    Purpose: Using a database of prior treated patients, it is possible to predict the dose to critical structures for future patients. Automatic treatment planning speeds the planning process by generating a good initial plan from predicted dose values. Methods: A SQL relational database of previously approved treatment plans is populated via an automated export from Pinnacle3. This script outputs dose and machine information and selected Regions of Interests as well as its associated Dose-Volume Histogram (DVH) and Overlap Volume Histograms (OVHs) with respect to the target structures. Toxicity information is exported from Mosaiq and added to the database for each patient. The SQL query is designed to ask the system for the lowest achievable dose for a specified region of interest (ROI) for each patient with a given volume of that ROI being as close or closer to the target than the current patient. Results: The additional time needed to calculate OVHs is approximately 1.5 minutes for a typical patient. Database lookup of planning objectives takes approximately 4 seconds. The combined additional time is less than that of a typical single plan optimization (2.5 mins). Conclusions: An automatic treatment planning interface has been successfully used by dosimetrists to quickly produce a number of SBRT pancreas treatment plans. The database can be used to compare dose to individual structures with the toxicity experienced and predict toxicities before planning for future patients.

  13. Ofatumumab-based chemoimmunotherapy is effective and well tolerated in patients with previously untreated CLL

    PubMed Central

    Shanafelt, Tait; Lanasa, Mark C.; Call, Timothy G; Beaven, Anne W.; Leis, Jose F.; LaPlant, Betsy; Bowen, Deborah; Conte, Michael; Jelinek, Diane F.; Hanson, Curtis A.; Kay, Neil E.; Zent, Clive S.

    2013-01-01

    Purpose Although rituximab-based chemoimmunotherapy (CIT) has substantially improved clinical outcomes in chronic lymphocytic leukemia (CLL), only 40-50% of patients achieve a complete remission (CR). There remains interest in identifying new approaches to improve the effectiveness of CIT. Ofatumumab is a fully human anti-CD20 monoclonal antibody with greater apparent single agent activity than rituximab in CLL patients. Methods Previously untreated CLL patients in need of therapy received 6 cycles of CIT induction with pentostatin, cyclophosphamide and ofatumumab (PCO) followed by response assessment. Results Of the 48 patients enrolled, 77% completed PCO induction. Adverse events during induction included grade 3+ hematologic toxicity (27%) and grade 3+ non-hematologic toxicity (23%). Median CD4 count post induction and 6 months later were 186 ×106/L and 272 ×106/L. The overall response rate was 96% (46/48) and the CR rate was 46% (22/48). Among the 38 patients who underwent minimal residual disease (MRD) evaluation, 7 (18%) were MRD negative. After median follow-up of 24 months, 10 (21%) patients have progressed and 8 (17%) have required retreatment. The efficacy and toxicity of ofatumumab-based CIT compare favorably to our historical trials of rituximab-based CIT using an identical chemotherapy backbone (n=64). Time to retreatment also appeared longer for ofatumumab-based CIT (free of retreatment at 24 months: 86% [95%CI: 75-99] vs 68% [95% CI: 56-81]). Conclusion Ofatumumab-based CIT is well tolerated in patients with previously untreated CLL. The efficacy of ofatumumab-based CIT compares favorably to historical trials of rituximab-based CIT suggesting randomized trials comparing ofatumumab-based CIT and rituximab-based CIT should be considered. PMID:23922059

  14. Among a German Sample of Forensic Patients, Previous Animal Abuse Mediates Between Psychopathy and Sadistic Actions.

    PubMed

    Stupperich, Alexandra; Strack, Micha

    2016-05-01

    In an attempt to explain the relationship between psychopathy and severe violent behavior, this study associates previous animal abuse, psychopathy, and sadistic acting in forensic patients. Two topics are addressed: (i) whether previous animal abuse can be identified by a patient's Psychopathy Checklist profile and (ii) whether animal abuse statistically mediates between psychopathy and sadistic acting. In a German forensic hospital, 60 patients were investigated. Animal abuse was assessed using face-to-face interviews and the Psychopathy Checklist: Screening Version (PCL:SV), and sadistic acting was identified by file records.Discriminant analysis separated previous animal abuse (10/60) by high adolescent antisocial behavior, superficiality, lack of remorse, lack of empathy, and grandiosity. The mediation from psychopathy to sadistic acting (6/60) through animal abuse was found to be complete.The results, although sample size is limited and base rate of animal abuse and sadistic acting are low, fit with a model suggestive of animal abuse as a causal step toward sadistic crimes. Animal abuse correlates with callous, unemotional traits, and a development of sadistic crimes. PMID:27122409

  15. Among a German Sample of Forensic Patients, Previous Animal Abuse Mediates Between Psychopathy and Sadistic Actions.

    PubMed

    Stupperich, Alexandra; Strack, Micha

    2016-05-01

    In an attempt to explain the relationship between psychopathy and severe violent behavior, this study associates previous animal abuse, psychopathy, and sadistic acting in forensic patients. Two topics are addressed: (i) whether previous animal abuse can be identified by a patient's Psychopathy Checklist profile and (ii) whether animal abuse statistically mediates between psychopathy and sadistic acting. In a German forensic hospital, 60 patients were investigated. Animal abuse was assessed using face-to-face interviews and the Psychopathy Checklist: Screening Version (PCL:SV), and sadistic acting was identified by file records.Discriminant analysis separated previous animal abuse (10/60) by high adolescent antisocial behavior, superficiality, lack of remorse, lack of empathy, and grandiosity. The mediation from psychopathy to sadistic acting (6/60) through animal abuse was found to be complete.The results, although sample size is limited and base rate of animal abuse and sadistic acting are low, fit with a model suggestive of animal abuse as a causal step toward sadistic crimes. Animal abuse correlates with callous, unemotional traits, and a development of sadistic crimes.

  16. Induction treatment of previously undiagnosed ANCA-associated vasculitis in a renal transplant patient with Rituximab

    PubMed Central

    Graham-Brown, M. P. M.; Aljayyousi, R.; Baines, R. J.; Burton, J. O.; Brunskill, N. J.; Furness, P.; Topham, P.

    2016-01-01

    We report the case of a 40-year-old female transplant patient with undiagnosed ANCA-associated vasculitis (AAV) and renal allograft dysfunction who achieved disease remission with restoration of transplant function following induction therapy with rituximab. There are currently no trial data looking at the use of rituximab for induction of remission of renal transplant patients with AAV. Although recurrence of AAV following renal transplantation is rare, such patients have invariably had multiple previous exposures to induction and maintenance immunosuppressive regimens, often limiting treatment options post-transplantation. In this case, rituximab was well tolerated with no side effects, and was successful in salvaging transplant function. Optimal treatment regimens for relapsed AAV in the transplant population are not known, and clinical trials are needed to evaluate the efficacy and safety of rituximab at inducing and maintaining disease remission in relapsed AAV following transplantation. PMID:27699052

  17. Induction treatment of previously undiagnosed ANCA-associated vasculitis in a renal transplant patient with Rituximab

    PubMed Central

    Graham-Brown, M. P. M.; Aljayyousi, R.; Baines, R. J.; Burton, J. O.; Brunskill, N. J.; Furness, P.; Topham, P.

    2016-01-01

    We report the case of a 40-year-old female transplant patient with undiagnosed ANCA-associated vasculitis (AAV) and renal allograft dysfunction who achieved disease remission with restoration of transplant function following induction therapy with rituximab. There are currently no trial data looking at the use of rituximab for induction of remission of renal transplant patients with AAV. Although recurrence of AAV following renal transplantation is rare, such patients have invariably had multiple previous exposures to induction and maintenance immunosuppressive regimens, often limiting treatment options post-transplantation. In this case, rituximab was well tolerated with no side effects, and was successful in salvaging transplant function. Optimal treatment regimens for relapsed AAV in the transplant population are not known, and clinical trials are needed to evaluate the efficacy and safety of rituximab at inducing and maintaining disease remission in relapsed AAV following transplantation.

  18. Production of tumour necrosis factor and interleukin 1 by monocytes of patients with previous Yersinia arthritis.

    PubMed Central

    Repo, H; Jäättelä, M; Leirisalo-Repo, M; Hurme, M

    1988-01-01

    We studied production of tumour necrosis factor (TNF) and interleukin 1 (IL-1) by using purified peripheral blood monocytes of patients with previous yersinia arthritis (YA) and of healthy HLA-B27 positive and negative controls. Lipopolysaccharide-exposed cells of HLA-B27 positive and negative patients, and those of HLA-B27 positive controls, generated significantly more TNF than did HLA-B27 negative control cells. There was a positive correlation between the levels of TNF and IL-1. Our results give credence to the view that augmented production of phlogistic mediators may contribute to inflammatory symptoms in patients with HLA-B27 associated disease. PMID:3262459

  19. Previous PICC Placement May Be Associated With Catheter-Related Infections in Hemodialysis Patients

    SciTech Connect

    Butler, Philip J. Sood, Shreya; Mojibian, Hamid; Tal, Michael G.

    2011-02-15

    Background: Catheter-related infections (CRIs) are a significant source of morbidity and mortality in hemodialysis patients. The identification of novel, modifiable risk factors for CRIs may lead to improved outcomes in this population. Peripherally inserted central catheters (PICCs) have been hypothesized to compromise vascular access due to vascular damage and venous thrombosis, whereas venous thrombosis has been linked to the development of CRIs. Here we examine the association between PICC placement and CRIs. Methods: A retrospective review was performed of all chronic hemodialysis catheter placements and exchanges performed at a large university hospital from September 2003 to September 2008. History of PICC line use was determined by examining hospital radiologic records from December 1993 to September 2008. Catheter-related complications were assessed and correlated with PICC line history. Results: One hundred eighty-five patients with 713 chronic tunneled hemodialysis catheter placements were identified. Thirty-eight of those patients (20.5%) had a history of PICC placement; these patients were more likely to have CRIs (odds ratio = 2.46, 95% confidence interval = 1.71-3.53, p < .001) compared with patients without a history of PICC placement. There was no difference between the two groups in age or number of catheters placed. Conclusion: Previous PICC placement may be associated with catheter-related infections in hemodialysis patients.

  20. Tooth discoloration in patients with neonatal diabetes after transfer onto glibenclamide: a previously unreported side effect.

    PubMed

    Kumaraguru, Janani; Flanagan, Sarah E; Greeley, Siri Atma W; Nuboer, Roos; Støy, Julie; Philipson, Louis H; Hattersley, Andrew T; Rubio-Cabezas, Oscar

    2009-08-01

    OBJECTIVE To assess if tooth discoloration is a novel side effect of sulfonylurea therapy in patients with permanent neonatal diabetes due to mutations in KCNJ11. RESEARCH DESIGN AND METHODS A total of 67 patients with a known KCNJ11 mutation who had been successfully transferred from insulin injections onto oral sulfonylureas were contacted and asked about the development of tooth discoloration after transfer. RESULTS Altered tooth appearance was identified in 5 of the 67 patients. This was variable in severity, ranging from mild discoloration/staining (n = 4) to loss of enamel (n = 1) and was only seen in patients taking glibenclamide (glyburide). CONCLUSIONS These previously unreported side effects may relate to the developing tooth and/or to the high local concentrations in the children who frequently chewed glibenclamide tablets or took it as a concentrated solution. Given the multiple benefits of sulfonylurea treatment for patients with activating KCNJ11 mutations, this association warrants further investigation but should not preclude such treatment. PMID:19435956

  1. Detection of mumps virus genotype H in two previously vaccinated patients from Mexico City.

    PubMed

    Del Valle, Alberto; García, Alí A; Barrón, Blanca L

    2016-06-01

    Infections caused by mumps virus (MuV) have been successfully prevented through vaccination; however, in recent years, an increasing number of mumps outbreaks have been reported within vaccinated populations. In this study, MuV was genotyped for the first time in Mexico. Saliva samples were obtained from two previously vaccinated patients in Mexico City who had developed parotitis. Viral isolation was carried out in Vero cells, and the SH and HN genes were amplified by RT-PCR. Amplicons were sequenced and compared to a set of reference sequences to identify the MuV genotype. PMID:26935913

  2. Safety of {sup 90}Y Radioembolization in Patients Who Have Undergone Previous External Beam Radiation Therapy

    SciTech Connect

    Lam, Marnix G.E.H.; Abdelmaksoud, Mohamed H.K.; Chang, Daniel T.; Eclov, Neville C.; Chung, Melody P.; Koong, Albert C.; Louie, John D.; Sze, Daniel Y.

    2013-10-01

    Purpose: Previous external beam radiation therapy (EBRT) is theoretically contraindicated for yttrium-90 ({sup 90}Y) radioembolization (RE) because the liver has a lifetime tolerance to radiation before becoming vulnerable to radiation-induced liver disease. We analyzed the safety of RE as salvage treatment in patients who had previously undergone EBRT. Methods and Materials: Between June 2004 and December 2010, a total of 31 patients who had previously undergone EBRT were treated with RE. Three-dimensional treatment planning with dose–volume histogram (DVH) analysis of the liver was used to calculate the EBRT liver dose. Liver-related toxicities including RE-induced liver disease (REILD) were reviewed and classified according to Common Terminology Criteria for Adverse Events version 4.02. Results: The mean EBRT and RE liver doses were 4.40 Gy (range, 0-23.13 Gy) and 57.9 Gy (range, 27.0-125.9 Gy), respectively. Patients who experienced hepatotoxicity (≥grade2; n=12) had higher EBRT mean liver doses (7.96 ± 8.55 Gy vs 1.62 ± 3.39 Gy; P=.037), the only independent predictor in multivariate analysis. DVH analysis showed that the fraction of liver exposed to ≥30 Gy (V30) was the strongest predictor of hepatotoxicity (10.14% ± 12.75% vs 0.84% ± 3.24%; P=.006). All patients with V30 >13% experienced hepatotoxicity. Fatal REILD (n=2) occurred at the 2 highest EBRT mean liver doses (20.9 Gy and 23.1 Gy) but also at the highest cumulative liver doses (91.8 Gy and 149 Gy). Conclusions: Prior exposure of the liver to EBRT may lead to increased liver toxicity after RE treatment, depending on fractional liver exposure and dose level. The V30 was the strongest predictor of toxicity. RE appears to be safe for the treatment of hepatic malignancies only in patients who have had limited hepatic exposure to prior EBRT.

  3. Mitoxantrone and cytosine arabinoside in previously untreated adult patients with acute non-lymphocytic leukemia.

    PubMed

    Osman, I; Akin, U; Ismet, A; Meral, B; Hamdi, A; Haluk, K

    1996-01-01

    Twenty-five adult patients with previously untreated acute non-lymphocytic leukemia (ANLL) were treated with mitoxantrone (Mto) 12 mg/m2 daily by 30 minutes intravenous (IV) infusion for 3 days and cytosine arabinoside (Ara-C) 200 mg/m2 daily by continuous infusion for 7 days, as an induction therapy. After complete remission (CR) was observed, they were given two more courses of consolidation therapy which was as Mto 12 mg/m2 daily by 30 minutes IV infusion for one day, and Ara-C 200 mg/m2 daily by 30 minutes IV infusion for 5 days. CR was obtained in 18 of 25 patients (72%). Median remission duration was 294 days and length of survival was 366 days. 11 patients (44%) are still in remission. Myelosupression developed in all patients following induction therapy, but it was not observed after consolidation therapies. Non-hematological side-effects consisted of nausea, vomiting, alopecia, stomatitis, and transient elevation in liver enzymes. Our therapeutic responses are similar to those obtained by others. PMID:14651226

  4. Does Previous Abdominal Surgery Alter the Outcome of Pediatric Patients Subjected to Orthotopic Liver Transplantation?

    PubMed Central

    CUERVAS-MONS, VALENTIN; RIMOLA, ANTONI; VAN THIEL, DAVID H.; GAVALER, JUDITH S.; SCHADE, ROBERT R.; STARZL, THOMAS E.

    2010-01-01

    The medical, anesthesia, and surgical records of 89 consecutive pediatric patients who underwent an orthotopic hepatic transplantation procedure at the University of Pittsburgh from February 1981 to May 1984 were reviewed to evaluate the effect of prior abdominal surgery upon the morbidity and mortality of orthotopic liver transplantation in children. Fifty-seven children (group 1) had had prior abdominal surgery, whereas 32 (group 2) had not. The group 1 subjects were younger (p < 0.001), had better prothrombin times (p < 0.01), and better platelet counts (p < 0.02) than did those in group 2. No difference in the duration of anesthesia or intra-operative use of fresh frozen plasma or platelets was evident between the two groups. However, group 1 patients were given more red blood cells intraoperatively than were the group 2 patients (p < 0.01). The group 1 patients had more total postoperative infections (p < 0.05), which was due solely to a greater number of abdominal infections (p < 0.05), but similar total hospital and intensive care unit stays as did the group 2 patients. When those in group 1 were divided into those having a previous Kasai procedure versus those who did not, no differences between the two groups were apparent except for age. Based upon these data, we conclude that prior abdominal surgery does not affect mortality, the duration of hospital or intensive care unit stay, plasma or platelet requirements, and total anesthesia time required for orthotopic liver transplantation, but does enhance the number of red blood cell transfusions and infections, particularly abdominal infections, in children undergoing this procedure. PMID:3512356

  5. Effects of morphine on left ventricular dimensions and function in patients with previous myocardial infarction.

    PubMed

    Ryan, W F; Henning, H; Karliner, J S

    1979-12-01

    To assess the effects of morphine sulfate on left ventricular function and dimensions we administered 15 mg of this agent to 11 stable patients with previous transmural myocardial infarction. All studies were carried out in the supine position. Before morphine administration an echocardiogram was obtained, and this procedure was repeated at 15, 30, 60, 120, and 240 min after morphine. Heart rate decreased from a control value of 69 +/- 4 to 62 +/- 5 beats/min 2 h after morphine (p less than 0.01, analysis of variance); this slower heart rate persisted for 4 h after morphine. Serial measurements of blood pressure, echocardiographic ejection fraction, percent of fractional shortening, and mean normalized velocity of circumferential fiber shortening also showed no significant alterations after morphine. We conclude that in stable patients with chronic ischemic heart disease studied in the supine position, 1) morphine exerts no effect on left ventricular dimensions, an observation which does not support the concept that this agent acts in humans by producing a 'pharmacologic phlebotomy'; and 2) morphine does not alter left ventricular function at rest. Whether different results will be found in patients with increased sympathetic activity, such as occurs in the setting of an acute myocardial infarction or during an episode of acute pulmonary edema, remains to be investigated.

  6. Improved prediction of inhibitor development in previously untreated patients with severe haemophilia A.

    PubMed

    Hashemi, S M; Fischer, K; Moons, K G M; van den Berg, H M

    2015-03-01

    Treatment of previously untreated patients (PUPs) with severe haemophilia A is complicated by the formation of inhibitors. Prediction of PUPs with high risk is important to allow altering treatment with the intention to reduce the occurrence of inhibitors. An unselected multicentre cohort of 825 PUPs with severe haemophilia A (FVIII<0.01 IU mL(-1) ) was used. Patients were followed until 50 exposure days (EDs) or inhibitor development. All predictors of the existing prediction model including three new potential predictors were studied using multivariable logistic regression. Model performance was quantified [area under the curve (AUC), calibration plot] and internal validation (bootstrapping) was performed. A nomogram for clinical application was developed. Of the 825 patients, 225 (28%) developed inhibitors. The predictors family history of inhibitors, F8 gene mutation and an interaction variable of dose and number of EDs of intensive treatment were independently associated with inhibitor development. Age and reason for first treatment were not associated with inhibitor development. The AUC was 0.69 (95% CI 0.65-0.72) and calibration was good. An improved prediction model for inhibitor development and a nomogram for clinical use were developed in a cohort of 825 PUPs with severe haemophilia A. Clinical applicability was improved by combining dose and duration of intensive treatment, allowing the assessment of the effects of treatment decisions on inhibitor risk and potentially modify treatment.

  7. Reconstruction of mandibular defects in irradiated patients

    SciTech Connect

    Klotch, D.W.; Gump, J.; Kuhn, L. )

    1990-10-01

    In this prospective study, mandibular reconstruction using titanium plates was evaluated in 31 patients treated between July 1988 and January 1990. Sixteen patients had prior surgery; 13 had prior radiotherapy. In 11 patients, prior radiation and surgery had failed. Sixteen patients received postoperative radiotherapy either in standard or accelerated fractions. Twelve patients had complications of either intraoral (8), extraoral (5), or combined (1) plate exposure or fistula formation (2). Factors significantly related to complications were poor nutrition, accelerated radiation, and recurrence. Sixty-one percent of all patients healed uneventfully. When patients with complications secondary to recurrence who subsequently died were excluded, the success rate was 73%. Only one patient had an unacceptable result that produced a cosmetic and functional deformity despite secondary repair.

  8. Effects of irradiation on alaryngeal voice of totally laryngectomized patients

    SciTech Connect

    Izdebski, K.; Fontanesi, J.; Ross, J.C.; Hetzler, D.

    1988-06-01

    The effects of radiation therapy on the ability of totally laryngectomized patients to produce voice and speech were examined using objective non-invasive methods. Moderate to severe losses were noted in patients producing voice with all types of alaryngeal modalities: tracheoesophageal, esophageal, and electrolaryngeal. Voice and speech losses were related to the impaired motility and vibratory capability of the esophageal wall and mucosa, to fibrosis of the submandibular region and to trismus. Tracheoesophageal and esophageal voice was recovered some weeks after completion of irradiation. No voice losses were observed in alaryngeal speakers who did not undergo voice restoration until after irradiation. All irradiated patients also showed various degrees of dysphagia during the treatment.

  9. Robotic Left Ventricular Assist Device Implantation Using Left Thoracotomy Approach in Patients with Previous Sternotomies.

    PubMed

    Khalpey, Zain; Bin Riaz, Irbaz; Marsh, Katherine M; Ansari, Muhammad Zubair Ahmad; Bilal, Jawad; Cooper, Anthony; Paidy, Samata; Schmitto, Jan D; Smith, Richard; Friedman, Mark; Slepian, Marvin J; Poston, Robert

    2015-01-01

    Left ventricular assist devices (LVADs) are commonly used as either a bridge-to-transplant or a destination therapy. The traditional approach for LVAD implantation is via median sternotomy, but many candidates for this procedure have a history of failed cardiac surgeries and previous sternotomy. Redo sternotomy increases the risk of heart surgery, particularly in the setting of advanced heart failure. Robotics facilitates a less invasive approach to LVAD implantation that circumvents some of the morbidity associated with a redo sternotomy. We compared the outcomes of all patients at our institution who underwent LVAD implantation via either a traditional sternotomy or using robotic assistance. The robotic cohort showed reduced resource utilization including length of hospital stay and use of blood products. As the appropriate candidates become elucidated, robotic assistance may improve the safety and cost-effectiveness of reoperative LVAD surgery. PMID:25914953

  10. A meta-analysis and systematic review of thalidomide for patients with previously untreated multiple myeloma.

    PubMed

    Hicks, Lisa K; Haynes, Adam E; Reece, Donna E; Walker, Irwin R; Herst, Jordan A; Meyer, Ralph M; Imrie, Kevin

    2008-08-01

    A systematic review and meta-analysis was performed to determine the efficacy and toxicity of thalidomide in previously untreated patients with myeloma. Medline, Embase, Cochrane Controlled Trials Register, and abstracts from the American Society of Hematology and the American Society of Clinical Oncology were searched for randomized controlled trials (RCTs) of either induction or maintenance thalidomide in adults with previously untreated myeloma. Nine RCTs of induction thalidomide, three RCTs of maintenance thalidomide, and one RCT of induction and maintenance thalidomide were identified, involving a total of 4144 subjects. When thalidomide was added to standard, non-transplantation myeloma therapy, overall survival (OS) improved (HR 0.67; 95% CI 0.56-0.81). When thalidomide was given as maintenance following autologous transplantation (ASCT), there was a trend to improved OS (HR 0.61, 95% CI 0.37-1.01); when the only trial which combined induction and maintenance thalidomide was excluded from this analysis, a significant survival advantage emerged (HR 0.49, 95% CI 0.32-0.74). The relative risk of venous thromboembolism (VTE) with induction thalidomide was 2.56 (95% CI 1.88-3.49). A meta-analysis of trials/sub-groups administering low molecular weight heparin (LMWH) as VTE prophylaxis, suggested a persistently increased relative risk of VTE with induction thalidomide (RR 1.54, 95% CI 1.07-2.22). The relative risk of VTE was substantially lower, but still elevated, when thalidomide was given as maintenance therapy following ASCT (RR 1.95, 95% CI 1.15-3.30). In summary, thalidomide appears to improve the overall survival of patients with newly diagnosed myeloma both when it is added to standard, non-transplantation therapy, and when it is given as maintenance therapy following ASCT. However, thalidomide is associated with toxicity, particularly a significantly increased risk of VTE.

  11. Enhanced mucosal reactions in AIDS patients receiving oropharyngeal irradiation

    SciTech Connect

    Watkins, E.B.; Findlay, P.; Gelmann, E.; Lane, H.C.; Zabell, A.

    1987-09-01

    The oropharynx and hypopharynx are common sites of involvement in AIDS patients with mucocutaneous Kaposi's sarcoma. The radiotherapist is often asked to intervene with these patients due to problems with pain, difficulty in swallowing, or impending airway obstruction. We have noted an unexpected decrease in normal tissue tolerance of the oropharyngeal mucosa to irradiation in AIDS patients treated in our department. Data on 12 patients with AIDS and Kaposi's sarcoma receiving oropharyngeal irradiation are presented here. Doses ranged from 1000 cGy to 1800 cGy delivered in 150-300 cGy fractions. Seven of eight patients receiving doses of 1200 cGy or more developed some degree of mucositis, four of these developed mucositis severe enough to require termination of treatment. All patients in this study received some form of systemic therapy during the course of their disease, but no influence on mucosal response to irradiation was noted. Four patients received total body skin electron treatments, but no effect on degree of mucositis was seen. Presence or absence of oral candidiasis was not an obvious factor in the radiation response of the oral mucosa in these patients. T4 counts were done on 9 of the 12 patients. Although the timing of the T4 counts was quite variable, no correlation with immune status and degree of mucositis was found. The degree of mucositis seen in these patients occurred at doses much lower than expected based on normal tissue tolerances seen in other patient populations receiving head and neck irradiations. We believe that the ability of the oral mucosa to repair radiation damage is somehow altered in patients with AIDS.

  12. Risk of oesophageal cancer among patients previously hospitalised with eating disorder

    PubMed Central

    Brewster, David H.; Nowell, Siân L.; Clark, David N.

    2015-01-01

    Background It has been suggested that the risk of oesophageal adenocarcinoma might be increased in patients with a history of eating disorders due to acidic damage to oesophageal mucosa caused by self-induced vomiting practiced as a method of weight control. Eating disorders have also been associated with risk factors for squamous cell carcinoma of the oesophagus, including alcohol use disorders, as well as smoking and nutritional deficiencies, which have been associated with both main sub-types of oesophageal cancer. There have been several case reports of oesophageal cancer (both main sub-types) arising in patients with a history of eating disorders. Methods We used linked records of hospitalisation, cancer registration and mortality in Scotland spanning 1981–2012 to investigate the risk of oesophageal cancer among patients with a prior history of hospitalisation with eating disorder. The cohort was restricted to patients aged ≥10 years and <60 years at the date of first admission with eating disorder. Disregarding the first year of follow-up, we calculated indirectly standardised incidence ratios using the general population as the reference group to generate expected numbers of cases (based on age-, sex-, socio-economic deprivation category-, and calendar period-specific rates of disease). Results After exclusions, the cohort consisted of 3617 individuals contributing 52,455 person-years at risk. The median duration of follow-up was 13.9 years. Seven oesophageal cancers were identified, as compared with 1.14 expected, yielding a standardised incidence ratio of 6.1 (95% confidence interval: 2.5–12.6). All were squamous cell carcinomas arising in females with a prior history of anorexia nervosa. Conclusions Patients hospitalised previously with eating disorders are at increased risk of developing oesophageal cancer. Confounding by established risk factors (alcohol, smoking, and nutritional deficiency) seems a more likely explanation than acidic damage

  13. The quality of voice in patients irradiated for laryngeal carcinoma

    SciTech Connect

    Karim, A.B.; Snow, G.B.; Siek, H.T.; Njo, K.H.

    1983-01-01

    Data from 150 patients with laryngeal carcinoma, consecutively treated primarily by radiotherapy from 1965 through 1974 was analyzed to assess the quality of voice. The voice appears to improve in majority of the successfully irradiated patients. In 76% of the evaluable patients in this group, the quality of voice appears to have attained normalcy or near normalcy. Smoking appears to have a negative influence. High incidence of bronchogenic carcinoma along with the negative influence of smoking on the quality of voice in this series of patients indicate that the patients should be advised against smoking in day-to-day clinical practice.

  14. Dementia Risk in Irradiated Patients With Head and Neck Cancer

    PubMed Central

    Chen, Jin-Hua; Yen, Yu-Chun; Liu, Shing-Hwa; Lee, Fei-Peng; Lin, Kuan-Chou; Lai, Ming-Tang; Wu, Chia-Che; Chen, Tsung-Ming; Yuan, Sheng-Po; Chang, Chia-Lun; Wu, Szu-Yuan

    2015-01-01

    Abstract Patients with head and neck cancer are treated through surgery, radiotherapy (RT), and chemotherapy (CT). Carotid artery damage and neurotoxicity were previously observed in these patients. This study estimated the dementia risk associated with different treatment modalities in a head and neck cancer population with long-term follow-up. Taiwan's National Health Insurance claims database and a cancer registry database from the Collaboration Center of Health Information Application were linked for the present analysis. Patients with head and neck cancer, treated from January 1, 2002 to December 31, 2010, were included in the study. The follow-up duration was the period from the index date to December 31, 2012. Inclusion criteria were head and neck cancer; an age >20 years; and having undergone surgery, CT, concurrent CT, or surgery with adjuvant treatment. Exclusion criteria were another cancer diagnosed before the head and neck cancer, death or being diagnosed with dementia within 2 years after the treatment of the head and neck cancer, stroke before the index date, distant metastasis, in situ carcinoma, sarcoma, head and neck cancer recurrence, an unknown sex, and an age <20 years. In total, 20,135 patients were included. In patient groups that underwent surgery alone, surgery and adjuvant chemoradiotherapy, and chemoradiotherapy alone, the dementia incidence per 1000 person-years was 1.44, 1.04, and 1.98, respectively. The crude hazard ratio (HR) of dementia was 1.84 (95% confidence interval [CI] 1.21–2.81) in the RT with or without CT group. After adjustment for age, sex, clinical stage, and comorbidity, the HR was 1.92 (95% CI 1.14–3.24). Examining the dementia risk in patients who received different treatment modalities according to the Cox proportional-hazard model revealed that an age >65 years and having undergone RT with or without CT were risk factors (P < 0.001 and P = 0.015; and HRs of 16.5 and 1.92, respectively). The dementia risk

  15. Timing of retreatment for patients with previously coiled or clipped intracranial aneurysms: Analysis of 156 patients with multiple treatments

    PubMed Central

    Okada, Takeshi; Ishikawa, Tatsuya; Moroi, Junta; Suzuki, Akifumi

    2016-01-01

    Background: Some patients require a second surgical intervention for recurrence of treated aneurysms, untreated aneurysms in patients with multiple lesions, or de novo aneurysm. This retrospective review of the data was undertaken to evaluate when retreatment is necessary after initial aneurysm treatment. Methods: Cerebral aneurysms in 1755 patients were treated via clipping or coiling between January 1995 and September 2012. Postoperative follow-up was performed at 6 months after treatment and was repeated every 12 months (or longer) after treatment using three-dimensional computed tomography angiography or magnetic resonance angiography. Results: A cumulative total of 156 patients (8.9%) (117 women, 39 men; mean age: 55.0 years; range: 25–79 years) needed retreatment for rupture or regrowth of aneurysm (n = 31; ruptured (R)/remaining unruptured (U), 26/5), formation of de novo aneurysm (n = 45; R/U, 23/22), known untreated aneurysm in patients with multiple lesions (n = 78; R/U, 5/73), and hemorrhage from undetected aneurysm (n = 2). The regrowth risk is higher after endovascular treatment than after craniotomy and clipping. Median time to retreatment was 187 months (range: 11–280 months) for regrowth, 165 months (range: 22–330 months) for de novo, and 24 months (range: 2.8–417 months) for known untreated aneurysm. Regrowth or known with subarachnoid hemorrhage were frequently treated within 2 years from initial treatment. Conclusions: Aneurysms with residua or untreated aneurysms in patients with multiple lesions carry a risk of bleeding during a relatively short period, whereas there is a small but significant risk of de novo formation and subsequent hemorrhage at over 10 years after previous treatment. PMID:26862460

  16. Tuberculosis and pulmonary candidiasis co-infection present in a previously healthy patient

    PubMed Central

    Jiménez Borré, Gustavo; Gómez Camargo, Doris; Chalavé Jiménez, Neylor; Bellido Rodríguez, Javier; Cuadrado Cano, Bernarda; Navarro Gómez, Shirley

    2016-01-01

    Background: The coexistance among fungal pathogens and tuberculosis pulmonary is a clinical condition that generally occurs in immunosuppressive patients, however, immunocompetent patients may have this condition less frequently. Objective: We report the case of an immunocompetent patient diagnosed with coinfection Mycobacterium tuberculosis and Candida albicans. Case Description: A female patient, who is a 22-years old, with fever and a new onset of hemoptysis. Clinical findings and diagnosis: Diminished vesicular breath sounds in the apical region and basal crackling rales in the left lung base were found in the physical examination. Microbiological tests include: chest radiography and CAT scan pictograms in high resolution, Ziehl-Neelsen stain, growth medium for fungus and mycobacteria through Sabouraudís agar method with D-glucose. Medical examinations showed Candida albicans fungus and Mycobacterium tuberculosis present in the patient. Treatment and Outcome: Patient was treated with anti-tuberculosis and anti-fungal medications, which produced good responses. Clinical relevance: Pulmonary tuberculosis and fungal co-infection are not common in immunocompetent patients. However, we can suspect that there is a presence of these diseases by detecting new onset of hemoptysis in patients. PMID:27546933

  17. Lateral patellofemoral ligament reconstruction to restore functional capacity in patients previously undergoing lateral retinacular release

    PubMed Central

    Beckert, Mitch; Crebs, Dylan; Nieto, Michael; Gao, Yubo; Albright, John

    2016-01-01

    AIM To study patient outcomes after surgical correction for iatrogenic patellar instability. METHODS This retrospective study looked at 17 patients (19 knees) suffering from disabling medial patellar instability following lateral release surgery. All patients underwent lateral patellofemoral ligament (LPFL) reconstruction by a single surgeon. Assessments in all 19 cases included functional outcome scores, range of motion, and assessment for the presence of apprehension sign of the patella to determine if LPFL reconstruction surgery was successful at restoring patellofemoral stability. RESULTS No patients reported any residual postoperative symptoms of patellar instability. Also no patients demonstrated medial patellar apprehension or examiner induced subluxation with the medial instability test described earlier following LPFL reconstruction. Furthermore, all patients recovered normal range of motion compared to the contralateral limb. For patients with pre and postoperative outcome scores, the mean overall knee injury and osteoarthritis outcome score increased significantly, from 34.39 preoperatively (range: 7.7-70.12) to 69.54 postoperatively (range: 26.82-91.46) at final follow-up (P < 0.0001). CONCLUSION This novel technique for LPFL reconstruction is effective at restoring lateral restraint of the patellofemoral joint and improving joint functionality. PMID:27574606

  18. [Rhegmatogenous retinal detachment in a patient with previous penetrating keratoplasty (clinical case)].

    PubMed

    Burcea, M; Muşat, O; Gheorghe, Andreea; Mahdi, Labib; Colta, Diana; Cernat, Corina; Mansour, Agajani

    2014-01-01

    We present the case of a 54 year old patient diagnosed with rhegmatogenous retinal detachment and perforating keratoplasty. Surgery is recommended and we performed posterior vitrectomy, endolaser, and internal heavy oil tamponade. The post-operative course was favorable.

  19. Left ventricular noncompaction in patients with β-thalassemia: uncovering a previously unrecognized abnormality.

    PubMed

    Piga, Antonio; Longo, Filomena; Musallam, Khaled M; Veltri, Andrea; Ferroni, Francesca; Chiribiri, Amedeo; Bonamini, Rodolfo

    2012-12-01

    Left ventricular noncompaction (LVNC) is a rare cardiomyopathy with potentially serious outcomes. It results in multiple and excessive trabeculations, deep intertrabecular recesses, and a thickened ventricular myocardium with two distinct layers, compacted and noncompacted. The condition is most commonly congenital; however, acquired forms have also been described. A recent report of LVNC detected in a β-thalassemia twin suggested an association with cardiac siderosis. In a cross-sectional study of 135 transfusion-dependent patients with β-thalassemia (130 major and 5 intermedia, mean age 29.6 ± 7.7 years, 49.6% males) presenting for cardiac iron assessment by magnetic resonance imaging (MRI), we evaluated the prevalence and risk factors for LVNC. None of the patients had neuromuscular or congenital heart disease. Eighteen patients (13.3%; 95% confidence interval [CI] = 8.6-20.1) fulfilled the preassigned strict criteria for LVNC on cardiac MRI. There were no statistically significant differences between patients with and without LVNC with respect to demographics; hemoglobin levels; splenectomy status; systemic, hepatic, and cardiac iron overload indices; hepatic disease and infection studies; or iron chelator type. Patients with LVNC were more likely to have heart failure (adjusted odds ratio = 1.77; 95% CI = 0.29-10.89); although with high uncertainty. Patients with β-thalassemia have a higher prevalence of LVNC than normal individuals. As this finding could not be explained by conventional risk factors in this patient population, further investigation of the underlying mechanisms of LVNC is warranted. This remains crucial for an entity with adverse cardiac outcomes, especially in patients with β-thalassemia where cardiac disease remains a primary cause of mortality.

  20. Pregnancy, Delivery, and Neonatal Outcomes of In Vitro Fertilization-Embryo Transfer in Patient with Previous Cesarean Scar.

    PubMed

    Zhang, Ningyuan; Chen, Hua; Xu, Zhipeng; Wang, Bin; Sun, Haixiang; Hu, Yali

    2016-01-01

    BACKGROUND What role should previous cesarean section play in affecting clinical pregnancy outcomes and avoiding the complications of in vitro fertilization? In this article, we focus on elective single-embryo transfer (eSET) versus double-embryo transfer (DET) and assess the clinical efficacy and safety of eSET in patients who have a previous cesarean scar. MATERIAL AND METHODS The pregnancy, delivery, and neonatal outcomes of 130 patients who had a previous cesarean scar and received in vitro fertilization-embryo transfer (IVF-ET) were retrospectively analyzed. The number of transferred embryos was chosen depending on patients' desire after acknowledging all benefits and risks, including eSET (eSET group, n=56) and DET (DET group, n=74). A total of 101 patients with previous vaginal delivery receiving IVF-ET in the same period were included as a control group. RESULTS The pregnancy rates, multiple birth rates, abortion rates, ectopic pregnancy rates, gestational age at delivery, preterm birth rates, neonatal birth weight, and take-home baby rates were similar between the previous cesarean section group and the previous vaginal delivery group. A previous cesarean section scar did not affect embryo implantation and pregnancy outcomes in IVF. In the eSET and DET groups of previous cesarean section patients, the embryo implantation rates, pregnancy rates, abortion rates, and take-home baby rates were similar. However, the rate of multiple pregnancies reached 50% in the DET group, which led to more preterm births and lower birth weight. CONCLUSIONS Elective single-embryo transfer is a well-accepted strategy to avoid multiple pregnancies and improve the obstetric and neonatal outcomes of singleton pregnancy in IVF patients with a previous cesarean section. PMID:27636504

  1. Effect of radiation quality on mutagenic joining of enzymatically-induced DNA double-strand breaks in previously irradiated human cells.

    PubMed

    Li, Zhentian; Wang, Huichen; Wang, Ya; Murnane, John P; Dynan, William S

    2014-11-01

    Previous work has shown that high charge and energy particle irradiation of human cells evokes a mutagenic repair phenotype, defined by increased mutagenic repair of new double-strand breaks that are introduced enzymatically, days or weeks after the initial irradiation. The effect was seen originally with 600 MeV/u (56)Fe particles, which have a linear energy transfer (LET) value of 174 keV/μm, but not with X rays or γ rays (LET ≤ 2 keV/μm). To better define the radiation quality dependence of the phenomenon, we tested two ions with intermediate LET values, 1,000 MeV/u (48)Ti (LET = 108 keV/μm) and 300 MeV/u (28)Si (LET = 69 keV/μm). These experiments used a previously validated assay, where a rare-cutting nuclease introduces double-strand breaks in two reporter transgene cassettes, which are located on different chromosomes. Deletions of a block of sequence in one of the cassettes, or translocations between cassettes, are measured independently using a multicolor fluorescence assay. The results showed that (48)Ti was a potent, but transient, inducer of mutagenic repair, based on increased frequency of nuclease-induced translocations. The (48)Ti ions did not affect the frequency of nuclease-induced deletions. The (28)Si ions had no measurable effect on either endpoint. There was a close correlation between the induction of the mutagenic repair phenomenon and the frequency of micronuclei in the targeted population (R(2) = 0.74), whereas there was no apparent correlation with radiation-induced cell inactivation. Together, these results better define the radiation quality dependence of the mutagenic repair phenomenon and establish its correlation, or lack of correlation, with other endpoints.

  2. Vulnerability of healthy vertebrae in patients with and without previous vertebral fracture.

    PubMed

    Morosano, Mario E; Menoyo, Inés; Caferra, Digna A; Sánchez, Ariel; Tomat, María F; Bocanera, Roberto; Pezzotto, Stella M; Masoni, Ana M

    2011-04-01

    Vertebral deformities are associated with a marked increase in morbidity, mortality, and burden in terms of sanitary expenditures. Patients with vertebral fractures have a negative impact in their health, less quality of life, and loss of functional capacity and independence. The purpose of this study was to explore the vulnerability of healthy vertebrae in patients who have sustained already a compression fracture and in patients who do not have prevalent fractures in the thoracic spine; and to explore the association of the deformity in healthy vertebrae with different variables, such as bone mineral density (BMD), body mass index, age, loss of height, presence of clinical kyphosis, history of other osteoporotic fractures, and falls occurring during the last year. Clinical data and complementary studies from 175 postmenopausal outpatients were analyzed. These women (age: 69.7±11.1 years) had not received any treatment for osteoporosis. Anteroposterior and lateral radiographs of the thoracic spine and bone densitometry of the hip were obtained; morphometry was performed in 1575 thoracic vertebrae from T4 to T12. The angle of wedging of each vertebral body was calculated using a trigonometric formula. Then, the sum of wedge angles of vertebral bodies (SWA) was determined, and Cobb angle was measured. In patients with vertebral fractures, after excluding the angles of fractured vertebral bodies, the mean wedge angle of the remaining vertebrae (MWAhealthy) was calculated. The same procedure was followed in patients without vertebral fractures. MWAhealthy was considered as an indicator of the structural vulnerability of non-fractured vertebrae. Patients with prevalent fractures had lower BMD, wider Cobb angle, and higher sum of wedge angles than patients without vertebral fractures. The proportion of patients with accentuation of clinical kyphosis was higher in the group with prevalent vertebral fractures. A highly significant difference was found in the MWAhealthy

  3. Peginesatide for Maintenance Treatment of Anemia in Hemodialysis and Nondialysis Patients Previously Treated with Darbepoetin Alfa

    PubMed Central

    Roger, Simon D.; Martin, Edouard; Runyan, Grant; O’Neil, Janet; Qiu, Ping; Locatelli, Francesco

    2013-01-01

    Summary Background and objectives Peginesatide (Omontys) is a novel, synthetic, PEGylated, peptide-based erythropoiesis-stimulating agent (ESA) that is designed to specifically stimulate the erythropoietin receptor. This study evaluated maintenance of hemoglobin levels in patients after conversion from darbepoetin alfa to once-monthly peginesatide. Design, setting, participants, & measurements This open-label, multicenter study included 101 CKD patients, 52 of whom were receiving dialysis. The duration of the study was 24 weeks. The primary endpoint was the mean change in hemoglobin from baseline to the evaluation period (weeks 19–24). The study was conducted during the period from September 22, 2008 to December 24, 2009. Results The mean change among hemodialysis patients was –0.42 g/dl (95% confidence interval, –0.65 to –0.19) and the mean change among CKD nondialysis patients was 0.49 g/dl (95% confidence interval, 0.26–0.71). The percentages of patients who maintained hemoglobin levels within ±1.0 g/dl of baseline values were as follows: 80.0% for hemodialysis and 68.1% for nondialysis, and73.3% for hemodialysis and 68.1% for nondialysis within the target range of 10.0–12.0 g/dl. Few patients received red blood cell transfusions (hemodialysis, 5.8%; nondialysis, 2.0%). Seventy-nine patients experienced adverse events, the majority of which were mild or moderate in severity. There were 40 serious adverse events and 2 deaths reported. Conclusions In this study, once-monthly peginesatide resulted in a slight decrease in mean hemoglobin levels in individuals on hemodialysis and a small increase in individuals with CKD who were not on dialysis. PMID:23243269

  4. Pregnancy, Delivery, and Neonatal Outcomes of In Vitro Fertilization-Embryo Transfer in Patient with Previous Cesarean Scar

    PubMed Central

    Zhang, Ningyuan; Chen, Hua; Xu, Zhipeng; Wang, Bin; Sun, Haixiang; Hu, Yali

    2016-01-01

    Background What role should previous cesarean section play in affecting clinical pregnancy outcomes and avoiding the complications of in vitro fertilization? In this article, we focus on elective single-embryo transfer (eSET) versus double-embryo transfer (DET) and assess the clinical efficacy and safety of eSET in patients who have a previous cesarean scar. Material/Methods The pregnancy, delivery, and neonatal outcomes of 130 patients who had a previous cesarean scar and received in vitro fertilization-embryo transfer (IVF-ET) were retrospectively analyzed. The number of transferred embryos was chosen depending on patients’ desire after acknowledging all benefits and risks, including eSET (eSET group, n=56) and DET (DET group, n=74). A total of 101 patients with previous vaginal delivery receiving IVF-ET in the same period were included as a control group. Results The pregnancy rates, multiple birth rates, abortion rates, ectopic pregnancy rates, gestational age at delivery, preterm birth rates, neonatal birth weight, and take-home baby rates were similar between the previous cesarean section group and the previous vaginal delivery group. A previous cesarean section scar did not affect embryo implantation and pregnancy outcomes in IVF. In the eSET and DET groups of previous cesarean section patients, the embryo implantation rates, pregnancy rates, abortion rates, and take-home baby rates were similar. However, the rate of multiple pregnancies reached 50% in the DET group, which led to more preterm births and lower birth weight. Conclusions Elective single-embryo transfer is a well-accepted strategy to avoid multiple pregnancies and improve the obstetric and neonatal outcomes of singleton pregnancy in IVF patients with a previous cesarean section. PMID:27636504

  5. Management of previously treated tuberculosis patients in Kalutara district, Sri Lanka: how are we faring?

    PubMed

    Abeygunawardena, S C; Sharath, B N; Van den Bergh, R; Naik, B; Pallewatte, N; Masaima, M N N

    2014-06-21

    Contexte : Dispensaire de pneumologie du district de Kalutara, Sri Lanka.Objectif : Déterminer la couverture du test de culture et de sensibilité aux médicaments (CDST), les délais des tests de résistance aux médicaments, de mise en œuvre du traitement et d'obtention des résultats du CDST ainsi que les résultats du traitement chez des patients tuberculeux déjà traités auparavant.Schéma : Etude rétrospective de cohorte par revue de dossiers et de rapports. Tous les patients tuberculeux de janvier 2008 à juin 2013 déjà traités ont été inclus dans l'étude.Résultats : Sur 160 patients, 126 (79%) ont été référés pour un CDST ; 79 (63%) avaient une culture positive et il n'y a eu aucun cas de TB-MDR. Environ 9% et 15% des patients, respectivement, ont eu un retard d'expédition des échantillons (retard médian 21 jours) et de réception du rapport du CDST (retard médian 71 jours), tandis que 20% ont subi un retard de mise en œuvre de la reprise du traitement (retard médian 11,5 jours). Le taux de succès thérapeutique de la cohorte atteignait 82%.Conclusion : Parmi tous les patients en retraitement, seulement 79% ont bénéficié d'un CDST et il y a eu des retards considérables dans le transport des échantillons et la mise en œuvre du traitement. Des discussions sont en cours afin de renforcer le programme.

  6. Irradiation of hemoderivatives for transfusion in immunodepressed patients

    NASA Astrophysics Data System (ADS)

    Miranda, J. Fernandez; Castillo, Elsa Lidia

    In this paper we describe a methodology for irradiating hemotherapeutic products that allows the use of radiator GAMMA-CELL-500-001. Irradiation conditions for PVC 300 mL bags were characterized in which blood plasma, erythrocyte and thrombocyte concentrates, and leukocyte mass were packed. Lacking suitable systems in a 10-40 Gy dose range, we modified the Fricke dosimeter system and verified it according to international standards. This modified system showed good repeatibility and homogeinity of results and linearity in the 10-40 Gy range. The linear correlation coefficient was 0.9966, and the reproductibility was ± 2%. More than 300 bags were processed by this established methodology. Hemoderivatives were transfused to patients with malignant hemopathic disorders, subjected to treatment with cytostatics and immunosuppressors, and in general immunodepressed. At present, results are promising from dosimetric and clinical points of view.

  7. Segmented photon beams technique for irradiation of postmastectomy patients

    PubMed Central

    Semaniak, Anna; Jodkiewicz, Zbigniew; Skowrońska-Gardas, Anna

    2012-01-01

    Aim To present the segmented photon beams technique (SPBT) for irradiation of postmastectomy patients. Background In majority of techniques for irradiation of posmastectomy patients, a few adjacent photon or electron beams were usually implemented in order to encompass different parts of the target. In the presented SPBT technique, the radiotherapy plan consists of 6 isocentric photon beams and the area CTV includes both the chest wall and the supraclavicular area. This makes it possible to provide a uniform dose to the CTV with no hot and cold points and enables the determination of doses for the entire volume of critical organs. Methods and material The treatment forward-IMRT plan comprises six isocentric 4 and 15 MV photon beams. Modulation of the dose distribution for each field was obtained by applying three segments on average. The total dose of 45 Gy was administered in 20 fractions. Dose distributions in target volume and organs at risk were evaluated for 70 randomly chosen patients. Results On average, 94.8% of the CTV volume received doses within 95–107% of the prescribed dose. The average volume of the heart receiving a dose of 30 Gy and lager was 2% for patients with left breast cancer. The average dose to the lung on the irradiation side was always lower than 15.5 Gy and the average V20 Gy was below 35.5%. Conclusions The SPBT complies with requirements for high dose homogeneity within the target volume and satisfactory level of sparing of organs at risk. PMID:24377005

  8. Myeloproliferative disorders in patients with rheumatoid arthritis treated with total body irradiation

    SciTech Connect

    Urowitz, M.B.; Rider, W.D.

    1985-01-21

    Four patients with refractory rheumatoid arthritis were treated with total body irradiation administered in two sittings, 300 to 400 rads to each half of the body. All four patients had taken antimetabolites prior to receiving total body irradiation, and two continued to use them after total body irradiation. Two patients had taken alkylating agents before, and one had used them after total body irradiation. All patients showed clinical improvement. However, in two patients myeloproliferative disorders developed: a myelodysplastic preleukemia at 40 months after total body irradiation in one and acute myelogenous leukemia at 25 months in the other. Total body irradiation differs from total nodal irradiation in the total dose of irradiation (300 to 400 rads versus 2,000 to 3,000), and in the duration of the therapy (two sittings versus treatment over several weeks to months). Furthermore, the patients in the total body irradiation study frequently used cytotoxic drugs before and/or after irradiation, whereas in one total nodal irradiation study, azathioprine (2 mg/kg per day or less) was permitted, but no other cytotoxic agents were allowed. Rheumatologists may therefore face a binding decision when deciding to treat a patient with rheumatoid arthritis with either a cytotoxic drug or irradiation.

  9. Previously Undiagnosed Malignant Brain Tumor Discovered During Examination of a Patient Seeking Chiropractic Care

    PubMed Central

    Anderson, Brian

    2016-01-01

    Objective This case report describes the diagnosis of a malignant brain tumor in a patient requesting chiropractic care for headaches after a motor vehicle accident. Clinical Features A 30-year-old man presented with numbness and tingling in all extremities, lower extremity muscle weakness, and a recent increase in headaches with the loss of ability to concentrate. He was involved in a high-speed motor vehicle collision approximately 4 months before the onset of symptoms. Examination showed slow gait with a lack of arm swing, bilateral hip flexors and knee extensors were all graded as 4/5 on muscle testing, and cranial nerve examination was unremarkable with the exception of 2 beats of nystagmus on left lateral eye movement. Because of these findings and a family history of multiple sclerosis, the patient was referred for a brain magnetic resonance imaging scan. Intervention and Outcome Imaging showed a craniocervical junction mass centered at the floor of the fourth ventricle with obstruction of foramina and marked impingement on the medulla. A posterior fossa craniotomy and tumor removal procedure was performed by a neurosurgeon, followed by 34 sessions of radiation therapy. The final diagnosis was a grade II glioma with features of ependymoma. Conclusions This report describes the clinical presentation, examination, and medical management of a 30-year-old man presenting to a chiropractic practice with an unsuspected malignant brain tumor. PMID:27069431

  10. PERTUZUMAB FOR THE TREATMENT OF PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE METASTATIC BREAST CANCER

    PubMed Central

    Smith, M.B.; Reardon, J.; Olson, E.M.

    2013-01-01

    SUMMARY Pertuzumab is a humanized monoclonal antibody directed at the dimerization domain of the receptor tyrosine-protein kinase erbB-2 (HER2) receptor. It possesses a unique and complimentary mechanism of action compared to trastuzumab, which has historically been the cornerstone of therapy for HER2-amplified breast cancer. Clinical trials demonstrate improved outcomes, with minimal increases in toxicity with the addition of pertuzumab to trastuzumab in patients with HER2-positive metastatic breast cancer, indicating the advantage of dual HER2 receptor blockade. Pertuzumab is approved as first-line therapy in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer, with future opportunities to investigate its efficacy in other stages of breast cancer, as well as in the treatment of other malignancies. PMID:23170307

  11. Docetaxel does not impair cardiac autonomic function in breast cancer patients previously treated with anthracyclines.

    PubMed

    Ekholm, Eeva; Rantanen, Virpi; Syvänen, Kari; Jalonen, Jarmo; Antila, Kari; Salminen, Eeva

    2002-04-01

    The effects of docetaxel treatment on autonomic cardiac function was studied with 24-h ECG recordings in breast cancer patients pretreated with anthracyclines. Twenty-four women were evaluated before docetaxel treatment and after 3-4 courses of docetaxel 100 mg/m(2). The heart rate, cardiac extrasystoles and heart rate variability (HRV) in both the time and frequency domain were assessed from 24-h ECG recordings. The acute effects of docetaxel were calculated from 1-h recordings immediately prior to, during and after infusion. Long-term effects were evaluated from 24-h recordings performed before treatment and after 3-4 courses of docetaxel. There was no increase in the number of cardiac extrasystoles during docetaxel infusion. The number of ventricular extrasystoles decreased from 14 (23) to 7 (14) during and 5 (10) after the first infusion (p=0.02). The heart rate, HRV and extrasystoles were similar before and after 3-4 courses of docetaxel. The treatment did not abolish circadian variability of the heart rate. Docetaxel did not deteriorate autonomic cardiac function. In conclusion, our findings suggest that docetaxel does not have harmful cumulative effects on autonomic control of the heart and is therefore unlikely to be cardiotoxic.

  12. Observational cohort study focused on treatment continuity of patients administered XELOX plus bevacizumab for previously untreated metastatic colorectal cancer

    PubMed Central

    Kotaka, Masahito; Ikeda, Fusao; Tsujie, Masaki; Yoshioka, Shinichi; Nakamoto, Yoshihiko; Ishii, Takaaki; Kyogoku, Takahisa; Kato, Takeshi; Tsuji, Akihito; Kobayashi, Michiya

    2016-01-01

    Background There has been remarkable progress in systemic chemotherapy for metastatic colorectal cancer due to the widespread use of irinotecan, oxaliplatin, anti-vascular endothelial growth factor antibody, and anti-epidermal growth factor receptor antibody. It is important to continue treatment with the optimal combination of these drugs and prolong progression-free survival (PFS) to improve overall survival (OS). We conducted a prospective observational cohort study of 40 patients treated with XELOX plus bevacizumab for previously untreated metastatic colorectal cancer to investigate treatment continuity. Patients and methods Eligibility criteria were as follows: 1) histologically confirmed metastatic colorectal cancer; 2) lesions evaluable by imaging; 3) previously untreated; 4) suitable condition to receive XELOX plus bevacizumab; and 5) written informed consent. Outcomes were treatment continuity, overall response rate, resection rate, liver resection rate, time to treatment failure, PFS, and OS. Forty patients were enrolled and followed up for 2 years. Results Between July 2010 and June 2012, 40 patients were enrolled. The median number of treatment cycles was 7.5, and the reasons for discontinuation of treatment were as follows: complete response (five patients), resection (ten patients), progression (15 patients), adverse events (seven patients), and patient refusal (three patients). The overall response rate was 57.5%, resection rate was 25%, and liver resection rate was 15%. After a median follow-up of 31.4 months, the median time to treatment failure, PFS, and OS were 5.3, 13.3, and 38.9 months, respectively. Conclusion Although the median time to treatment failure was 5.3 months, the median PFS and OS were prolonged to 13.3 and 38.9 months, respectively. This may have resulted from the chemotherapy-free interval due to complete response in five patients and resection in ten patients. PMID:27468238

  13. Damped sinusoidal function to model acute irradiation in radiotherapy patients.

    PubMed

    Tukiendorf, Andrzej; Miszczyk, Leszek; Bojarski, Jacek

    2013-09-01

    In the paper, we suggest a damped sinusoidal function be used to model a regenerative response of mucosa in time after the radiotherapy treatment. The medical history of 389 RT patients irradiated within the years 1994-2000 at the Radiotherapy Department, Cancer Center, Maria Skłodowska-Curie Memorial Institute of Oncology, Gliwice, Poland, was taken into account. In the analyzed group of patients, the number of observations of a single patient ranged from 2 to 25 (mean = 8.3, median = 8) with severity determined by use of Dische's scores from 0 to 24 (mean = 7.4, median = 7). Statistical modeling of radiation-induced mucositis was performed for five groups of patients irradiated within the following radiotherapy schedules: CAIR, CB, Manchester, CHA-CHA, and Conventional. All of the regression parameters of the assumed model, i.e. amplitude, damping coefficient, angular frequency, phase of component, and offset, estimated in the analysis were statistically significant (p-value < 0.05) for the radiotherapy schedules. The model was validated using a non-oscillatory function. Following goodness-of-fit statistics, the damped sinusoidal function fits the data better than the non-oscillatory damped function. Model curves for harmonic characteristics with confidence intervals were plotted separately for each of the RT schedules and together in a combined design. The suggested model might be helpful in the numeric evaluation of the RT toxicity in the groups of patients under analysis as it allows for practical comparisons and treatment optimization. A statistical approach is also briefly described in the paper.

  14. Frequency and Clinical Significance of Previously Undetected Incidental Findings Detected on Computed Tomography Simulation Scans for Breast Cancer Patients

    SciTech Connect

    Nakamura, Naoki; Tsunoda, Hiroko; Takahashi, Osamu; Kikuchi, Mari; Honda, Satoshi; Shikama, Naoto; Akahane, Keiko; Sekiguchi, Kenji

    2012-11-01

    Purpose: To determine the frequency and clinical significance of previously undetected incidental findings found on computed tomography (CT) simulation images for breast cancer patients. Methods and Materials: All CT simulation images were first interpreted prospectively by radiation oncologists and then double-checked by diagnostic radiologists. The official reports of CT simulation images for 881 consecutive postoperative breast cancer patients from 2009 to 2010 were retrospectively reviewed. Potentially important incidental findings (PIIFs) were defined as any previously undetected benign or malignancy-related findings requiring further medical follow-up or investigation. For all patients in whom a PIIF was detected, we reviewed the clinical records to determine the clinical significance of the PIIF. If the findings from the additional studies prompted by a PIIF required a change in management, the PIIF was also recorded as a clinically important incidental finding (CIIF). Results: There were a total of 57 (6%) PIIFs. The 57 patients in whom a PIIF was detected were followed for a median of 17 months (range, 3-26). Six cases of CIIFs (0.7% of total) were detected. Of the six CIIFs, three (50%) cases had not been noted by the radiation oncologist until the diagnostic radiologist detected the finding. On multivariate analysis, previous CT examination was an independent predictor for PIIF (p = 0.04). Patients who had not previously received chest CT examinations within 1 year had a statistically significantly higher risk of PIIF than those who had received CT examinations within 6 months (odds ratio, 3.54; 95% confidence interval, 1.32-9.50; p = 0.01). Conclusions: The rate of incidental findings prompting a change in management was low. However, radiation oncologists appear to have some difficulty in detecting incidental findings that require a change in management. Considering cost, it may be reasonable that routine interpretations are given to those who have not

  15. Plane Systems for Irradiation of a Patient from Any Directions

    NASA Astrophysics Data System (ADS)

    Kats, M. M.; Onossovsky, K. K.

    1997-05-01

    The system for transportation of a beam used for proton therapy is suggested. In this system a prone patient is placed perpendicularly to the beam axis. The beam is bent and focused in the vertical plane in such a way that makes possible patient irradiation from any direction. Three versions of such a system are discussed. All of them give the opportunity to transport protons with energy up to 250 MeV and R*R' up to 10-5 m*rad to targets with linear size in the interval between 10 and 300 mm. As compared to systems described earlier (GANTRY, Corcscrew etc.) the systems described in this paper have smaller weight of movable equipment, occupy less space and consume less power. Coauthor deseased

  16. Temperament and Character in Euthymic Major Depressive Disorder Patients: The Effect of Previous Suicide Attempts and Psychotic Mood Episodes

    PubMed Central

    Albayrak, Yakup; Ekinci, Aslı Erkan

    2012-01-01

    Objective The purpose of this study was to examine personality traits of patients with major depressive disorder and explore the possible connections between personality and clinical and sociodemographic variables. Methods The sociodemographic and clinical properties of 80 patients with major depression, who were euthymic according to Hamilton Depression Scale scores, were recorded. Their personality was evaluated by using Temperament and Character Inventory and results were compared with 80 age- and sex-matched healthy controls. We used general linear model analysis to evaluate the manner in which the variables contributed to TCI scores. Results Remitted depressive patients scored significantly lower on on self-directedness and higher on harm avoidance than HC. Previous suicide attempts had a main effect only on harm avoidance while previous psychotic mood episodes were significantly associated with novelty seeking, self-directedness and cooperativeness. With respect to numeric clinical variables, only duration of illness was significantly and negatively correlated with NS and RD scores. Conclusion Patients with euthymic major depressive disorder may have significantly different personality traits than the normal population, and patients with different clinical and sociodemographic characteristics may show different personality patterns. In addition, assessment of major depressed patients by means of the Temperament and Character Inventory may be helpful to get a deeper insight into those personality traits underlying suicidality and the emergence of psychotic mood episode. PMID:22707961

  17. Bevacizumab and weekly docetaxel in patients with metastatic castrate-resistant prostate cancer previously exposed to docetaxel.

    PubMed

    Francini, Filippo; Pascucci, Alessandra; Francini, Edoardo; Bargagli, Gianluca; Conca, Raffaele; Licchetta, Antonella; Roviello, Giandomenico; Martellucci, Ignazio; Chiriacò, Giorgio; Miano, Salvatora Tindara; Marzocca, Giuseppe; Manganelli, Antonio; Ponchietti, Roberto; Savelli, Vinno; Petrioli, Roberto

    2011-01-01

    Background. The aim of this paper was to evaluate the activity and tolerability of docetaxel (D) and bevacizumab (Bev) in patients with metastatic castrate-resistant prostate cancer (CRPC) previously exposed to D. Methods. Treatment consisted of D 30 mg/m(2) i.v. for four consecutive weekly administrations followed by a 2-week rest interval, in addition to Bev 5 mg/kg i.v. every 2 weeks. Results. Forty-three patients were enrolled: a PSA response was observed in 27 patients (62.7%, 95% CI: 0.41 to 0.91), and a palliative response was achieved in 31 patients (72.1%, 95%CI: 0.48 to 1.02). After a median followup of 11.3 months, only five patients had died. The regimen was generally well tolerated. Conclusion. Weekly D + biweekly Bev seems to be an effective and well-tolerated treatment option for patients with metastatic CRPC previously exposed to D-based chemotherapy. PMID:22096653

  18. Bevacizumab and Weekly Docetaxel in Patients with Metastatic Castrate-Resistant Prostate Cancer Previously Exposed to Docetaxel

    PubMed Central

    Francini, Filippo; Pascucci, Alessandra; Francini, Edoardo; Bargagli, Gianluca; Conca, Raffaele; Licchetta, Antonella; Roviello, Giandomenico; Martellucci, Ignazio; Chiriacò, Giorgio; Miano, Salvatora Tindara; Marzocca, Giuseppe; Manganelli, Antonio; Ponchietti, Roberto; Savelli, Vinno; Petrioli, Roberto

    2011-01-01

    Background. The aim of this paper was to evaluate the activity and tolerability of docetaxel (D) and bevacizumab (Bev) in patients with metastatic castrate-resistant prostate cancer (CRPC) previously exposed to D. Methods. Treatment consisted of D 30 mg/m2 i.v. for four consecutive weekly administrations followed by a 2-week rest interval, in addition to Bev 5 mg/kg i.v. every 2 weeks. Results. Forty-three patients were enrolled: a PSA response was observed in 27 patients (62.7%, 95% CI: 0.41 to 0.91), and a palliative response was achieved in 31 patients (72.1%, 95%CI: 0.48 to 1.02). After a median followup of 11.3 months, only five patients had died. The regimen was generally well tolerated. Conclusion. Weekly D + biweekly Bev seems to be an effective and well-tolerated treatment option for patients with metastatic CRPC previously exposed to D-based chemotherapy. PMID:22096653

  19. A Flexible-Dose Study of Paliperidone ER in Patients With Nonacute Schizophrenia Previously Treated Unsuccessfully With Oral Olanzapine

    PubMed Central

    KOTLER, MOSHE; DILBAZ, NESRIN; ROSA, FERNANDA; PATERAKIS, PERIKLIS; MILANOVA, VIHRA; SMULEVICH, ANATOLY B.; LAHAYE, MARJOLEIN

    2016-01-01

    Objective: The goal of this study was to explore the tolerability, safety, and treatment response of switching from oral olanzapine to paliperidone extended release (ER). Methods: Adult patients with nonacute schizophrenia who had been treated unsuccessfully with oral olanzapine were switched to flexible doses of paliperidone ER (3 to 12 mg/d). The primary efficacy outcome was a ≥20% improvement in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to endpoint for patients who switched medications because of lack of efficacy with olanzapine and noninferiority versus previous olanzapine treatment (mean endpoint change in PANSS total scores vs. baseline of ≤5 points) for patients who switched for reasons other than lack of efficacy. Safety and tolerability were assessed by monitoring adverse events, extrapyramidal symptoms, and weight change. Results: Of 396 patients, 65.2% were men, mean age was 40.0±12.0 years, and 75.5% had paranoid schizophrenia. Among the patients whose main reason for switching was lack of efficacy, an improvement in the PANSS total score of ≥20% occurred in 57.4% of patients. Noninferiority was confirmed for each subgroup of patients whose main reason for switching was something other than lack of efficacy. Paliperidone ER was generally well tolerated. Extrapyramidal symptoms as measured by total Extrapyramidal Symptom Rating Scale scores showed statistically significant and clinically relevant improvements at endpoint, the average weight decreased by 0.8±5.2 kg at endpoint, and a clinically relevant weight gain of ≥7% occurred in 8.0% of patients. Conclusion: Paliperidone ER flexibly-dosed over 6 months was well tolerated and associated with a meaningful clinical response in patients with nonacute schizophrenia who had previously been unsuccessfully treated with oral olanzapine. PMID:26813484

  20. Short-term outcomes after laparoscopic colorectal surgery in patients with previous abdominal surgery: A systematic review

    PubMed Central

    Figueiredo, Marleny Novaes; Campos, Fabio Guilherme; D’Albuquerque, Luiz Augusto; Nahas, Sergio Carlos; Cecconello, Ivan; Panis, Yves

    2016-01-01

    AIM: To perform a systematic review focusing on short-term outcomes after colorectal surgery in patients with previous abdominal open surgery (PAOS). METHODS: A broad literature search was performed with the terms “colorectal”, “colectomy”, “PAOS”, “previous surgery” and “PAOS”. Studies were included if their topic was laparoscopic colorectal surgery in patients with PAOS, whether descriptive or comparative. Endpoints of interest were conversion rates, inadvertent enterotomy and morbidity. Analysis of articles was made according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses. RESULTS: From a total of 394 citations, 13 full-texts achieved selection criteria to be included in the study. Twelve of them compared patients with and without PAOS. All studies were retrospective and comparative and two were case-matched. The selected studies comprised a total of 5005 patients, 1865 with PAOS. Among the later, only 294 (16%) had history of a midline incision for previous gastrointestinal surgery. Conversion rates were significantly higher in 3 of 12 studies and inadvertent enterotomy during laparoscopy was more prevalent in 3 of 5 studies that disclosed this event. Morbidity was similar in the majority of studies. A quantitative analysis (meta-analysis) could not be performed due to heterogeneity of the studies. CONCLUSION: Conversion rates were slightly higher in PAOS groups, although not statistical significant in most studies. History of PAOS did not implicate in higher morbidity rates. PMID:27462396

  1. Isochromosome 15q of maternal origin in two Prader-Willi syndrome patients previously diagnosed erroneously as cytogenetic deletions

    SciTech Connect

    Saitoh, Shinji; Niikawa, Norio; Mutirangura, A.; Kuwano, A.; Ledbetter, D.H.

    1994-03-01

    Since a previous report on two Prader-Willi syndrome (PWS) patients with t(15q;15q) was erroneous, the authors report new data and a corrected interpretation. Reexamination of the parental origin of their t(15q;15q) using polymorphic DNA markers that are mapped to various regions of 15q documented no molecular deletions at the 15q11-q13 region in either patient. Both patients were homozygous at all loci examined and their haplotypes on 15q coincided with one of those in their respective mothers. These results indicate that the presumed t(15q;15q) in each patient was actually an isochromosome 15q producing maternal uniparental disomy, consistent with genomic imprinting at the PWS locus. 30 refs., 1 fig., 3 tabs.

  2. Chance fracture in an older patient with positive sagittal imbalance and previous lumbar arthrodesis: what can be done?

    PubMed

    Zwolak, Pawel; Kröber, Markus

    2016-04-01

    The Chance fracture occurs frequently in school-aged patients' population and is related to flexion-distraction injury in motor vehicle accidents. It is so called seat-belt syndrome because the seatbelt lies over the abdomen. After sudden deceleration bends the child around the lap belt causing injuries to the abdomen, and the spine (e.g., Chance fracture). The Chance fracture after a low energy fall in elderly patient's population has rarely been reported. We present an 82 years old patient who suffered unrecognized Chance fracture after a low energy fall. The management of this patient with positive sagittal imbalance and previous arthrodesis consisted of decompression, Smith-Petersen osteotomy and posterior pedicle screw instrumentation.

  3. High rates of ofloxacin resistance in Mycobacterium tuberculosis among both new and previously treated patients in Tamil Nadu, South India.

    PubMed

    Selvakumar, N; Kumar, Vanaja; Balaji, S; Prabuseenivasan, S; Radhakrishnan, R; Sekar, Gomathi; Chandrasekaran, V; Kannan, T; Thomas, Aleyamma; Arunagiri, S; Dewan, Puneet; Swaminathan, Soumya

    2015-01-01

    Periodic drug resistance surveillance provides useful information on trends of drug resistance and effectiveness of tuberculosis (TB) control measures. The present study determines the prevalence of drug resistance among new sputum smear positive (NSP) and previously treated (PT) pulmonary TB patients, diagnosed at public sector designated microscopy centers (DMCs) in the state of Tamil Nadu, India. In this single-stage cluster-sampling prevalence survey, 70 of 700 DMCs were randomly selected using a probability-proportional to size method. A cluster size of 24 for NSP and a varying size of 0 to 99 for PT cases were fixed for each selected DMC. Culture and drug susceptibility testing was done on Lowenstein-Jensen medium using the economic variant of proportion sensitivity test for isoniazid (INH), rifampicin (RMP), ofloxacin (OFX) and kanamycin (KAN). Human Immunodeficiency Virus (HIV) status was collected from patient records. From June 2011 to August 2012, 1524 NSP and 901 PT patients were enrolled. Any RMP resistance and any INH resistance were observed in 2.6% and 15.1%, and in 10.4% and 30% respectively in NSP and PT cases. Among PT patients, multi drug resistant TB (MDR-TB) was highest in the treatment failure (35%) group, followed by relapse (13%) and treatment after default (10%) groups. Extensively drug resistant TB (XDRTB) was seen in 4.3% of MDR-TB cases. Any OFX resistance was seen in 10.4% of NSP, 13.9% of PT and 29% of PT MDR-TB patients. The HIV status of the patient had no impact on drug resistance levels. RMP resistance was present in 2.6% of new and 15.1% of previously treated patients in Tamil Nadu. Rates of OFX resistance were high among NSP and PT patients, especially among those with MDR-TB, a matter of concern for development of new treatment regimens for TB.

  4. Accuracy of patient positioning in mantle field irradiation.

    PubMed

    Creutzberg, C L; Visser, A G; De Porre, P M; Meerwaldt, J H; Althof, V G; Levendag, P C

    1992-04-01

    A prospective study of the accuracy of patient positioning in mantle field irradiation was carried out in 13 lymphoma patients treated with curative radiotherapy. Patients were treated in the supine and prone position for anterior and posterior fields, respectively. Individually shaped divergent shielding blocks were placed in a fixed position in a template which was positioned on a tray above the patient. A total number of 94 megavoltage portal films (MV) was analysed and compared to 26 simulation films (SIM). MV-SIM differences were larger for posterior fields than for anterior fields. Regarding the position of the lung shielding blocks, mean MV-SIM differences ranged from 1.3 to 4.4 mm and errors exceeding 1 cm were found in 7.2% of cases. Most discrepancies appeared to be randomly distributed. A 4-5 mm systematic cranial shift of patients in the posterior treatment position was noted. Discrepancies in the position of the laryngeal block, spinal cord shielding block and humerus blocks were small with mean MV-SIM differences ranging from 0.3 to 2.7 mm. Differences between simulation set-up and treatment set-up were modest as compared to error rates reported in the literature. Shielding of tumour-bearing areas did not occur. It was concluded that the present standardised technique of patient positioning and the design of treatment fields results in acceptable error rates. Attention should be directed towards increasing the stability of patients in the prone treatment position in order to further reduce both systematic and random error rates. PMID:1609130

  5. Accuracy of patient positioning in mantle field irradiation.

    PubMed

    Creutzberg, C L; Visser, A G; De Porre, P M; Meerwaldt, J H; Althof, V G; Levendag, P C

    1992-04-01

    A prospective study of the accuracy of patient positioning in mantle field irradiation was carried out in 13 lymphoma patients treated with curative radiotherapy. Patients were treated in the supine and prone position for anterior and posterior fields, respectively. Individually shaped divergent shielding blocks were placed in a fixed position in a template which was positioned on a tray above the patient. A total number of 94 megavoltage portal films (MV) was analysed and compared to 26 simulation films (SIM). MV-SIM differences were larger for posterior fields than for anterior fields. Regarding the position of the lung shielding blocks, mean MV-SIM differences ranged from 1.3 to 4.4 mm and errors exceeding 1 cm were found in 7.2% of cases. Most discrepancies appeared to be randomly distributed. A 4-5 mm systematic cranial shift of patients in the posterior treatment position was noted. Discrepancies in the position of the laryngeal block, spinal cord shielding block and humerus blocks were small with mean MV-SIM differences ranging from 0.3 to 2.7 mm. Differences between simulation set-up and treatment set-up were modest as compared to error rates reported in the literature. Shielding of tumour-bearing areas did not occur. It was concluded that the present standardised technique of patient positioning and the design of treatment fields results in acceptable error rates. Attention should be directed towards increasing the stability of patients in the prone treatment position in order to further reduce both systematic and random error rates.

  6. Transfemoral Valve-in-Valve Transcatheter Aortic Valve Implantation (TAVI) in a Patient With Previous Endovascular Aortic Repair (EVAR).

    PubMed

    Ruparelia, Neil; Panoulas, Vasileios F; Frame, Angela; Nathan, Anthony W; Ariff, Ben; Jaffer, Usman; Sutaria, Nilesh; Chukwuemeka, Andrew; Mikhail, Ghada W; Malik, Iqbal S

    2016-07-01

    A 90-year-old man presented with increasing exertional breathlessness. He had previous implantation of a Perimount bioprosthetic aortic valve (Edwards Lifesciences) and coronary artery bypass graft surgery. Due to severe transvalvular bioprosthetic regurgitation with preserved left ventricular dimensions and ejection fraction, the heart team decided on valve-in- valve transcatheter aortic valve implantation via the transfemoral route in view of the patient's prohibitively high surgical and anesthetic risk. The patient had an uncomplicated recovery and was symptomatically much improved at 3-month follow-up. PMID:27342209

  7. Predicting Radiation Pneumonitis After Stereotactic Ablative Radiation Therapy in Patients Previously Treated With Conventional Thoracic Radiation Therapy

    SciTech Connect

    Liu Hui; Zhang Xu; Vinogradskiy, Yevgeniy Y.; Swisher, Stephen G.; Komaki, Ritsuko; Chang, Joe Y.

    2012-11-15

    Purpose: To determine the incidence of and risk factors for radiation pneumonitis (RP) after stereotactic ablative radiation therapy (SABR) to the lung in patients who had previously undergone conventional thoracic radiation therapy. Methods and Materials: Seventy-two patients who had previously received conventionally fractionated radiation therapy to the thorax were treated with SABR (50 Gy in 4 fractions) for recurrent disease or secondary parenchymal lung cancer (T <4 cm, N0, M0, or Mx). Severe (grade {>=}3) RP and potential predictive factors were analyzed by univariate and multivariate logistic regression analyses. A scoring system was established to predict the risk of RP. Results: At a median follow-up time of 16 months after SABR (range, 4-56 months), 15 patients had severe RP (14 [18.9%] grade 3 and 1 [1.4%] grade 5) and 1 patient (1.4%) had a local recurrence. In univariate analyses, Eastern Cooperative Oncology Group performance status (ECOG PS) before SABR, forced expiratory volume in 1 second (FEV1), and previous planning target volume (PTV) location were associated with the incidence of severe RP. The V{sub 10} and mean lung dose (MLD) of the previous plan and the V{sub 10}-V{sub 40} and MLD of the composite plan were also related to RP. Multivariate analysis revealed that ECOG PS scores of 2-3 before SABR (P=.009), FEV1 {<=}65% before SABR (P=.012), V{sub 20} {>=}30% of the composite plan (P=.021), and an initial PTV in the bilateral mediastinum (P=.025) were all associated with RP. Conclusions: We found that severe RP was relatively common, occurring in 20.8% of patients, and could be predicted by an ECOG PS score of 2-3, an FEV1 {<=}65%, a previous PTV spanning the bilateral mediastinum, and V{sub 20} {>=}30% on composite (previous RT+SABR) plans. Prospective studies are needed to validate these predictors and the scoring system on which they are based.

  8. Factors Associated with Unfavorable Treatment Outcomes in New and Previously Treated TB Patients in Uzbekistan: A Five Year Countrywide Study

    PubMed Central

    Gadoev, Jamshid; Asadov, Damin; Tillashaykhov, Mirzagolib; Tayler-Smith, Katie; Isaakidis, Petros; Dadu, Andrei; de Colombani, Pierpaolo; Gudmund Hinderaker, Sven; Parpieva, Nargiza; Ulmasova, Dilrabo; Jalolov, Avazbek; Hamraev, Atadjan; Ali, Engy; van den Boom, Martin; Hammerich, Asmus; Gozalov, Ogtay; Dara, Masoud

    2015-01-01

    Background TB is one of the main health priorities in Uzbekistan and relatively high rates of unfavorable treatment outcomes have recently been reported. This requires closer analysis to explain the reasons and recommend interventions to improve the situation. Thus, by using countrywide data this study sought to determine trends in unfavorable outcomes (lost-to-follow-ups, deaths and treatment failures) and describe their associations with socio-demographic and clinical factors. Method A countrywide retrospective cohort study of all new and previously treated TB patients registered in the National Tuberculosis programme between January 2006 and December 2010. Results Among 107,380 registered patients, 67% were adults, with smaller proportions of children (10%), adolescents (4%) and elderly patients (19%). Sixty per cent were male, 66% lived in rural areas, 1% were HIV-infected and 1% had a history of imprisonment. Pulmonary TB (PTB) was present in 77%, of which 43% were smear-positive and 53% were smear-negative. Overall, 83% of patients were successfully treated, 6% died, 6% were lost-to-follow-up, 3% failed treatment and 2% transferred out. Factors associated with death included being above 55 years of age, HIV-positive, sputum smear positive, previously treated, jobless and living in certain provinces. Factors associated with lost-to-follow-up were being male, previously treated, jobless, living in an urban area, and living in certain provinces. Having smear-positive PTB, being an adolescent, being urban population, being HIV-negative, previously treated, jobless and residing in particular provinces were associated with treatment failure. Conclusion Overall, 83% treatment success rate was achieved. However, our study findings highlight the need to improve TB services for certain vulnerable groups and in specific areas of the country. They also emphasize the need to develop unified monitoring and evaluation tools for drug-susceptible and drug-resistant TB, and

  9. Isolating the Role of Bevacizumab in Elderly Patients With Previously Untreated Nonsquamous Non–Small Cell Lung Cancer

    PubMed Central

    Socinski, Mark A.; Patel, Jyoti D.; Sandler, Alan B.; Schiller, Joan H.; Leon, Larry; Hazard, Sebastien J.; Ramalingam, Suresh S.

    2016-01-01

    Background: Patient-level data from 2 phase III studies in patients with previously untreated, advanced-stage, nonsquamous non–small cell lung cancer (NSCLC) were pooled to examine outcomes with bevacizumab and chemotherapy based on age. Methods: Data from patients randomized to paclitaxel–carboplatin (PC)+bevacizumab in the Eastern Cooperative Oncology Group 4599 (E4599) and PointBreak studies were pooled and compared with E4599 patients randomized to PC alone. Patients were grouped by age: below 65, 65 to 74, 70 to 74, below 75, and 75 years or above. A multivariable model was used to calculate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) using time-to-event outcomes. Adverse events (AEs) were assessed by age group in each study. Results: The PC+bevacizumab and PC arms comprised 901 and 444 patients, respectively. PC+bevacizumab was associated with significant increases in overall survival relative to PC in patients below 65 years (hazards ratio [HR], 0.75; 95% confidence interval [CI], 0.62-0.89), 65 to 74 years (HR, 0.80; 95% CI, 0.64-1.00), 70 to 74 years (HR, 0.68; 95% CI, 0.48-0.96), and below 75 years (HR, 0.78; 95% CI, 0.68-0.89) but not in those aged 75 years or above (HR, 1.05; 95% CI, 0.70-1.57). Increased incidence of grade ≥3 AEs was reported with PC+bevacizumab versus PC in patients below 75 years (63% vs. 48%; P<0.05) and 75 years or above (81% vs. 56%; P <0.05) in E4599. Conclusions: This analysis suggests that the survival benefits associated with PC+bevacizumab extend to patient subgroups below 75 years with advanced-stage NSCLC; no benefit, however, was observed for bevacizumab-eligible patients who were 75 years or above. PMID:25628268

  10. Risk factors and outcome for colistin-resistant Acinetobacter nosocomialis bacteraemia in patients without previous colistin exposure.

    PubMed

    Wang, Y-C; Lee, Y-T; Yang, Y-S; Chen, C-T; Chiu, C-H; Yin, T; Kuo, S-C; Chen, T-L; Lin, J-C; Wang, F-D; Fung, C-P; Chang, F-Y

    2015-08-01

    The clinical characteristics of patients with colistin-resistant Acinetobacter baumannii bacteraemia have been documented, but those of patients with bacteraemia caused by other Acinetobacter species remain unknown. Previous exposure to colistin has been shown to be associated with the emergence of colistin resistance, but may be not the only predisposing factor. In the current study, we highlight the risk and outcome of patients without previous exposure to colistin who acquired colistin-resistant Acinetobacter nosocomialis (ColRAN) bacteraemia. This 11-year single-centre retrospective study analysed 58 patients with ColRAN bacteraemia and 213 patients with colistin-susceptible A. nosocomialis (ColSAN) bacteraemia. Antimicrobial susceptibilities were determined with an agar dilution method. The clonal relationship of ColRAN isolates was determined with pulsed-field gel electrophoresis. A conjugation mating-out assay was conducted to delineate the potential transfer of colistin resistance genes. Multivariable analysis was performed to evaluate the risk factors for ColRAN bacteraemia. Chronic obstructive pulmonary disease (COPD) was independently associated with ColRAN bacteraemia (OR 3.04; 95% CI 1.45-6.37; p 0.003). Patients with ColRAN bacteraemia had higher APACHE II scores, but the two groups showed no significant differences in 14-day mortality (10.3% vs. 10.3%) or 28-day mortality (15.5% vs. 15.0%). ColRAN isolates had greater resistance than ColSAN isolates to all antimicrobial agents except for ciprofloxacin (0% vs. 6.6%). There were 16 different ColRAN pulsotypes, and two major clones were found. Colistin resistance did not transfer to colistin-susceptible A. baumannii or A. nosocomialis. These results show that COPD is an independent risk factor for acquisition of ColRAN bacteraemia. The mortality rates were similar between patients with ColRAN and ColSAN bacteraemia.

  11. Prophylactic sternal plating with pectoralis advancement flaps after sternotomy in patients with a history of chest irradiation.

    PubMed

    Neaman, Keith C; Blount, Andrew L; Kim, John A; Renucci, John D; Hooker, Robert L

    2011-03-01

    Deep sternal infections secondary to bony instability and malunion, can result in mediastinitis. Previous authors have described the use of prophylactic rigid plate fixation in high-risk patients. The purpose of our study is to review the use of prophylactic sternal platting with pectoralis advancement flaps in high-risk patients with a history of chest irradiation. Fourteen patients (July 2003-September 2008) with a history of chest irradiation who underwent a median sternotomy followed by prophylactic rigid plate fixation of the sternum were reviewed. Breast cancer was the most common etiology of chest irradiation (n=11, 78%). The average EuroSCORE was 24.06% with 72% of patients having a preoperative New York Heart Association (NYHA) class≥III. There were no episodes of sternal non-union, mediastinitis or death. Follow-up was 100% with a 0% 30-day and a 7.1% one-year mortality rate (non-cardiac). A comparison between mean preoperative left ventricular ejection fraction (LVEF) (49.6%) and postoperative LVEF (59.7%) was statistically significant (P<0.0001). All living patients currently maintain a NYHA class I/II. Prophylactic rigid plate fixation and pectoralis flap coverage decreases the risk of developing sternal dehiscence and postoperative wound complications and should therefore be considered in high-risk patients with a history of chest irradiation. PMID:21138917

  12. Risk of pneumonia recurrence in patients previously hospitalized for pneumonia--a retrospective study (1998-2000).

    PubMed

    Polić-Vizintin, Marina; Leppée, Marcel; Stimac, Danijela; Vodopija, Ivan; Cindrić, Jasna

    2005-06-01

    Although elderly hospitalized patients, irrespective of the cause of hospitalization, are known to be at a high risk of subsequent development of pneumonia, some studies suggest the risk to be even higher in those hospitalized for pneumonia than in those hospitalized for other diseases. The aim of this retrospective study was to determine the association of hospitalization for pneumonia and some other diseases with subsequent pneumonia morbidity and mortality. The risk of recurrent pneumonia in patients hospitalized for pneumonia was investigated. Rehospitalization of pneumonia patients previously hospitalized for the same disease was followed-up and compared with rehospitalization of patients hospitalized for other diseases during the same study period. The study included patients aged overl8, initially hospitalized in 1998 for pneumonia (J12-J18), or for some particular gastrointestinal (K20-K31) and urogenital diseases (N10-N12, N30-N39). All rehospitalizations for pneumonia in nine Zagreb hospitals were followed-up during a 3-year study period (1998-2000). Out of 975 patients followed-up for rehospitalization, 227 (23.3%) had initially been hospitalized for pneumonia, and 748 (76.7%) for other diagnoses. During the 3-year period, 30 patients were rehospitalized for pneumonia, out of which number 22 had initially been hospitalized for pneumonia, yielding a statistically significant difference between the two study groups (chi2 = 34.780, p < 0.001). The mortality directly caused by pneumonia was also significantly higher in the group of patients with the initial diagnosis of pneumonia than in the group of patients with other diagnoses (chi2 = 15.82, p < 0.001).

  13. Effect of selective elimination of the oral flora on mucositis in irradiated head and neck cancer patients

    SciTech Connect

    Spijkervet, F.K.; Van Saene, H.K.; Van Saene, J.J.; Panders, A.K.; Vermey, A.; Mehta, D.M.; Fidler, V. )

    1991-03-01

    Recently it has been reported that chlorhexidine 0.1% rinsing was not successful in eradication of gram-negative bacilli in patients who have head and neck cancer. These bacilli could play a role in irradiation mucositis. This study reports the effect of lozenges containing 2 mg polymyxin E, 1.8 mg tobramycin, and 10 mg amphotericin B qid on the oropharyngeal flora in 15 irradiated head and neck cancer patients. The results were compared with those of a previous study in two groups of 15 patients comparing chlorhexidine rinsing with placebo. In all patients using lozenges, eradication of gram-negative bacilli and yeasts was achieved within 3 weeks. A significant increase of enterococci was found. Mucositis was significantly reduced compared with the previous two groups. All patients showed erythema only, whereas 80% of both the placebo and chlorhexidine rinsing patients suffered from severe mucositis, with signs of pseudomembranes developing from the third week of conventional irradiation protocol. The effect of selective elimination of gram-negative bacilli from the oropharynx and the prevention of severe mucositis may be explained by the eradication of these bacteria and/or neutralization of salivary endotoxin, released by gram-negative bacilli, mediating the inflammatory processes.

  14. Shunt malfunction causing acute neurological deterioration in 2 patients with previously asymptomatic Chiari malformation Type I. Report of two cases.

    PubMed

    Elliott, Robert; Kalhorn, Stephen; Pacione, Donato; Weiner, Howard; Wisoff, Jeffrey; Harter, David

    2009-08-01

    Patients with symptomatic Chiari malformation Type I (CM-I) typically exhibit a chronic, slowly progressive disease course with evolution of symptoms. However, some authors have reported acute neurological deterioration in the setting of CM-I and acquired Chiari malformations. Although brainstem dysfunction has been documented in patients with CM-II and hydrocephalus or shunt malfunction, to the authors' knowledge only 1 report describing ventriculoperitoneal (VP) shunt malfunction causing neurological deterioration in a patient with CM-I exists. The authors report on their experience with the treatment of previously asymptomatic CM-I in 2 children who experienced quite different manifestations of acute neurological deterioration secondary to VP shunt malfunction. Presumably, VP shunt malfunction created a positive rostral pressure gradient across a stenotic foramen magnum, resulting in tetraparesis from foramen magnum syndrome in 1 patient and acute ataxia and cranial nerve deficits from syringobulbia in the other. Although urgent shunt revisions yielded partial recovery of neurological function in both patients, marked improvement occurred only after posterior fossa decompression.

  15. Accelerated partial breast irradiation utilizing brachytherapy: patient selection and workflow.

    PubMed

    Shah, Chirag; Wobb, Jessica; Manyam, Bindu; Khan, Atif; Vicini, Frank

    2016-02-01

    Accelerated partial breast irradiation (APBI) represents an evolving technique that is a standard of care option in appropriately selected woman following breast conserving surgery. While multiple techniques now exist to deliver APBI, interstitial brachytherapy represents the technique used in several randomized trials (National Institute of Oncology, GEC-ESTRO). More recently, many centers have adopted applicator-based brachytherapy to deliver APBI due to the technical complexities of interstitial brachytherapy. The purpose of this article is to review methods to evaluate and select patients for APBI, as well as to define potential workflow mechanisms that allow for the safe and effective delivery of APBI. Multiple consensus statements have been developed to guide clinicians on determining appropriate candidates for APBI. However, recent studies have demonstrated that these guidelines fail to stratify patients according to the risk of local recurrence, and updated guidelines are expected in the years to come. Critical elements of workflow to ensure safe and effective delivery of APBI include a multidisciplinary approach and evaluation, optimization of target coverage and adherence to normal tissue guideline constraints, and proper quality assurance methods. PMID:26985202

  16. Bulimia nervosa patient diagnosed with previously unsuspected ADHD in adulthood: clinical case report, literature review, and diagnostic challenges.

    PubMed

    Ioannidis, Konstantinos; Serfontein, Jaco; Müller, Ulrich

    2014-05-01

    There is increasing literature suggesting a link between attention-deficit hyperactivity disorder (ADHD) and eating disorders (EDs), especially bulimia nervosa. ADHD is under-diagnosed in girls and children of high intelligence are typically missed. We identified a case of a 23-year-old woman suffering from severe bulimia nervosa and previously unsuspected ADHD in adulthood; we diagnosed and treated her with extended-release methylphenidate. We performed a literature review on the ADHD and bulimia nervosa comorbidity. We discuss the reasons why her ADHD remained undiagnosed and the difficulties in diagnosing ADHD in patients with EDs. We suggest that identifying comorbid ADHD is crucial for these patients and argue for the use of a structured interview, collateral history and investigation of onset of symptoms to establish a diagnosis of ADHD in adults with bulimia nervosa. Comorbidities and overlap of symptomatology need to be taken into account.

  17. Long-term followup of rheumatoid arthritis patients treated with total lymphoid irradiation

    SciTech Connect

    Tanay, A.; Field, E.H.; Hoppe, R.T.; Strober, S.

    1987-01-01

    Total lymphoid irradiation was administered to 32 patients with intractable rheumatoid arthritis. Twenty-four patients showed at least a 25% improvement in 3 of 4 disease activity parameters, which persisted during the followup period of up to 48 months. Eight of the 32 patients required adjunctive immunosuppressive drug therapy to maintain improvement. Four patients died after total lymphoid irradiation; the causes of death were acute myocardial infarction (1 patient), pulmonary embolism (1 patient), and rheumatoid lung disease complicated by respiratory infection (2 patients). After therapy, patients exhibited a prolonged reduction in the number and function of circulating T helper cells.

  18. Varenicline precipitating psychosis in a patient with no previous psychiatric history: a case report of a Spanish patient who was later diagnosed with paranoid personality disorder.

    PubMed

    Forcen, Fernando Espi; Martinez, Fernando Luis Espi; Moya, Amparo Martinez

    2012-01-01

    Varenicline is gaining popularity for the treatment of nicotine dependence. General treatment guidelines recommend monitoring for behavioral changes in patients with a mental illness. There are very few cases reported on patients developing psychiatric symptoms with no previous history. We are reporting the case of a Spanish patient who had developed a first-psychotic episode after he was started on varenicline. He was ultimately diagnosed with a paranoid personality disorder. Therefore, prior to starting a patient on varenicline, the clinician must identify possible paranoid and other cluster A personality traits. It is essential to monitor for new onset of psychotic symptoms during the treatment with this drug.

  19. Patterns and Determinants of Treatment Seeking among Previously Untreated Psychotic Patients in Aceh Province, Indonesia: A Qualitative Study

    PubMed Central

    Marthoenis, Marthoenis; Aichberger, Marion C.; Schouler-Ocak, Meryam

    2016-01-01

    Immediate treatment of first-episode psychosis is essential in order to achieve a positive outcome. However, Indonesian psychiatric patients often delay accessing health services, the reason for which is not yet fully understood. The current study aimed to understand patterns of treatment seeking and to reveal determinants of the delay in accessing psychiatric care among first-time user psychotic patients. Qualitative interviews were conducted with sixteen family members who accompanied the patients to a psychiatric hospital. Many families expressed beliefs that mental illness appertains to village sickness and not hospital sickness; therefore, they usually take the patients to traditional or religious healers before taking them to a health professional. They also identified various factors that potentially delay accessing psychiatric treatment: low literacy and beliefs about the cause of the illness, stigmatisation, the role of extended family, financial problems, and long distance to the psychiatric hospital. On the other hand, the family mentioned various factors related to timely help seeking, including being a well-educated family, living closer to health facilities, previous experience of successful psychotic therapy, and having more positive symptoms of psychosis. The findings call for mental health awareness campaigns in the community. PMID:27382501

  20. Patterns and Determinants of Treatment Seeking among Previously Untreated Psychotic Patients in Aceh Province, Indonesia: A Qualitative Study.

    PubMed

    Marthoenis, Marthoenis; Aichberger, Marion C; Schouler-Ocak, Meryam

    2016-01-01

    Immediate treatment of first-episode psychosis is essential in order to achieve a positive outcome. However, Indonesian psychiatric patients often delay accessing health services, the reason for which is not yet fully understood. The current study aimed to understand patterns of treatment seeking and to reveal determinants of the delay in accessing psychiatric care among first-time user psychotic patients. Qualitative interviews were conducted with sixteen family members who accompanied the patients to a psychiatric hospital. Many families expressed beliefs that mental illness appertains to village sickness and not hospital sickness; therefore, they usually take the patients to traditional or religious healers before taking them to a health professional. They also identified various factors that potentially delay accessing psychiatric treatment: low literacy and beliefs about the cause of the illness, stigmatisation, the role of extended family, financial problems, and long distance to the psychiatric hospital. On the other hand, the family mentioned various factors related to timely help seeking, including being a well-educated family, living closer to health facilities, previous experience of successful psychotic therapy, and having more positive symptoms of psychosis. The findings call for mental health awareness campaigns in the community. PMID:27382501

  1. [Ultrasound-assisted neuraxial anesthesia in a patient with previous lumbar laminectomy and fusion: a case report].

    PubMed

    Geng, J; Li, M

    2016-02-18

    A patient with previous L3-4 posterior lumbar interbody fusion, pedicle screws instrumentation and L3-4 decompression, was scheduled for left total hip arthroplasty. Two years ago, due to poor landmarks palpation, the patient experienced a failed lumbar puncture after multiple attempts before herniorrhaphy. His plain radiography showed bilateral partial laminectomy at L3-4 level, and between L3 and L4, two posterior pedicle screws connected by metal rods on both sides. This time, we used ultrasound to locate L4-5 interlaminar space in paramedian sagittal oblique view and identified the spine midline by transverse interlaminar view before puncture. According to this information, L4-5 puncture point was verified and the combined spinal-epidural anesthesia was performed in a paramedian approach. After withdrawing clear cerebral spinal fluid, 15 mg hyperbaric bupivicaine was injected into intrathecal space. An epidural catheter was then inserted into the epidural space. The sensory block level was fixed at T10 to S within 10 minutes. Intraoperatively, the patient received 10 mL 2% (mass fraction) lidocaine through the epidural catheter in total. The surgery was uneventful. No neurologic complication was observed after the surgery. This case report demonstrates that ultRASound imaging can provide useful information for neuraxial needle placement and can be a valuable tool in managing patients with anatomical change around the spine. PMID:27538165

  2. Complete response after rechallenge with trabectedin in a patient with previously responding high-grade undifferentiated sarcoma

    PubMed Central

    Di Donato, Samantha; Fargnoli, Rossana; Dona, Manjola; Bertulli, Rossella; Parisi, Elisabetta; Fantini, Lorenzo; Sbaraglia, Marta; Panella, Mauro

    2016-01-01

    Evidence supporting rechallenge in patients responding to first exposure to trabectedin is limited. We report on a 39-year-old woman with advanced high-grade undifferentiated sarcoma (US) retreated twice with trabectedin after first response. The patient presented in June 2006 with an abdominal mass originating from the rear fascia of the rectus abdominis. Staging examinations did not indicate metastases and she underwent surgery; pathology showed a high-grade (FNCLCC G3) US. Subsequently, the patient received five cycles of adjuvant chemotherapy with epirubicin and ifosfamide. In February 2009 a computed tomography (CT) scan showed an abdominal mass involving the transverse mesocolon. R0 surgery was performed. In September 2009, peritoneal lesions appeared. Trabectedin was initiated at a dose of 1.5 mg/m2 by a 24 h intravenous infusion every 3 weeks, without relevant toxicity. After six cycles (March 2010), CT and PET-CT scans showed complete disappearance of metastases. In February 2012, new secondary lesions in the subdiaphragmatic region and a peritoneal lesion appeared. We rechallenged the patient with the same schedule of trabectedin; a complete response was achieved after two cycles. In October 2013, new secondary lesions in the subdiaphragmatic region and a retroperitoneal lesion were found. We rechallenged with the same schedule of trabectedin; PET-CT scans after two cycles showed complete response on the subdiaphragmatic lesion. Radiotherapy on the retroperitoneal lesion was performed. The patient underwent a total of 18 cycles and remains free from radiologically detectable disease. We report complete radiological remission after two rechallenges with trabectedin in a patient with previously responding high-grade US. PMID:27348763

  3. Patterns of patient specific dosimetry in total body irradiation

    SciTech Connect

    Akino, Yuichi; McMullen, Kevin P.; Das, Indra J.

    2013-04-15

    Purpose: Total body irradiation (TBI) has been used for bone marrow transplant for hematologic and immune deficiency conditions. The goal of TBI is to deliver a homogeneous dose to the entire body, with a generally accepted range of dose uniformity being within {+-}10% of the prescribed dose. The moving table technique for TBI could make dose uniform in whole body by adjusting couch speed. However, it is difficult to accurately estimate the actual dose by calculation and hence in vivo dosimetry (IVD) is routinely performed. Here, the authors present patterns of patient-specific IVD in 161 TBI patients treated at our institution. Methods: Cobalt-60 teletherapy unit (Model C9 Cobalt-60 teletherapy unit, Picker X-ray Corporation) with customized moving bed (SITI Industrial Products, Inc., Fishers, IN) were used for TBI treatment. During treatment, OneDose{sup TM} (Sicel Technology, NC) Metal Oxide-silicon Semiconductor Field Effect Transistor detectors were placed at patient body surface; both entrance and exit side of the beam at patient head, neck, mediastinum, umbilicus, and knee to estimate midplane dose. When large differences (>10%) between the prescribed and measured dose were observed, dose delivery was corrected for subsequent fractions by the adjustment of couch speed and/or bolus placement. Under IRB exempt status, the authors retrospectively analyzed the treatment records of 161 patients who received TBI treatment between 2006 and 2011. Results: Across the entire cohort, the median {+-} SD (range) percent variance between calculated and measured dose for head, neck, mediastinum, umbilicus, and knee was -2.3 {+-} 10.2% (-66.2 to +35.3), 1.1 {+-} 11.5% (-62.2 to +40.3), -1.9 {+-} 9.5% (-66.4 to +46.6), -1.1 {+-} 7.2% (-35.2 to +42.9), and 3.4 {+-} 12.2% (-47.9 to +108.5), respectively. More than half of treatments were within {+-}10% of the prescribed dose for all anatomical regions. For 80% of treatments (10%-90%), dose at the umbilicus was within {+-}10

  4. Risk factors and therapeutic coverage at 6 years in patients with previous myocardial infarction: the CASTUO study

    PubMed Central

    Félix-Redondo, Francisco Javier; Lozano Mera, Luis; Consuegra-Sánchez, Luciano; Giménez Sáez, Fernando; Garcipérez de Vargas, Francisco Javier; Castellano Vázquez, José María; Fernández-Bergés, Daniel

    2016-01-01

    Objectives To determine the degree of risk factor control, the clinical symptoms and the therapeutic management of patients with a history of previous myocardial infarction. Methods Cross-sectional study at 6 years of a first episode of acute myocardial infarction between 2000 and 2009, admitted at a hospital in the region of Extremadura (Spain). Of 2177 patients with this diagnosis, 1365 remained alive and therefore were included in the study. Results We conducted a person-to-person survey in 666 (48.8%) individuals and telephone survey in 437 (31.9%) individuals. The former are analysed. 130 were female (19.5%). The mean age was 67.4 years and the median time since the event was 5.8 (IQR 3.6–8.2) years. Active smokers made up 13.8%, low-density lipoprotein (LDL) cholesterol was ≥70 mg/dL: 82%, blood pressure ≥140/90 mm Hg (≥140/85 in diabetics): 49.8%, fasting glucose ≥126 mg/dL: 26%, heart rate 50–59 bpm: 60.7%, and obesity: 45.9%. Patients reported presenting angina comprised 22.4% and those with dyspnoea, 29.3%. Drug coverage was: 88.0% antiplatelet drugs, 86.5% statins, 75.6% β-blockers and 65.8% blockers of the renin-angiotensin system. Patients receiving all four types of drugs made up 41.9%, with only 3.0% having jointly controlled cholesterol, blood pressure, heart rate and glycaemia. Conclusions LDL cholesterol, heart rate and blood pressure were risk factors with less control. More than 1/5 of patients had angina and more than 1/4, dyspnoea. Risk factor control and the clinical condition were far from optimal, as was drug coverage, although to a lesser degree. PMID:27127637

  5. Ascending aortic aneurysm in a patient with an aortic Starr-Edwards ball valve prosthesis implanted 39 years previously.

    PubMed

    Nishigawa, Kosaku; Totsugawa, Toshinori; Yoshitaka, Hidenori; Tsushima, Yoshimasa; Kuinose, Masahiko; Chikazawa, Genta

    2010-03-01

    A 53-year-old man who had undergone aortic valve replacement with a Starr-Edwards ball valve prosthesis 39 years previously was admitted to our hospital under the diagnosis of ascending aortic aneurysm. Operative findings revealed that the ball valve was functioning normally. The markedly dilated ascending aorta was replaced with a 30-mm prosthetic vascular graft, and the ball valve was replaced with a19-mm bileaflet valve prosthesis. The patient's postoperative course was uneventful, and he was discharged from our hospital 19 days after surgery. Dilatation of the ascending aorta in this case might have been caused by the poststenotic dilatation mechanism, which seems to be one of the long-term complications of Starr-Edwards ball valve implantation.

  6. Efficacy of a preservative-free formulation of fixed-combination bimatoprost and timolol (Ganfort PF) in treatment-naïve patients vs previously treated patients

    PubMed Central

    Cordeiro, M Francesca; Goldberg, Ivan; Schiffman, Rhett; Bernstein, Paula; Bejanian, Marina

    2015-01-01

    Purpose To evaluate, using subgroup analysis, the effect of treatment status on the intraocular pressure (IOP)-lowering efficacy of a preservative-free formulation of fixed-combination bimatoprost 0.03%/timolol 0.5% (FCBT PF). Methods A primary, multicenter, randomized, double-masked, 12-week study compared the efficacy and safety of FCBT PF with preserved FCBT (Ganfort®) in 561 patients diagnosed with glaucoma or ocular hypertension. For this analysis, eligible patients were treatment-naïve or had inadequate IOP lowering and underwent a washout of previous treatment. IOP (8 am, 10 am, and 4 pm) was measured at baseline and weeks 2, 6, and 12. Subgroup analysis of the FCBT PF arm assessed changes in average eye IOP from baseline in treatment-naïve vs previously treated patients. To evaluate the effect of treatment status at baseline (treatment-naïve vs previously treated) on IOP reduction in the FCBT PF treatment group, an analysis of covariance model was used with treatment status and investigator as fixed effects, and baseline average eye IOP, age, glaucoma diagnosis, and baseline average eye corneal thickness as covariates. P-values and the 95% confidence intervals were determined using the model. Results In the FCBT PF arm, IOP mean changes from baseline ranged from −8.7 mmHg to −9.8 mmHg in treatment-naïve patients (N=50), compared with −7.3 mmHg to −8.5 mmHg in previously treated patients (N=228). Baseline IOP, age, glaucoma diagnosis, and corneal thickness significantly affected IOP reduction in the FCBT PF group. Adjusting for these covariates, FCBT PF had a greater IOP-lowering effect (0.8–1.7 mmHg) in treatment-naïve patients than previously treated patients, which was statistically significant (P≤0.05) at seven of nine time points. Conclusion In this subgroup analysis, FCBT PF reduced IOP more effectively in treatment-naïve than in previously treated patients possibly due, in part, to altered responsiveness or tachyphylaxis that has

  7. Surgical Results of Trabeculectomy and Ahmed Valve Implantation Following a Previous Failed Trabeculectomy in Primary Congenital Glaucoma Patients

    PubMed Central

    Lee, Naeun; Ma, Kyoung Tak; Bae, Hyoung Won; Hong, Samin; Seong, Gong Je; Hong, Young Jae

    2015-01-01

    Purpose To compare the surgical results of trabeculectomy and Ahmed glaucoma valve implantation after a previous failed trabeculectomy. Methods A retrospective comparative case series review was performed on 31 eye surgeries in 20 patients with primary congenital glaucoma who underwent trabeculectomy or Ahmed glaucoma valve implantation after a previous failed trabeculectomy with mitomycin C. Results The preoperative mean intraocular pressure was 25.5 mmHg in the trabeculectomy group and 26.9 mmHg in the Ahmed glaucoma valve implantation group (p = 0.73). The 48-month postoperative mean intraocular pressure was 19.6 mmHg in the trabeculectomy group and 20.2 mmHg in the Ahmed glaucoma valve implantation group (p = 0.95). The 12-month trabeculectomy success rate was 69%, compared with 64% for Ahmed glaucoma valve implantation, and the 48-month success rates were 42% and 36% for trabeculectomy and valve implantation, respectively. The success rates following the entire follow-up period were not significantly different between the two groups (p > 0.05 by log rank test). Postoperative complications occurred in 25% of the trabeculectomy-operated eyes and 9% of the Ahmed-implanted eyes (p = 0.38). Conclusions There was no significant difference in surgical outcome between the trabeculectomy and Ahmed glaucoma valve implantation groups, neither of which had favorable results. However, the trabeculectomy group demonstrated a higher prevalence of adverse complications such as post-operative endophthalmitis. PMID:25829827

  8. Cardiotoxic Effects of Tangential Breast Irradiation in Early Breast Cancer Patients: The Role of Irradiated Heart Volume

    SciTech Connect

    Borger, Jacques H. Hooning, Maartje J.; Snijders-Keilholz, Antonia; Brussel, Sara van; Toorn, Peter-Paul van der; Alwhouhayb, Maitham; Leeuwen, Flora E. van

    2007-11-15

    Purpose: To assess the risk of cardiovascular disease (CVD) after postlumpectomy irradiation restricted to tangential fields. Methods and Materials: We assessed the incidence of CVD in 1601 patients with T1-2N0 breast cancer (BC) treated with breast tangentials in five different hospitals between 1980 and 1993. Patients treated with radiation fields other than breast tangentials and those treated with adjuvant chemotherapy were excluded. For patients with left-sided BC, maximum heart distance (MHD) was measured on the simulator films as a proxy for irradiated heart volume. Risk of CVD by laterality and MHD categories was evaluated by Cox proportional hazards regression analysis. Results: Follow-up was complete for 94% of the patients, and median follow-up was 16 years. The incidence of CVD overall was 14.1%, of ischemic heart disease 7.3%, and for other types of heart disease 9.2%, with a median time to event of 10 to 11 years. The incidence of CVD was 11.6% in patients with right-sided BC, compared with 16.0% in left-sided cases. The hazard ratio associated with left-sided vs. right-sided BC was 1.38 (95% confidence interval [CI], 1.05-1.81) for CVD overall, 1.35 (95% CI, 0.93-1.98) for ischemic heart disease , and 1.53 (95% CI, 1.09-2.15) for other heart disease, adjusted for age, diabetes, and history of CVD. The risk of CVD did not significantly increase with increasing MHD. Conclusions: Patients irradiated for left-sided BC with tangential fields have a higher incidence of CVD compared with those with right-sided cancer. However, the risk does not seem to increase with larger irradiated heart volumes.

  9. Incidence and risk factors for inhibitor development in previously untreated severe haemophilia A patients born between 2005 and 2010.

    PubMed

    Vézina, C; Carcao, M; Infante-Rivard, C; Lillicrap, D; Stain, A M; Paradis, E; Teitel, J; Rivard, G E

    2014-11-01

    The objective of this study was to evaluate the inhibitor development (ID) in previously untreated patients (PUPs) with severe haemophilia A (FVIII ≤ 0.01 IU mL(-1) ). All Canadian Haemophilia Treatment Centres completed a questionnaire on patients born between September 2005 and August 2010 and followed for up to 7 years. Eligible patients had at least 20 exposure days (ED) or had developed an inhibitor. The odds ratio (OR) and 95% confidence intervals (95% CI) for risk factors to develop an inhibitor were estimated using unconditional logistic regression. A total of 99 haemophilia A PUPs were studied. Thirty-four (34%) developed an inhibitor (24/34 of high titre). Inhibitors developed in 25/63 (40%) patients with a high-risk mutation. ID was most frequent in Aboriginals (86%). Dose intensity (IU kg(-1)  day(-1) X number of ED) at first exposure to factor VIII (FVIII) was associated with a crude OR increase of 1.10 (95% CI: 0.99-1.23) with each increase of 100 dose-intensity units. Haemarthrosis and intracranial bleeding as the indication for first exposure to FVIII concentrate were associated with a crude OR for ID of 7.63 (95% CI: 2.14-27.17) and 5.08 (95% CI: 1.11-23.31) respectively. ID according to FVIII concentrate used was: Advate (®) 18/50 (36%), Kogenate FS(®) or Helixate FS(®) 15/36 (42%), Wilate(®) 0/11 and Xyntha(®) 1/2. In multivariate analysis, Aboriginal ethnicity (OR = 11.69; 95% CI: 1.11-122.86) and haemarthrosis (OR = 4.49; 95% CI: 1.08-18.61) were statistically significant. The cumulative incidence of ID in severe haemophilia A PUPs was 34% and varied according to ethnicity, type of bleeding at first ED, type of FVIII product and dose intensity at first exposure.

  10. Influence of He-Ne laser blood irradiation on morphofunctional state of monocytes in asthmatic patients

    NASA Astrophysics Data System (ADS)

    Paleev, N. R.; Slinchenko, O. I.; Ilchenko, V. A.; Vasilenko, Irina A.; Konradov, Alexander A.; Tychinsky, Vladimir P.

    1996-01-01

    In recent years we have been working out a new method of treatment of steroid-resistant asthma -- extracorporeal He-Ne-laser blood irradiation. The procedures gave good clinical effect and allowed reduction of steroid dose in a majority of patients. The monocytes were investigated by luminol-dependent chemiluminescence and the method of living cell microcopy. Extracorporeal He-Ne laser blood irradiation normalized both monocytes chemiluminescence and cell oscillation in asthmatic patients significantly earlier than in cases of ordinary treatment, although the mechanisms of action of He-Ne-laser irradiation upon blood steroid-resistant asthmatics were not fully determined.

  11. T- and B-cell responses and previous exposure to hepatitis B virus in 'anti-HBc alone' patients.

    PubMed

    Wang, Q; Sachse, P; Semmo, M; Lokhande, M; Montani, M; Dufour, J-F; Zoulim, F; Klenerman, P; Semmo, N

    2015-12-01

    A serologic response to hepatitis B virus (HBV) defined as 'anti-HBc alone' is commonly observed, but its significance remains unclear. This study aimed to define the relationship between 'anti-HBc alone' serostatus and HBV infection, including HBV-specific T- and B-cell memory responses. We enrolled 31 'anti-HBc alone' patients. Total HBV DNA and cccDNA were tested by nested polymerase chain reaction (PCR) analysis in liver samples from 22 'anti-HBc alone' patients vs controls (chronic or resolved HBV infection), followed by HBsAg/HBcAg immunohistochemical (IHC) staining. IFN-γ secretion by HBV-specific T cells was compared in individuals who were 'anti-HBc alone' (n = 27), resolved HBV (n = 21), chronic HBV (n = 24) and 12 healthy controls using enzyme-linked immunospot (ELISpot) assays. An HBsAg-IgG B-cell ELISpot assay was performed in 'anti-HBc alone' patients before and after one dose of recombinant HBsAg vaccine. The majority (23/31, 74.2%) of the 'anti-HBc alone' individuals were co-infected with HCV. Infrequent intrahepatic total HBV DNA (2/22, 9.1%) and cccDNA (1/22, 4.5%) were detected in biopsies; HBsAg and HBcAg IHC staining was negative. HBV-specific T-cell responses were similar between 'anti-HBc alone' individuals and HBV resolvers. Circulating HBV-memory B-cell responses were detected in all 'anti-HBc alone' individuals, consistent with an HBsAg-specific memory pool. After one HBV vaccine dose, increased anti-HBs antibody levels were observed, accompanied by an expansion of HBsAg-specific memory B cells (P = 0.0226). 'Anti-HBc alone' individuals showed HBV-specific T-cell and memory B-cell responses typical of previous viral exposure and protective memory, suggesting a resolved infection.

  12. Bortezomib: A Review in Mantle Cell Lymphoma in Previously Untreated Patients Unsuitable for Stem-Cell Transplantation.

    PubMed

    McCormack, Paul L

    2015-06-01

    Bortezomib (Velcade(®)) is a proteasome inhibitor that is approved for the treatment of multiple myeloma and mantle cell lymphoma (MCL). This article reviews the efficacy and tolerability of bortezomib in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (VR-CAP) in the treatment of previously untreated MCL unsuitable for stem-cell transplantation, and overviews the pharmacology of bortezomib. In the large, randomized, assessor-blinded, multinational LYM-3002 trial, induction therapy with VR-CAP improved progression-free survival significantly more than R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) after a median follow-up of 40 months in patients with newly diagnosed MCL ineligible or not considered for stem-cell transplantation. Complete response and certain other secondary endpoints were improved significantly more with VR-CAP than R-CHOP. Overall survival data were not mature at the time of assessment. The improved efficacy with VR-CAP was accompanied by an increased incidence of grade 3 or higher adverse events, particularly haematological adverse events.

  13. Relapse Analysis of Irradiated Patients Within the HD15 Trial of the German Hodgkin Study Group

    SciTech Connect

    Kriz, Jan; Reinartz, Gabriele; Dietlein, Markus; Kobe, Carsten; Kuhnert, Georg; Haverkamp, Heinz; Haverkamp, Uwe; Engenhart-Cabillic, Rita; Herfarth, Klaus; Lukas, Peter; Schmidberger, Heinz; Staar, Susanne; Hegerfeld, Kira; Baues, Christian; Engert, Andreas; Eich, Hans Theodor

    2015-05-01

    Purpose: To determine, in the setting of advanced-stage of Hodgkin lymphoma (HL), whether relapses occur in the irradiated planning target volume and whether the definition of local radiation therapy (RT) used by the German Hodgkin Study Group (GHSG) is adequate, because there is no harmonization of field and volume definitions among the large cooperative groups in the treatment of advanced-stage HL. Methods and Materials: All patients with residual disease of ≥2.5 cm after multiagent chemotherapy (CTX) were evaluated using additional positron emission tomography (PET), and those with a PET-positive result were irradiated with 30 Gy to the site of residual disease. We re-evaluated all sites of disease before and after CTX, as well as the PET-positive residual tumor that was treated in all relapsed patients. Documentation of radiation therapy (RT), treatment planning procedures, and portal images were carefully analyzed and compared with the centrally recommended RT prescription. The irradiated sites were compared with sites of relapse using follow-up computed tomography scans. Results: A total of 2126 patients were enrolled, and 225 patients (11%) received RT. Radiation therapy documents of 152 irradiated patients (68%) were analyzed, with 28 irradiated patients (11%) relapsing subsequently. Eleven patients (39%) had an in-field relapse, 7 patients (25%) relapsed outside the irradiated volume, and an additional 10 patients (36%) showed mixed in- and out-field relapses. Of 123 patients, 20 (16%) with adequately performed RT relapsed, compared with 7 of 29 patients (24%) with inadequate RT. Conclusions: The frequency and pattern of relapses suggest that local RT to PET-positive residual disease is sufficient for patients in advanced-stage HL. Insufficient safety margins of local RT may contribute to in-field relapses.

  14. Total lymphoid irradiation and cyclophosphamide conditioning prior to bone marrow transplantation for patients with severe aplastic anemia

    SciTech Connect

    Ramsay, N.K.; Kim, T.H.; McGlave, P.; Goldman, A.; Nesbit, M.E. Jr.; Krivit, W.; Woods, W.G.; Kersey, J.H.

    1983-09-01

    A preparative regimen, consisting of total lymphoid irradiation and cyclophosphamide, was utilized in 40 patients with severe aplastic anemia undergoing allogeneic marrow transplantation. This regimen was successful in decreasing rejection in these previously transfused patients, as only one patient rejected the marrow graft. Twenty-nine of the 40 transplanted patients are surviving from 1.5 to 59 mo, with a median follow-up of 24 mo. The actuarial survival rate for these heavily transfused patients with aplastic anemia is 72% at 2 yr. This preparative regimen is extremely effective in decreasing rejection following transplantation for severe aplastic anemia. Future efforts in this area must be aimed at the elimination of graft-versus-host disease and control of fatal infections.

  15. Treatment outcomes of patients with small cell lung cancer without prophylactic cranial irradiation

    PubMed Central

    Maebayashi, Toshiya; Aizawa, Takuya; Ishibashi, Naoya; Saito, Tsutomu

    2016-01-01

    Background Prophylactic cranial irradiation (PCI) is indicated for limited disease (LD) in small cell lung cancer (SCLC) patients who achieve a complete or near-complete response; however, it is sometimes not administered because of possible adverse reactions or patient refusal. Here we assessed treatment outcomes among patients with SCLC who were not treated with PCI. Methods The medical records of 60 patients (45 men, 15 women; mean age, 68 years; age range, 51–82 years) with SCLC were retrospectively reviewed. The tumors were staged by TNM classification. Two, 2, 5, 4, 32, and 15 patients had stage IA, IB, IIA, IIB, IIIA, and IIIB tumors, respectively. The patients were treated with thoracic radiotherapy (TRT) and four courses of chemotherapy. Results Our subjects had a median survival of 25 months and 2- and 5-year survival rates of 52.6% and 25.3%, respectively. Univariate analysis revealed that the development of brain metastasis, performance status (PS), and T-stage were significant factors correlated with survival rate. Multivariate analysis identified only PS [hazard ratio (HR), 5.845, 95% confidence interval (CI), 2.333–14.63, P=0.002] and brain metastasis as independent prognostic variables (HR, 2.344, 95% CI, 1.071–5.128, P=0.033). Conclusions The results of our study demonstrated that the outcomes of treatment without PCI were improved, as compared with those of previously published data. Our findings may be used as reference data when PCI cannot be performed.

  16. Sensori-neural hearing loss in patients treated with irradiation for nasopharyngeal carcinoma

    SciTech Connect

    Grau, C.; Moller, K.; Overgaard, M.; Overgaard, J.; Elbrond, O. )

    1991-08-01

    The present investigation has been carried out to evaluate the sensitivity of the inner ear to irradiation. Cochlear function was tested in a cohort of 22 patients before and 7-84 months after receiving external irradiation for nasopharyngeal carcinoma. The pre-irradiation sensori-neural hearing threshold at 500, 1000, 2000, and 4000 Hz was used as a baseline for the individual patient, and the observed sensori-neural hearing loss (SNHL) was calculated as the difference between pre- and post-irradiation values. The pre-irradiation hearing level or patient age was not correlated with the actual SNHL. In contrast, there was a significant correlation between the total radiation dose to the inner ear and the observed hearing impairment. SNHL was most pronounced in the high frequencies, with values up to 35 dB (4000 Hz) and 25 dB (2000 Hz) in some patients. The latent period for the complication appeared to be 12 months or more. The deleterious effect of irradiation on the hearing should be kept in mind both in treatment planning and in the follow-up after radiotherapy.

  17. [Urinary diversion in patients treated with pelvic irradiation: transverse colon conduit revisited].

    PubMed

    Matsui, Yoshiyuki; Kanematsu, Akihiro; Negoro, Hiromitsu; Kobayashi, Takashi; Terada, Naoki; Sugino, Yoshio; Yamasaki, Toshinari; Inoue, Takahiro; Kamba, Tomomi; Yoshimura, Koji; Ogawa, Osamu

    2014-08-01

    In patients receiving pelvic irradiation for gynecological or genitourinary malignancies, urinary diversion is sometimes required for complete resection of malignancies or treatment of urological complications by irradiation. We report our attempts to promote healing and prevent complications by urinary diversion using a transverse colon conduit in cases in which urinary reconstruction was performed with irradiated lower abdominal organs such as small intestine or distal ureters. Between 2008 and 2012, 9 patients with pelvic irradiation received transverse colon conduit urinary diversion. Six patients received diversion for genitourinary complications, while 3 patients received complete resection of pelvic malignancies. Colostomy formation and lithotripsy of vesical stones were simultaneously performed in 4 cases. Wallace method was adopted for ureterointestinal anastomosis. There was no operative mortality. Although acute pyelonephritis, ileus, wound dehiscence and pelvic abscess formation were seen as postoperative complications, all but two improved without any additional procedure. Cases of pelvic abscess or wound dehiscence were treated by abscess drainage. In observation periods, no patients required urinary stent placement and none suffered from defecation problems. We think that transverse colon conduit can be a viable option for patients with pelvic irradiation history, affording them reasonable quality of life postoperatively. PMID:25179985

  18. Outcome After Conservative Surgery and Breast Irradiation in 5,717 Patients With Breast Cancer: Implications for Supraclavicular Nodal Irradiation

    SciTech Connect

    Livi, Lorenzo; Scotti, Vieri; Saieva, Calogero; Meattini, Icro; Detti, Beatrice; Simontacchi, Gabriele; Cardillo, Carla Deluca; Paiar, Fabiola; Mangoni, Monica; Marrazzo, Livia; Agresti, Benedetta; Cataliotti, Luigi; Bianchi, Simonetta; Biti, Giampaolo

    2010-03-15

    Purpose: To evaluate the outcome and predictive factors of patients who underwent breast-conserving surgery and adjuvant radiotherapy to the whole breast only, without supraclavicular nodal irradiation. Methods and Materials: A total of 5,717 patients with pT1-T4 breast cancer were treated at the University of Florence. The median age of the patient population was 55 years (range, 30-80 years). All patients were followed for a median of 6.8 years (range, 1-27 years). Adjuvant chemotherapy was recommended in 1,535 patients (26.9%). Tamoxifen was prescribed in 2,951 patients (51.6%). The patients were split into three groups according to number of positive axillary nodes (PAN): P1, negative axillary lymph nodes; P2, one to three PAN; P3, more than three PAN. Results: The P3 patients had a higher incidence of supraclavicular fossa recurrence (SFR) compared with P2 and P1 patients. However, the incidence of SFR in P3 patients was low (only 5.5%), whereas the incidence of distant metastases (DM) was 27.2%. Distant metastasis was the only independent prognostic factor for breast cancer survival. Additionally, in the subgroup of patients who developed local recurrence, DM was the most important death predictor. Conclusion: Our series suggests that isolated SFR in patients who did not receive supraclavicular radiotherapy is infrequent, as well as in those patients who have more than three PAN, and SFR seems not to influence the outcome, which depends on DM occurrence.

  19. Evaluation of instant cup noodle, irradiated for immuno-compromised patients

    NASA Astrophysics Data System (ADS)

    Lee, Ji-Hye; Kim, Jae-Kyung; Park, Jae-Nam; Yoon, Young-Min; Sung, Nak-Yun; Kim, Jae-Hun; Song, Beom-Seok; Yook, Hong-Sun; Kim, Byeong-Keun; Lee, Ju-Woon

    2012-08-01

    In the present study, initial microbial load of instant cup noodle (ICN) was investigated and gamma irradiation applied to develop immuno-compromised patients food for their safe consumption. The initial microbial population of dried vegetable and meat, and noodle was below the detection limit (1 log CFU/g); however, that of seasoning powder was just above 4 log CFU/g. Moreover, rehydrated-ICN with water at 100 °C still show above 3 log CFU/g of microbial load, which indicates the need for an additional process to control microbial safety of the seasoning powder. The total aerobic bacteria in seasoning powder and rehydrated-ICN could be controlled with 17 kGy gamma irradiation. This result referred 17 kGy gamma irradiation could reach 'practical sterility' of ICN. The overall difference in sensory properties between the non-irradiated and irradiated ICN was insignificant. Thus, gamma irradiation could improve the microbial quality of ICN, and reduce the risk of infection posed by the seasoning powder, without any adverse effects on their sensory quality. These results suggest that gamma-irradiated ICN can be used as a snack food for immuno-compromised patients.

  20. Acute myocardial infarction after heart irradiation in young patients with Hodgkin's disease

    SciTech Connect

    Joensuu, H.

    1989-02-01

    Forty-seven patients younger than 40 years at the time of the diagnosis, and irradiated to the mediastinum for Hodgkin's disease at Turku University Central Hospital from 1977 to 1982, were regularly followed for 56 to 127 months after therapy. Two patients developed an acute myocardial infarction ten and 50 months after cardiac irradiation at the age of only 28 and 24 years, respectively. None of the patients died from lymphoma within five years from the diagnosis, but one of the infarctions was eventually fatal. Since acute myocardial infarction is rare in this age group, the result suggests strongly that prior cardiac irradiation is a risk factor for acute myocardial infarction. The possibility of radiation-induced myocardial infarction should be taken into account both in treatment planning and follow-up of patients with Hodgkin's disease.

  1. CyberKnife-based prostate cancer patient radioablation – early results of irradiation in 200 patients

    PubMed Central

    Napieralska, Aleksandra; Namysł-Kaletka, Agnieszka; Głowacki, Grzegorz; Grabińska, Kinga; Woźniak, Grzegorz; Stąpór-Fudzińska, Małgorzata

    2015-01-01

    Introduction Prostrate cancer (PC) is one of the most common malignancies and is frequently treated with an 8-week course of radiotherapy. CyberKnife (CK) based radioablation enables completion of therapy within 5-9 days. The aim of this study is an evaluation of the effectiveness and tolerance of CyberKnife-based radioablation in prostate cancer patients. Material and methods 200 PC patients (94 low risk [LR], 106 intermediate risk [IR]) underwent CK irradiation every other day (fraction dose [fd] 7.25 Gy, total dose [TD] 36.25 Gy, time 9 days). PSA varied from 1.1 to 19.5 (median 7.7) and T stage from T1c to T2c. The percentage of patients with Androgen Deprivation Therapy (ADT), GI (gastrointestinal) and GU (genitourinary) toxicity (EORTC/RTOG scale), and PSA were checked at 1, 4 and 8 months, and thereafter every 6 months – up to a total of 26 months – post-treatment. Results The percentage of patients without ADT increased from 47.5% to 94.1% after 26 months. The maximum percentage of acute G3 adverse effects was 0.6% for GI, 1% for GU and G2 – 2.1% for GI and 8.5% for GU. No late G3 toxicity was observed. The maximum percentage of late G2 toxicity was 0.7% for GI and 3.4% for GU. Median PSA decreased from 7.7 to 0.1 ng/ml during FU. One patient relapsed and was treated with salvage brachytherapy. Conclusions We conclude that CK-based radioablation in low and intermediate risk PC patients is an effective treatment modality enabling OTT reduction and presents a very low percentage of adverse effects. PMID:26568868

  2. Pediatric Craniospinal Axis Irradiation With Helical Tomotherapy: Patient Outcome and Lack of Acute Pulmonary Toxicity

    SciTech Connect

    Penagaricano, Jose; Moros, Eduardo; Corry, Peter; Saylors, Robert; Ratanatharathorn, Vaneerat

    2009-11-15

    Purpose: To present the patient outcomes and risk of symptomatic acute radiation pneumonitis (ARP) in 18 pediatric patients treated with helical tomotherapy to their craniospinal axis for a variety of neoplasms. Methods and Materials: A total of 18 patients received craniospinal axis irradiation with helical tomotherapy. The median age was 12 years (range, 2.5-21). The follow-up range was 3-48 months (median, 16.5). Of the 18 patients, 15 received chemotherapy in the neoadjuvant, adjuvant, or concomitant setting. Chemotherapy was tailored to the particular histologic diagnosis; 10 of 18 patients underwent surgical removal of the gross primary tumor. The patients were followed and evaluated for ARP starting at 3-6 months after completion of craniospinal axis irradiation. ARP was graded using the Common Toxicity Criteria, version 3. Results: At the last follow-up visit, 14, 2, and 2 patients were alive without disease, alive with disease, and dead of disease, respectively. The cause-specific survival rate was 89% (16 of 18), disease-free survival rate was 78% (14 of 18), and overall survival rate was 89% (16 of 18). No patient had treatment failure at the cribriform plate. No patient developed symptoms of ARP. Conclusion: Craniospinal axis irradiation using helical tomotherapy yielded encouraging patient outcomes and acute toxicity profiles. Although large volumes of the lung received low radiation doses, no patient developed symptoms of ARP during the follow-up period.

  3. A novel quantification method for determining previously undetected silent infarcts on MR-perfusion in patients following carotid endarterectomy

    NASA Astrophysics Data System (ADS)

    Liu, Xin; Imielinska, Celina; Rosiene, Joel; Rampersad, Anita; Zurica, Joseph; Wilson, David; Halazun, Hadi; Williams, Susan C.; Ligneli, Angela; D'Ambrosio, Anthony; Sughrue, Michael; Connolly, E. S., Jr.; Heyer, Eric J.

    2005-04-01

    The purpose of this paper is to evaluate the post-operative Magnetic Resonance Perfusion (MRP) scans of patients undergoing carotid endarterectomy (CEA), using a novel image-analysis algorithm, to determine if post-operative neurocognitive decline is associated with cerebral blood flow changes. CEA procedure reduces the risk of stroke in appropriately selected patients with significant carotid artery stenosis. However, 25% of patients experience subtle cognitive deficits after CEA compared to a control group. It was hypothesized that abnormalities in cerebral blood flow (CBF) are responsible for these cognitive deficits. A novel algorithm for analyzing MR-perfusion (MRP) scans to identify and quantify the amount of CBF asymmetry in each hemisphere was developed and to quantify the degree of relative difference between three corresponding vascular regions in the ipsilateral and contralateral hemispheres, the Relative Difference Map (RDM). Patients undergoing CEA and spine surgery (controls) were examined preoperatively, and one day postoperatively with a battery of neuropsychometric (NPM) tests, and labeled "injured" patients with significant cognitive deficits, and "normal" if they demonstrated no decline in neurocognitive function. There are apparently significant RDM differences with MRP scans between the two hemispheres in patients with cognitive deficits which can be used to guide expert reviews of the imagery. The proposed methodology aids in the analysis of MRP parameters in patients with cognitive impairment.

  4. Stress thallium-201 myocardial scintigraphy for the detection of individual coronary arterial lesions in patients with and without previous myocardial infarction

    SciTech Connect

    Rigo, P.; Bailey, I.K.; Griffith, L.S.; Pitt, B.; Wagner, H.N. Jr.; Becker, L.C.

    1981-08-01

    The value of stress thallium-201 scintigraphy for detecting individual coronary arterial stenoses was analyzed in 141 patients with angiographically proved coronary artery disease, 101 with and 40 without a previous myocardial infarction. In patients without infarction, the sensitivity for detecting greater than 50 percent narrowing in the left anterior descending, the right and the left circumflex coronary artery was 66, 53 and 24 percent, respectively. In those with a previous infarction, the sensitivity for demonstrating disease in the artery corresponding to the site of infarction was 100 percent for the left anterior descending, 79 percent for the right and 63 percent for the left circumflex coronary artery. In patients with a prior anterior infarction, concomitant right or left circumflex coronary arterial lesions were detected in only 1 of 12 cases, whereas in those with previous inferior or inferolateral infarction, the sensitivity for left anterior descending coronary artery disease was 69 percent. Because of the reasonably high sensitivity for detecting left anterior descending arterial disease, irrespective of the presence and location of previous infarction, myocardial scintigraphy was useful in identifying multivessel disease in patients with a previous inferior infarction. However, because of its relative insensitivity for right or left circumflex coronary artery disease, scintigraphy proved to be a poor predictor of multivessel disease in patients with a prior anterior infarction and in patients without previous myocardial infarction.

  5. A patient previously treated with ALK inhibitors for central nervous system lesions from ALK rearranged lung cancer: a case report

    PubMed Central

    Kashima, Jumpei; Okuma, Yusuke; Hishima, Tsunekazu

    2016-01-01

    Background Patients with anaplastic lymphoma kinase (ALK)-rearranged non-small-cell lung cancer (NSCLC) are now preferentially treated with tyrosine kinase inhibitors (TKIs). However, patients treated with ALK inhibitors end up with acquired resistance. Case presentation We present a patient with recurrent ALK-rearranged NSCLC that developed multiple brain metastases and meningitis carcinomatosa after sequential treatment with several lines of cytotoxic chemotherapy, crizotinib, and alectinib. After the patient underwent retreatment with crizotinib as salvage therapy because of poor performance status, the intracranial metastatic foci and meningeal thickening were shrank within 1 week. Conclusion Our experience with this case suggests that alectinib may restore sensitivity to crizotinib or amplified pathway such as MET which bestowed alectinib resistance was inhibited with crizotinib. PMID:27785052

  6. Safety and efficacy of the addition of simvastatin to panitumumab in previously treated KRAS mutant metastatic colorectal cancer patients.

    PubMed

    Baas, Jara M; Krens, Lisanne L; Bos, Monique M; Portielje, Johanneke E A; Batman, Erdogan; van Wezel, Tom; Morreau, Hans; Guchelaar, Henk-Jan; Gelderblom, Hans

    2015-09-01

    Panitumumab has proven efficacy in patients with metastatic or locally advanced colorectal cancer patients, provided that they have no activating KRAS mutation in their tumour. Simvastatin blocks the mevalonate pathway and thereby interferes with the post-translational modification of KRAS. We hypothesize that the activity of the RAS-induced pathway in patients with a KRAS mutation might be inhibited by simvastatin. This would theoretically result in increased sensitivity to panitumumab, potentially comparable with tumours with wild-type KRAS. A Simon two-stage design single-arm, phase II study was designed to test the safety and efficacy of the addition of simvastatin to panitumumab in colorectal cancer patients with a KRAS mutation after failing fluoropyrimidine-based, oxaliplatin-based and irinotecan-based therapy. The primary endpoint of this study was the proportion of patients alive and free from progression 11 weeks after the first administration of panitumumab, aiming for at least 40%, which is comparable with, although slightly lower than, that in KRAS wild-type patients in this setting. If this 40% was reached, then the study would continue into the second step up to 46 patients. Explorative correlative analysis for mutations in the KRAS and related pathways was carried out. One of 14 patients was free from progression at the primary endpoint time. The median progression-free survival was 8.4 weeks and the median overall survival status was 19.6 weeks. We conclude that the concept of mutant KRAS phenotype expression modulation with simvastatin was not applicable in the clinic.

  7. Glycyrrhizin in patients who failed previous interferon alpha-based therapies: biochemical and histological effects after 52 weeks.

    PubMed

    Manns, M P; Wedemeyer, H; Singer, A; Khomutjanskaja, N; Dienes, H P; Roskams, T; Goldin, R; Hehnke, U; Inoue, H

    2012-08-01

    Chronic hepatitis C patients often fail to respond to interferon-based therapies. This phase III study aimed at confirming the efficacy and safety of glycyrrhizin in interferon + ribavirin-based therapy non-responders. A randomised, double-blind, placebo-controlled, comparison of glycyrrhizin, administered intravenously 5×/or 3×/week, and 5×/week placebo for 12 weeks to 379 patients, was followed by a randomised, open comparison of glycyrrhizin i.v. 5×/versus 3×/week for 40 weeks. Primary endpoints were: (1) the proportion of patients with ≥50% ALT (alanine aminotransferase) reduction after 12 weeks double-blind phase, and (2) the proportion of patients with improvement of necro-inflammation after 52 weeks as compared with baseline. The proportion of patients with ALT reduction ≥50% after 12 weeks was significantly higher with 5×/week glycyrrhizin (28.7%, P < 0.0001) and 3×/week glycyrrhizin (29.0%, P < 0.0001) compared with placebo (7.0%). The proportion of patients with improvement in necro-inflammation after 52 weeks was 44.9% with 5×/week and 46.0% with 3×/week, respectively. Glycyrrhizin exhibited a significantly higher ALT reduction compared to placebo after 12 weeks of therapy and an improvement of necro-inflammation and fibrosis after 52-weeks treatment. Generally, glycyrrhizin treatment was well tolerated.

  8. Postmortem examination of 22 pancreatic carcinoma patients treated with helium ion irradiation

    SciTech Connect

    Woodruff, K.H.; Castro, J.R.; Quivey, J.M.; Saunders, W.M.; Chen, G.T.; Lyman, J.T.; Pitluck, S.; Tobias, C.A.; Walton, R.E.; Peters, T.C.

    1984-02-01

    Postmortem findings are available in this report in 22 patients with pancreatic carcinoma treated with helium ions at Lawrence Berkeley Laboratory; California. This represents the largest group evaluated histologically in the literature and is the first report evaluating effects of particle radiation in pancreatic tissue. Patient survival after therapy averaged 9 months. Most died of infection and/or pulmonary emboli. Local control was achieved in 27%. The pancreatic tumors had histologically more severe radiation changes than nontumor bearing pancreas. Irradiated bone marrow was severely hypocellular, and irradiated skin was atrophic. Five patients had radiation injury in the gastrointestinal tract. The spinal cord, liver, and kidneys showed no damage. This study demonstrates the safety of helium particle irradiation with present therapeutic planning. Injury to tumor was seen without excessive damage to adjacent tissues.

  9. Draft Genome Sequence of Lactobacillus delbrueckii Strain #22 Isolated from a Patient with Short Bowel Syndrome and Previous d-Lactic Acidosis and Encephalopathy.

    PubMed

    Domann, Eugen; Fischer, Florence; Glowatzki, Fabian; Fritzenwanker, Moritz; Hain, Torsten; Zechel-Gran, Silke; Giffhorn-Katz, Susanne; Neubauer, Bernd A

    2016-01-01

    d-Lactic acidosis with associated encephalopathy caused by overgrowth of intestinal lactic acid bacteria is a rarely diagnosed neurological complication of patients with short bowel syndrome. Here, we report the draft genome sequence of Lactobacillus delbrueckii strain #22 isolated from a patient with short bowel syndrome and previous d-lactic acidosis/encephalopathy. PMID:27469967

  10. Draft Genome Sequence of Lactobacillus delbrueckii Strain #22 Isolated from a Patient with Short Bowel Syndrome and Previous d-Lactic Acidosis and Encephalopathy

    PubMed Central

    Fischer, Florence; Glowatzki, Fabian; Fritzenwanker, Moritz; Hain, Torsten; Zechel-Gran, Silke; Giffhorn-Katz, Susanne; Neubauer, Bernd A.

    2016-01-01

    d-Lactic acidosis with associated encephalopathy caused by overgrowth of intestinal lactic acid bacteria is a rarely diagnosed neurological complication of patients with short bowel syndrome. Here, we report the draft genome sequence of Lactobacillus delbrueckii strain #22 isolated from a patient with short bowel syndrome and previous d-lactic acidosis/encephalopathy. PMID:27469967

  11. Effect of different treatment plans on irradiated small-bowel volume in gynecologic patients undergoing whole-pelvic irradiation.

    PubMed

    Chang, Shih-Chen; Lee, Hsiao-Fei; Ting, Hui-Min; Pan, Tzu-Chao; Liu, Shu-Yu; Chen, Chien-Fu; Wang, Teng-Yi; Juan, Kuo-Jung; Liao, Tsung-I; Huang, Eng-Yen

    2013-09-01

    To evaluate the effect of different treatment plans for whole-pelvic irradiation on small-bowel volumes (SBVs) in patients with gynecologic malignancies, 40 patients were enrolled in this study. Computed tomography (CT) simulations were performed, and the small bowel of each patient was outlined manually. Treatment plans with equal-weighted (EW) and non-equal-weighted (NEW) (70% in bilateral directions) techniques of four-field and intensity-modulated radiation therapy (IMRT) were performed. The V10-V100 represented the volume (cm³) at different levels of the prescribed doses (10-100%). The V10-V100 was compared among the different treatment planning techniques, and patients who were suitable for IMRT or NEW were identified. IMRT and NEW significantly reduced the V50-V100 and V40-V60 levels compared with EW, respectively. NEW caused a significant reduction in the V30-V60 levels in patients with a BMI ≥26 kg/m². Patients with IMRT demonstrated lower V70-V100 levels compared with those with NEW. In patients with a BMI ≥26 kg/m² or an age ≥55 years, lower V20-V50 levels were noted using NEW compared with IMRT. Treatment planning with larger weighting in the bilateral directions in four-field radiotherapy reduces the low-dose SBV in patients with gynecologic malignancies, especially in those with a high BMI or the elderly. IMRT effectively reduces high-dose SBV, especially in patients with a low BMI.

  12. Analysis of endodontic therapy in patients irradiated for head and neck cancer

    SciTech Connect

    Seto, B.G.; Beumer, J. 3d.; Kagawa, T.; Klokkevold, P.; Wolinsky, L.

    1985-11-01

    The outcome of endodontic therapy in 16 patients irradiated for head and neck cancer was studied. Thirty-five postradiation endodontically treated teeth (54 roots) were included in the study. The follow-up period ranged from 6 months to 54 months. At the time of last follow-up, 46 of 54 roots were being maintained. No osteoradionecroses were seen in association with teeth that had been endodontically treated. From this review, it is clear that endodontic therapy is a viable method of treating diseased teeth in patients irradiated for oral neoplasms.

  13. Tailored total lymphoid irradiation in heart transplant patients: 10-years experience of one center

    PubMed Central

    2010-01-01

    Background To assess safety and efficacy of tailored total lymphoid irradiation (tTLI) in cardiac transplant patients. Methods A total of seven patients, of which five had recalcitrant cellular cardiac allograft rejection (RCCAR), confirmed by endomyocardial biopsies, and two had side effects of immunosuppressive drug therapy, were all treated with tTLI. tTLI was defined by the adjustment of both the fraction interval and the final irradiation dosage both being dependent on the patients general condition, irradiation-dependent response, and the white blood and platelet counts. A mean dose of 6.4 Gy (range, 1.6 - 8.8 Gy) was given. Median follow-up was 7 years (range, 1.8 - 12.2 years). Results tTLI was well tolerated. Two patients experienced a severe infection during tTLI (pneumocystis jirovecii pneumonia, urosepsis and generalized herpes zoster) and one patient developed a lymphoproliferative disorder after tTLI. The rate of rejection episodes before tTLI was 0.43 episodes/patient/month and decreased to 0.02 episodes/patient/month after tTLI (P < .001). At the end of the observation time, all patients except one were alive. Conclusions tTLI is a useful treatment strategy for the management of RCCAR and in patients with significant side effects of immunosuppressive drug therapy. In this series tTLI demonstrated significantly decreased rejection rates without causing relevant treatment-related toxicity. PMID:20078889

  14. Rapidly progressed aortic stenosis in a patient with previous diagnosis of polycythemia vera and post-polycythemia vera myelofibrosis.

    PubMed

    Kiso, Shohei; Naito, Ryo; Fukao, Kosuke; Hiki, Makoto; Miyazaki, Tetsuro; Takagi, Atsutoshi; Miyauchi, Katsumi; Daida, Hiroyuki

    2016-06-01

    Polycythemia vera (PV) is a chronic myeloproliferative disease that is often complicated with thromboembolism. However, aortic stenosis (AS) could be a manifestation of the cardiovascular complications of PV possibly through shear stress and atherosclerosis. We report a rare case of rapidly progressed AS in a patient with PV.

  15. Phase III randomized trial of sunitinib versus capecitabine in patients with previously treated HER2-negative advanced breast cancer

    PubMed Central

    Liu, Mei-Ching; Lee, Soo Chin; Vanlemmens, Laurence; Ferrero, Jean-Marc; Tabei, Toshio; Pivot, Xavier; Iwata, Hiroji; Aogi, Kenjiro; Lugo-Quintana, Roberto; Harbeck, Nadia; Brickman, Marla J.; Zhang, Ke; Kern, Kenneth A.; Martin, Miguel

    2010-01-01

    This multicenter, randomized, open-label phase III trial (planned enrollment: 700 patients) was conducted to test the hypothesis that single-agent sunitinib improves progression-free survival (PFS) compared with capecitabine as treatment for advanced breast cancer (ABC). Patients with HER2-negative ABC that recurred after anthracycline and taxane therapy were randomized (1:1) to sunitinib 37.5 mg/day or capecitabine 1,250 mg/m2 (1,000 mg/m2 in patients >65 years) BID on days 1–14 q3w. The independent data-monitoring committee (DMC) determined during the first interim analysis (238 patients randomized to sunitinib, 244 to capecitabine) that the trial be terminated due to futility in reaching the primary endpoint. No statistical evidence supported the hypothesis that sunitinib improved PFS compared with capecitabine (one-sided P = 0.999). The data indicated that PFS was shorter with sunitinib than capecitabine (median 2.8 vs. 4.2 months, respectively; HR, 1.47; 95% CI, 1.16–1.87; two-sided P = 0.002). Median overall survival (15.3 vs. 24.6 months; HR, 1.17; two-sided P = 0.350) and objective response rates (11 vs. 16%; odds ratio, 0.65; P = 0.109) were numerically inferior with sunitinib versus capecitabine. While no new or unexpected safety findings were reported, sunitinib treatment was associated with higher frequencies and greater severities of many common adverse events (AEs) compared with capecitabine, resulting in more temporary discontinuations due to AEs with sunitinib (66 vs. 51%). The relative dose intensity was lower with sunitinib than capecitabine (73 vs. 95%). Based on these efficacy and safety results, sunitinib should not be used as monotherapy for patients with ABC. PMID:20339913

  16. Accelerated partial breast irradiation with brachytherapy: patient selection and technique considerations

    PubMed Central

    Trifiletti, Daniel M; Romano, Kara D; Showalter, Shayna L; Reardon, Kelli A; Libby, Bruce; Showalter, Timothy N

    2015-01-01

    Accelerated partial breast irradiation (APBI) through breast brachytherapy is a relatively recent development in breast radiotherapy that has gained international favor because of its reduction in treatment duration and normal tissue irradiation while maintaining favorable cancer-specific and cosmetic outcomes. Despite the fact that several large national trials have not reported final results yet, many providers are currently offering APBI to select patients and APBI is listed as a treatment option for selecting patients in the National Comprehensive Cancer Network guidelines. Multiple consensus guidelines exist in selecting patients for APBI, some with conflicting recommendations. In this review, the existing patient selection guidelines are reported, compared, and critiqued, grouping them in helpful subcategories. Unique patient and technical selection factors for APBI with brachytherapy are explored. PMID:26251627

  17. Changes in T-cell subsets in patients with rheumatoid arthritis treated with total lymphoid irradiation

    SciTech Connect

    Kotzin, B.L.; Kansas, G.S.; Engleman, E.G.; Hoppe, R.T.; Kaplan, H.S.; Strober, S.

    1983-05-01

    Patients with intractable rheumatoid arthritis (RA) were treated with total lymphoid irradiation (TLI, 2000 rads). We previously reported long-lasting clinical improvement associated with marked suppression of in vitro lymphocyte function in this group. In an attempt to better understand the mechanism of immunosuppression and clinical changes observed after TLI, we studied in greater detail changes in peripheral blood T-cell subsets identified by monoclonal antibodies. Before TLI, RA patients had a higher percentage of Leu-3 (helper subset) cells and a lower percentage of Leu-2 (suppressor/cytotoxic subset) cells than normals. Immediately after TLI, the absolute numbers of both Leu-2 and Leu-3 cells were reduced by at least 90%. Within 6-12 weeks, the number of Leu-2 cells returned to the pretreatment levels, but the levels of Leu-3 cells remained depressed for months thereafter. The lack of repopulation of Leu-3 cells resulted in a marked increase in the ratio of Leu-2 to Leu-3 cells as compared to pretreatment values (1.73 +/- 0.23 vs 0.39 +/- 0.06), and in a decrease in the percentage and absolute number of total T (Leu-1 and Leu-4) cells. The failure of Leu-3 cells (which mediate predominantly helper/inducer functions) to repopulate the peripheral blood may contribute to the prolonged clinical immunosuppression observed after TLI. Similar changes in T-cell subsets were not observed in RA patients given remittive drugs or low doses (200 rads) of radiotherapy. Thus, TLI differs from other treatment modalities with regard to its prolonged selective effect on the Leu-3 subset.

  18. Intrapatient emergence of OXA-247: a novel carbapenemase found in a patient previously infected with OXA-163-producing Klebsiella pneumoniae.

    PubMed

    Gomez, S; Pasteran, F; Faccone, D; Bettiol, M; Veliz, O; De Belder, D; Rapoport, M; Gatti, B; Petroni, A; Corso, A

    2013-05-01

    Two genetically related Klebsiella pneumoniae strains carrying OXA-type carbapenemases were isolated from a single patient 1 month apart. Kpn163 harboured OXA-163 and Kpn247 a new variant named OXA-247 that showed susceptibility to carbapenems and expanded-spectrum cephalosporins similar to OXA-48. Our epidemiological, biochemical and molecular results suggest the intrapatient emergence of blaOXA -247 from blaOXA -163.

  19. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial.

    PubMed

    Fischer, Kirsten; Bahlo, Jasmin; Fink, Anna Maria; Goede, Valentin; Herling, Carmen Diana; Cramer, Paula; Langerbeins, Petra; von Tresckow, Julia; Engelke, Anja; Maurer, Christian; Kovacs, Gabor; Herling, Marco; Tausch, Eugen; Kreuzer, Karl-Anton; Eichhorst, Barbara; Böttcher, Sebastian; Seymour, John F; Ghia, Paolo; Marlton, Paula; Kneba, Michael; Wendtner, Clemens-Martin; Döhner, Hartmut; Stilgenbauer, Stephan; Hallek, Michael

    2016-01-14

    Despite promising results with targeted drugs, chemoimmunotherapy with fludarabine, cyclophosphamide (FC), and rituximab (R) remains the standard therapy for fit patients with untreated chronic lymphocytic leukemia (CLL). Herein, we present the long-term follow-up of the randomized CLL8 trial reporting safety and efficacy of FC and FCR treatment of 817 treatment-naïve patients with CLL. The primary end point was progression-free survival (PFS). With a median follow-up of 5.9 years, median PFS were 56.8 and 32.9 months for the FCR and FC group (hazard ratio [HR], 0.59; 95% confidence interval [CI], 0.50-0.69, P < .001). Median overall survival (OS) was not reached for the FCR group and was 86.0 months for the FC group (HR, 0.68; 95% CI, 0.54-0.89, P = .001). In patients with mutated IGHV (IGHV MUT), FCR improved PFS and OS compared with FC (PFS: HR, 0.47; 95% CI, 0.33-0.68, P < .001; OS: HR, 0.62; 95% CI, 0.34-1.11, P = .1). This improvement remained applicable for all cytogenetic subgroups other than del(17p). Long-term safety analyses showed that FCR had a higher rate of prolonged neutropenia during the first year after treatment (16.6% vs 8.8%; P = .007). Secondary malignancies including Richter's transformation occurred in 13.1% in the FCR group and in 17.4% in the FC group (P = .1). First-line chemoimmunotherapy with FCR induces long-term remissions and highly relevant improvement in OS in specific genetic subgroups of fit patients with CLL, in particular those with IGHV MUT. This trial was registered at www.clinicaltrials.gov as #NCT00281918. PMID:26486789

  20. Monotypic plasma cell interstitial nephritis as the only clinical manifestation in a patient with previously undiagnosed indolent multiple myeloma

    PubMed Central

    Attias, Philippe; Moktefi, Anissa; Matignon, Marie; Dupuis, Jehan; Debiais-Delpech, Céline; Grimbert, Philippe; Lang, Philippe; Audard, Vincent

    2016-01-01

    Abstract Introduction: Predominantly monotypic plasma cell infiltrates are an uncommon renal finding in patients with malignant lymphoplasmacytic proliferation. Case presentation: We report the case of a 52-year-old man with chronic kidney disease and significant proteinuria associated with a monoclonal immunoglobulin spike (IgGκ). Kidney biopsy revealed the presence of atypical multinucleated CD138+ plasma cells with voluminous nuclei stained exclusively with a κ antibody. Electron microscopy showed mesangial and segmental parietal electron-dense, nonorganized hyaline deposits without immunogold labeling for the κ light chain. The bone marrow aspirate revealed 6% of apparently mature plasmocytes without dystrophy. We therefore concluded that the patient had an indolent multiple myeloma with specific renal involvement in the form of malignant monotypic interstitial plasmacytic infiltration. We initiated a specific chemotherapy regimen including bortezomib–cyclophosphamide–dexamethasone. After 4 months of follow-up, creatinine levels had improved slightly and free κ light-chain levels had decreased significantly within the normal range. Conclusion: This case highlights the need to consider neoplastic interstitial plasma cell infiltration systematically in patients diagnosed with an apparently benign monoclonal gammopathy and to consider adaptation of the chemotherapy regimen, to improve renal function. PMID:27495052

  1. A Catecholamine-Secreting Skull Base Sinonasal Paraganglioma Presenting with Labile Hypertension in a Patient with Previously Undiagnosed Genetic Mutation

    PubMed Central

    Hahn, Samuel; Palmer, James N.; Adappa, Nithin D.

    2012-01-01

    Sinonasal paragangliomas are very uncommon neuroendocrine tumors that can present as skull base lesions. Functional paragangliomas are exceedingly rare. They can be associated with genetic mutations that have been associated with increased risk of head and neck paragangliomas. We present a case of a rare functioning sinonasal paraganglioma of the skull base in a patient with distant history of prior abdominal paragangliomas. The patient underwent subtotal endoscopic resection of the skull base lesion limited by carotid encasement of the tumor. They were treated with postoperative adjuvant radiation and therapeutic metaiodobenzylguanidine (MIBG) therapy. Genetic testing revealed succinate dehydrogenase B (SDHB) mutation. Skull base paragangliomas are rare tumors that may preclude complete surgical resection. 131Iodine-MIBG can be used as adjuvant therapy in postoperative external beam radiation and in MIBG avid tumors. Long-term follow-up is needed given locally aggressive nature of these tumors, especially for patients with history of genetic mutations such as SDHB mutations as recurrent paragangliomas may develop. PMID:23946921

  2. Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy

    ClinicalTrials.gov

    2015-02-05

    Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Myeloid Leukemia

  3. Prophylactic plastic surgery closure of neurosurgical scalp incisions reduces the incidence of wound complications in previously-operated patients treated with bevacizumab (Avastin®) and radiation.

    PubMed

    Golas, Alyssa Reiffel; Boyko, Tatiana; Schwartz, Theodore H; Stieg, Philip E; Boockvar, John A; Spector, Jason A

    2014-09-01

    Neurosurgical craniotomy, craniectomy, or other trans-galeal interventions are performed for a variety of indications, including the resection of benign or malignant tumors, hematoma evacuation, and for the management of intractable seizure disorders. Despite an overall low complication rate of intervention, wound healing complications such as dehiscence, surgical site infection, and cerebrospinal fluid leak are not uncommon. A retrospective review was performed of all patients who underwent scalp incision closure at a single institution by a single plastic surgeon between 2006 and 2013. Sixty patients (83 procedures) were included in the study. Fifty-seven patients (95.0 %) underwent previous craniotomy, craniectomy, or other trans-galeal procedure. Of the total 60 patients, 35 patients received preoperative radiation. Sixteen patients received bevacizumab prior to their index case, while 12 received bevacizumab postoperatively. Ten patients (16.7 %) required additional plastic surgical intervention for wound complications after their index plastic surgery procedure. Plastic surgery was consulted prophylactically in 34 patients (38 procedures). When plastic surgery was consulted prophylactically, 4 patients (11.8 %) required further wound revision. None of the 14 patients who underwent prophylactic plastic surgery closure for previous scalp incision, preoperative bevacizumab, and XRT administration required re-intervention. Plastic surgery closure of complex scalp incisions reduces the incidence of wound complications among patients who underwent previous neurosurgical intervention, XRT administration, and preoperative bevacizumab administration. This is particularly true when plastic surgery closure is performed "prophylactically." Further collaboration between the neurosurgical and plastic surgery teams is therefore warranted, particularly in the setting of these high-risk cases.

  4. Antepartum uterine rupture in a twin gestation presenting as an advanced extrauterine pregnancy in a patient with a previous lower segment Caesarean section.

    PubMed

    Ngene, Nnabuike C; Naidoo, Thinagrin D; Titus, Mokete; Moodley, Jagidesa; Craib, Shirley; Stutterheim, James

    2014-07-01

    We present a case of spontaneous antepartum uterine rupture through a previous lower segment Caesarean section (LSCS) scar with clinical features mimicking an advanced extrauterine pregnancy (AEUP) in a twin pregnancy at 28 weeks gestation. This report illustrates the need to consider a diagnosis of a ruptured uterus in any patient with a previous abdominal delivery who presents with mild abdominal tenderness and an ultrasonographic image suggestive of demised fetus in the intra-peritoneal cavity.

  5. Re-irradiation with hypo-fractionated stereotactic robotic radiotherapy for salvage in adult patients with brainstem glioma

    PubMed Central

    Susheela, Sridhar P; Revannasiddaiah, Swaroop; Muzumder, Sandeep; Mallarajapatna, Govindarajan; Kallur, Kumar; Basavalingaiah, Ajaikumar S

    2013-01-01

    Purpose Brainstem glioma (BSG) is often treated with definitive irradiation. However, subsequent progression and death occur as a rule rather than the exception, after varying periods of control. The outlook of patients with post-irradiation progression is dismal, and most of these patients are treated with supportive care alone. Despite the obvious risks with an area as critical as the brainstem, it is a possibility to encounter situations wherein the patients (themselves or their associates) ask for re-irradiation, with the hope of a few extra months of life. The risk of radiation-induced brainstem toxicity may be justifiable under the strict assumption that the patients stand a chance of benefiting from re-irradiation but still may not live long enough to manifest brainstem toxicity. Methods Five adult BSG patients were treated with re-irradiation using robotic-arm stereotactic radiation therapy (SRT) between September 2009 and July 2012, primarily at the request of the concerned patient parties. Re-irradiation doses ranged from 16 to 25 Gray (Gy) delivered by robotic arm stereotactic irradiation in 2–5 fractions. Results Four out of five patients enjoyed a prolongation of survival in the order of months (three, five, six, and 14 months), which was very significant given that all patients had severe neurological compromise and poor performance status prior to re-irradiation. One patient has survived 36 months after re-irradiation and thus has lived long enough to manifest late radiation-induced brainstem toxicity. Conclusion Despite the obvious risks of brainstem toxicity associated with the use of re-irradiation for BSG, the use of fractionated stereotactic re-irradiation seems to offers prospects of additional periods of local control and augments duration of life. PMID:24171050

  6. Influenza H1N1 Infection Leading To Cardiac Tamponade in a Previously Healthy Patient: A Case Report

    PubMed Central

    Sidhu, Robinder S.; Sharma, Abhinav; Paterson, Ian D.; Bainey, Kevin R.

    2016-01-01

    Introduction The cardiac manifestations of influenza A are broad, ranging from self-limited pericarditis to fatal cardiomyopathy. The 2009 H1N1 influenza A (H1N1) strain is a rare cause of pericarditis, and its role in developing a pericardial effusion leading to tamponade has infrequently been reported. Case Presentation We describe a case of a young female with no prior cardiovascular history who presents with a pericardial effusion and shock secondary to cardiac tamponade from pericarditis due to H1N1 influenza A. Conclusions This case highlights the potential severity of H1N1 infections and the utility of considering cardiac tamponade in patients presenting with influenza symptoms and circulatory collapse. PMID:27800452

  7. Effect of preoperative angina pectoris on cardiac outcomes in patients with previous myocardial infarction undergoing major noncardiac surgery (data from ACS-NSQIP).

    PubMed

    Pandey, Ambarish; Sood, Akshay; Sammon, Jesse D; Abdollah, Firas; Gupta, Ena; Golwala, Harsh; Bardia, Amit; Kibel, Adam S; Menon, Mani; Trinh, Quoc-Dien

    2015-04-15

    The impact of preoperative stable angina pectoris on postoperative cardiovascular outcomes in patients with previous myocardial infarction (MI) who underwent major noncardiac surgery is not well studied. We studied patients with previous MI who underwent elective major noncardiac surgeries within the American College of Surgeons-National Surgical Quality Improvement Program (2005 to 2011). Primary outcome was occurrence of an adverse cardiac event (MI and/or cardiac arrest). Multivariable logistic regression models evaluated the impact of stable angina on outcomes. Of 1,568 patients (median age 70 years; 35% women) with previous MI who underwent major noncardiac surgery, 5.5% had postoperative MI and/or cardiac arrest. Patients with history of preoperative angina had significantly greater incidence of primary outcome compared to those without anginal symptoms (8.4% vs 5%, p = 0.035). In secondary outcomes, reintervention rates (22.5% vs 11%, p <0.001) and length of stay (median 6-days vs 5-days; p <0.001) were also higher in patients with preoperative angina. In multivariable analyses, preoperative angina was a significant predictor for postoperative MI (odds ratio 2.49 [1.20 to 5.58]) and reintervention (odds ratio 2.40 [1.44 to 3.82]). In conclusion, our study indicates that preoperative angina is an independent predictor for adverse outcomes in patients with previous MI who underwent major noncardiac surgery, and cautions against overreliance on predictive tools, for example, the Revised Cardiac Risk Index, in these patients, which does not treat stable angina and previous MI as independent risk factors during risk prognostication.

  8. Late radiation side-effects in three patients undergoing parotid irradiation for benign disease.

    PubMed

    Armour, A; Ghanna, P; O'Rielly, B; Habeshaw, T; Symonds, P

    2000-01-01

    We report three patients in whom standard radiation therapy was given and serious late radiation damage was seen. The first patient suffered recurrent parotiditis and a parotid fistula. He was treated initially with 20 Gy in ten fractions via a 300 kV field. Further irradiation was required 1 year later and 40 Gy was given in 2 Gy fractions by an oblique anterior and posterior wedged photon pair. Ten years later he developed localized temporal bone necrosis. The second patient, with pleomorphic salivary adenoma, developed localized temporal bone necrosis 6 years after 60 Gy had been given using standard fractionation and technique. The third patient received 55 Gy in 25 fractions for a pleomorphic salivary adenoma and after 3 years developed temporal bone necrosis. Sixteen years later the same patient developed cerebellar and brainstem necrosis. All patients developed chronic persistent infection during or shortly after the radiation therapy, which increased local tissue sensitivity to late radiation damage. As a result, severe bone, cerebellar and brainstem necrosis was observed at doses that are normally considered safe. We therefore strongly recommend that any infection in a proposed irradiated area should be treated aggressively, with surgical debridement if necessary, before radiotherapy is administered, or that infection developing during or after irradiation is treated promptly.

  9. Target volume definition and target conformal irradiation technique for breast cancer patients.

    PubMed

    Kiricuta, I C; Götz, U; Schwab, F; Fehn, M; Neumann, H H

    2000-01-01

    The aim of this study was to present the target volume and irradiation technique in the most complex situation where the breast or chest wall and the locoregional lymphatics (mammaria interna lymph nodes, axillary and supraclavicular lymph nodes) have to be irradiated. The study comprised 125 breast cancer patients treated with curative intent after primary surgery in the last two years at our institute. In 62 cases the target volume included the breast or chest wall and the locoregional lymphatics, which were treated using our irradiation technique. The target conformal irradiation technique is a multiple non-opposed beams one isocenter technique developed to protect the heart and lungs. This technique, consisting of several rotation beams modulated with wedge filters and individual lung absorbers as well as additional fixed beams, was used in our study to apply a homogeneous dose of 46 to 56 Gy to the target volume; the irradiation technique was optimized by means of dose-volume histograms. After pre-localization, the patients underwent computerized tomographic scanning, with sections at 1.0 cm intervals. Contouring of target volume and organs at risk was carried out with a MULTIDATA workstation for regions of interest (mammaria interna and/or axillary and/or supraclavicular lymphatics and the breast or chest wall) as well as the organs at risk, such as heart and lung parenchyma. Planning target volume coverage was examined by three-dimensional isodose visualization for all CT axial sections for each patient. To determine the incidence of acute or late side effects on the lung parenchyma, conventional chest x-rays and CT studies were carried out at 1 month, 3 months and 6 months after completion of radiotherapy. Dose-volume histogram analysis revealed that this irradiation technique permits the application of a homogeneous dose to the target volume, conforming to the ICRU norms. The maximum dose applied to the ipsilateral lung parenchyma was less than 50-70% of

  10. Cystoid macular edema after cataract surgery in a patient with previous severe iritis following argon laser peripheral iridoplasty

    PubMed Central

    Bagnis, Alessandro; Saccà, Sergio Claudio; Iester, Michele; Traverso, Carlo Enrico

    2011-01-01

    This report describes a patient who had exaggerated responses to different inflammatory stimuli represented by laser and incisional surgery, respectively. These separate episodes should have a common link represented by a genetic predisposition to abnormal release of proinflammatory mediators within the eye. This 51-year old Hispanic woman showed a narrow iridocorneal angle with plateau iris configuration. Nd-YAG laser peripheral iridotomy was successfully performed to both eyes. No substantial changes in the iridotrabecular angle occurred despite patent iridotomies, thus confirming the diagnosis of plateau iris configuration. Argon laser iridoplasty was then performed to the right eye, while the left eye was scheduled for a later session. A severe inflammatory reaction within the anterior chamber developed after tapering of a one-week course of steroid therapy. Phacoemulsification of the lens was performed some months later when no signs of inflammation were detectable; no intraoperative complications occurred during surgery and an intraocular lens was placed. Cystoid macular edema developed four weeks after surgery despite no apparent risk factors, and resolved completely after anti-inflammatory medical therapy. Based on this case report, the unusual occurrence of severe iritis after laser treatment should be regarded as a risk factor for any other incisional or nonincisional procedures because it might indicate that the patient’s ocular tissues are prone to release of abnormally elevated proinflammatory mediators. Although further studies are needed to confirm this predisposition, prophylactic adjunctive topical nonsteroidal anti-inflammatory drug administration after cataract surgery should be considered in such cases in order to prevent potentially sight-threatening conditions. PMID:21573094

  11. Reconstruction with vascularized composite tissue in patients with excessive injury following surgery and irradiation

    SciTech Connect

    Serafin, D.; DeLand, M.; Lesesne, C.B.; Smith, P.J.; Noell, K.T.; Georgiade, N.

    1982-01-01

    The biological effects of a single high dose of radiation are examined. Both cellular injury and repair are reviewed during early, intermediate, and late phases. Anticipated composite tissue morbidity is detailed for therapeutic radiation doses administered to the head and neck, breast and thorax, and perineum. Patients who demonstrated excessive time-dose fractionation values were irradiated with lower x-ray energies. Those in whom there was an overlap of treatment fields presented a serious challenge to the reconstructive surgeon. Judicious selection of well-vascularized composite tissue outside the portals of irradiation, preferably with a long vascular pedicle, facilitated reconstruction. When possible, both donor and recipient vasculature should be outside the irradiated area to ensure uninterrupted blood flow to the transferred or transplanted tissue.

  12. [Systematization of types and methods of radiotherapy, methods and methodology of irradiating patients].

    PubMed

    Vaĭnberg, M Sh

    1991-01-01

    The paper is concerned with the principles of systematization and classification of radiation therapy, approaches to the regulation of its terminology. They are based on the distinction of the concepts of radiation therapy and irradiation of patients. The author gives a concise historical review of improvement of the methodology of radiation therapy in the course of developing of its methods and facilities. Problems of terminology are under discussion. There is a table of types and methods of radiation therapy, methods and techniques of irradiation. In the appendices one can find a table of typical legends and examples of graphic signs to denote methods of irradiation. Potentialities of a practical use of the system are described.

  13. Imaging of HER2 may improve the outcome of external irradiation therapy for prostate cancer patients

    PubMed Central

    ANDERSSON, JENNIE; ROSESTEDT, MARIA; ORLOVA, ANNA

    2015-01-01

    Prostate cancer (PCa) is the most common type of cancer among males. Human epidermal growth factor receptor type 2 (HER2) expression in PCa has been reported by several studies and its involvement in the progression towards androgen-independent PCa has been discussed. External irradiation is one of the existing therapies, which has been demonstrated to be efficient in combination with androgen deprivation therapy for the treatment of advanced PCa. However, 20–40% of patients develop recurrent and more aggressive PCa within 10 years. The current study investigates the involvement of HER2 in survival and radioresistance in PCa cells and we hypothesized that, by monitoring HER2 expression, treatment may be personalized. The PCa cell lines, LNCap, PC3 and DU-145, received a 6 Gy single dose of external irradiation. The number of PC3 cells was not affected by a single dose of radiation, whereas a 5-fold decrease in cell number was detected in LNCap (P<0.00001) and DU-145 (P<0.0001) cells. The HER2 expression in PC3 exhibited a significant increase post irradiation, however, the expression was stable in the remaining cell lines. The administration of trastuzumab post-irradiation resulted in a 2-fold decrease in the PC3 cell number, while the drug did not demonstrate additional effects in LNCap and DU-145 cells, when compared with that of irradiation treatment alone. The results of the present study demonstrated that an increase in membranous HER2 expression in response to external irradiation may indicate cell radioresistance. Furthermore, imaging of HER2 expression prior to and following external irradiation may present a step towards personalized therapy in PCa. PMID:25624915

  14. Suppression of pokeweed mitogen-stimulated immunoglobulin production in patients with rheumatoid arthritis after treatment with total lymphoid irradiation

    SciTech Connect

    Kotzin, B.L.; Strober, S.; Kansas, G.S.; Terrell, C.P.; Engleman, E.G.

    1984-02-01

    Patients with intractable rheumatoid arthritis (RA) were treated with total lymphoid irradiation (TLI, 200 rad). The authors previously reported long-lasting clinical improvement in this group associated with a persistent decrease in circulating Leu-3 (helper subset) T cells and marked impairment of in vitro lymphocyte function. In the present experiments, they studied the mechanisms underlying the decrease in pokeweed mitogen stimulated immunoglobulin (Ig) secretion observed after TLI. Peripheral blood mononuclear cells (PBL) from TLI-treated patients produced 10-fold less Ig (both IgM and IgG) in response to pokeweed mitogen than before radiotherapy. This decrease in Ig production was associated with the presence of suppressor cells in co-culture studies. By using responder cells obtained from normal individuals (allogeneic system), PBL from eight of 12 patients after TLI suppressed Ig synthesis by more than 50%. In contrast, PBL from the same patients before TLI failed to suppress Ig synthesis. PBL with suppressive activity contained suppressor T cells, and the latter cells bore the Leu-2 surface antigen. In 50% of the patients studied suppressor cells were also found in the non-T fraction and were adherent to plastic. Interestingly, the Leu-2/sup +/ cells from TLI-treated patients were no more potent on a cell per cell basis than purified Leu-2/sup +/ cells obtained before TLI. Additional experiments suggested that the suppression mediated by T cells after TLI is related to the increased ratio of Leu-2 to Leu-3 cells observed after radiotherapy.

  15. Microbial analysis and survey test of gamma-irradiated freeze-dried fruits for patient's food

    NASA Astrophysics Data System (ADS)

    Park, Jae-Nam; Sung, Nak-Yun; Byun, Eui-Hong; Byun, Eui-Baek; Song, Beom-Seok; Kim, Jae-Hun; Lee, Kyung-A.; Son, Eun-Joo; Lyu, Eun-Soon

    2015-06-01

    This study examined the microbiological and organoleptic qualities of gamma-irradiated freeze-dried apples, pears, strawberries, pineapples, and grapes, and evaluated the organoleptic acceptability of the sterilized freeze-dried fruits for hospitalized patients. The freeze-dried fruits were gamma-irradiated at 0, 1, 2, 3, 4, 5, 10, 12, and 15 kGy, and their quality was evaluated. Microorganisms were not detected in apples after 1 kGy, in strawberries and pears after 4 kGy, in pineapples after 5 kGy, and in grapes after 12 kGy of gamma irradiation. The overall acceptance score, of the irradiated freeze-dried fruits on a 7-point scale at the sterilization doses was 5.5, 4.2, 4.0, 4.1, and 5.1 points for apples, strawberries, pears, pineapples, and grapes, respectively. The sensory survey of the hospitalized cancer patients (N=102) resulted in scores of 3.8, 3.7, 3.9, 3.9, and 3.7 on a 5-point scale for the gamma-irradiated freeze-dried apples, strawberries, pears, pineapples, and grapes, respectively. The results suggest that freeze-dried fruits can be sterilized with a dose of 5 kGy, except for grapes, which require a dose of 12 kGy, and that the organoleptic quality of the fruits is acceptable to immuno-compromised patients. However, to clarify the microbiological quality and safety of freeze-dried fruits should be verified by plating for both aerobic and anaerobic microorganisms.

  16. Thrombotic Microangiopathy In Metastatic Melanoma Patients Treated with Adoptive Cell Therapy and Total Body Irradiation

    PubMed Central

    Tseng, Jennifer; Citrin, Deborah E.; Waldman, Meryl; White, Donald E.; Rosenberg, Steven A.; Yang, James C.

    2014-01-01

    Background Thrombotic microangioapathy (TMA) is a complication that developed in some patients receiving 12 Gy total body irradiation in addition to lymphodepleting preparative chemotherapy prior to infusion of autologous tumor infiltrating lymphocytes (TIL) with high-dose aldesleukin (IL-2). This paper describes the incidence, presentation and course of radiation-associated TMA. Methods The data for patients with metastatic melanoma who received ACT with TIL plus aldesleukin following myeloablative chemotherapy and 12 Gy total body irradiation was examined, looking at patient characteristics and the natural history of TMA. Results The median time to presentation was approximately 8 months after completing TBI. The estimated cumulative incidence of TMA was 31.2% (median follow-up of 24 months). Noninvasive criteria for diagnosis included newly elevated creatinine levels, new-onset hypertension, new-onset anemia, microscopic hematuria, thrombocytopenia, low haptoglobin and elevated lactate dehydrogenase values. Once diagnosed, patients were managed with control of their hypertension with multiple agents and supportive red blood cell transfusions. TMA typically stabilized or improved and no patient progressed to dialysis. TMA was associated with a higher probability of an anti-tumor response. Conclusions Thrombotic microangiopathy occurs in approximately a third of patients treated with a lymphodepleting preparative chemotherapy regimen with total body irradiation prior to autologous T-cell therapy. The disease has a variable natural history, however no patient developed end-stage renal failure. Successful management with supportive care and aggressive hypertension control is vital to the safe application of a systemic therapy that has shown curative potential for patients with disseminated melanoma. PMID:24474396

  17. Development of a Metabolomic Radiation Signature in Urine from Patients Undergoing Total Body Irradiation

    PubMed Central

    Laiakis, Evagelia C.; Mak, Tytus D.; Anizan, Sebastien; Amundson, Sally A.; Barker, Christopher A.; Wolden, Suzanne L.; Brenner, David J.; Fornace, Albert J.

    2014-01-01

    The emergence of the threat of radiological terrorism and other radiological incidents has led to the need for development of fast, accurate and noninvasive methods for detection of radiation exposure. The purpose of this study was to extend radiation metabolomic biomarker discovery to humans, as previous studies have focused on mice. Urine was collected from patients undergoing total body irradiation at Memorial Sloan-Kettering Cancer Center prior to hematopoietic stem cell transplantation at 4–6 h postirradiation (a single dose of 1.25 Gy) and 24 h (three fractions of 1.25 Gy each). Global metabolomic profiling was obtained through analysis with ultra performance liquid chromatography coupled to time-of-flight mass spectrometry (TOFMS). Prior to further analyses, each sample was normalized to its respective creatinine level. Statistical analysis was conducted by the nonparametric Kolmogorov-Smirnov test and the Fisher’s exact test and markers were validated against pure standards. Seven markers showed distinct differences between pre- and post-exposure samples. Of those, trimethyl-l-lysine and the carnitine conjugates acetylcarnitine, decanoylcarnitine and octanoylcarnitine play an important role in the transportation of fatty acids across mitochondria for subsequent fatty acid β-oxidation. The remaining metabolites, hypoxanthine, xanthine and uric acid are the final products of the purine catabolism pathway, and high levels of excretion have been associated with increased oxidative stress and radiation induced DNA damage. Further analysis revealed sex differences in the patterns of excretion of the markers, demonstrating that generation of a sex-specific metabolomic signature will be informative and can provide a quick and reliable assessment of individuals in a radiological scenario. This is the first radiation metabolomics study in human urine laying the foundation for the use of metabolomics in biodosimetry and providing confidence in biomarker

  18. Development of a metabolomic radiation signature in urine from patients undergoing total body irradiation.

    PubMed

    Laiakis, Evagelia C; Mak, Tytus D; Anizan, Sebastien; Amundson, Sally A; Barker, Christopher A; Wolden, Suzanne L; Brenner, David J; Fornace, Albert J

    2014-04-01

    The emergence of the threat of radiological terrorism and other radiological incidents has led to the need for development of fast, accurate and noninvasive methods for detection of radiation exposure. The purpose of this study was to extend radiation metabolomic biomarker discovery to humans, as previous studies have focused on mice. Urine was collected from patients undergoing total body irradiation at Memorial Sloan-Kettering Cancer Center prior to hematopoietic stem cell transplantation at 4-6 h postirradiation (a single dose of 1.25 Gy) and 24 h (three fractions of 1.25 Gy each). Global metabolomic profiling was obtained through analysis with ultra performance liquid chromatography coupled to time-of-flight mass spectrometry (TOFMS). Prior to further analyses, each sample was normalized to its respective creatinine level. Statistical analysis was conducted by the nonparametric Kolmogorov-Smirnov test and the Fisher's exact test and markers were validated against pure standards. Seven markers showed distinct differences between pre- and post-exposure samples. Of those, trimethyl-l-lysine and the carnitine conjugates acetylcarnitine, decanoylcarnitine and octanoylcarnitine play an important role in the transportation of fatty acids across mitochondria for subsequent fatty acid β-oxidation. The remaining metabolites, hypoxanthine, xanthine and uric acid are the final products of the purine catabolism pathway, and high levels of excretion have been associated with increased oxidative stress and radiation induced DNA damage. Further analysis revealed sex differences in the patterns of excretion of the markers, demonstrating that generation of a sex-specific metabolomic signature will be informative and can provide a quick and reliable assessment of individuals in a radiological scenario. This is the first radiation metabolomics study in human urine laying the foundation for the use of metabolomics in biodosimetry and providing confidence in biomarker

  19. [Irradiation of lymphogranulomatosis patients with large fields of complex configuration, calculating absorbed doses by microcomputer].

    PubMed

    Belyĭ, E K; Miasnikov, A A; Mendeleev, I M

    1985-01-01

    The authors demonstrated advantages of irradiating lymphogranulomatosis patients with large fields of complex configuration. The use of computer eliminates the difficulties of dosage calculation. Application for these purposes of the 15 VUMS-28 unit based on the microcomputer "Elektronika-60" is suggested. Algorithm of the dosage calculation program is presented. The program is drawn up according to the GOST so that it can be used by other institutions concerned.

  20. Successful treatment of major depression with electroconvulsive therapy in a pregnant patient with previous non-response to prefrontal rTMS.

    PubMed

    Gahr, M; Blacha, C; Connemann, B J; Freudenmann, R W; Schönfeldt-Lecuona, C

    2012-03-01

    The treatment of psychiatric disorders during pregnancy poses a challenge particularly regarding limited pharmacological possibilities. Repetitive transcranial magnetic stimulation (rTMS) and electroconvulsive therapy (ECT) have been described to be successful in single cases, however, guidelines are lacking. In order to contribute to the pool of empirical data that is necessary to create evidenced-based recommendations we present a case of successful treatment of major depression with ECT in a pregnant patient with previous non-response to rTMS.

  1. Safety and Palliative Efficacy of Single-Dose 8-Gy Reirradiation for Painful Local Failure in Patients With Stage IV Non-Small Cell Lung Cancer Previously Treated With Radical Chemoradiation Therapy

    SciTech Connect

    Topkan, Erkan; Yildirim, Berna Akkus; Guler, Ozan Cem; Parlak, Cem; Pehlivan, Berrin; Selek, Ugur

    2015-03-15

    Purpose: To investigate the safety and efficacy of single-dose 8-Gy palliative chest reirradiation (CRI) in metastatic non-small cell lung cancer (M-NSCLC) patients with painful thoracic failures (TF) within the previous radiation portal. Patients and Methods: We retrospectively analyzed the clinical data of 78 M-NSCLC patients who received single-dose 8-Gy CRI for painful TF after concurrent chemoradiation therapy to a total radiation dose of 52 to 66 Gy between 2007 and 2012. Primary endpoints included significant pain relief (SPR) defined as a ≥2 point decrement in the Visual Analogue Scale for Pain inventory (VAS-P), time to pain relief, and duration of pain control. Secondary objectives were survival and prognostic factors. Results: Treatment was well tolerated, with only 5.1% grade 3 pneumonitis and 1.3% grade 2 esophagitis. Pre-CRI median and post-CRI minimum VAS-P were 7 and 3 (P<.001), respectively. SPR was noted in 67 (85.9%) patients, and only 3 (3.9%) scored progressive pain. Median time to lowest VAS-P and duration of pain control were 27 days and 6.1 months, respectively. Median overall survival (OS) was 7.7 months, and the 1-year OS rate was 26.5%. On multivariate analyses, lower Eastern Cooperative Oncology group score (1-2; P<.001), absence of anemia (P=.001), and fewer metastatic sites (1-2; P<.001) were found to be associated with longer OS. Conclusions: Single-dose 8-Gy CRI provides safe, effective, and durable pain palliation for TF in radically irradiated M-NSCLC patients. Because of its convenience, lower cost, and higher comfort, the present protocol can be considered an appropriate option for patients with limited life spans.

  2. Laparoscopic ovarian transposition prior to pelvic irradiation in a young female patient with advanced rectal cancer.

    PubMed

    Kihara, Kyoichi; Yamamoto, Seiichiro; Ohshiro, Taihei; Fujita, Shin

    2015-12-01

    In the report, we describe the first case of laparoscopic ovarian transposition prior to pelvic radio-chemo therapy in a young female patient with advanced rectal cancer in Japan. A 14-year-old female visited a hospital because of consistent diarrhea and melena. Colonoscopy examination showed a bulky tumor of the rectum, which was diagnosed as moderately to poorly differentiated adenocarcinoma. The diagnosis was cT3N2aM1a (due to lymph node in pelvic side wall), cStage IVA. In an attempt to improve local control and sphincter preservation, neoadjuvant concurrent radio-chemo therapy was planned. Considering that pelvic irradiation particularly in young female might cause ovarian failure, laparoscopic ovarian transposition was carried out prior to pelvic irradiation. Sequentially the patient underwent low anterior resection of the rectum and lymphadenectomy including pelvic side wall. The menstruation was maintained with delay for 6 months after adjuvant chemotherapy. There is no evidence of cancer recurrence at 3 years after the surgery.In premenopausal patients with rectal cancer undergoing pelvic irradiation, laparoscopic ovarian transposition is one of the choices to prevent ovarian failure. PMID:26943437

  3. Myocardial viability in patients with chronic coronary artery disease and previous myocardial infarction: comparison of myocardial contrast echocardiography and myocardial perfusion scintigraphy.

    PubMed

    Vernon, S; Kaul, S; Powers, E R; Camarano, G; Gimple, L W; Ragosta, M

    1997-11-01

    The aim of this study was to compare perfusion patterns on myocardial contrast echocardiography with those on myocardial perfusion scintigraphy for the assessment of myocardial viability in patients with previous myocardial infarction. Accordingly, perfusion scores with the two techniques were compared in 91 ventricular regions in 21 patients with previous (>6 weeks old) myocardial infarction. Complete concordance between the two techniques was found in 63 (69%) regions; 25 (27%) regions were discordant by only 1 grade, and complete discordance (2 grades) was found in only 3 (3%) regions. A kappa statistic of 0.65 indicated good concordance between the two techniques. Although the scores on both techniques demonstrated a relation with the wall motion score, the correlation between the myocardial contrast echocardiography and wall motion scores was closer (r = -0.63 vs r = -0.50, p = 0.05). It is concluded that myocardial contrast echocardiography provides similar information regarding myocardial viability as myocardial perfusion scintigraphy in patients with coronary artery disease and previous myocardial infarction.

  4. Treatment with dasatinib or nilotinib in chronic myeloid leukemia patients who failed to respond to two previously administered tyrosine kinase inhibitors – a single center experience

    PubMed Central

    Ribeiro, Beatriz Felicio; Miranda, Eliana C M; de Albuquerque, Dulcinéia Martins; Delamain, Márcia T; Oliveira-Duarte, Gislaine; Almeida, Maria Helena; Vergílio, Bruna; da Silveira, Rosana Antunes; Oliveira-Duarte, Vagner; Lorand-Metze, Irene; De Souza, Carmino A; Pagnano, Katia B B

    2015-01-01

    OBJECTIVE: To evaluate hematological, cytogenetic and molecular responses as well as the overall, progression-free and event-free survivals of chronic myeloid leukemia patients treated with a third tyrosine kinase inhibitor after failing to respond to imatinib and nilotinib/dasatinib. METHODS: Bone marrow karyotyping and real-time quantitative polymerase chain reaction were performed at baseline and at 3, 6, 12 and 18 months after the initiation of treatment with a third tyrosine kinase inhibitor. Hematologic, cytogenetic and molecular responses were defined according to the European LeukemiaNet recommendations. BCR-ABL1 mutations were analyzed by Sanger sequencing. RESULTS: We evaluated 25 chronic myeloid leukemia patients who had been previously treated with imatinib and a second tyrosine kinase inhibitor. Nine patients were switched to dasatinib, and 16 patients were switched to nilotinib as a third-line therapy. Of the chronic phase patients (n=18), 89% achieved a complete hematologic response, 13% achieved a complete cytogenetic response and 24% achieved a major molecular response. The following BCR-ABL1 mutations were detected in 6/14 (43%) chronic phase patients: E255V, Y253H, M244V, F317L (2) and F359V. M351T mutation was found in one patient in the accelerated phase of the disease. The five-year overall, progression-free and event-free survivals were 86, 54 and 22% (p<0.0001), respectively, for chronic phase patients and 66%, 66% and 0% (p<0.0001), respectively, for accelerated phase patients. All blast crisis patients died within 6 months of treatment. Fifty-six percent of the chronic phase patients lost their hematologic response within a median of 23 months. CONCLUSIONS: Although the responses achieved by the third tyrosine kinase inhibitor were not sustainable, a third tyrosine kinase inhibitor may be an option for improving patient status until a donor becomes available for transplant. Because the long-term outcome for these patients is poor, the

  5. Enzyme replacement therapy with taliglucerase alfa: 36-month safety and efficacy results in adult patients with Gaucher disease previously treated with imiglucerase.

    PubMed

    Pastores, Gregory M; Shankar, Suma P; Petakov, Milan; Giraldo, Pilar; Rosenbaum, Hanna; Amato, Dominick J; Szer, Jeffrey; Chertkoff, Raul; Brill-Almon, Einat; Zimran, Ari

    2016-07-01

    Taliglucerase alfa is the first available plant cell-expressed human recombinant therapeutic protein. It is indicated for treatment of patients with type 1 Gaucher disease (GD) in adult and pediatric patients in several countries. Study PB-06-002 examined the safety and efficacy of taliglucerase alfa for 9 months in patients who previously received imiglucerase. The results of adult patients from Study PB-06-002 who continued receiving taliglucerase alfa in extension Study PB-06-003 for up to 36 months are reported here. Eighteen patients received at least one dose of taliglucerase alfa in Study PB-06-003; 10 patients completed 36 total months of therapy, and four patients who transitioned to commercial drug completed 30-33 months of treatment. In patients who completed 36 total months of treatment, mean percent (±standard error) changes from baseline/time of switch to taliglucerase alfa to 36 months were as follows: hemoglobin concentration, -1.0% (±1.9%; n = 10); platelet count, +9.3% (±9.8%; n = 10); spleen volume measured in multiples of normal (MN), -19.8% (±9.9%; n = 7); liver volume measured in MN, +0.9% (±5.4%; n = 8); chitotriosidase activity, -51.5% (±8.1%; n = 10); and CCL18 concentration, -36.5 (±8.0%; n = 10). Four patients developed antidrug antibodies, including one with evidence of neutralizing activity in vitro. All treatment-related adverse events were mild or moderate and transient. The 36-month results of switching from imiglucerase to taliglucerase alfa treatment in adults with GD provide further data on the clinical safety and efficacy of taliglucerase alfa beyond the initial 9 months of the original study. www.clinicaltrials.gov identifier NCT00705939. Am. J. Hematol. 91:661-665, 2016. © 2016 Wiley Periodicals, Inc. PMID:27102949

  6. Modified Valsalva manoeuvre to treat recurrent supraventricular tachycardia: description of the technique and its successful use in a patient with a previous near fatal complication of DC cardioversion

    PubMed Central

    Appelboam, Andrew; Gagg, James; Reuben, Adam

    2014-01-01

    Patients with attacks of re-entrant supraventricular tachycardia (SVT) frequently present to the emergency department (ED). The Valsalva manoeuvre (VM) is the most effective and safe vagal manoeuvre and advocated as the first-line treatment in stable patients but has a relatively low cardioversion success rate. Improving its efficacy would reduce patients’ exposure to the side effects and complications of second-line treatments and has other potential benefits. We describe a modification to the VM, which is currently being studied, and present the case of a 23-year-old patient who was successfully treated with this modified VM after a previous near-fatal complication of direct current (DC) cardioversion. PMID:25006052

  7. Iodine-125 implant and external beam irradiation in patients with localized pancreatic carcinoma. [Efficacy and complications

    SciTech Connect

    Shipley, W.U.; Nardi, G.L.; Cohen, A.M.; Ling, C.C.

    1980-02-15

    Twelve patients with biopsy-proven clinically localized ductal pancreatic cancers (less than 7 cm in greatest diameter) judged unsuitable for resection were treated by bypass surgery, an Iodine-125 implant (20 to 39 mCi), and postoperative irradiation (4000 to 4500 rads). The potential problems of significant bleeding, pancreatic fistula, or pancreatitis were not experienced. A local recurrence developed in one patient and two recurred in regional lymph nodes. The projected median survival of the group is 11 months with four of the 12 patients still surviving. For purposes of comparison all patients with pancreatic ductal carcinoma treated by radical resection during a similar time were evaluated. All ten have died with a median survival of six months. Twelve of 22 (55%) of the combined implanted and resected groups have developed distant metastasis. Further pursuit of intraoperative techniques of irradiation in combination with adjuvant multidrug chemotherapy seems indicated in an attempt to prolong patient survival which is now limited by hematogenous metastases.

  8. Randomized Phase III Trial of Ixabepilone Plus Capecitabine Versus Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane

    PubMed Central

    Sparano, Joseph A.; Vrdoljak, Eduard; Rixe, Oliver; Xu, Binghe; Manikhas, Alexey; Medina, Carlos; Ventilari Da Costa, Susanne Crocamo; Ro, Jungsil; Rubio, Gonzalo; Rondinon, Monica; Perez Manga, Gumersindo; Peck, Ronald; Poulart, Valerie; Conte, Pierfranco

    2010-01-01

    Purpose We sought to determine whether the combination of ixabepilone plus capecitabine improved overall survival (OS) compared with capecitabine alone in patients with metastatic breast cancer (MBC) previously treated with anthracyclines and taxanes. Patients and Methods A total of 1,221 patients with MBC previously treated with anthracycline and taxanes were randomly assigned to ixabepilone (40 mg/m2 intravenously on day 1) plus capecitabine (2,000 mg/m2 orally on days 1 through 14) or capecitabine alone (2,500 mg/m2 on the same schedule) given every 21 days. The trial was powered to detect a 20% reduction in the hazard ratio (HR) for death. Results There was no significant difference in OS between the combination and capecitabine monotherapy arm, the primary end point (median, 16.4 v 15.6 months; HR = 0.9; 95% CI, 078 to 1.03; P = .1162). The arms were well balanced with the exception of a higher prevalence of impaired performance status (Karnofsky performance status 70% to 80%) in the combination arm (32% v 25%). In a secondary Cox regression analysis adjusted for performance status and other prognostic factors, OS was improved for the combination (HR = 0.85; 95% CI, 0.75 to 0.98; P = .0231). In 79% of patients with measurable disease, the combination significantly improved progression-free survival (PFS; median, 6.2 v 4.2 months; HR = 0.79; P = .0005) and response rate (43% v 29%; P < .0001). Grade 3 to 4 neuropathy occurred in 24% treated with the combination, but was reversible. Conclusion This study confirmed a previous trial demonstrating improved PFS and response for the ixabepilone-capecitabine combination compared with capecitabine alone, although this did not result in improved survival. PMID:20530276

  9. Prospective phase II trial of pazopanib plus CapeOX (capecitabine and oxaliplatin) in previously untreated patients with advanced gastric cancer

    PubMed Central

    Kim, Seung Tae; Lee, Jeeyun; Lee, Su Jin; Park, Se Hoon; Jung, Sin-Ho; Park, Young Suk; Lim, Ho Yeong; Kang, Won Ki; Park, Joon Oh

    2016-01-01

    We designed a single-arm, open label phase II study to determine the efficacy and toxicity of the combination of pazopanib with CapeOx (capecitabine and oxaliplatin) in metastatic /recurrent advanced gastric cancer (AGC) patients. Previously untreated AGC patients received capecitabine (850 mg/m2 bid, day 1–14) plus oxaliplatin (130 mg/m2, day 1) in combination with pazopanib (800 mg, day 1–21) every three weeks. Treatment was continued until progression of the disease or intolerable toxicity was observed. In all, 66 patients were treated with pazopanib plus CapeOx. The median age of the patients was 51.5 years (range, 23.0–77), and the median ECOG performance status was 1 (0–1). Among all 66 patients, one complete response and 37 partial responses were observed (overall response rate, 62.4%; 95% confidence interval (CI), 45.7–73.5% accounting for the 2-stage design of this trial). Stable disease was observed in 23 patients (34.8%), revealing a 92.4% disease control rate. The median progression free survival and overall survival were 6.5 months (95% CI, 5.6–7.4) and 10.5 months (95% CI, 8.1–12.9), respectively. Thirty-four patients (51.5%) experienced a treatment-related toxicity of grade 3 or more. The most common toxicities of grade 3 or more were neutropenia (15.1%), anemia (10.6%), thrombocytopenia (10.6%), anorexia (7.6%), nausea (3.0%), and vomiting (3.0%). There were no treatment-related deaths. The combination of pazopanib and CapeOx showed moderate activity and an acceptable toxicity profile as a first-line treatment in metastatic / recurrent AGC patients (ClinicalTrials.gov NCT01130805). PMID:27003363

  10. Evaluation of response from axitinib per Response Evaluation Criteria in Solid Tumors versus Choi criteria in previously treated patients with metastatic renal cell carcinoma

    PubMed Central

    Karakiewicz, Pierre I; Nott, Louise; Joshi, Abhishek; Kannourakis, George; Tarazi, Jamal; Alam, Mahmood

    2016-01-01

    efficacy profiles of axitinib were consistent with reports from previous studies in patients with mRCC, and patients generally maintained QoL. The sizeable difference observed in objective response rate by RECIST versus Choi criteria merits further research. PMID:27274281

  11. Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: a prospective randomized controlled study.

    PubMed

    Brox, Jens Ivar; Reikerås, Olav; Nygaard, Øystein; Sørensen, Roger; Indahl, Aage; Holm, Inger; Keller, Anne; Ingebrigtsen, Tor; Grundnes, Oliver; Lange, Johan Emil; Friis, Astrid

    2006-05-01

    The effectiveness of lumbar fusion for chronic low back pain after surgery for disc herniation has not been evaluated in a randomized controlled trial. The aim of the present study was to compare the effectiveness of lumbar fusion with posterior transpedicular screws and cognitive intervention and exercises. Sixty patients aged 25-60 years with low back pain lasting longer than 1 year after previous surgery for disc herniation were randomly allocated to the two treatment groups. Experienced back surgeons performed transpedicular fusion. Cognitive intervention consisted of a lecture intended to give the patient an understanding that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it. This was reinforced by three daily physical exercise sessions for 3 weeks. The primary outcome measure was the Oswestry Disability Index (ODI). Outcome data were analyzed on an intention-to-treat basis. Ninety-seven percent of the patients, including seven of eight patients who had either not attended treatment (n=5) or changed groups (n=2), completed 1-year follow-up. ODI was significantly improved from 47 to 38 after fusion and from 45 to 32 after cognitive intervention and exercises. The mean difference between treatments after adjustment for gender was -7.3 (95% CI -17.3 to 2.7, p=0.15). The success rate was 50% in the fusion group and 48% in the cognitive intervention/exercise group. For patients with chronic low back pain after previous surgery for disc herniation, lumbar fusion failed to show any benefit over cognitive intervention and exercises. PMID:16545523

  12. Efficacy and tolerability of brinzolamide/brimonidine suspension and prostaglandin analogs in patients previously treated with dorzolamide/timolol solution and prostaglandin analogs

    PubMed Central

    Lo, Jonathan S; Pang, Pierre M; Lo, Samuel C

    2016-01-01

    Objective Fixed combination glaucoma medication is increasingly used in glaucoma treatment. There is a lack of comparative study in the literature of non-beta blocker combination agents used adjunctively with a glaucoma agent in a different class. The objective of this study is to evaluate the effect of intraocular pressure (IOP) control and tolerability of non-beta blocker combination suspension with prostaglandin analogs (PGA) in patients with open angle glaucoma who were previously treated with beta blocker combination solution with PGA. Design Open-label retrospective review of patient records. Patients and methods This study looked at patients with open angle glaucoma taking dorzolamide/timolol solution with PGA that were switched to brinzolamide/brimonidine combination suspension with PGA. This study reviewed the charts of all patients who were at least 21 years old with a clinical diagnosis of open-angle glaucoma or ocular hypertension in at least one eye. Patients needed to have been treated with concomitant use of PGA and dorzolamide/timolol solution for at least one month. Patients using dorzolamide/timolol solution plus PGA with medication related ocular irritation were switched to brinzolamide/brimonidine suspension with the same PGA. Best-corrected visual acuity, ocular hyperemia grading, slit lamp biomicroscopy and Goldmann applanation tonometry measurements, and patient medication preferences were assessed at baseline, 1 month and 3 months. Results Forty eyes with open angle glaucoma. The mean age of the patients was 68 and 60% were females. The IOP before the switch was 17.2 and 16.5 (P=0.70) following the switch at 3 months. We found a decreasing trend of ocular hyperemia (P=0.064) and strong preference (P=0.011) for non-beta blocker combination suspension but no difference of visual acuity and slit lamp findings. Conclusion Brinzolamide/brimonidine combination suspension when used adjunctively with PGA is equally effective. Patients in this study

  13. Toxicity of fludarabine and cyclophosphamide with or without rituximab as initial therapy for patients with previously untreated mantle cell lymphoma: results of a randomised phase II study.

    PubMed

    Eve, Heather E; Linch, David; Qian, Wendi; Ross, Moira; Seymour, John F; Smith, Paul; Stevens, Lindsey; Rule, Simon A J

    2009-02-01

    The National Cancer Research Network (NCRN) is currently coordinating a Phase III randomised study (LY05) comparing fludarabine and cyclophosphamide (FC) with or without rituximab (R) for previously untreated mantle cell lymphoma (MCL). The combination of FC is well-recognised as significantly immunosuppressive and there are concerns that adding rituximab may increase infection risk further. The impact of rituximab on other markers of toxicity is also unclear. We analysed the toxicity data on 139 patients treated within the NCRN LY05 trial. Non-hematological toxicity was similar between the two treatment arms. The only difference in hematological toxicity was a higher rate of lymphocytopenia with fludarabine cyclophosphamide and rituximab (FCR), which did not translate into increased febrile episodes or infections. In conclusion, the addition of rituximab to FC for previously untreated MCL has no significant impact on toxicity.

  14. QualiCOP: real-world effectiveness, tolerability, and quality of life in patients with relapsing-remitting multiple sclerosis treated with glatiramer acetate, treatment-naïve patients, and previously treated patients.

    PubMed

    Ziemssen, Tjalf; Calabrese, Pasquale; Penner, Iris-Katharina; Apfel, Rainer

    2016-04-01

    Treatment of symptoms and signs beyond the expanded disability status scale remains a major target in multiple sclerosis. QualiCOP was an observational, non-interventional, open-label study conducted at 170 sites in Germany. Of the 754 enrolled patients, 96 % had relapsing-remitting multiple sclerosis (MS) and were either disease-modifying therapy naïve (de novo, n = 481) or previously treated (n = 237) with once-daily, subcutaneous 20-mg/mL glatiramer acetate (GA). Assessments of relapse rate, disease progression, overall functioning, quality of life (QoL), cognition, fatigue, and depression were performed over 24 months. GA treatment over 24 months was associated with reduced annual relapse rate for previously treated (from 0.98 to 0.54 relapses) and de novo (from 0.81 to 0.48 relapses) patients. Multiple Sclerosis Functional Composite scores showed slight improvement in both cohorts (all p < 0.01). Paced Auditory Serial Addition Test and Multiple Sclerosis Inventory Cognition scale scores showed robust improvement in cognition among previously treated and de novo cohorts (all p < 0.001). General Depression Scale scores showed significantly reduced depressive symptoms (p < 0.001). Disease severity, fatigue, and QoL were stable over the observational period. These real-world findings suggest that patients with MS show benefit from GA treatment in important QoL parameters beyond standard measures of relapse and disease severity.

  15. Oligodeoxynucleotide CpG 7909 delivered as intravenous infusion demonstrates immunologic modulation in patients with previously treated non-Hodgkin lymphoma.

    PubMed

    Link, Brian K; Ballas, Zuhair K; Weisdorf, Daniel; Wooldridge, James E; Bossler, Aaron D; Shannon, Mary; Rasmussen, Wendy L; Krieg, Arthur M; Weiner, George J

    2006-01-01

    Oligodeoxynucleotides containing CpG motifs (CpG ODN) can alter various immune cell subsets important in antibody therapy of malignancy. We undertook a phase I trial of CPG 7909 (also known as PF-3512676) in patients with previously treated lymphoma with the primary objective of evaluating safety across a range of doses, and secondary objectives of evaluating immunomodulatory effects and clinical effects. Twenty-three patients with previously treated non-Hodgkin lymphoma received up to 3 weekly 2-hour intravenous (IV) infusions of CPG ODN 7909 at dose levels 0.01 to 0.64 mg/kg. Evaluation of immunologic parameters and clinical endpoints occurred for 6 weeks. Infusion-related toxicity included grade 1 nausea, hypotension, and IV catheter discomfort. Serious adverse hematologic events observed more than once included anemia (2=Gr3, 2=Gr4), thrombocytopenia (4=Gr3), and neutropenia (2=Gr3), and were largely judged owing to progressive disease. Immunologic observations included: (1) The mean ratio of NK-cell concentrations compared with pretreatment at day 2 was 1.44 (95% CI=0.94-1.94) and at day 42 was 1.53 (95% CI=1.14-1.91); (2) NK activity generally increased in subjects; and (3) Antibody-dependent cellular cytotoxicity activity increased in select cohorts. No clinical responses were documented radiographically at day 42. Two subjects demonstrated late response. We conclude CpG 7909 can be safely given as a 2-hour IV infusion to patients with previously treated non-Hodgkin lymphoma at doses that have immunomodulatory effects. PMID:16971811

  16. Combining Amplitude Spectrum Area with Previous Shock Information Using Neural Networks Improves Prediction Performance of Defibrillation Outcome for Subsequent Shocks in Out-Of-Hospital Cardiac Arrest Patients

    PubMed Central

    He, Mi; Lu, Yubao; Zhang, Lei; Zhang, Hehua; Gong, Yushun; Li, Yongqin

    2016-01-01

    Objective Quantitative ventricular fibrillation (VF) waveform analysis is a potentially powerful tool to optimize defibrillation. However, whether combining VF features with additional attributes that related to the previous shock could enhance the prediction performance for subsequent shocks is still uncertain. Methods A total of 528 defibrillation shocks from 199 patients experienced out-of-hospital cardiac arrest were analyzed in this study. VF waveform was quantified using amplitude spectrum area (AMSA) from defibrillator's ECG recordings prior to each shock. Combinations of AMSA with previous shock index (PSI) or/and change of AMSA (ΔAMSA) between successive shocks were exercised through a training dataset including 255shocks from 99patientswith neural networks. Performance of the combination methods were compared with AMSA based single feature prediction by area under receiver operating characteristic curve(AUC), sensitivity, positive predictive value (PPV), negative predictive value (NPV) and prediction accuracy (PA) through a validation dataset that was consisted of 273 shocks from 100patients. Results A total of61 (61.0%) patients required subsequent shocks (N = 173) in the validation dataset. Combining AMSA with PSI and ΔAMSA obtained highest AUC (0.904 vs. 0.819, p<0.001) among different combination approaches for subsequent shocks. Sensitivity (76.5% vs. 35.3%, p<0.001), NPV (90.2% vs. 76.9%, p = 0.007) and PA (86.1% vs. 74.0%, p = 0.005)were greatly improved compared with AMSA based single feature prediction with a threshold of 90% specificity. Conclusion In this retrospective study, combining AMSA with previous shock information using neural networks greatly improves prediction performance of defibrillation outcome for subsequent shocks. PMID:26863222

  17. Long term outcomes in patients with intracranial germinomas: a single institution experience of irradiation with or without chemotherapy.

    PubMed

    Kawabata, Yasuhiro; Takahashi, Jun A; Arakawa, Yoshiki; Shirahata, Mitsuaki; Hashimoto, Nobuo

    2008-06-01

    Complete remission can be achieved soon after irradiation in patients with intracranial germinoma. This study aimed to analyze the follow-up outcome of intracranial germinoma patients. About 39 intracranial germinoma patients (29 males and 10 females; average age, 15 years; range, 7-27 years) treated at Kyoto University Hospital from 1978 to 2004 were included in the study group. Six patients had multifocal disease at initial diagnosis, and 10 had human chorionic gonadotropin (HCG)-producing tumors. Thirteen patients were treated with craniospinal axis irradiation, 6 with whole-brain irradiation, 17 with whole-ventricle irradiation, and 3 with local field irradiation. Since 1997, 15 patients were treated with reduced-dose whole-ventricle irradiation (median, 23.4 Gy; range, 20.4-27 Gy) followed by a local boost (median, 40.8 Gy; range, 36-54 Gy) combined with chemotherapy. The median follow-up was 94 months (18 months to 25 years). The 5- and 10-year overall survival (OS) rates of the entire group were 97 and 90%, respectively. The 5- and 10-year progression-free survival (PFS) rates of the entire group were 91 and 87%, respectively. The 8-year OS and PFS in 15 patients treated by whole-ventricle irradiation combined with chemotherapy were 100% and 92%, respectively. Four patients had recurrences within a median period of 59.5 months (51-85 months). All relapses occurred outside the radiation fields. Tumor site, tumor size, HCG production, multifocal disease and radiation dose to the primary site or whole ventricle did not significantly affect PFS. All initial recurrences of intracranial germinoma occurred at the distant site out of the radiation field. Our data suggested that reduced doses to the whole ventricle, combined with chemotherapy, should be sufficiently effective in patients with intracranial germinoma.

  18. Recurrence of Hyperparathyroid Hypercalcemia in a Patient With the HRPT-2 Mutation and a Previous Parathyroid Carcinoma in Hyperparathyroidism-Jaw Tumor Syndrome

    PubMed Central

    Mele, Marco; Rolighed, Lars; Jespersen, MarieLouise; Rejnmark, Lars; Christiansen, Peer

    2016-01-01

    Introduction Cancer in the parathyroid gland is rare, but parathyroid cancer is occasionally seen in relation to genetic abnormalities. Due to a limited amount of evidence, the optimal handling of these cases is not clear. Furthermore, the presence of a malignant parathyroid tumor is rarely known at the time of the initial operation; therefore, re-operations are often necessary. The aim of this study was to present the case of a patient with a previously diagnosed jaw tumor and parathyroid carcinoma that presents as a recurrence of hyperparathyroid hypercalcemia. Case Presentation A 41-year-old patient who was already diagnosed with a parathyroid carcinoma and a jaw tumor caused by a CDC73 mutation, presented with biochemical evidence of increasing parathyroid hormone (PTH) and calcium levels after a previous total parathyroidectomy. The patient’s ionized calcium increased to 1.55 mmol/L and PTH increased to 16.0 pmol/L. A previous genetic analysis revealed a mutation in the CDC73 gene. There was no family history of hyperparathyroidism. We performed a sestamibi scintigraphy and an 11-C methionine (MET) positron emission tomography (PET) scan that showed a recurrence on the left side of the trachea. The patient underwent a third neck operation for the removal of a tumor on the left side of the trachea. The pathology report revealed that the tumor was a lymph node metastasis from the previous parathyroid carcinoma. The patient is currently enrolled in our follow-up regime. Hyperparathyroidism-jaw tumor (HPT-JT) syndrome is a rare autosomal dominant disorder characterized by a parathyroid adenoma or carcinoma, fibro-osseous lesions (ossifying fibroma) of the mandible and maxilla, and renal cysts and tumors. This autosomal dominant familial cancer syndrome has been reported with a variable and incomplete penetrance, and up to 10% of gene carriers do not show any clinical manifestations. Here we present a patient’s case and discuss the literature related to this

  19. Recurrence of Hyperparathyroid Hypercalcemia in a Patient With the HRPT-2 Mutation and a Previous Parathyroid Carcinoma in Hyperparathyroidism-Jaw Tumor Syndrome

    PubMed Central

    Mele, Marco; Rolighed, Lars; Jespersen, MarieLouise; Rejnmark, Lars; Christiansen, Peer

    2016-01-01

    Introduction Cancer in the parathyroid gland is rare, but parathyroid cancer is occasionally seen in relation to genetic abnormalities. Due to a limited amount of evidence, the optimal handling of these cases is not clear. Furthermore, the presence of a malignant parathyroid tumor is rarely known at the time of the initial operation; therefore, re-operations are often necessary. The aim of this study was to present the case of a patient with a previously diagnosed jaw tumor and parathyroid carcinoma that presents as a recurrence of hyperparathyroid hypercalcemia. Case Presentation A 41-year-old patient who was already diagnosed with a parathyroid carcinoma and a jaw tumor caused by a CDC73 mutation, presented with biochemical evidence of increasing parathyroid hormone (PTH) and calcium levels after a previous total parathyroidectomy. The patient’s ionized calcium increased to 1.55 mmol/L and PTH increased to 16.0 pmol/L. A previous genetic analysis revealed a mutation in the CDC73 gene. There was no family history of hyperparathyroidism. We performed a sestamibi scintigraphy and an 11-C methionine (MET) positron emission tomography (PET) scan that showed a recurrence on the left side of the trachea. The patient underwent a third neck operation for the removal of a tumor on the left side of the trachea. The pathology report revealed that the tumor was a lymph node metastasis from the previous parathyroid carcinoma. The patient is currently enrolled in our follow-up regime. Hyperparathyroidism-jaw tumor (HPT-JT) syndrome is a rare autosomal dominant disorder characterized by a parathyroid adenoma or carcinoma, fibro-osseous lesions (ossifying fibroma) of the mandible and maxilla, and renal cysts and tumors. This autosomal dominant familial cancer syndrome has been reported with a variable and incomplete penetrance, and up to 10% of gene carriers do not show any clinical manifestations. Here we present a patient’s case and discuss the literature related to this

  20. Extramedullary Relapse Following Total Marrow and Lymphoid Irradiation in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation

    SciTech Connect

    Kim, Ji Hyun; Stein, Anthony; Schultheiss, Timothy E.; Palmer, Joycelynne; Liu, An; Rosenthal, Joseph; Forman, Stephen J.

    2014-05-01

    Purpose: Approximately 5% to 20% of patients who undergo total body irradiation (TBI) in preparation for hematopoietic cell transplantation (HCT) can develop extramedullary (EM) relapse. Whereas total marrow and lymphoid irradiation (TMLI) provides a more conformally targeted radiation therapy for patients, organ sparing has the potential to place the patient at a higher risk for EM relapse than TBI. This study evaluated EM relapse in patients treated with TMLI at our institution. Methods and Materials: Patients eligible for analysis had been enrolled in 1 of 3 prospective TMLI trials between 2006 and 2012. The TMLI targeted bones, major lymph node chains, liver, spleen, testes, and brain, using image-guided tomotherapy with total dose ranging from 12 to 15 Gy. Results: A total of 101 patients with a median age of 47 years were studied. The median follow-up was 12.8 months. Incidence of EM relapse and bone marrow (BM) relapse were 12.9% and 25.7%, respectively. Of the 13 patients who had EM relapse, 4 also had BM relapse, and 7 had EM disease prior to HCT. There were a total of 19 EM relapse sites as the site of initial recurrence: 11 soft tissue, 6 lymph node, 2 skin. Nine of these sites were within the target region and received ≥12 Gy. Ten initial EM relapse sites were outside of the target region: 5 sites received 10.1 to 11.4 Gy while 5 sites received <10 Gy. Pretransplantation EM was the only significant predictor of subsequent EM relapse. The cumulative incidence of EM relapse was 4% at 1 year and 11.4% at 2 years. Conclusions: EM relapse incidence was as frequent in regions receiving ≥10 Gy as those receiving <10 Gy. EM relapse rates following TMLI that included HCT regimens were comparable to published results with regimens including TBI and suggest that TMLI is not associated with an increased EM relapse risk.

  1. The influence of previous infections and antichlamydia pneumoniae seropositivity on functional outcome in ischemic stroke patients: results from the IN2 study.

    PubMed

    Consoli, Domenico; Vidale, Simone; Aguglia, Umberto; Bassi, Pietro; Cavallini, Anna; Consoli, Arturo; Galati, Franco; Guidetti, Donata; Micieli, Giuseppe; Neri, Giuseppe; Rasura, Maurizia; Sterzi, Roberto; Toni, Danilo; Inzitari, Domenico

    2015-05-01

    Although a growing attention is being paid to acute ischemic stroke patients, the correlation between clinical outcome and infectious events in this population has been poorly investigated. 749 ischemic stroke (mean age 71 years old, males 56%) patients were enrolled in this prospective case-control study by 11 Italian Stroke Units. Demographic data, vascular risk factors, previous infections and post-stroke infections (PSIs) were recorded. Blood samples were collected and the enzyme-linked immunoassay was chosen to measure Chlamydia pneumoniae IgG and IgA plasma antibodies (antibody titers were classified with specific cut-off levels: IgA > 1:16 and IgG > 1:64). Early poor outcome was defined as mRS score >2 at discharge, while poor outcome at 6-month follow-up. Univariate and multivariate analyses were performed. Median NIHSS was 7, IgA and IgG antichlamydia pneumoniae seropositivities were observed in 308 (37.1%) and 207 (23.6%) patients, respectively. Multivariate analyses showed significant correlations between PSIs and NIHSS (RR: 1.06; 95% CI 1.02-1.09; p < 0.001) and PSIs and IgA antichlamydia pneumoniae seropositivity (RR: 3.84; 95% CI 2.53-5.84; p < 0.001). Significant disability was associated with baseline NIHSS (RR: 1.32; 95% CI 1.16-1.50; p < 0.001), IgA (RR: 2.67; 95% CI 1.06-6.70; p = 0.035) and IgG antichlamydia (RR: 5.75; 95% CI 1.83-18.03; p = 0.003) seropositivity and atrial fibrillation (RR: 2.58; 95% CI 1.81-3.67; p < 0.001). While previous infections were not associated with functional outcome, antichlamydia antibodies play a negative role in ischemic stroke patients. Preventive strategies may reduce the stroke burden and improve the clinical outcome.

  2. Long term follow-up of patients with Cushing's disease treated by interstitial irradiation

    SciTech Connect

    Sandler, L.M.; Richards, N.T.; Carr, D.H.; Mashiter, K.; Joplin, G.F.

    1987-09-01

    The first 86 patients with Cushing's disease treated with interstitial irradiation (by needle implantation) as the sole therapy were reviewed. In the 82 patients who were reassessed 1 yr after treatment 63 (77%) achieved remission. This study comprises the outcome and complications in the 54 patients who had a remission and whom we were able to follow. The follow-up period ranged from 3-26 yr (mean, 10.5) from the time of remission. No instance of clinical or radiological relapse has occurred. Of these 54 patients, yttrium-90 alone was used in 32, of whom 12 (37%) required corticosteroid or T4 replacement therapy in a mean time of 3.5 months; in 7 of these 12 we elected to give an ablative dose. Gold-198 alone was used in 15 patients, of whom 7 (47%) developed hypopituitarism in a mean time of 76 months. Both isotopes were used in 7 patients. A diurnal serum cortisol rhythm was found in 28 of the 31 patients who were not receiving corticosteroid therapy. In 5 of the 7 patients with an initially abnormal pituitary fossa, serial radiological studies revealed remodelling in 3. There have been no complications in the last 17 years. Pituitary implantation with yttrium-90 is an effective alternative to transsphenoidal hypophysectomy, with a high remission rate, no recurrence (as yet), no operative complications, and avoidance of hormone replacement in the majority.

  3. Prognostic factors in multiple myeloma: definition of risk groups in 410 previously untreated patients: a Grupo Argentino de Tratamiento de la Leucemia Aguda study.

    PubMed

    Corrado, C; Santarelli, M T; Pavlovsky, S; Pizzolato, M

    1989-12-01

    Four hundred ten previously untreated multiple myeloma patients entered onto two consecutive Grupo Argentino de Tratamiento de la Leucemia Aguda (GATLA) protocols were analyzed to identify significant prognostic factors influencing survival. The univariate analysis selected the following variables: performance status, renal function, percentage of bone marrow plasma cells at diagnosis, hemoglobin, and age. A multivariate analysis showed that performance status, renal function, percentage of bone marrow plasma cells, hemoglobin, and age were the best predictive variables for survival. A score was assigned to each patient according to these variables, which led to their classification in three groups: good, intermediate, and poor risk, with a probability of survival of 26% and 10% at 96 months, and 5% at 56 months, and median survival of 60, 37, and 14 months, respectively (P = .0000). In our patient population, this model proved to be superior to the Durie-Salmon staging system in defining prognostic risk groups, and separating patients with significantly different risks within each Durie-Salmon stage.

  4. Phase I study of the anti-CD74 monoclonal antibody milatuzumab (hLL1) in patients with previously treated B-cell lymphomas

    PubMed Central

    Martin, Peter; Furman, Richard R.; Rutherford, Sarah; Ruan, Jia; Ely, Scott; Greenberg, June; Coleman, Morton; Goldsmith, Stanley J.; Leonard, John P.

    2016-01-01

    Milatuzumab (hLL1), a humanized anti-CD74 monoclonal antibody, has activity in preclinical NHL models. We conducted a phase 1 trial in previously treated B-cell malignancies. Dose escalation included 4 planned dose levels (1.5, 4, 6, and 8 mg/kg) with milatuzumab given twice weekly for 6 weeks. After dose level 1, the schedule was changed to daily (Monday-Friday) for 10 days. Twenty-two patients were treated. The most common possibly-related toxicities were infusion reaction, anemia, lymphopenia, neutropenia, and thrombocytopenia. Three patients experienced dose-limiting toxicity (neutropenia, neutropenia, rash) at dose levels 1, 2, and 4 respectively. Eight patients had stable disease, with no objective responses. The serum half-life of milatuzumab was ~2 hours. In 7 patients, In-111-imaging showed no clear evidence of tumor targeting. The short half-life may reflect CD74 rapid internalization and presence on extratumoral tissues; this antigen sink must be overcome to capitalize on the promising preclinical activity of the drug. PMID:25754579

  5. Enzalutamide for treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel: U.S. Food and Drug Administration drug approval summary.

    PubMed

    Ning, Yangmin M; Pierce, William; Maher, V Ellen; Karuri, Stella; Tang, Sheng-Hui; Chiu, Haw-Jyh; Palmby, Todd; Zirkelbach, Jeanne Fourie; Marathe, Dhananjay; Mehrotra, Nitin; Liu, Qi; Ghosh, Debasis; Cottrell, Christy L; Leighton, John; Sridhara, Rajeshwari; Ibrahim, Amna; Justice, Robert; Pazdur, Richard

    2013-11-15

    This article summarizes the regulatory evaluation that led to the full approval of enzalutamide (XTANDI, Medivation Inc.) by the U.S. Food and Drug Administration (FDA) on August 31, 2012, for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. This approval was based on the results of a randomized, placebo-controlled trial which randomly allocated 1,199 patients with mCRPC who had received prior docetaxel to receive either enzalutamide, 160 mg orally once daily (n = 800), or placebo (n = 399). All patients were required to continue androgen deprivation therapy. The primary endpoint was overall survival. At the prespecified interim analysis, a statistically significant improvement in overall survival was demonstrated for the enzalutamide arm compared with the placebo arm [HR = 0.63; 95% confidence interval: 0.53-0.75; P < 0.0001]. The median overall survival durations were 18.4 months and 13.6 months in the enzalutamide and placebo arms, respectively. The most common adverse reactions (≥10%) included asthenia or fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, and upper respiratory infection. Seizures occurred in 0.9% of patients on enzalutamide compared with no patients on the placebo arm. Overall, the FDA's review and analyses of the submitted data confirmed that enzalutamide had a favorable benefit-risk profile in the study patient population, thus supporting its use for the approved indication. The recommended dose is 160 mg of enzalutamide administered orally once daily. Enzalutamide represents the third product that the FDA has approved in the same disease setting within a period of 2 years. Clin Cancer Res; 19(22); 6067-73. ©2013 AACR.

  6. Outcomes After Accelerated Partial Breast Irradiation in Patients With ASTRO Consensus Statement Cautionary Features

    SciTech Connect

    McHaffie, Derek R.; Patel, Rakesh R.; Adkison, Jarrod B.; Das, Rupak K.; Geye, Heather M.; Cannon, George M.

    2011-09-01

    Purpose: To evaluate outcomes among women with American Society for Radiation Oncology (ASTRO) consensus statement cautionary features treated with brachytherapy-based accelerated partial breast irradiation (APBI). Methods and Materials: Between March 2001 and June 2006, 322 consecutive patients were treated with high-dose-rate (HDR) APBI at the University of Wisconsin. A total of 136 patients were identified who met the ASTRO cautionary criteria. Thirty-eight (27.9%) patients possessed multiple cautionary factors. All patients received 32 to 34 Gy in 8 to 10 twice-daily fractions using multicatheter (93.4%) or Mammosite balloon (6.6%) brachytherapy. Results: With a median follow-up of 60 months, there were 5 ipsilateral breast tumor recurrences (IBTR), three local, and two loco-regional. The 5-year actuarial rate of IBTR was 4.8% {+-} 4.1%. The 5-year disease-free survival was 89.6%, with a cause-specific survival and overall survival of 97.6% and 95.3%, respectively. There were no IBTRs among 32 patients with ductal carcinoma in situ (DCIS) vs. 6.1% for patients with invasive carcinoma (p = 0.24). Among 104 patients with Stage I or II invasive carcinoma, the IBTR rate for patients considered cautionary because of age alone was 0% vs. 12.7% in those deemed cautionary due to histopathologic factors (p = 0.018). Conclusions: Overall, we observed few local recurrences among patients with cautionary features. Women with DCIS and patients 50 to 59 years of age with Stage I/II disease who otherwise meet the criteria for suitability appear to be at a low risk of IBTR. Patients with tumor-related cautionary features will benefit from careful patient selection.

  7. Phase II study of reintroduction of oxaliplatin for advanced colorectal cancer in patients previously treated with oxaliplatin and irinotecan: RE-OPEN study

    PubMed Central

    Suenaga, Mitsukuni; Mizunuma, Nobuyuki; Matsusaka, Satoshi; Shinozaki, Eiji; Ozaka, Masato; Ogura, Mariko; Yamaguchi, Toshiharu

    2015-01-01

    Background The effectiveness of reintroducing oxaliplatin in patients with metastatic colorectal cancer refractory to standard chemotherapy has not been verified. We performed a single-arm, open-label, Phase II study to evaluate the safety and efficacy of reintroducing oxaliplatin. Methods Eligible patients had received prior chemotherapy including oxaliplatin and irinotecan that achieved a response or stable disease followed by confirmed disease progression ≥6 months previously during prior oxaliplatin-based therapy. The primary endpoint was the disease control rate (DCR) after 12 weeks of treatment starting. The DCR was defined as the sum of patients with complete response, partial response, and stable disease. Results Thirty-three patients were enrolled. The median age was 62 (range: 35–77) years and the male/female ratio was 19/14. Eastern Cooperative Oncology Group performance status was 0 in 84.8%. Fourteen primary tumors were in the colon and 19 were in the rectum. All patients received modified FOLFOX6 as the protocol treatment. After 12 weeks of treatment starting, the DCR was 39.4% (95% confidence interval 21.8–57.0) and the response rate (complete response and partial response) was 6.1%. The median number of chemotherapy cycles was five and the median total dose of oxaliplatin was 425 mg/m2. Median progression-free survival time was 98 days and median overall survival was 300 days. The incidence of grade ≥1 and grade ≥3 allergic reactions was 28.1% and 3.1%, respectively. The incidence of grade ≥1 and grade ≥3 peripheral sensory neuropathy was 53.1% and 0%, respectively. There were no other severe adverse events and no treatment-related deaths. Conclusion Reintroducing oxaliplatin can be both safe and effective. This may be a salvage option for patients with metastatic colorectal cancer who achieved a response or stable disease with prior oxaliplatin-based therapy followed by disease progression ≥6 months previously during prior

  8. Controlled study of lactoperoxidase gel on oral flora and saliva in irradiated patients with oral cancer.

    PubMed

    Nagy, Katalin; Urban, Edit; Fazekas, Olga; Thurzo, Laszlo; Nagy, Elisabeth

    2007-09-01

    The aim of this study was to determine if radiotherapy induces hyposalivation altering oral microbial flora. The purpose of this placebo-controlled, single-blind study was to determine beneficial effects of a saliva substitute and an oral hygiene product on irradiated patients with oropharyngeal cancer. Eighteen patients were assigned to the test group (Biotène Oral Balance gel [Lacléde Incorporated Healthcare Products, Gardena, CA] and toothpaste used daily), and another 18 were put on a conventional daily regimen (carboxymethylcellulose gel and Oral-B toothpaste [Laclede Pharmaceuticals, Gardena, CA]). Cultures for identifying and quantitating microorganisms, whole unstimulated saliva, and visual analog measurements for comfort were obtained before mucositis occurred and after treatment. Daily use of Biotène products enhanced control of microbial flora, improved salivary flow, and increased oral comfort as compared with control subjects. Four weeks after mucositis, some aerobic isolates disappeared in the test group; periodontal-associated bacteria were markedly decreased in the test group; and candidal species were significantly lowered in the test group. Although baseline saliva was lower in the test group (P = 0.001), after 4 weeks, no difference between groups existed; comfort was greater in the test group (P = 0.007). Use of enzyme-engineered Biotène products that assist in control of the oral microbial flora as well as supporting oral comfort through lubrication appear to be useful aids for irradiated patients with oropharyngeal cancer.

  9. Isolation of Novel Afipia septicemium and Identification of Previously Unknown Bacteria Bradyrhizobium sp. OHSU_III from Blood of Patients with Poorly Defined Illnesses

    PubMed Central

    Lo, Shyh-Ching; Hung, Guo-Chiuan; Li, Bingjie; Lei, Haiyan; Li, Tianwei; Nagamine, Kenjiro; Zhang, Jing; Tsai, Shien; Bryant, Richard

    2013-01-01

    Cultures previously set up for isolation of mycoplasmal agents from blood of patients with poorly-defined illnesses, although not yielding positive results, were cryopreserved because of suspicion of having low numbers of unknown microbes living in an inactive state in the broth. We re-initiated a set of 3 cultures for analysis of the "uncultivable" or poorly-grown microbes using NGS technology. Broth of cultures from 3 blood samples, submitted from OHSU between 2000 and 2004, were inoculated into culture flasks containing fresh modified SP4 medium and kept at room temperature (RT), 30°C and 35°C. The cultures showing evidence of microbial growth were expanded and subjected to DNA analysis by genomic sequencing using Illumina MiSeq. Two of the 3 re-initiated blood cultures kept at RT after 7–8 weeks showed evidence of microbial growth that gradually reached into a cell density with detectable turbidity. The microbes in the broth when streaked on SP4 agar plates produced microscopic colonies in ∼ 2 weeks. Genomic studies revealed that the microbes isolated from the 2 blood cultures were a novel Afipia species, tentatively named Afipia septicemium. Microbes in the 3rd culture (OHSU_III) kept at RT had a limited level of growth and could not reach a plateau with high cell density. Genomic sequencing identified the microbe in the culture as a previously unknown species of Bradyrhizobium bacteria. This study reports on the isolation of novel Afipia and Bradyrhizobium species. Isolation of Bradyrhizobium species bacteria has never been reported in humans. The study also reveals a previously unrecognized nature of hematogenous infections by the 2 unique groups of Bradyrhizobiaceae. Our studies show that improvement of culture system plus effective use of NGS technology can facilitate findings of infections by unusual microbes in patients having poorly-defined, sometimes mysterious illnesses. PMID:24155888

  10. [Effect of intravenous laser irradiation of blood on the homeostasis in patients with hemorrhagic pancreatitis].

    PubMed

    Dedenko, I K

    1989-08-01

    After intravenous blood exposure to low-intensity radiation of Helium-Neon laser patients with haemorrhagic pancreatitis exhibited inhibition of the blood proteolytic activity; enhancement of free-radical oxidation, kallikrein-kinin system activity, blood oxygen transport, correction of endotoxic pancreatogenic syndrome. In addition, the positive shifts were also observed in the immunological status, morphofunctional characteristics of the red blood cells and hemoglobin, hepatic and renal functions. In severe pancreatogenic endotoxicosis the highest response was achieved with combined use of hemosorption and intravenous laser irradiation. PMID:2811243

  11. Changes in surfactant in bronchoalveolar lavage fluid after hemithorax irradiation in patients with mesothelioma

    SciTech Connect

    Hallman, M.; Maasilta, P.; Kivisaari, L.; Mattson, K. )

    1990-04-01

    Experimental studies have shown that the surfactant system of the lung is affected shortly after irradiation. It is unclear, however, whether surfactant plays a role in the pathogenesis of radiation pneumonitis. In the present study surfactant components (saturated phosphatidylcholine, surfactant protein A, phosphatidylglycerol, and phosphatidylinositol) and other phospholipids of bronchoalveolar lavage fluid (BAL) were studied in four patients with pleural mesothelioma before and during hemithorax irradiation (70 Gy) as well as zero, 1, 2, 3, and 4 months following irradiation. The concentrations of these same components and of soluble proteins were also estimated in the epithelial lining fluid (ELF) using urea as a marker of dilution. After radiotherapy, the concentrations of the surfactant components in ELF decreased to 12 to 55% of the control values before radiation, whereas the concentration of sphingomyelin in ELF increased ninefold. There were small changes in the other phospholipids. The concentration of soluble protein in ELF increased sevenfold. The minimum surface activity of crude BAL increased from 12 +/- 4 to 32 +/- 6 mN/m, and that of the sediment fraction of BAL increased from 7 +/- 4 to 22 +/- 6 mN/m, p less than 0.001. The protein-rich supernatant fraction of BAL from irradiated lung had a inhibitory effect on normal surfactant. There were significant correlations between the increasing severity of the radiologic changes on the one hand and, on the other, the saturated phosphatidylcholine/sphingomyelin ratio (p less than 0.001), the concentrations of soluble protein (p less than 0.001), and the concentrations of the surfactant components (p less than 0.02-0.001) in ELF.

  12. Laser blood irradiation effect on electrophysiological characteristics of acute coronary syndrome patients

    NASA Astrophysics Data System (ADS)

    Khotiaintsev, Sergei N.; Doger-Guerrero, E.; Glebova, L.; Svirid, V.; Sirenko, Yuri

    1996-11-01

    This paper treats electro-physiological effects of the low- level laser irradiation of blood (LBI). The data presented here are based on the observation of almost 200 patients suffering from the acute disruption of coronary blood circulation, unstable angina pectoris and myocardial infarction. Statistically significant changes of the electro-physiological characteristics were observed in the group of 65 patients, treated by the LBI. In particular, the significant 6 percent extension of the effective refractory period was observed. The electrical situation threshold has increased by 20.6 percent. The significant changes of some other important electro-physiological characteristics were within the range of 5-15 percent. In this paper, the data obtained on the LBI effectiveness are compared also with the results obtained on 94 patients who in addition to the standard anti-angina therapy were treated by the autohaemo- transfusion performed simultaneously with the UV-light irradiation of the transfused blood. The results obtained demonstrate the significant positive effect of the low energy LBI. The electrophysiological data obtained have good correlation with observed anti-arrhythmic effect of the LBI. This is proved by the data obtained on the electro- physiological characteristics of the cardiovascular system and by other clinical data on the experimental and control group of patients. In the course of this research the exact effect of the low level LBI was established. LBI led to the pronounced positive changes in electro-physiological characteristics of the cardiovascular system of the patients, it also led to the pronounced anti-arrhythmic effect.

  13. Survival and Neurocognitive Outcomes After Cranial or Craniospinal Irradiation Plus Total-Body Irradiation Before Stem Cell Transplantation in Pediatric Leukemia Patients With Central Nervous System Involvement

    SciTech Connect

    Hiniker, Susan M.; Agarwal, Rajni; Modlin, Leslie A.; Gray, Christine C.; Harris, Jeremy P.; Million, Lynn; Kiamanesh, Eileen F.; Donaldson, Sarah S.

    2014-05-01

    Purpose: To evaluate survival and neurocognitive outcomes in pediatric acute lymphoblastic leukemia (ALL) patients with central nervous system (CNS) involvement treated according to an institutional protocol with stem cell transplantation (SCT) and a component of craniospinal irradiation (CSI) in addition to total-body irradiation (TBI) as preparative regimen. Methods and Materials: Forty-one pediatric ALL patients underwent SCT with TBI and received additional cranial irradiation or CSI because of CNS leukemic involvement. Prospective neurocognitive testing was performed before and after SCT in a subset of patients. Cox regression models were used to determine associations of patient and disease characteristics and treatment methods with outcomes. Results: All patients received a cranial radiation boost; median total cranial dose was 24 Gy. Eighteen patients (44%) received a spinal boost; median total spinal dose for these patients was 18 Gy. Five-year disease-free survival (DFS) for all patients was 67%. Those receiving CSI had a trend toward superior DFS compared with those receiving a cranial boost alone (hazard ratio 3.23, P=.14). Patients with isolated CNS disease before SCT had a trend toward superior DFS (hazard ratio 3.64, P=.11, 5-year DFS 74%) compared with those with combined CNS and bone marrow disease (5-year DFS 59%). Neurocognitive testing revealed a mean post-SCT overall intelligence quotient of 103.7 at 4.4 years. Relative deficiencies in processing speed and/or working memory were noted in 6 of 16 tested patients (38%). Pre- and post-SCT neurocognitive testing revealed no significant change in intelligence quotient (mean increase +4.7 points). At a mean of 12.5 years after transplant, 11 of 13 long-term survivors (85%) had completed at least some coursework at a 2- or 4-year college. Conclusion: The addition of CSI to TBI before SCT in pediatric ALL with CNS involvement is effective and well-tolerated. Craniospinal irradiation plus TBI is worthy

  14. Mediastinal irradiation in a patient affected by lung carcinoma after heart transplantation: Helical tomotherapy versus three dimensional conformal radiotherapy

    PubMed Central

    Iorio, Vincenzo; Cammarota, Fabrizio; Toledo, Diego; Senese, Rossana; Francomacaro, Ferdinando; Muto, Matteo; Muto, Paolo

    2016-01-01

    Abstract Patients who have undergone solid organ transplants are known to have an increased risk of neoplasia compared with the general population. We report our experience using mediastinal irradiation with helical tomotherapy versus three‐dimensional conformal radiation therapy to treat a patient with lung carcinoma 15 years after heart transplantation. Our dosimetric evaluation showed no particular difference between the techniques, with the exception of some organs. Mediastinal irradiation after heart transplantation is feasible and should be considered after evaluation of the risk. Conformal radiotherapy or intensity‐modulated radiotherapy appears to be the appropriate treatment in heart‐transplanted oncologic patients. PMID:27148425

  15. Mediastinal irradiation in a patient affected by lung carcinoma after heart transplantation: Helical tomotherapy versus three dimensional conformal radiotherapy.

    PubMed

    Giugliano, Francesca M; Iorio, Vincenzo; Cammarota, Fabrizio; Toledo, Diego; Senese, Rossana; Francomacaro, Ferdinando; Muto, Matteo; Muto, Paolo

    2016-04-26

    Patients who have undergone solid organ transplants are known to have an increased risk of neoplasia compared with the general population. We report our experience using mediastinal irradiation with helical tomotherapy versus three-dimensional conformal radiation therapy to treat a patient with lung carcinoma 15 years after heart transplantation. Our dosimetric evaluation showed no particular difference between the techniques, with the exception of some organs. Mediastinal irradiation after heart transplantation is feasible and should be considered after evaluation of the risk. Conformal radiotherapy or intensity-modulated radiotherapy appears to be the appropriate treatment in heart-transplanted oncologic patients.

  16. Loss of Autonoetic Awareness of Recent Autobiographical Episodes and Accelerated Long-Term Forgetting in a Patient with Previously Unrecognized Glutamic Acid Decarboxylase Antibody Related Limbic Encephalitis

    PubMed Central

    Witt, Juri-Alexander; Vogt, Viola Lara; Widman, Guido; Langen, Karl-Josef; Elger, Christian Erich; Helmstaedter, Christoph

    2015-01-01

    We describe a 35-year-old male patient presenting with depressed mood and emotional instability, who complained about severe anterograde and retrograde memory deficits characterized by accelerated long-term forgetting and loss of autonoetic awareness regarding autobiographical memories of the last 3 years. Months before he had experienced two breakdowns of unknown etiology giving rise to the differential diagnosis of epileptic seizures after various practitioners and clinics had suggested different etiologies such as a psychosomatic condition, burnout, depression, or dissociative amnesia. Neuropsychological assessment indicated selectively impaired figural memory performance. Extended diagnostics confirmed accelerated forgetting of previously learned and retrievable verbal material. Structural imaging showed bilateral swelling and signal alterations of temporomesial structures (left >right). Video-EEG monitoring revealed a left temporal epileptic focus and subclincal seizure, but no overt seizures. Antibody tests in serum and liquor were positive for glutamic acid decarboxylase antibodies. These findings led to the diagnosis of glutamic acid decarboxylase antibody related limbic encephalitis. Monthly steroid pulses over 6 months led to recovery of subjective memory and to intermediate improvement but subsequent worsening of objective memory performance. During the course of treatment, the patient reported de novo paroxysmal non-responsive states. Thus, antiepileptic treatment was started and the patient finally became seizure free. At the last visit, vocational reintegration was successfully in progress. In conclusion, amygdala swelling, retrograde biographic memory impairment, accelerated long-term forgetting, and emotional instability may serve as indicators of limbic encephalitis, even in the absence of overt epileptic seizures. The monitoring of such patients calls for a standardized and concerted multilevel diagnostic approach with repeated assessments

  17. Multiple sclerosis-like diagnosis as a complication of previously treated malaria in an iron and vitamin D deficient Nigerian patient.

    PubMed

    van Rensburg, Susan J; van Toorn, Ronald; Moremi, Kelebogile E; Peeters, Armand V; Oguniyi, Adesola; Kotze, Maritha J

    2016-02-01

    In contrast to malaria, multiple sclerosis (MS) is infrequently found in Black Africans. We describe a 29 year old Nigerian female who developed an MS-like condition with symptoms similar to relapsing-remitting MS following malaria infection, leading to a diagnosis of MS. However, absence of hyperintense lesions in the brain and spinal cord presented a conundrum since not all the diagnostic criteria for MS were met. Pathology supported genetic testing (PSGT) was applied to combine family and personal medical history, lifestyle factors, and biochemical test results for interpretation of genetic findings. This approach provides a means of identifying risk factors for different subtypes of demyelinating disease. The patient was subsequently treated according to an individualised intervention program including nutritional supplementation as well as a change in diet and lifestyle. Deficiencies of vitamin B12, iron and vitamin D were addressed. Genetic analysis revealed absence of the HLA DRB1*1501 allele, considered to be the most prominent genetic risk factor for MS. Extended mutation analysis identified variations in three genes in the folate-vitamin B12 metabolic pathway, which could have increased the patient's sensitivity to the antifolate drugs used to treat the malaria. A glutathione-S-transferase GSTM1 null allele, previously associated with neurological complications of malaria, was also detected. Furthermore, a heterozygous variation in the iron-related transmembrane protease serine 6 (TMPRSS6) gene, rs855791 was found, which could have impacted the patient's iron status following two successive blood donations and exposure to malaria preceding the MS diagnosis. PSGT identifies relevant risk factors for demyelinating disorders resembling MS and uses the data for individualised treatment programs, and to systematically build a database that can provide evidence in large patient cohorts. Follow-up investigations may be suggested, such as whole exome sequencing

  18. Multiple sclerosis-like diagnosis as a complication of previously treated malaria in an iron and vitamin D deficient Nigerian patient.

    PubMed

    van Rensburg, Susan J; van Toorn, Ronald; Moremi, Kelebogile E; Peeters, Armand V; Oguniyi, Adesola; Kotze, Maritha J

    2016-02-01

    In contrast to malaria, multiple sclerosis (MS) is infrequently found in Black Africans. We describe a 29 year old Nigerian female who developed an MS-like condition with symptoms similar to relapsing-remitting MS following malaria infection, leading to a diagnosis of MS. However, absence of hyperintense lesions in the brain and spinal cord presented a conundrum since not all the diagnostic criteria for MS were met. Pathology supported genetic testing (PSGT) was applied to combine family and personal medical history, lifestyle factors, and biochemical test results for interpretation of genetic findings. This approach provides a means of identifying risk factors for different subtypes of demyelinating disease. The patient was subsequently treated according to an individualised intervention program including nutritional supplementation as well as a change in diet and lifestyle. Deficiencies of vitamin B12, iron and vitamin D were addressed. Genetic analysis revealed absence of the HLA DRB1*1501 allele, considered to be the most prominent genetic risk factor for MS. Extended mutation analysis identified variations in three genes in the folate-vitamin B12 metabolic pathway, which could have increased the patient's sensitivity to the antifolate drugs used to treat the malaria. A glutathione-S-transferase GSTM1 null allele, previously associated with neurological complications of malaria, was also detected. Furthermore, a heterozygous variation in the iron-related transmembrane protease serine 6 (TMPRSS6) gene, rs855791 was found, which could have impacted the patient's iron status following two successive blood donations and exposure to malaria preceding the MS diagnosis. PSGT identifies relevant risk factors for demyelinating disorders resembling MS and uses the data for individualised treatment programs, and to systematically build a database that can provide evidence in large patient cohorts. Follow-up investigations may be suggested, such as whole exome sequencing

  19. Prophylactic irradiation of the lungs to prevent development of pulmonary metastases in patients with osteosarcoma of the limbs

    SciTech Connect

    Breur, K.; Schweisguth, O.; Cohen, P.; Voute, P.A.

    1981-04-01

    A controlled clinical trial conducted by the European Organization for Research on Treatment of Cancer Radiotherapy Cooperative Group has shown that prophylactic lung irradiation is effective in preventing lung metastases in patients under 17 years of age. Recently, a new three-armed trial has started in which prophylactic chemotherapy and lung irradiation and chemotherapy combined with radiotherapy to the lungs will be compared for their ability to prevent the development of lung metastases.

  20. Finger reconstruction with triple toe transfer from the same foot for a patient with a special job and previous foot trauma.

    PubMed

    Chen, H C; Tang, Y B; Wei, F C; Noordhoff, M S

    1991-09-01

    After the loss of four fingers at the metacarpal level, triple toe transfer from the same foot was performed in the dominant hand of an art worker who needed three ulnar digits to work with the intact thumb. The toes of the left foot could not be used because of a previous injury. Long-term follow-up at 3 years showed good results in terms of function. He regained dexterity for calligraphy, notably the brush calligraphy and painting that are important in his job. The donor site was treated very carefully to prevent complications. There was minimal donor site morbidity. He still can walk very well and runs fast. Gait analysis of the donor foot is presented. This was a unique situation, and satisfactory results were obtained through the cooperation of the patient as well as detailed analysis before surgery. PMID:1952754

  1. Effectiveness of prophylactic retropharyngeal lymph node irradiation in patients with locally advanced head and neck cancer

    PubMed Central

    2012-01-01

    Background The aim of the study is to assess the effectiveness of intensity-modulated radiotherapy (IMRT) or image-guided radiotherapy (IGRT) for the prevention of retropharyngeal nodal recurrences in locally advanced head and neck cancer. Methods A retrospective review of 76 patients with head and neck cancer undergoing concurrent chemoradiation or postoperative radiotherapy with IMRT or IGRT who were at risk for retropharyngeal nodal recurrences because of anatomic site (hypopharynx, nasopharynx, oropharynx) and/or the presence of nodal metastases was undertaken. The prevalence of retropharyngeal nodal recurrences was assessed on follow-up positron emission tomography (PET)-CT scans. Results At a median follow-up of 22 months (4–53 months), no patient developed retropharyngeal nodal recurrences. Conclusion Prophylactic irradiation of retropharyngeal lymph nodes with IMRT or IGRT provides effective regional control for individuals at risk for recurrence in these nodes. PMID:22708791

  2. Optimal Extent of Prophylactic Irradiation of Paraaortic Lymph Nodes in Patients with Uterine Cervical Cancer

    PubMed Central

    Choi, Jinhyun; Yoon, Hong In; Lee, Jeongshim; Keum, Ki Chang; Kim, Gwi Eon; Kim, Yong Bae

    2015-01-01

    Purpose The purpose of this study was to determine optimal extent of prophylactic irradiation of paraaortic lymph nodes (PALN) in patients with uterine cervical cancer who had metastatic pelvic LNs. Methods and Materials We retrospectively evaluated 103 patients with cervical cancer and pelvic lymph node metastasis who were treated with prophylactic semi-extended field radiotherapy (SEFRT) between 1990 and 2012. The semi-extended field included PALN below the second lumbar spine with prescribed doses of 45 to 50 Gy. Survival outcomes were calculated using the Kaplan-Meier method, and acute and late toxicities were scored using the Radiation Therapy Oncology Group and European Organisation for Research and Treatment of Cancer toxicity criteria. Results The median follow-up after SEFRT was 61 (range 5–296) months. Overall, 28 patients (27.2%) experienced treatment failures, which were classified as local in 8 patients (7.8%), regional in 8 patients (7.8%), and distant in 13 patients (12.6%). Of the regional failures, only two involved PALN failure around the renal artery or the renal hilum area at the upper margin of the semi-extended field. At 5 years, the overall survival was 82%. Grade 3 or higher acute gastrointestinal and genitourinary toxicities occurred in one and two patients, respectively. As a late toxicity, one patient developed grade 3 small bowel obstruction. Conclusion Prophylactic SEFRT provided favorable outcomes with little acute or late gastrointestinal toxicity. For prophylaxis of PALN recurrences, upper part of PALN might not need to be included in patients with uterine cervical cancer and metastatic pelvic LNs. PMID:26659867

  3. Usefulness of postoperative hip irradiation in the prevention of heterotopic bone formation in a high risk group of patients

    SciTech Connect

    MacLennan, I.; Keys, H.M.; Evarts, C.M.; Rubin, P.

    1984-01-01

    Heterotopic ossification is a complication of total hip arthroplasty in 14 to 30% of patients. Significant functional impairment will occur in up to 28% of patients with ectopic bone. The high risk group includes those with preexisting heterotopic bone in either hip, those suffering from hypertrophic osteoarthritis or ankylosing spondylitis and patients who have had multiple procedures on the hip. Fifty-eight patients (67 hips) were irradiated after surgical removal of ectopic bone (53 hips) or received radiation prophylaxis of heterotopic ossification (14 hips). Ninety-five percent of patients had either no bone visible or insignificant amounts of ectopic bone visible on postoperative hip X-rays. Only 5% of patients showed significant persistence of ectopic bone. Postoperative hip function was dramatically improved compared to preoperative function in all patients treated. The importance of early commencement of irradiation is emphasized.

  4. Unexpected finding of T-cell lymphoma in a previously healthy 16-year-old patient after a thorax trauma: a case report

    PubMed Central

    2014-01-01

    Introduction We describe the clinical course and emphasize the difficulties in diagnosing T-cell lymphoblastic lymphoma. The differential diagnostic difficulties have previously been described in regard to pneumonia, but to the best of the authors’ knowledge this is the first case report to describe lymphoma in relation to trauma. Case presentation A previously healthy 16-year-old Danish boy presented to our hospital with chest pain and accentuated protruding thoracic veins. Ten days prior to hospitalization he had suffered a blunt thoracic trauma while playing soccer. After drainage of an excessive amount of pleural fluid, he developed severe respiratory distress. A chest tube was inserted and he was transferred to a level 1 trauma centre. Here, a computed tomography scan unexpectedly revealed significantly swollen mediastinal and retroperitoneal lymph nodes, and he was later diagnosed with T-cell lymphoblastic lymphoma. Conclusions This case emphasizes the importance of reacting to an unexplained large amount of pleural fluid after a patient suffers thoracic trauma and to consider possible underlying causes. This report is mainly addressed to emergency personnel, but it is also relevant to pediatricians, surgeons, anesthesiologists, and general practitioners. PMID:25403976

  5. Unresolved or Contradictory Issues About Management of Patients With Patent Foramen Ovale and Previous Cryptogenic Stroke: Additional Randomized Controlled Trials Are Eagerly Awaited

    PubMed Central

    De Vecchis, Renato; Baldi, Cesare

    2016-01-01

    Stating a well-codified and widely accepted therapeutic conduct for patients with patent foramen ovale (PFO) and previous cryptogenic stroke is made difficult and somewhat controversial by several issues remained unresolved so far. In this short review, some aspects of the possible role played by the PFO in the pathogenesis of cryptogenic stroke are succinctly analyzed. First, some aspects of cardiovascular anatomy of the human fetus and the adult are outlined. Subsequently, the three randomized controlled trials (RCTs) that have been accomplished so far to compare the implant of a transeptal occluding device with a simple medical therapy in patients with PFO and history of cryptogenic stroke are briefly examined. These RCTs, when assessed using the “intention to treat” method, do not show a greater protective effect of therapy with transeptal device as regards the recurrences of stroke. Afterwards, there is a brief presentation of the findings of several meta-analyses that have been derived from the three above mentioned RCTs, whose results are strikingly discordant with each other. In fact, some of them come to the conclusion that the transcatheter closure of PFO does not offer significant advantages compared to antithrombotic therapy for the secondary prevention of cryptogenic stroke, while others based on subgroup analyses argue that the transcatheter closure of PFO with Amplatzer device, differently from the one performed using the STARFlex device, would be associated with significantly lower incidence of cerebrovascular events compared with medical therapy alone. Finally, the authors argue the need to adhere to the current scientific guidelines. They substantially deny an alleged superior efficacy of transcatheter PFO occlusion compared to medical therapy with antithrombotic agents (anticoagulants or antiplatelet agents), except for selected cases of patients with documented PFO and concomitant clinical-instrumental picture of deep venous thrombosis. PMID

  6. Unresolved or Contradictory Issues About Management of Patients With Patent Foramen Ovale and Previous Cryptogenic Stroke: Additional Randomized Controlled Trials Are Eagerly Awaited.

    PubMed

    De Vecchis, Renato; Baldi, Cesare

    2016-05-01

    Stating a well-codified and widely accepted therapeutic conduct for patients with patent foramen ovale (PFO) and previous cryptogenic stroke is made difficult and somewhat controversial by several issues remained unresolved so far. In this short review, some aspects of the possible role played by the PFO in the pathogenesis of cryptogenic stroke are succinctly analyzed. First, some aspects of cardiovascular anatomy of the human fetus and the adult are outlined. Subsequently, the three randomized controlled trials (RCTs) that have been accomplished so far to compare the implant of a transeptal occluding device with a simple medical therapy in patients with PFO and history of cryptogenic stroke are briefly examined. These RCTs, when assessed using the "intention to treat" method, do not show a greater protective effect of therapy with transeptal device as regards the recurrences of stroke. Afterwards, there is a brief presentation of the findings of several meta-analyses that have been derived from the three above mentioned RCTs, whose results are strikingly discordant with each other. In fact, some of them come to the conclusion that the transcatheter closure of PFO does not offer significant advantages compared to antithrombotic therapy for the secondary prevention of cryptogenic stroke, while others based on subgroup analyses argue that the transcatheter closure of PFO with Amplatzer device, differently from the one performed using the STARFlex device, would be associated with significantly lower incidence of cerebrovascular events compared with medical therapy alone. Finally, the authors argue the need to adhere to the current scientific guidelines. They substantially deny an alleged superior efficacy of transcatheter PFO occlusion compared to medical therapy with antithrombotic agents (anticoagulants or antiplatelet agents), except for selected cases of patients with documented PFO and concomitant clinical-instrumental picture of deep venous thrombosis. PMID

  7. Incidence and Correlates of Radiation Pneumonitis in Pediatric Patients With Partial Lung Irradiation

    SciTech Connect

    Hua Chiaho; Hoth, Kelly A.; Wu Shengjie; Kun, Larry E.; Metzger, Monika L.; Spunt, Sheri L.; Xiong Xiaoping; Krasin, Mathew J.

    2010-09-01

    Purpose: To provide a radiation pneumonitis risk estimate and investigate the correlation of clinical and dosimetric factors in pediatric patients receiving chest irradiation. Methods and Materials: A total of 122 patients diagnosed with sarcoma or Hodgkin lymphoma who received radiotherapy to the chest were evaluated for symptomatic radiation pneumonitis (Common Toxicity Criteria Grade 1 with respiratory symptom or higher grade). Pneumonitis data were collected from either prospective toxicity screenings as part of a clinical trial or through chart review. Dosimetric parameters including V{sub 10}-V{sub 25}, mean lung dose, binned lung dose, and tissue complication probability models were used, as well as clinical features to correlate with the development of pneumonitis. Results: The 1- and 2-year cumulative incidence of symptomatic radiation pneumonitis for all patients was 8.2% and 9.1%, respectively. Nine patients experienced symptomatic Grade 1 toxicity, and 2 experienced Grade 2. From univariate analysis, chemotherapy containing bleomycin ({chi}{sup 2} test, p = 0.027) and V{sub 24} (logistic regression, p = 0.019) were the clinical and dosimetric factors that resulted in statistically significant differences in the occurrence of pneumonitis. The probability of pneumonitis increased more dramatically with increasing V{sub 24} in patients receiving bleomycin than in those who did not. Adult tissue complication models did not differentiate pediatric patients with radiation pneumonitis from those without. Conclusions: The incidence of symptomatic radiation pneumonitis in pediatric patients is low and its severity mild. Parameters frequently used in adult radiation oncology provide some guidance as to risk, but pediatric patients warrant their own specific models for risk assessment, incorporating dosimetry and clinical factors.

  8. INCIDENCE AND CORRELATES OF RADIATION PNEUMONITIS IN PEDIATRIC PATIENTS WITH PARTIAL LUNG IRRADIATION

    PubMed Central

    Hua, Chiaho; Hoth, Kelly A.; Wu, Shengjie; Kun, Larry E.; Metzger, Monika L.; Spunt, Sheri L.; Xiong, Xiaoping; Krasin, Mathew J.

    2012-01-01

    Purpose To provide a radiation pneumonitis risk estimate and investigate the correlation of clinical and dosimetric factors in pediatric patients receiving chest irradiation. Methods and Materials A total of 122 patients diagnosed with sarcoma or Hodgkin lymphoma who received radiotherapy to the chest were evaluated for symptomatic radiation pneumonitis (Common Toxicity Criteria Grade 1 with respiratory symptom or higher grade). Pneumonitis data were collected from either prospective toxicity screenings as part of a clinical trial or through chart review. Dosimetric parameters including V10–V25, mean lung dose, binned lung dose, and tissue complication probability models were used, as well as clinical features to correlate with the development of pneumonitis. Results The 1- and 2-year cumulative incidence of symptomatic radiation pneumonitis for all patients was 8.2% and 9.1%, respectively. Nine patients experienced symptomatic Grade 1 toxicity, and 2 experienced Grade 2. From univariate analysis, chemotherapy containing bleomycin (χ2 test, p = 0.027) and V24 (logistic regression, p = 0.019) were the clinical and dosimetric factors that resulted in statistically significant differences in the occurrence of pneumonitis. The probability of pneumonitis increased more dramatically with increasing V24 in patients receiving bleomycin than in those who did not. Adult tissue complication models did not differentiate pediatric patients with radiation pneumonitis from those without. Conclusions The incidence of symptomatic radiation pneumonitis in pediatric patients is low and its severity mild. Parameters frequently used in adult radiation oncology provide some guidance as to risk, but pediatric patients warrant their own specific models for risk assessment, incorporating dosimetry and clinical factors. PMID:20056346

  9. Medulloblastoma: Long-term follow-up of patients treated with electron irradiation of the spinal field

    SciTech Connect

    Gaspar, L.E.; Dawson, D.J.; Tilley-Gulliford, S.A.; Banerjee, P. )

    1991-09-01

    Thirty-two patients with posterior fossa medulloblastoma underwent treatment with electron irradiation to the spinal field. The 5- and 10-year actuarial survival rates were 57% and 50%, respectively. Late complications observed in the 15 patients followed up for more than 5 years were short stature (six patients), decreased sitting-standing height ratio (four patients), scoliosis (two patients), poor school performance (seven patients), xerostomia (one patient), esophageal stricture (one patient), pituitary dysfunction (four patients), primary hypothyroidism (one patient), bilateral eighth-nerve deafness (one patient), and carcinoma of the thyroid (one patient). Complications following treatment with electrons to a spinal field are compared with reported complications following treatment with photons to the spinal field. Although short-term reactions were minimal, the authors found no difference in late complications. More sophisticated treatment planning may show such a long-term benefit in the future.

  10. Relation between acute and late irradiation impairment of four basic tastes and irradiated tongue volume in patients with head-and-neck cancer

    SciTech Connect

    Yamashita, Hideomi . E-mail: yamachan07291973@yahoo.co.jp; Nakagawa, Keiichi; Nakamura, Naoki; Abe, Keiko; Asakage, Takahiro; Ohmoto, Makoto; Okada, Shinji; Matsumoto, Ichiro; Hosoi, Yoshio; Sasano, Nakashi; Yamakawa, Sen; Ohtomo, Kuni

    2006-12-01

    Purpose: Taste loss is a major cause of morbidity in patients undergoing head-and-neck irradiation. The relationship between the time course and the degree of taste disorder was studied in both acute and late phases. Methods and Materials: Taste ability was measured by the taste threshold for the four basic tastes using a filter paper disc method in patients before, during, and after radiotherapy. The subjects were divided into two groups. In Group A, Radiation fields included most of the tongue (n = 100), and in Group B Radiation fields did not include the tip of the tongue (n = 18). Results: In Group A, there was a significant impairment of the threshold of all four basic tastes at 3 weeks after starting radiotherapy (RT), and this impairment remained at 8 weeks (p < 0.05). This was not seen in Group B. In Group A, there was no significant difference in the patterns of taste sensitivity change between the high-dose (>20 Gy) and low-dose ({<=}20 Gy) groups. In the late phase, recovery of taste loss was seen in both groups since 4 months after completing RT. Conclusions: Unless the anterior part of the tongue was irradiated, taste loss was not observed during RT. When the anterior part of the tongue was irradiated, a difference by radiation dose was not observed in the taste loss pattern. Additionally, radiation-induced taste dysfunction appears to be a temporal effect.

  11. Plantar Pressure in Diabetic Peripheral Neuropathy Patients with Active Foot Ulceration, Previous Ulceration and No History of Ulceration: A Meta-Analysis of Observational Studies

    PubMed Central

    Fernando, Malindu Eranga; Crowther, Robert George; Pappas, Elise; Lazzarini, Peter Anthony; Cunningham, Margaret; Sangla, Kunwarjit Singh; Buttner, Petra; Golledge, Jonathan

    2014-01-01

    Aims Elevated dynamic plantar pressures are a consistent finding in diabetes patients with peripheral neuropathy with implications for plantar foot ulceration. This meta-analysis aimed to compare the plantar pressures of diabetes patients that had peripheral neuropathy and those with neuropathy with active or previous foot ulcers. Methods Published articles were identified from Medline via OVID, CINAHL, SCOPUS, INFORMIT, Cochrane Central EMBASE via OVID and Web of Science via ISI Web of Knowledge bibliographic databases. Observational studies reporting barefoot dynamic plantar pressure in adults with diabetic peripheral neuropathy, where at least one group had a history of plantar foot ulcers were included. Interventional studies, shod plantar pressure studies and studies not published in English were excluded. Overall mean peak plantar pressure (MPP) and pressure time integral (PTI) were primary outcomes. The six secondary outcomes were MPP and PTI at the rear foot, mid foot and fore foot. The protocol of the meta-analysis was published with PROPSERO, (registration number CRD42013004310). Results Eight observational studies were included. Overall MPP and PTI were greater in diabetic peripheral neuropathy patients with foot ulceration compared to those without ulceration (standardised mean difference 0.551, 95% CI 0.290–0.811, p<0.001; and 0.762, 95% CI 0.303–1.221, p = 0.001, respectively). Sub-group analyses demonstrated no significant difference in MPP for those with neuropathy with active ulceration compared to those without ulcers. A significant difference in MPP was found for those with neuropathy with a past history of ulceration compared to those without ulcers; (0.467, 95% CI 0.181– 0.753, p = 0.001). Statistical heterogeneity between studies was moderate. Conclusions Plantar pressures appear to be significantly higher in patients with diabetic peripheral neuropathy with a history of foot ulceration compared to those with diabetic neuropathy

  12. Should patients with laryngeal small cell neuroendocrine carcinoma receive prophylactic cranial irradiation?

    PubMed

    Coca-Pelaz, Andrés; Devaney, Kenneth O; Rodrigo, Juan P; Halmos, Gyorgy B; Strojan, Primož; Mendenhall, William M; Eisbruch, Avraham; Smee, Robert; Kusafuka, Kimihide; Rinaldo, Alessandra; Ferlito, Alfio

    2016-10-01

    While small cell neuroendocrine carcinomas (SCNCs) most often arise in the lung, extrapulmonary SCNCs arise in a variety of locations-including the head and neck region. In particular, laryngeal SCNCs-while rare tumors-are nevertheless recognized as distinct lesions. The rarity of laryngeal SCNC gives rise to two distinct difficulties: first (particularly with small biopsy specimens), laryngeal SCNC can be difficult to diagnose by routine light microscopy; second, limited experience with these tumors can make the crafting of a treatment plan for individual patients difficult. As regards the first problem, pathologic diagnosis is greatly enhanced by the application of immunohistochemistry. The second problem-crafting a successful treatment strategy-presents a much larger difficulty. It is tempting to extrapolate from experience with the (more common) pulmonary SCNC in search of a strategy applicable to laryngeal SCNC; such an extrapolation, however, may not be uniformly successful. In particular, while a combination of radiation therapy and chemotherapy appears to be as valuable in the treatment of extrapulmonary as it is in the treatment of pulmonary SCNC, prophylactic cranial irradiation (PCI)-which has enjoyed some success in the treatment of some patients with pulmonary SCNC-does not appear to have similar utility in patients with laryngeal SCNC. Accordingly, the use of PCI does not appear to have a role to play at this point in time in the treatment of patients with laryngeal SCNC.

  13. Should patients with laryngeal small cell neuroendocrine carcinoma receive prophylactic cranial irradiation?

    PubMed

    Coca-Pelaz, Andrés; Devaney, Kenneth O; Rodrigo, Juan P; Halmos, Gyorgy B; Strojan, Primož; Mendenhall, William M; Eisbruch, Avraham; Smee, Robert; Kusafuka, Kimihide; Rinaldo, Alessandra; Ferlito, Alfio

    2016-10-01

    While small cell neuroendocrine carcinomas (SCNCs) most often arise in the lung, extrapulmonary SCNCs arise in a variety of locations-including the head and neck region. In particular, laryngeal SCNCs-while rare tumors-are nevertheless recognized as distinct lesions. The rarity of laryngeal SCNC gives rise to two distinct difficulties: first (particularly with small biopsy specimens), laryngeal SCNC can be difficult to diagnose by routine light microscopy; second, limited experience with these tumors can make the crafting of a treatment plan for individual patients difficult. As regards the first problem, pathologic diagnosis is greatly enhanced by the application of immunohistochemistry. The second problem-crafting a successful treatment strategy-presents a much larger difficulty. It is tempting to extrapolate from experience with the (more common) pulmonary SCNC in search of a strategy applicable to laryngeal SCNC; such an extrapolation, however, may not be uniformly successful. In particular, while a combination of radiation therapy and chemotherapy appears to be as valuable in the treatment of extrapulmonary as it is in the treatment of pulmonary SCNC, prophylactic cranial irradiation (PCI)-which has enjoyed some success in the treatment of some patients with pulmonary SCNC-does not appear to have similar utility in patients with laryngeal SCNC. Accordingly, the use of PCI does not appear to have a role to play at this point in time in the treatment of patients with laryngeal SCNC. PMID:26530293

  14. Duration of disease, neuropathic symptoms, and plantar sensitivity in patients with diabetes with and without previous plantar ulceration.

    PubMed

    de Almeida Bacarin, Tatiana; Akashi, Paula M H; de C N Sacco, Prof Isabel

    2008-02-01

     This study compared the duration of disease, the prevalence of neuropathy symptoms, and plantar insensitivity among subjects with diabetic neuropathy, with and without previous history of plantar ulcers, to a nondiabetic group of subjects. Correlations were made between the neuropathic symptoms observed and the results of sensory tests. Thermal and tactile sensitivities and sensitive chronaxie were measured in the control group (CG, n = 19), a diabetic neuropathic group (DG, n = 16), and a diabetic neuropathic group with previous history of plantar ulceration (UDG, n = 9). Plantar sensitivity was investigated in 5 areas of the plantar surface of both feet: heel, midfoot, lateral forefoot, medial forefoot, and hallux. The neuropathy symptoms were investigated using the Michigan Neuropathy Screening Instrument (MNSI). The neuropathic groups did not differ in duration of diabetes onset (DG = 13 years ± 8; UDG = 14 years ± 5; P = 0.243) and they presented similar mean for symptoms according to MNSI score (DG = 6.94 ± 1.81; UDG = 6.78 ± 2.44; P = 0.352). The frequency of subjects with abnormal sensitivity was higher in UDG. The MNSI showed moderate correlation with tactile sensitivity (r <-0.42, P <0.05). Patients with diabetic neuropathy and an ulcer had decreased sensitivity in their feet. The symptoms may indicate loss of sensation, but symptoms alone are not able to differentiate between neuropathic subjects with different progressions of diabetic peripheral neuropathy (DPN). Duration of diabetes and symptoms did not explain the severity of neuropathy in people with a diabetic ulcer.

  15. Inhibitors incidence rate in Czech previously untreated patients with haemophilia A has not increased since introduction of recombinant factor VIII treatment in 2003.

    PubMed

    Blatny, Jan; Komrska, Vladimir; Blazek, Bohumir; Penka, Miroslav; Ovesna, Petra

    2015-09-01

    Our objective was to assess the incidence of inhibitors development in Czech Republic since the introduction of recombinant factor VIII (rFVIII) and to look for the factors potentially influencing this parameter. It is to be expected that inhibitors risk may be increased after the introduction of recombinant products. Data of Czech National Haemophilia Programme registry entered from 2003 till 2013 were analysed. Both annual and absolute incidences of newly developed inhibitors in previously untreated patients (PUPs) were calculated. Bleeding and treatment data were also extracted, and association to the treatment regimen and development of inhibitors were analysed. Within the given period, we commenced 45 PUPs with haemophilia A on rFVIII and treated them for 137 treatment-years. Twenty-two of the PUPs had severe haemophilia A, being treated for 88 treatment-years. Treatment strategy for them was prophylaxis. Other PUPs were treated on demand. Median annual bleeding rate was 5 for boys with severe haemophilia, 3 for moderate haemophilia and 1 for mild form of the disease. No inhibitors developed in PUPs with moderate/mild haemophilia A. Annual inhibitor incidence rate in PUPs with severe haemophilia A treated with rFVIII was 56.8 per 1000 treatment-years. Absolute incidence was 22.7% (5/22). All inhibitors appeared within the first 50 exposure days. Comparing rFVIII-treated group with the control group treated under same/similar conditions with plasma-derived FVIII during the same follow-up period, we were not able to find significant difference in inhibitor development between these two groups. Our results support the finding that use of rFVIII is not a proven risk factor for inhibitor development in patients with haemophilia A.

  16. Radiation Therapy Risk Factors for Development of Lymphedema in Patients Treated With Regional Lymph Node Irradiation for Breast Cancer

    SciTech Connect

    Chandra, Ravi A.; Miller, Cynthia L.; Skolny, Melissa N.; Warren, Laura E.G.; Horick, Nora; Jammallo, Lauren S.; Sadek, Betro T.; Shenouda, Mina N.; O'Toole, Jean; Specht, Michelle C.; Taghian, Alphonse G.

    2015-03-15

    Purpose: We previously evaluated the risk of breast cancer-related lymphedema (LE) with the addition of regional lymph node irradiation (RLNR) and found an increased risk when RLNR is used. Here we analyze the association of technical radiation therapy (RT) factors in RLNR patients with the risk of LE development. Methods and Materials: From 2005 to 2012, we prospectively screened 1476 women for LE who underwent surgery for breast cancer. Among 1507 breasts treated, 172 received RLNR and had complete technical data for analysis. RLNR was delivered as supraclavicular (SC) irradiation (69% [118 of 172 patients]) or SC plus posterior axillary boost (PAB) (31% [54 of 172]). Bilateral arm volume measurements were performed pre- and postoperatively. Patients' RT plans were analyzed for SC field lateral border (relative to the humeral head), total dose to SC, RT fraction size, beam energy, and type of tangent (normal vs wide). Cox proportional hazards models were used to analyze associated risk factors for LE. Results: Median postoperative follow-up was 29.3 months (range: 4.9-74.1 months). The 2-year cumulative incidence of LE was 22% (95% confidence interval [CI]: 15%-32%) for SC and 20% (95% CI: 11%-37%) for SC plus PAB (SC+PAB). None of the analyzed variables was significantly associated with LE risk (extent of humeral head: P=.74 for <1/3 vs >2/3, P=.41 for 1/3 to 2/3 vs >2/3; P=.40 for fraction size of 1.8 Gy vs 2.0 Gy; P=.57 for beam energy 6 MV vs 10 MV; P=.74 for tangent type wide vs regular; P=.66 for SC vs SC+PAB). Only pretreatment body mass index (hazard ratio [HR]: 1.09; 95% CI: 1.04-1.15, P=.0007) and the use of axillary lymph node dissection (HR: 7.08, 95% CI: 0.98-51.40, P=.05) were associated with risk of subsequent LE development. Conclusions: Of the RT parameters tested, none was associated with an increased risk of LE development. This study underscores the need for future work investigating alternative RLNR risk factors for LE.

  17. A phase I study of WR-2721 in combination with total body irradiation (TBI) in patients with refractory lymphoid malignancies

    SciTech Connect

    Coia, L.; Krigel, R.; Hanks, G.; Comis, R.; Algazy, K.; Peters, R.; McCulloch, W.; Schien, P. )

    1992-01-01

    This Phase I study was designed to establish the maximum tolerated dose (MTD) of WR-2721 when given twice weekly with total body irradiation (TBI) in the treatment of patients with advanced refractory lymphoid malignancies and to define the toxicities of this combination and schedule. Patients eligible for this study had advanced recurrent indolent non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL). Patients had symptomatic or progressive disease, a performance status of 0, 1, or 2, and adequate bone marrow, hepatic, and renal function. Only patients failing one or two regimens of prior chemotherapy were eligible. Patients who had received prior extended field irradiation were ineligible. Patients received TBI twice weekly (Tuesday and Friday) to a total of 10 doses at 15 cGy/fx. WR-2721 was given intravenously over 15 min beginning 30 min before irradiation. The escalation of WR-2721 was Level 1: 740 mg/m2 and Level 2: 910 mg/m2. The MTD of WR-2721 was that dose which produced predictable and reversible toxicity and would not interfere with patient well-being. Seven patients were entered onto the study, three at 740 mg/m2 and four at 910 mg/m2. Five patients had CLL and two patients small lymphocytic NHL. No patient had hypotension or nausea requiring reduction in dose level or even interruption of infusion of WR-2721. At 740 mg/m2 no grade 3 or 4 toxicities related to WR-2721 were observed, but two patients could not complete treatment because of TBI-induced prolonged thrombocytopenia following treatments 5 and 8. One patient completed all 10 treatments. At 910 mg/m2 of WR-2721, two patients requested removal from study because of malaise, one after 5 cycles and one after 7 cycles. One patient completed all 10 treatments.

  18. Recommendations for authors of manuscripts reporting inhibitor cases developed in previously treated patients with hemophilia: communication from the SSC of the ISTH.

    PubMed

    Iorio, A; Barbara, A M; Bernardi, F; Lillicrap, D; Makris, M; Peyvandi, F; Rosendaal, F

    2016-08-01

    Aim The scope of this recommendation is to provide guidance for reporting of inhibitor cases in previously treated patients (PTPs) with hemophilia A. This guidance is intended to improve transparency and completeness of reporting of observed events; it does not cover planning, executing or analyzing original studies aimed at the assessment of inhibitor rates. Recommendation We recommend that for each case of inhibitor development reported in a published paper, a paragraph or a table is included in the main publication reporting as a minimum the underlined data fields in Table . We recommend transparent reporting when any of the suggested information is not available. We recommend that particular care is used in reporting the timeline of events by clearly identifying a reference time-point. We suggest that journals in the field adopt this guidance as instructions for the authors and as a guide for reviewers. Conclusion Development of inhibitors in PTPs is a very rare event. Standardized reporting of inhibitor characteristics will contribute to generating a body of evidence otherwise not available. Case by case reporting of the recommended data elements may shed light on the natural history and risk factors of inhibitor development in PTPs and be useful for tailoring care in similar future cases. PMID:27496160

  19. Salmonella Typhi-Induced Septic Shock and Acute Respiratory Distress Syndrome in a Previously Healthy Teenage Patient Treated With High-Dose Dexamethasone.

    PubMed

    Ugas, Melissa Brosset; Carroll, Timothy; Kovar, Lacey; Chavez-Bueno, Susana

    2016-01-01

    Typhoid fever is commonly characterized by fever and abdominal pain. Rare complications include intestinal hemorrhage, bowel perforation, delirium, obtundation, and septic shock. Herein we describe the case of a previously healthy 16-year-old male without history of travel, diagnosed with typhoid fever complicated by septic shock and acute respiratory distress syndrome treated with high-dose dexamethasone. This case details severe complications of typhoid fever that are uncommonly seen in developed countries, and the successful response to high-dose dexamethasone as adjunct therapy. High-dose dexamethasone treatment has reportedly decreased Salmonella Typhi mortality, but controlled studies specifically performed in children are lacking, and most reports of its use are over 30 years old and all have originated in developing countries. Providers should include Salmonella Typhi in the differential diagnosis of the pediatric patient with fever, severe abdominal pain, and enteritis, and be aware of its potentially severe complications and the limited data on safety and efficacy of adjunctive therapies that can be considered in addition to antibiotics. PMID:27294165

  20. Clinical Outcomes Using Accelerated Partial Breast Irradiation in Patients With Invasive Lobular Carcinoma

    SciTech Connect

    Shah, Chirag; Wilkinson, J. Ben; Shaitelman, Simona; Grills, Inga; Wallace, Michelle; Mitchell, Christina; Vicini, Frank

    2011-11-15

    Purpose: We compared clinical outcomes of women diagnosed with either invasive lobular carcinoma (ILC) or invasive ductal carcinoma (IDC) treated with accelerated partial breast irradiation (APBI). Methods and Materials: A total of 16 patients with ILC received APBI as part of their breast-conservation therapy (BCT) and were compared with 410 patients with IDC that received APBI as part of their BCT. Clinical, pathologic, and treatment related variables were analyzed including age, tumor size, hormone receptor status, surgical margins, lymph node status, adjuvant hormonal therapy, adjuvant chemotherapy, and APBI modality. Clinical outcomes including local recurrence (LR), regional recurrence (RR), disease-free survival (DFS), cause-specific survival (CSS), and overall survival (OS) were analyzed. Results: Median follow-up was 3.8 years for the ILC patients and 6.0 years for the IDC patients. ILC patients were more likely to have positive margins (20.0% vs. 3.9%, p = 0.006), larger tumors (14.1 mm vs. 10.9 mm, p = 0.03) and less likely to be node positive (0% vs. 9.5%, p < 0.001) when compared with patients diagnosed with IDC. The 5-year rate of LR was 0% for the ILC cohort and 2.5% for the IDC cohort (p = 0.59). No differences were seen in the rates of RR (0% vs. 0.7%, p = 0.80), distant metastases (0% vs. 3.5%, p = 0.54), DFS (100% vs. 94%, p = 0.43), CSS (100% vs. 97%, p = 0.59), or OS (92% vs. 89%, p = 0.88) between the ILC and IDC patients, respectively. Additionally, when node-positive patients were excluded from the IDC cohort, no differences in the rates of LR (0% vs. 2.2%, p = 0.62), RR (0% vs. 0%), DFS (100% vs. 95%, p = 0.46), CSS (100% vs. 98%, p = 0.63), or OS (92% vs. 89%, p = 0.91) were noted between the ILC and IDC patients. Conclusion: Women with ILC had excellent clinical outcomes after APBI. No difference in local control was seen between patients with invasive lobular versus invasive ductal histology.

  1. A clinical staging system and treatment guidelines for maxillary osteoradionecrosis in irradiated nasopharyngeal carcinoma patients

    SciTech Connect

    Cheng, S.-J.; Lee, J.-J.; Ting, L.-L.; Tseng, I.-Y.; Chang, H.-H.; Chen, H.-M.; Kuo, Y.-S.; Hahn, L.-J.; Kok, S.-H. . E-mail: kok@ha.mc.ntu.edu.tw

    2006-01-01

    Purpose: To develop a clinical staging system for maxillary osteoradionecrosis (ORN) in irradiated nasopharyngeal carcinoma (NPC) patients. Methods and Materials: The data of maxillary ORN cases among 1,758 irradiated NPC patients were analyzed. A staging system based on the degrees of bone exposure (E), infection (I), and bleeding (B) was developed. Correlations between various clinical parameters and stages of maxillary ORN and relationships between treatment modalities and outcomes at each stage were evaluated. Cumulative success of treatment and risk factors that affect treatment outcomes were analyzed. Results: The incidence of maxillary ORN was 2.7% (48/1,758). TNM stage of NPC (p < 0.001), radiation dose (p = 0.029), and tooth extraction (p < 0.001) appeared to have significant influences on disease severity. Success rates between conservative therapy and surgical treatment were not significantly different for Stage I ORN but differed significantly for Stage II (p = 0.013) and Stage III (p = 0.008) lesions. Grade 3 infection and bleeding significantly jeopardized treatment success (p = 0.043 and 0.015, respectively). The risk ratios of treatment failure for Grade 3 infection and bleeding were 2.523 (p = 0.034) and 3.141 (p = 0.027), respectively. Conclusions: More serious maxillary ORN tended to occur in cases with more advanced NPC, higher radiation dose, and history of tooth extraction. Surgical treatment was usually required in Stage II and III ORN. The grades of infection and bleeding are important factors in guidance of treatment and prediction of outcomes.

  2. Monte Carlo optimization of total body irradiation in a phantom and patient geometry

    NASA Astrophysics Data System (ADS)

    Chakarova, R.; Müntzing, K.; Krantz, M.; Hedin, E.; Hertzman, S.

    2013-04-01

    The objective of this work is to apply a Monte Carlo (MC) accelerator model, validated by experimental data at isocentre distances, to a large-field total body irradiation (TBI) technique and to develop a strategy for individual patient treatment on the basis of MC dose distributions. Calculations are carried out using BEAMnrc/DOSXYZnrc code packages for a 15 MV Varian accelerator. Acceptable agreement is obtained between MC data and measurements in a large water phantom behind a spoiler at source-skin distances (SSD) = 460 cm as well as in a CIRS® thorax phantom. Dose distributions in patients are studied when simulating bilateral beam delivery at a distance of 480 cm to the patient central sagittal plane. A procedure for individual improvement of the dose uniformity is suggested including the design of compensators in a conventional treatment planning system (TPS) and a subsequent update of the dose distribution. It is demonstrated that the dose uniformity for the simple TBI technique can be considerably improved. The optimization strategy developed is straightforward and suitable for clinics where the TPS available is deficient to calculate 3D dose distributions at extended SSD.

  3. Late term tolerance in head neck cancer patients irradiated in the IMRT era

    PubMed Central

    2013-01-01

    Background The aim was to quantify severe transient and persisting late term effects in our single institution head neck cancer (HNC) cohort treated with curatively intended intensity modulated radiation therapy (IMRT). Hypothesis was if a 2-year follow up (FU) is sufficient to estimate the long term tolerance in HNC irradiated in the IMRT era. Methods Between 01/2002-8/2012, 707/1211 (58%) consecutively treated IMRT patients met the inclusion criteria of a FU time >12 months and loco-regional disease control (LRC). 45% presented with loco-regionally advanced disease; 55% were referred for curative definitive IMRT (66 Gy-72 Gy in 30–35 fractions), 45% underwent postoperative IMRT (60-66 Gy in 30–33 fractions). Systemic concomitant therapy was administered in 85%. Highly consistent treatment procedures were performed with respect to contouring processes, dose constraints, radiation schedules, and the use of systemic therapy. Grade 3/4 late term effects were prospectively assessed and analyzed with respect to subgroups at particular risk for specific late effects. Results Mean/median FU of the cohort was 41/35 months (15–124). 13% of the patients (92/707) experienced any grade 3/4 late effects (101 events in 92/707 patients), 81% in the first 12 months after radiation. 4% of all developed persisting late grade 3/4 effects (25 events in 25/707 patients). Conclusions IMRT led to a high late term tolerance in loco-regionally disease free HNC patients. The onset of any G3/4 effects showed a plateau at 2 years. The question of the cervical vessel tolerance in disease free long time survivors is still open and currently under evaluation at our institution. PMID:24192223

  4. Patterns of failure in patients with locally advanced head and neck cancer treated postoperatively with irradiation or concomitant irradiation with Mitomycin C and Bleomycin

    SciTech Connect

    Zakotnik, Branko . E-mail: bzakotnik@onko-i.si; Budihna, Marjan; Smid, Lojze; Soba, Erika; Strojan, Primoz; Fajdiga, Igor; Zargi, Miha; Oblak, Irena; Lesnicar, Hotimir

    2007-03-01

    Purpose: The long term results and patterns of failure in patients with squamous cell head and neck carcinoma (SCHNC) treated in a prospective randomized trial in which concomitant postoperative radiochemotherapy with Mitomycin C and Bleomycin (CRT) was compared with radiotherapy only (RT), were analyzed. Patients and Methods: Between March 1997 and December 2001, 114 eligible patients with Stage III or IV SCHNC were randomized. Primary surgical treatment was performed with curative intent in all patients. Patients in both groups were postoperatively irradiated to the total dose of 56-70 Gy. Chemotherapy included Mitomycin C 15 mg/m{sup 2} after 10 Gy and 5 mg of Bleomycin twice weekly during irradiation. Median follow-up was 76 months (48-103 months). Results: At 5 years in the RT and CRT arms, the locoregional control was 65% and 88% (p = 0.026), disease-free survival 33% and 53% (p = 0.035), and overall survival 37% and 55% (p = 0.091) respectively. Patients who benefited from chemotherapy were those with high-risk factors. The probability of distant metastases was 22% in RT and 20% in CRT arm (p = 0.913), of grade III or higher late toxicity 19% in RT and 26% in CRT arm (p = 0.52) and of thyroid dysfunction 36% in RT and 56% in CRT arm (p = 0.24). The probability to develop a second primary malignancy (SPM) was 34% in the RT and 8% in the CRT arm (p = 0.023). One third of deaths were due to infection, but there was no difference between the 2 groups. Conclusion: With concomitant radiochemotherapy, locoregional control and disease free survival were significantly improved. Second primary malignancies in the CRT arm compared to RT arm were significantly less frequent. The high probability of post treatment hypothyroidism in both arms warrants regular laboratory evaluation.

  5. Effect of mediastinal irradiation on cardiac function of patients treated during childhood and adolescence for Hodgkin's disease

    SciTech Connect

    Green, D.M.; Gingell, R.L.; Pearce, J.; Panahon, A.M.; Ghoorah, J.

    1987-02-01

    To determine the frequency of cardiac dysfunction in patients treated during childhood or adolescence with mediastinal irradiation for Hodgkin's disease (HD), 28 patients underwent cardiac evaluation 19 to 182 months (median, 90 months) after the completion of radiation therapy. No patient had symptoms of cardiac disease. All were normotensive. All patients had a normal cardiothoracic ratio. There were no abnormalities of voltage or rhythm in the ECGs. The left ventricular end diastolic volume was increased in 19.2% of patients, none of whom had evidence of impaired left ventricular function. The left ventricular ejection fraction (LVEF) was increased in 15.3% of patients. No patient had a decreased LVEF. Pericardial thickening was demonstrated on echocardiograms from 12 of 28 patients (42.9%). Thickening was more frequent among those patients observed for 72 or more months (47.1%; eight of 17) than among those with shorter periods of follow-up (36.4%; four of 11). This study demonstrates that cardiac dysfunction is an infrequent sequela of mediastinal irradiation following treatment using an equally weighted, anterior-posterior technique. Longitudinal study of these patients will be necessary to determine the clinical significance and evolution of the occult pericardial thickening that was identified.

  6. Autophagy Inhibition to Augment mTOR Inhibition: A Phase I/II Trial of RAD001 and Hydroxychloroquine in Patients With Previously Treated Renal Cell Carcinoma

    ClinicalTrials.gov

    2015-12-07

    Histological Evidence of Metastatic Clear Cell Renal Cell Carcinoma; That Has Been Previously Treated With 1-3 Prior Regimens. Phase 1 Only, Any Number of Prior Regimens; With Evidence of Progressive Disease on or Within 6 Months; of Discontinuing Sunitinib, Sorafenib or Pazopanib. Previous; Therapy With Bevacizumab, IL2, or Interferon Are Permitted.

  7. A Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation: First Report of Acute Toxicity, Feasibility, and Patient Satisfaction

    SciTech Connect

    Dragun, Anthony E.; Quillo, Amy R.; Riley, Elizabeth C.; Roberts, Teresa L.; Hunter, Allison M.; Rai, Shesh N.; Callender, Glenda G.; Jain, Dharamvir; McMasters, Kelly M.; Spanos, William J.

    2013-03-01

    Purpose: To report on early results of a single-institution phase 2 trial of a 5-fraction, once-weekly radiation therapy regimen for patients undergoing breast-conserving surgery (BCS). Methods and Materials: Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins were eligible to receive whole breast radiation therapy to a dose of 30 Gy in 5 weekly fractions of 6 Gy with or without an additional boost. Elective nodal irradiation was not permitted. There were no restrictions on breast size or the use of cytotoxic chemotherapy for otherwise eligible patients. Patients were assessed at baseline, treatment completion, and at first posttreatment follow-up to assess acute toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and quality of life (European Organization for Research and Treatment of Cancer QLQ-BR23). Results: Between January and September 2011, 42 eligible patients underwent weekly hypofractionated breast irradiation immediately following BCS (69.0%) or at the conclusion of cytotoxic chemotherapy (31.0%). The rates of grade ≥2 radiation-induced dermatitis, pain, fatigue, and breast edema were 19.0%, 11.9%, 9.5%, and 2.4%, respectively. Only 1 grade 3 toxicity—pain requiring a course of narcotic analgesics—was observed. One patient developed a superficial cellulitis (grade 2), which resolved with the use of oral antibiotics. Patient-reported moderate-to-major breast symptoms (pain, swelling, and skin problems), all decreased from baseline through 1 month, whereas breast sensitivity remained stable over the study period. Conclusions: The tolerance of weekly hypofractionated breast irradiation compares well with recent reports of daily hypofractionated whole-breast irradiation schedules. The regimen appears feasible and cost-effective. Additional follow-up with continued accrual is needed to assess late toxicity, cosmesis, and disease-specific outcomes.

  8. Comparison of prostate MRI-3D transrectal ultrasound fusion biopsy for first-time and repeat biopsy patients with previous atypical small acinar proliferation

    PubMed Central

    Cool, Derek W.; Romagnoli, Cesare; Izawa, Jonathan I.; Chin, Joseph; Gardi, Lori; Tessier, David; Mercado, Ashley; Mandel, Jonathan; Ward, Aaron D.; Fenster, Aaron

    2016-01-01

    Introduction: This study evaluates the clinical benefit of magnetic resonance-transrectal ultrasound (MR-TRUS) fusion biopsy over systematic biopsy between first-time and repeat prostate biopsy patients with prior atypical small acinar proliferation (ASAP). Materials: 100 patients were enrolled in a single-centre prospective cohort study: 50 for first biopsy, 50 for repeat biopsy with prior ASAP. Multiparameteric magnetic resonance imaging (MP-MRI) and standard 12-core ultrasound biopsy (Std-Bx) were performed on all patients. Targeted biopsy using MRI-TRUS fusion (Fn-Bx) was performed f suspicious lesions were identified on the pre-biopsy MP-MRI. Classification of clinically significant disease was assessed independently for the Std-Bx vs. Fn-Bx cores to compare the two approaches. Results: Adenocarcinoma was detected in 49/100 patients (26 first biopsy, 23 ASAP biopsy), with 25 having significant disease (17 first, 8 ASAP). Fn-Bx demonstrated significantly higher per-core cancer detection rates, cancer involvement, and Gleason scores for first-time and ASAP patients. However, Fn-Bx was significantly more likely to detect significant cancer missed on Std-Bx for ASAP patients than first-time biopsy patients. The addition of Fn-Bx to Std-Bx for ASAP patients had a 166.7% relative risk reduction for missing Gleason ≥ 3 + 4 disease (number needed to image with MP-MRI=10 patients) compared to 6.3% for first biopsy (number to image=50 patients). Negative predictive value of MP-MRI for negative biopsy was 79% for first-time and 100% for ASAP patients, with median followup of 32.1 ± 15.5 months. Conclusions: MR-TRUS Fn-Bx has a greater clinical impact for repeat biopsy patients with prior ASAP than biopsy-naïve patients by detecting more significant cancers that are missed on Std-Bx. PMID:27800057

  9. Sofosbuvir with peginterferon-ribavirin for 12 weeks in previously treated patients with hepatitis C genotype 2 or 3 and cirrhosis

    PubMed Central

    Lawitz, Eric; Poordad, Fred; Brainard, Diana M; Hyland, Robert H; An, Di; Dvory-Sobol, Hadas; Symonds, William T; McHutchison, John G; Membreno, Fernando E

    2015-01-01

    Sofosbuvir (SOF) in combination with ribavirin (RBV) for 12 or 24 weeks is the current standard of care for patients infected with hepatitis C virus (HCV) genotypes 2 and 3, respectively. However, in clinical trials treatment-experienced patients, particularly those with cirrhosis, had suboptimal sustained virological response (SVR) rates. We assessed the efficacy and safety of sofosbuvir plus peginterferon and ribavirin (SOF+Peg-IFN+RBV) administered for 12 weeks to treatment-experienced patients with HCV genotypes 2 and 3, with and without cirrhosis. We enrolled 47 patients in this open-label, nonrandomized, uncontrolled phase 2 study. The primary endpoint was the proportion of patients with SVR at 12 weeks after cessation of study treatment (SVR12). The overall rate of SVR12 was 89% (95% confidence interval [CI]: 77-97). Rates of SVR12 were higher in patients with genotype 2 than in those with genotype 3, 96% (95% CI: 78-100) and 83% (95% CI: 62-95), respectively. Rates of SVR12 were similar in patients with and without cirrhosis: for genotype 2, 93% of patients with cirrhosis and 100% of patients without cirrhosis achieved SVR12, and for genotype 3, the SVR12 rate was 83% in patients both with and without cirrhosis. One patient discontinued study treatment because of an adverse event and four patients experienced serious adverse events. The most common adverse events were influenza-like illness, fatigue, anemia, and neutropenia. Conclusion: In treatment-experienced patients with HCV genotypes 2 and 3, 12-week administration of SOF+Peg-IFN+RBV provided high SVR rates, irrespective of cirrhosis status. No safety concerns were identified. (Hepatology 2015;61:769–775) PMID:25322962

  10. Late tissue reactions after single-fraction sequential half-body irradiation (HBI) in patients with non-Hodgkin's lymphomas

    SciTech Connect

    Awwad, H.K.; El Badawy, S.; el Ghamrawy, K.; el Mongy, M.; Rizk, S. )

    1990-11-01

    Lung and hepatic toxicities constituted the main radiation-related damage after half-body irradiation (HBI) used as the treatment for patients with non-Hodgkin's lymphomas (NHL). Liver damage was mostly transient after a single dose of 8 Gy and could be well monitored by serum enzyme levels. A dose-response relationship could be shown for lung damage in the single dose range of 6.25-9.25 Gy, but the relationship did not reach statistical significance. A significant dose-rate effect could be shown. Mediastinal involvement by lymphoma seemed to increase the risk of pneumonitis. In a radical setting half-body irradiation is recommended to be used at a low dose-rate or as a multifraction irradiation in order to reduce the risk of liver and lung toxicities.

  11. Radiotherapy for testicular seminoma stage I: treatment results and long-term post-irradiation morbidity in 365 patients

    SciTech Connect

    Fossa, S.D.A.; Aass, N.; Kaalhus, O.

    1989-02-01

    After infradiaphragmatic radiotherapy the cancer-related 10 year survival was 99% in 365 patients with seminoma Stage I referred to the Norwegian Radium Hospital between 1970 and 1982. Thirteen patients relapsed, 11 of them within the first 3 years after treatment. Nine of the recurrent patients were cured by radiotherapy alone (4) or in combination with chemotherapy (5). There is no need to include the inguinal lymph nodes into the irradiation field or to give scrotal irradiation, not even to patients with tumor infiltration beyond the testicular tissue, or to those with prior scrotal or inguinal surgery. At least 1 year after radiotherapy moderate or more severe dyspepsia was observed in 16 patients. Nine patients developed a peptic ulcer. In general, there was no increased risk for development of a second non-germ cell cancer after radiotherapy. However, 4 patients developed a pulmonary cancer indicating a border-line significance of increased risk for this type of malignancy. (p:0.05). In conclusion, infradiaphragmatic radiotherapy remains the optimal routine treatment in seminoma patients with Stage I.

  12. A US Claims-Based Analysis of Real-World Lipid-Lowering Treatment Patterns in Patients With High Cardiovascular Disease Risk or a Previous Coronary Event.

    PubMed

    Quek, Ruben G W; Fox, Kathleen M; Wang, Li; Li, Lu; Gandra, Shravanthi R; Wong, Nathan D

    2016-02-15

    The objective was to examine real-world treatment patterns of lipid-lowering therapies and their possible associated intolerance and/or ineffectiveness in patients with high cardiovascular disease (CVD) risk initiating statins and/or ezetimibe. Patients aged ≥18 years who initiated statins and/or ezetimibe from January 01, 2007, to June 30, 2011, were retrospectively identified from the IMS LifeLink PharMetrics Plus commercial claims database. Patients were further classified into 2 cohorts: (1) history of cardiovascular event (CVE) and (2) history of coronary heart disease risk equivalent (CHD RE). Patients had continuous health plan enrollment ≥1 year pre- and post-index date (statin and/or ezetimibe initiation date). Primary outcomes were index statin intensity, treatment modifications, possible associated statin/nonstatin intolerance and/or ineffectiveness issues (based on treatment modification), and time-to-treatment modifications. Analyses for each cohort were stratified by age group (<65 and ≥65 years). A total of 41,934 (history of CVE) and 170,344 patients (history of CHD RE) were included. On the index date, 8.8% to 25.1% of patients were initiated on high-intensity statin. Among patients aged <65, 79.2% and 48.8% of those with history of CVE and 78.6% and 47.3% of those with a history of CHD RE had ≥1 and 2 treatment modifications, respectively. Among all patients, 24.6% to 25.6% had possible statin intolerance and/or ineffectiveness issues after accounting for second treatment modification (if any). In conclusion, in patients with high CVD risk, index statin treatment modifications that imply possible statin intolerance and/or ineffectiveness were frequent; low use of high-intensity statins indicates unmet need in the management of hyperlipidemia and possible remaining unaccounted CVD residual risk. PMID:26742468

  13. A Phase III Study of Durvalumab (MEDI4736) With or Without Tremelimumab for Previously Treated Patients With Advanced NSCLC: Rationale and Protocol Design of the ARCTIC Study.

    PubMed

    Planchard, David; Yokoi, Takashi; McCleod, Michael J; Fischer, Jürgen R; Kim, Young-Chul; Ballas, Marc; Shi, Kelvin; Soria, Jean-Charles

    2016-05-01

    Anti-programmed cell death-1 and anti-programmed cell death ligand-1 (PD-L1) monotherapies have shown promising clinical activity in advanced, refractory non-small-cell lung cancer (NSCLC), but antitumor activity appears to be greater in patients with PD-L1(+) tumors compared with patients harboring PD-L1(-) tumors. Combining the anti-PD-L1 antibody durvalumab and the anti-cytotoxic T-lymphocyte antigen 4 antibody tremelimumab offers the potential for antitumor activity in patients with advanced NSCLC, regardless of PD-L1 tumor status. ARCTIC (NCT02352948) is a global, phase III, randomized, open-label multicenter study in patients with advanced NSCLC assessing the safety and clinical activity of durvalumab versus standard of care (SoC; erlotinib, gemcitabine, or vinorelbine) in patients with PD-L1(+) tumors (≥25% of tumor cells with membrane staining using VENTANA PD-L1 [SP263] CDx Assay) (Sub-study A) and the combination of durvalumab + tremelimumab or either agent as monotherapy versus SoC in patients with PD-L1(-) tumors (Sub-study B). Eligible patients are those with locally advanced or metastatic NSCLC (Stage IIIB/IV), without epidermal growth factor receptor tyrosine kinase activating mutations or anaplastic lymphoma kinase rearrangements, who have received at least 2 prior systemic regimens, including 1 platinum-based chemotherapy regimen. Co-primary endpoints are progression-free survival and overall survival. Secondary endpoints include the proportion of patients alive at 12 months, objective response rate, duration of response, progression-free survival at 6 and 12 months, safety and tolerability, pharmacokinetics, immunogenicity, and quality of life. The exploratory endpoints will assess potential biomarkers of treatment response. Recruitment started in January 2015 and is ongoing. PMID:27265743

  14. A Phase III Study of Durvalumab (MEDI4736) With or Without Tremelimumab for Previously Treated Patients With Advanced NSCLC: Rationale and Protocol Design of the ARCTIC Study.

    PubMed

    Planchard, David; Yokoi, Takashi; McCleod, Michael J; Fischer, Jürgen R; Kim, Young-Chul; Ballas, Marc; Shi, Kelvin; Soria, Jean-Charles

    2016-05-01

    Anti-programmed cell death-1 and anti-programmed cell death ligand-1 (PD-L1) monotherapies have shown promising clinical activity in advanced, refractory non-small-cell lung cancer (NSCLC), but antitumor activity appears to be greater in patients with PD-L1(+) tumors compared with patients harboring PD-L1(-) tumors. Combining the anti-PD-L1 antibody durvalumab and the anti-cytotoxic T-lymphocyte antigen 4 antibody tremelimumab offers the potential for antitumor activity in patients with advanced NSCLC, regardless of PD-L1 tumor status. ARCTIC (NCT02352948) is a global, phase III, randomized, open-label multicenter study in patients with advanced NSCLC assessing the safety and clinical activity of durvalumab versus standard of care (SoC; erlotinib, gemcitabine, or vinorelbine) in patients with PD-L1(+) tumors (≥25% of tumor cells with membrane staining using VENTANA PD-L1 [SP263] CDx Assay) (Sub-study A) and the combination of durvalumab + tremelimumab or either agent as monotherapy versus SoC in patients with PD-L1(-) tumors (Sub-study B). Eligible patients are those with locally advanced or metastatic NSCLC (Stage IIIB/IV), without epidermal growth factor receptor tyrosine kinase activating mutations or anaplastic lymphoma kinase rearrangements, who have received at least 2 prior systemic regimens, including 1 platinum-based chemotherapy regimen. Co-primary endpoints are progression-free survival and overall survival. Secondary endpoints include the proportion of patients alive at 12 months, objective response rate, duration of response, progression-free survival at 6 and 12 months, safety and tolerability, pharmacokinetics, immunogenicity, and quality of life. The exploratory endpoints will assess potential biomarkers of treatment response. Recruitment started in January 2015 and is ongoing.

  15. A proposal for the reliable culture of Borrelia burgdorferi from patients with chronic Lyme disease, even from those previously aggressively treated.

    PubMed

    Phillips, S E; Mattman, L H; Hulínská, D; Moayad, H

    1998-01-01

    Since culture of Borrelia burgdorferi from patients with chronic Lyme disease has been an extraordinarily rare event, clarification of the nature of the illness and proving its etiology as infectious have been difficult. A method for reliably and reproducibly culturing B. burgdorferi from the blood of patients with chronic Lyme disease was therefore sought by making a controlled blood culture trial studying 47 patients with chronic Lyme disease. All had relapsed after long-term oral and intravenous antibiotics. 23 patients with other chronic illness formed the control group. Positive cultures were confirmed by fluorescent antibody immuno-electron microscopy using monoclonal antibody directed against Osp A, and Osp A PCR. 43/47 patients (91%) cultured positive. 23/23 controls (100%) cultured negative. Although persistent infection has been, to date, strongly suggested in chronic Lyme disease by positive PCR and antigen capture, there are major problems with these tests. This new method for culturing B. burgdorferi from patients with chronic Lyme disease certainly defines the nature of the illness and establishes that it is of chronic infectious etiology. This discovery should help to reestablish the gold standard in laboratory diagnosis of Lyme disease.

  16. A phase II study of bortezomib added to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with previously untreated indolent non-Hodgkin's lymphoma.

    PubMed

    Cohen, Jonathon B; Switchenko, Jeffrey M; Koff, Jean L; Sinha, Rajni; Kaufman, Jonathan L; Khoury, H Jean; Bumpers, Nassoma; Colbert, Amanda; Hutchison-Rzepka, Amanda; Nastoupil, Loretta J; Heffner, Leonard T; Langston, Amelia A; Lechowicz, Mary Jo; Lonial, Sagar; Flowers, Christopher R

    2015-11-01

    Bortezomib-containing combinations are active in non-Hodgkin lymphoma (NHL) although peripheral neuropathy can limit their dose intensity. Based on our phase I findings, we conducted a phase II trial of bortezomib in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) with a modified dose of vincristine. Patients with untreated indolent NHL received bortezomib (1·6 mg/m(2) ) on days 1 and 8 of a 21-day cycle for up to 8 cycles and R-CHOP with a 1·5 mg cap of vincristine. Patients achieving a complete response (CR) received maintenance rituximab, and remaining patients received maintenance rituximab and bortezomib. The primary endpoint was CR rate; secondary survival analyses were evaluated using the Kaplan-Meier method. Among 29 eligible patients, NHL morphologies included follicular (n = 20), marginal zone (n = 5) and small lymphocytic lymphoma (n = 4). Nineteen patients had CR (66%) and 10 had partial response (34%), yielding a 100% overall response rate. With a median follow-up of 48·7 months, the 4-year progression-free and overall survivals were 83% and 93%. Twenty-two patients experienced peripheral neuropathy of any grade, and two had grade 3 neuropathy. The combination of bortezomib with R-CHOP is effective for indolent NHL, and we plan to evaluate therapies incorporating novel proteasome inhibitors in future studies in NHL.

  17. Influence of Arousal, Previous Experience, and Age on Surgery Preparation of Same Day of Surgery and In-Hospital Pediatric Patients.

    ERIC Educational Resources Information Center

    Faust, Jan; Melamed, Barbara G.

    1984-01-01

    Studied two pediatric surgery populations (N=66) to determine differences in retention of preparatory information. Results showed that children exposed to a hospital-relevant film retained more information than those children not prepared regardless of age, IQ, previous experience, sex, and time of film preparation. (LLL)

  18. Safety, long-term results, and predictors of recurrence after complete endocardial ventricular tachycardia substrate ablation in patients with previous myocardial infarction.

    PubMed

    Arenal, Ángel; Hernández, Jesús; Calvo, David; Ceballos, Cecilia; Atéa, Leonardo; Datino, Tomás; Atienza, Felipe; González-Torrecilla, Esteban; Eídelman, Gabriél; Miracle, Ángel; Avila, Pablo; Bermejo, Javier; Fernández-Avilés, Francisco

    2013-02-15

    Conduction channels and electrograms with isolated component/late potentials are sensitive markers of the substrate of post-myocardial infarction sustained monomorphic ventricular tachycardia (VT). Ablation of all conduction channels and isolated component/late potentials (complete endocardial VT substrate ablation [CEVTSA]) during sinus rhythm could simplify and facilitate the ablation procedure, mainly in patients without references for clinical VT substrate identification. The aim of this study was to assess the safety, efficacy, and predictors of VT recurrence after CEVTSA. Electroanatomic mapping and CEVTSA were performed in 59 post-myocardial infarction patients (mean age 67 ± 9 years, mean left ventricular ejection fraction 30 ± 11%), 24 of whom did not have clinical VT substrate references. The mean areas of scar (≤1.5 mV) and dense scar (≤0.5 mV) were 76 ± 42 and 34 ± 24 cm(2), respectively; isolated component/late potentials and conduction channels were identified and ablated in 97% and 83% of patients (mean ablation area 14 ± 10 cm(2)). No life-threatening complications occurred during the procedure. After 1 year and at the end of follow-up (mean 39 ± 21 months), 81% and 58% of patients were free of VT. No differences were observed between patients with and without specific clinical VT substrate identification. Univariate analysis identified the left ventricular ejection fraction, VT cycle length (VTCL), infarct location (inferior vs anterior), and dense scar area as predictors of VT recurrence, and Cox analysis identified VTCL (hazard ratio 0.42, p <0.001) and dense scar area (hazard ratio 2.65, p <0.0006) as independent predictors. No patients with dense scar area ≤25 cm(2) and VTCL >350 ms had recurrences. In conclusion, CEVTSA is safe and effective, even in patients without clinical VT substrate identification. Scar area and VTCL are valuable predictors of VT recurrence.

  19. Failure of lactose-restricted diets to prevent radiation-induced diarrhea in patients undergoing whole pelvis irradiation

    SciTech Connect

    Stryker, J.A.; Bartholomew, M.

    1986-05-01

    Sixty-four patients were randomized prior to pelvic radiotherapy into one of three dietary groups: the control group maintained a regular diet except that they drank at least 480 cc of milk daily; the lactose-restricted group was placed on a lactose-restricted diet; and the lactase group drank at least 480 cc of milk with lactase enzyme added to hydrolyze 90% of the lactose. The patients kept records of their stool frequency and the number of diphenoxylate tablets required to control their diarrhea during a 5 week course of standard whole pelvis irradiation. The data does not support the concept that one of the mechanisms of radiation-induced diarrhea associated with pelvic irradiation is a reduction the ability of the intestine to hydrolyze ingested lactose due to the effect of the radiation on the small intestine. There was not a significant difference in stool frequency or diphenoxylate usage among the dietary groups.

  20. Phase 1/2 study of mogamulizumab, a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous T-cell lymphoma.

    PubMed

    Duvic, Madeleine; Pinter-Brown, Lauren C; Foss, Francine M; Sokol, Lubomir; Jorgensen, Jeffrey L; Challagundla, Pramoda; Dwyer, Karen M; Zhang, Xiaoping; Kurman, Michael R; Ballerini, Rocco; Liu, Li; Kim, Youn H

    2015-03-19

    This phase 1/2 study evaluated the efficacy of mogamulizumab, a defucosylated, humanized, anti-CC chemokine receptor 4 monoclonal antibody, in 41 pretreated patients with cutaneous T-cell lymphoma. No dose-limiting toxicity was observed and the maximum tolerated dose was not reached in phase 1 after IV infusion of mogamulizumab (0.1, 0.3, and 1.0 mg/kg) once weekly for 4 weeks followed by a 2-week observation. In phase 2, patients were dosed with 1.0 mg/kg mogamulizumab according to the same schedule for the first course followed by infusion every 2 weeks during subsequent courses until disease progression. The most frequent treatment-emergent adverse events were nausea (31.0%), chills (23.8%), headache (21.4%), and infusion-related reaction (21.4%); the majority of events were grade 1/2. There were no significant hematologic effects. Among 38 evaluable patients, the overall response rate was 36.8%: 47.1% in Sézary syndrome (n = 17) and 28.6% in mycosis fungoides (n = 21). Eighteen of 19 (94.7%) patients with ≥B1 blood involvement had a response in blood, including 11 complete responses. Given the safety and efficacy of mogamulizumab, phase 3 investigation of mogamulizumab is warranted in cutaneous T-cell lymphoma patients. This trial was registered at www.clinicaltrials.gov as #NCT00888927. PMID:25605368

  1. Rehabilitation of irradiated patients with chemically modified and conventional SLA implants: five-year follow-up.

    PubMed

    Nack, C; Raguse, J-D; Stricker, A; Nelson, K; Nahles, S

    2015-01-01

    The aim of this study is to evaluate the clinical and radiological parameters of standard SLA surface implants compared to chemically modified hydrophilic SLActive implants in irradiated patients after the initial 12-month loading period up to 5 years. Twenty patients with a mean age of 61·1 years were treated with dental implants after ablative surgery and radio-chemotherapy of oral cancer. All patients were non-smokers. The placement of 102 implants (50 SLA, 52 SLActive) was performed bilaterally according to a split-mouth design. Mean crestal bone changes were evaluated using standardised orthopantomographies and clinical parameters. Data were analysed using a Kaplan-Meier curve, Mann-Whitney U-test and two-factorial non-parametric analysis. The average observation period was 60 months. The amount of bone loss at the implant shoulder of SLA implants was mesial and distal 0·7 mm. The SLActive implants displayed a bone loss of mesial 0·6 mm as well as distal 0·7 mm after 5 years. Two SLA implants were lost before loading. One patient lost five implants due to recurrence of a tumour. The overall cumulative 12-month, 3-year and 5-year survival rate of SLA implants was 92%, 80% and 75·8% and of SLActive implants 94·2%, 78·8% and 74·4%, respectively. Eighteen implants were considered lost because the patients had died. Sandblasted acid-etched implants with or without a chemically modified surface can be used in irradiated patients with a high predictability of success. Lower implant survival rates in patients with irradiated oral cancer may be associated with systemic effects rather than peri-implantitis.

  2. Simpson-Golabi-Behmel syndrome: congenital diaphragmatic hernia and radiologic findings in two patients and follow-up of a previously reported case.

    PubMed

    Chen, E; Johnson, J P; Cox, V A; Golabi, M

    1993-06-15

    This report suggests the association of congenital diaphragmatic hernia in Simpson-Golabi-Behmel syndrome by describing two unrelated males with this malformation. One male was the maternal half-nephew of our previously reported 8-year-old boy with this syndrome. Review of the skeletal roentgenograms of these 2 affected males, and those of the previously reported 8-year-old, documents flare of the iliac wings, narrow sacroiliac notches, and the presence of two carpal ossification centers as a newborn ("advanced bone age"). We also report the follow-up of the 8-year-old boy, now 16 years old, who continues to have significant overgrowth and speech, dental, developmental, and adjustment problems. PMID:8322824

  3. A previously undiagnosed case of Gerstmann-Sträussler-Scheinker disease revealed by PRNP gene analysis in patients with adult-onset ataxia.

    PubMed

    Cagnoli, Claudia; Brussino, Alessandro; Sbaiz, Luca; Di Gregorio, Eleonora; Atzori, Cristiana; Caroppo, Paola; Orsi, Laura; Migone, Nicola; Buffa, Carlo; Imperiale, Daniele; Brusco, Alfredo

    2008-07-30

    Ataxia is a frequently reported symptom in prion diseases (PD) and it is characteristic of Gerstmann-Sträussler-Scheinker syndrome (GSS), a genetic PD mainly related to the P102L mutation in the PRNP gene. Our aim was to screen for the P102L and other six known PRNP gene mutations (P105L, A117V, Y145X, E200K, D202N, and V210I) a group of 206 consecutive patients diagnosed with adult-onset cerebellar ataxia of unknown origin. The patients, negative for the most common acquired and genetic forms, were analyzed using a combination of restriction endonuclease digestion and pyrosequencing; eight, affected by ataxia and cognitive dysfunction, were also sequenced for the PRNP gene. One patient resulted to be heterozygous for the P102L mutation. Retrospectively, the clinical picture was consistent with a "classical" GSS phenotype. In conclusion, the screening for the P102L mutation, or even the sequencing of the PRNP gene should be taken in consideration in patients with late-onset ataxia (>50 years).

  4. Early change in proteinuria as a surrogate outcome in kidney disease progression: a systematic review of previous analyses and creation of a patient-level pooled dataset

    PubMed Central

    Stoycheff, Nicholas; Pandya, Kruti; Okparavero, Aghogho; Schiff, Abigail; Levey, Andrew S.; Greene, Tom; Stevens, Lesley A.

    2011-01-01

    Background. Proteinuria is a candidate surrogate end point for randomized controlled trials (RCTs) in chronic kidney disease (CKD). There is a reasonably sound biological basis for this hypothesis, but only preliminary empirical evidence currently exists. Methods. A systematic review and creation of a patient-level dataset of randomized controlled trials (RCTs) in CKD that reported changes in proteinuria and assessed progression of kidney disease as defined by dialysis, transplantation, death, or changes in GFR or creatinine were performed. Results. Systematic review. Seventy RCTs met the eligibility criteria; 17 eligible RCTs contained analyses of proteinuria as a predictor of outcomes; 15 RCTs concluded that greater proteinuria was associated with adverse outcomes. A majority were studies of diabetic or hypertensive kidney disease and tested renin–angiotensin system blockade. Definitions of predictor and outcome variables were too variable to conduct a meta-analysis of group data. Database creation. Over 4 years was required to create the patient-level dataset. The final dataset included 34 studies and > 9000 patients with a variety of CKD types and interventions. Conclusions. There are a relatively small number of RCTs designed to rigorously test therapies for kidney disease progression. Current analyses of change in proteinuria as a predictor of CKD progression are heterogeneous and incomplete, indicating further evaluation in a pooled individual patient-level database is necessary to advance knowledge in this field. PMID:20817671

  5. Paliperidone palmitate in non-acute patients with schizophrenia previously unsuccessfully treated with risperidone long-acting therapy or frequently used conventional depot antipsychotics

    PubMed Central

    Bergmans, P; Cherubin, P; Keim, S; Llorca, P-M; Cosar, B; Petralia, A; Corrivetti, G; Hargarter, L

    2015-01-01

    PALMFlexS, a prospective multicentre, open-label, 6-month, phase IIIb interventional study, explored tolerability, safety and treatment response in adults (n = 231) with non-acute but symptomatic schizophrenia switching to flexibly dosed paliperidone palmitate (PP) after unsuccessful treatment with risperidone long-acting injectable therapy (RLAT) or conventional depot antipsychotics (APs). Treatment response was measured by change in Positive and Negative Syndrome Scale (PANSS) total score from baseline (BL) to last-observation-carried-forward (LOCF) endpoint (EP). Safety and tolerability assessments included Extrapyramidal Symptom Rating Scale (ESRS) total score and treatment-emergent adverse events. Significant reductions in mean PANSS total score were observed for all groups (−7.5 to −10.6; p ⩽ 0.01 [BL to LOCF EP]). After switching to PP, more than 50% of all patients achieved ⩾20% and one-third of RLAT-treated patients even achieved ⩾50% improvement in PANSS total score. Across groups, there were significant improvements (p < 0.05) in symptom severity as measured by Clinical Global Impression-Severity (CGI-S; trend for improvement with RLAT; p = 0.0568), subjective well-being, medication satisfaction, and patient functioning with PP. PP was generally well tolerated. Clinically relevant benefits were observed in non-acute patients with schizophrenia switched from RLAT or conventional depot APs to PP. PMID:25999398

  6. Prone Accelerated Partial Breast Irradiation After Breast-Conserving Surgery: Five-year Results of 100 Patients

    SciTech Connect

    Formenti, Silvia C.; Hsu, Howard; Fenton-Kerimian, Maria; Roses, Daniel; Guth, Amber; Jozsef, Gabor; Goldberg, Judith D.; DeWyngaert, J. Keith

    2012-11-01

    Purpose: To report the 5-year results of a prospective trial of three-dimensional conformal external beam radiotherapy (3D-CRT) to deliver accelerated partial breast irradiation in the prone position. Methods and Materials: Postmenopausal patients with Stage I breast cancer with nonpalpable tumors <2 cm, negative margins and negative nodes, positive hormone receptors, and no extensive intraductal component were eligible. The trial was offered only after eligible patients had refused to undergo standard whole-breast radiotherapy. Patients were simulated and treated on a dedicated table for prone setup. 3D-CRT was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days with port film verification at each treatment. Rates of ipsilateral breast failure, ipsilateral nodal failure, contralateral breast failure, and distant failure were estimated using the cumulative incidence method. Rates of disease-free, overall, and cancer-specific survival were recorded. Results: One hundred patients were enrolled in this institutional review board-approved prospective trial, one with bilateral breast cancer. One patient withdrew consent after simulation, and another patient elected to interrupt radiotherapy after receiving two treatments. Ninety-eight patients were evaluable for toxicity, and, in 1 case, both breasts were treated with partial breast irradiation. Median patient age was 68 years (range, 53-88 years); in 55% of patients the tumor size was <1 cm. All patients had hormone receptor-positive cancers: 87% of patients underwent adjuvant antihormone therapy. At a median follow-up of 64 months (range, 2-125 months), there was one local recurrence (1% ipsilateral breast failure) and one contralateral breast cancer (1% contralateral breast failure). There were no deaths due to breast cancer by 5 years. Grade 3 late toxicities occurred in 2 patients (one breast edema, one transient breast pain). Cosmesis was rated good/excellent in 89% of patients with at least 36

  7. Ranibizumab for the Prevention of Radiation Complications in Patients Treated With Proton Beam Irradiation for Choroidal Melanoma

    PubMed Central

    Kim, Ivana K.; Lane, Anne Marie; Jain, Purva; Awh, Caroline; Gragoudas, Evangelos S.

    2016-01-01

    Purpose: To investigate the safety and potential efficacy of ranibizumab for prevention of radiation complications in patients treated with proton irradiation for choroidal melanoma Methods: Forty patients with tumors located within 2 disc diameters of the optic nerve and/or macula were enrolled in this open-label study. Participants received ranibizumab 0.5 mg or 1.0 mg at tumor localization and every 2 months thereafter for the study duration of 24 months. The incidence of adverse events, visual acuity, and other measures of ocular morbidity related to radiation complications were assessed. Historical controls with similar follow-up meeting the eligibility criteria for tumor size, location, and baseline visual acuity were assembled for comparison. Results: Fifteen patients with large tumors and 25 patients with small/medium tumors were enrolled. Thirty-two patients completed the month 24 visit. No serious ocular or systemic adverse events related to ranibizumab were observed. At 24 months, the proportion of patients with visual acuity ≥ 20/200 was 30/31 (97%) in the study group versus 92/205 (45%) in historical controls (P < .001). The proportion of patients with visual acuity ≥20/40 was 24/31 (77%) in the study group versus 46/205 (22%) in controls at 24 months (P<.001). Clinical evidence of radiation maculopathy at month 24 was seen in 8/24 (33%) patients with small/medium tumors versus 42/62 (68%) of controls (P = .004). Three patients with large tumors developed metastases. Conclusions: In this small pilot study, prophylactic ranibizumab appears generally safe in patients treated with proton irradiation for choroidal melanoma. High rates of visual acuity retention were observed through 2 years.

  8. Excess mortality after treatment with fludarabine and cyclophosphamide in combination with alemtuzumab in previously untreated patients with chronic lymphocytic leukemia in a randomized phase 3 trial.

    PubMed

    Lepretre, Stephane; Aurran, Therese; Mahé, Beatrice; Cazin, Bruno; Tournilhac, Olivier; Maisonneuve, Herve; Casasnovas, Olivier; Delmer, Alain; Leblond, Veronique; Royer, Bruno; Corront, Bernadette; Chevret, Sylvie; Delépine, Roselyne; Vaudaux, Sandrine; Van Den Neste, Eric; Béné, Marie Christine; Letestu, Remi; Cymbalista, Florence; Feugier, Pierre

    2012-05-31

    A French and Belgian multicenter phase 3 trial was conducted in medically fit patients with untreated chronic lymphocytic leukemia. Of 178 patients enrolled in the study, 165 were randomly assigned to receive 6 courses of oral fludarabine and cyclophosphamide (FC) in combination with rituximab (FCR; 375 mg/m(2) in cycle one, 500 mg/m(2) in all subsequent cycles) or alemtuzumab (FCCam; 30 mg subcutaneously injected on cycle days 1-3); each cycle was 28 days. Recruitment was halted prematurely because of excess toxicity; 8 patients died in the FCCam group, 3 from lymphoma and 5 from in-fection. Overall response rates were 91% with FCR and 90% with FCCam (P = .79). Complete remission rates were 33.75% with FCR and 19.2% with FCCam (P = .04). Three-year progression-free survival was 82.6% with FCR and 72.5% with FCCam (P = .21). Three-year overall survival was similar between the 2 arms at 90.1% in the FCR arm and 86.4% in the FCCam arm (P = .27). These results indicate that the FCCam regimen for the treatment of advanced chronic lymphocytic leukemia was not more effective than the FCR regimen and was associated with an unfavorable safety profile, representing a significant limitation of its use. This study is registered with www.clinicaltrials.gov as number NCT00564512. PMID:22337714

  9. Efficacy and safety of LY2963016 insulin glargine in patients with type 1 and type 2 diabetes previously treated with insulin glargine

    PubMed Central

    Hadjiyianni, I.; Dahl, D.; Lacaya, L. B.; Chang, C. L.; Ilag, L. L.

    2016-01-01

    The safety and efficacy of LY2963016 insulin glargine (LY IGlar) and Lantus® insulin glargine (IGlar), products with identical primary amino acid sequences, were assessed in subgroups of patients with type 1 (T1D, n = 452) or type 2 diabetes (T2D, n = 299) reporting prestudy IGlar treatment in 52‐week open‐label (ELEMENT‐1) and 24‐week double‐blind (ELEMENT‐2) studies. At randomization, patients transitioned from their prestudy IGlar to equivalent doses of LY IGlar or IGlar. Primary efficacy (change in glycated haemoglobin from baseline to 24 weeks), other efficacy and select safety outcomes of LY IGlar were compared with those of IGlar. Continuous data were analysed using analysis of covariance, categorical data by Fisher's exact test, and treatment comparisons for hypoglycaemia by Wilcoxon test. No statistically significant treatment differences were identified for efficacy and safety outcomes except for weight change (T1D), overall incidence of detectable insulin antibodies (T2D), and serious adverse events (T2D). These differences were neither consistently observed across both studies nor observed in the total study populations, and their magnitude suggests they were not clinically meaningful. LY IGlar and IGlar show similar efficacy and safety profiles in patients reporting prestudy IGlar treatment. PMID:26749289

  10. Locoregional Failure in Early-Stage Breast Cancer Patients Treated With Radical Mastectomy and Adjuvant Systemic Therapy: Which Patients Benefit From Postmastectomy Irradiation?

    SciTech Connect

    Trovo, Marco; Durofil, Elena; Polesel, Jerry; Roncadin, Mario; Perin, Tiziana; Mileto, Mario; Piccoli, Erica; Quitadamo, Daniela; Massarut, Samuele; Carbone, Antonino; Trovo, Mauro G.

    2012-06-01

    Purpose: To assess the locoregional failure in patients with Stage I-II breast cancer treated with radical mastectomy and to evaluate whether a subset of these patients might be at sufficiently high risk of locoregional recurrence (LRR) to benefit from postmastectomy irradiation (PMRT). Methods and Materials: Stage I-II breast cancer patients (n = 150) treated with radical mastectomy without adjuvant irradiation between 1999 and 2005 were analyzed. The pattern of LRR was reported. Kaplan-Meier analysis was used to calculate rates of LRR, and Cox proportional hazards methods were used to evaluate potential risk factors. Results: Median follow-up was 75 months. Mean patient age was 56 years. One-hundred forty-three (95%) patients received adjuvant systemic therapy: 85 (57%) hormonal therapy alone, 14 (9%) chemotherapy alone, and 44 (29%) both chemotherapy and hormonal therapy. Statistically significant factors associated with increased risk of LRR were premenopausal status (p = 0.004), estrogen receptor negative cancer (p = 0.02), pathologic grade 3 (p = 0.02), and lymphovascular invasion (p = 0.001). T and N stage were not associated with increased risk of regional recurrence. The 5-year LRR rate for patients with zero or one, two, three, and four risk factors was 1%, 10.3%, 24.2%, and 75%, respectively. Conclusions: A subset of patients with early-stage breast cancer is at high risk of LRR, and therefore PMRT might be beneficial.

  11. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study

    PubMed Central

    Canaud, Bernard; Mingardi, Giulio; Braun, Johann; Aljama, Pedro; Kerr, Peter G.; Locatelli, Francesco; Villa, Giuseppe; Van Vlem, Bruno; McMahon, Alan W.; Kerloëguen, Cécile; Beyer, Ulrich

    2008-01-01

    Background. Extending the administration interval of erythropoiesis-stimulating agents (ESAs) represents an opportunity to improve the efficiency of anaemia management in patients with chronic kidney disease (CKD). However, effective haemoglobin (Hb) maintenance can be challenging with epoetin alfa and epoetin beta administered at extended intervals. C.E.R.A., a continuous erythropoietin receptor activator, has a unique pharmacologic profile and long half-life (∼130 h), allowing administration at extended intervals. Phase III results have demonstrated that C.E.R.A. administered once every 4 weeks effectively maintains stable Hb levels in patients with CKD on dialysis. Methods. STRIATA (Stabilizing haemoglobin TaRgets in dialysis following IV C.E.R.A. Treatment for Anaemia) was a multicentre, open-label randomized phase III study to evaluate the efficacy and safety of intravenous C.E.R.A. administered once every 2 weeks (Q2W) for Hb maintenance following direct conversion from darbepoetin alfa (DA). Adult patients on dialysis receiving stable intravenous DA once weekly (QW) or Q2W were randomized (1:1) to continue their current DA regimen (n = 156) or receive intravenous C.E.R.A. Q2W (n = 157) for 52 weeks. Doses were adjusted to maintain Hb levels within ± 1.0 g/dl of baseline and between 10.0 and 13.5 g/dl. The primary endpoint was the mean Hb change between baseline and the evaluation period (weeks 29–36). Results. Most patients (>80%) received DA QW before randomization. The mean (95% CI) difference between C.E.R.A. and DA in the primary endpoint was 0.18 g/dl (−0.05, 0.41), within a pre-defined non-inferiority limit. C.E.R.A. was clinically non-inferior to DA (P < 0.0001) in maintaining Hb levels. Both treatments were well tolerated. Conclusions. Stable Hb levels were successfully maintained in patients on haemodialysis directly converted to Q2W intravenous C.E.R.A. from DA. PMID:18586762

  12. Bimatoprost 0.01% or 0.03% in patients with glaucoma or ocular hypertension previously treated with latanoprost: two randomized 12-week trials

    PubMed Central

    Myers, Jonathan S; Vold, Steven; Zaman, Fiaz; Williams, Julia M; Hollander, David A

    2014-01-01

    Background The purpose of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.01% or 0.03% as monotherapy in patients treated with latanoprost 0.005% monotherapy who require additional IOP lowering for their ocular hypertension or open-angle glaucoma. Methods Two prospective, investigator-masked, randomized, parallel-group, multicenter studies enrolled patients with baseline IOP ≥20 mmHg after ≥30 days of latanoprost 0.005% monotherapy. Patients were randomized to 12 weeks of study treatment (study 1, bimatoprost 0.01% once daily or bimatoprost 0.01% once daily plus brimonidine 0.1% three times daily; study 2, bimatoprost 0.03% once daily or bimatoprost 0.03% once daily plus fixed-combination brimonidine 0.2%/timolol 0.5% twice daily). Patient evaluations at weeks 4 and 12 included IOP at 8 am, 10 am, and 4 pm and safety assessments. Results in the monotherapy study arms (bimatoprost 0.01% or 0.03%) are presented. Results Latanoprost-treated baseline mean diurnal IOP (± standard error of the mean) was 22.2±0.3 mmHg and 22.1±0.4 mmHg in the bimatoprost 0.01% and bimatoprost 0.03% treatment arms, respectively (P=0.957). In both treatment arms, mean (± standard error of the mean) reduction in IOP from latanoprost-treated baseline was statistically significant at each time point at both follow-up visits (P<0.001), ranging from 3.7±0.4 (17.0%) mmHg to 4.4±0.4 (19.9%) mmHg with bimatoprost 0.01% and from 2.8±0.5 (12.8%) mmHg to 3.9±0.5 (16.7%) mmHg with bimatoprost 0.03%. Mean percentage IOP reduction from latanoprost-treated baseline was numerically greater with bimatoprost 0.01% than with bimatoprost 0.03% throughout follow-up. The incidence of conjunctival hyperemia of mild or greater severity increased from latanoprost baseline after 12 weeks of treatment only in the bimatoprost 0.03% treatment arm. Conclusion Many patients who do not reach their target IOP on latanoprost can achieve additional IOP

  13. A Patient with Autoimmune Pancreatitis Type 1 with Previously Known Lymphadenopathy, Both in the Context of IgG4-related Disease

    PubMed Central

    Alidjan, Fazil M.; Karim, Faiz; Verdijk, Rob M.; van Esser, Joost W.; van Heerde, Marianne J.

    2015-01-01

    Patient: Male, 62 Final Diagnosis: Auto-immune pancreatitis Symptoms: Jaundice • lymfadenopathy Medication: — Clinical Procedure: Laboratory • imaging Specialty: Gastroenterology and Hepatology Objective: Unusual clinical course Background: Autoimmune pancreatitis (AIP) is an important clinical pathologic concept of IgG-4-related disease. AIP is a rare cause of chronic pancreatitis, characterized by a fibroinflammatory process by lymphoplasmacytic infiltrates, storiform fibrosis, obliterative phlebitis, and increased IgG4+ plasma cells, leading to dysfunction of the pancreas. Affected patients with AIP frequently have disease affecting other organs or sites with similar histologic changes, elevated IgG4+ plasma cell infiltrate, and good response to corticosteroid therapy. These diseases often are not limited to the pancreas and the pancreas may not be involved at all. Case Report: We report a 62-year-old man with obstructive jaundice with pre-existent submandibular lymphadenopathy. Diagnosis of AIP was based on diagnostic criteria by the HISORT-criteria in combination with elevated IgG-4 serum levels. CT revealed a focal enlargement of the head of the pancreas, as well as mesenteric peripancreatic and mediastinal lymphadenopathy. He was treated with high-dose steroid in combination with azathioprine and showed good clinical response. Conclusions: We report a case with pre-existent submandibular lymphadenopathy and obstructive jaundice based on AIP type 1, both in the context of IgG4-related disease. PMID:26537530

  14. A Case of Disulfiram-Induced Psychosis in a Previously Asymptomatic Patient Maintained on Mixed Amphetamine Salts: A Review of the Literature and Possible Pathophysiological Explanations.

    PubMed

    Spiegel, David R; McCroskey, Aidan; Puaa, Kapaakea; Meeker, Grant; Hartman, Lauren; Hudson, Joshua; Hung, Yu C

    2016-01-01

    Although perhaps better known as an irreversible aldehyde dehydrogenase inhibitor causing increased acetaldehyde levels after concomitant intake of ethanol, disulfiram or one of its metabolites (diethyldithiocarbamate) also inhibit dopamine β-hydroxylase, an enzyme that converts dopamine to norepinephrine. This mechanism has been advanced as a possible explanation for the development of psychosis, during disulfiram treatment, either in monotherapy or in combination therapy, when interaction-emergent psychosis could be causal. We present a young woman who was taking mixed amphetamine salts for treatment of attention-deficit/hyperactivity disorder and developed a short-lived psychosis after introduction of disulfiram. The psychotic symptoms resolved after discontinuation of both medications, without the use of antipsychotic drugs. We proceed with a review of the literature of disulfiram-induced psychosis and discuss pathophysiological theories that possibly were involved in our patient's phenomenology. PMID:27466724

  15. Fourth Primary Malignant Tumor in a Patient with Possible Li-Fraumeni Syndrome: Synchronous Diagnosis of Postirradiation Sarcoma, Cutaneous Relapse of a Previous Soft Tissue Sarcoma, and Lung Adenocarcinoma

    PubMed Central

    Yumrukçal, Feridun; Dirik, Yalin; Çinar, Arda; Eralp, Levent

    2014-01-01

    We present a 46-year-old female patient who is diagnosed with synchronous postirradiation sarcoma, cutaneous relapse of a previous soft tissue sarcoma, and lung adenocarcinoma. More than one malignant tumor at the same time with an accompanying relapse of a previous malignant tumor is a rare entity. A relatively young patient diagnosed with adenocarcinoma of the urethra before age 40, which is an unusual tumor for that age, later three more different malignant tumors being diagnosed, two of which are synchronous, causes the suspicion of Li-Fraumeni syndrome. PMID:25506014

  16. Early severe scoliosis in a patient with atypical progressive pseudorheumatoid dysplasia (PPD): Identification of two WISP3 mutations, one previously unreported.

    PubMed

    Montané, Lucia Sentchordi; Marín, Oliver R; Rivera-Pedroza, Carlos I; Vallespín, Elena; Del Pozo, Ángela; Heath, Karen E

    2016-06-01

    Progressive pseudorheumatoid dysplasia (PPD) is a rare autosomal recessive disorder characterized by spondyloepiphyseal dysplasia associated with pain and stiffness of multiple joints, enlargement of the interphalangeal joints, normal inflammatory parameters, and absence of extra-skeletal manifestations. Homozygous or compound heterozygous WISP3 mutations cause PPD. We report two siblings from a non-consanguineous Ecuadorian family with a late-onset spondyloepiphyseal dysplasia. Mutation screening was undertaken in the two affected siblings using a customized skeletal dysplasia next generation sequencing (NGS) panel and confirmed by Sanger sequencing. Two compound heterozygous mutations were identified in WISP3 exon 2, c.[190G>A];[197G>A] (p.[(Gly64Arg)];[(Ser66Asn)]) in the two siblings, both of which had been inherited. The p. (Gly64Arg) mutation has not been previously described whilst the p. (Ser66Asn) mutation has been reported in two PPD families. The two siblings presented with atypical PPD, as they presented during late childhood, yet the severity was different between them. The progression was particularly aggressive in the male sibling who suffered severe scoliosis by the age of 13 years. This case reaffirms the clinical heterogeneity of this disorder and the clinical utility of NGS to genetically diagnose skeletal dysplasias, enabling adequate management, monitorization, and genetic counseling. © 2016 Wiley Periodicals, Inc. PMID:26991965

  17. Pattern Analysis of Acute Mucosal Reactions in Patients With Head and Neck Cancer Treated With Conventional and Accelerated Irradiation

    SciTech Connect

    Wygoda, Andrzej Maciejewski, Boguslaw; Skladowski, Krzysztof; Hutnik, Marcin; Pilecki, Boleslaw; Golen, Maria; Rutkowski, Tomasz

    2009-02-01

    Purpose: To evaluate severity of acute mucosal reactions (AMR) caused by conventional (CF) and accelerated fractionation (AF) regimens using a modified Dische system and to analyze differences in incidence and severity of AMR according to frequency and regularity of scoring. Methods and Materials: Sixty-six consecutive patients (33 CF, 33 AF) with head and neck cancer irradiated with 5 fractions in 5 days per week (CF) or with 7 fractions in 7 days (AF) to a total dose of 70 Gy. A modified Dische system was used for daily quantitation of AMR during radiotherapy until complete healing. Results: Confluent mucositis (CM) was noted in 79% of patients in the CF group and 85% in the AF group. In 24% of the CF group and 18% of the AF group the CM presented a wave-like pattern. In 55% of CF and 67% of AF a classic triphasic pattern was noted. In 12 patients acute reactions did not transgress the level of spotted mucositis. The present study clearly shows that quantitation of the incidence and severity of acute mucosal effects strongly depends on frequent and regular scoring. A significant difference in the incidence of CM between the CF and AF groups was noted, mainly in weeks 4-6 of irradiation. When once-weekly irregular instead of daily scoring was evaluated, the incidence of CM was underestimated by approximately 20-36%. Conclusions: Acute mucosal reactions occur as a complex of morphologic and functional disorders with individual intensity, even among patients treated with the same fractionation regimen. In some cases they present a 'wave-like' pattern during irradiation. Therefore, precise quantitation of acute effects requires regular and frequent scoring.

  18. Effect of six different cooking techniques in the nutritional composition of two fish species previously selected as optimal for renal patient's diet.

    PubMed

    Castro-González, Isabel; Maafs-Rodríguez, Ana Gabriela; Pérez-Gil Romo, Fernando

    2015-07-01

    Benefits of fish consumption are widely known, but there is little information about nutrient values of raw and cooked fish. The aim was to study the impact that six cooking techniques have on the nutritional composition of two fish species with low content of adverse nutrients in renal diet. Raw and steamed, foiled with aluminum, foiled with banana leaf, gas oven-baked, microwave oven-coked and fried lightly samples were chemically analyzed to determine their protein, phosphorus and lipid content. Crevalle jack: all methods increased lipid and protein content and fatty acids (FA) varied in all cooking methods. Phosphorus decreased in the steamed and microwave oven-cooked samples. Red drum: foiled and fried lightly increased lipid content compared to the raw sample. FA concentration changed in all cooking methods. Protein increased with every technique and phosphorus decreased in the steamed and gas oven-baked samples. Renal patients should preferably consume crevalle jack steamed or microwave oven-cooked and red drum steamed or gas oven-baked. PMID:26139884

  19. Langerhans cell histiocytosis of the urinary bladder in a patient with bladder cancer previously treated with intravesical Bacillus Calmette-Guérin therapy.

    PubMed

    Numakura, Satoe; Morikawa, Teppei; Ushiku, Tetsuo; Toyoshima, Toyoaki; Fukayama, Masashi

    2014-02-01

    We report an extremely rare case of Langerhans cell histiocytosis (LCH) of the urinary bladder. A 68-year-old man presented with gross hematuria. Cystoscopy showed multiple papillary tumors in the urinary bladder, and transurethral resection was performed. Pathological diagnosis was high-grade papillary urothelial carcinoma with lamina propria invasion. The patient received six treatments with intravesical Bacillus Calmette-Guérin (BCG) therapy. Seven months after surgery, follow-up cystoscopy showed three elevated lesions in the urinary bladder, two of which were identified histologically as recurrent urothelial carcinoma. Microscopic examination of the lesion at the anterior wall revealed diffuse infiltration of medium to large histiocytoid cells in the lamina propria, many of which had distorted nuclei and nuclear grooves. Dense eosinophilic infiltration was also observed. Immunohistochemically, the histiocytoid cells were diffusely positive for S-100 and CD1a, but negative for cytokeratin AE1/AE3 and melanosome-associated antigen recognized by HMB-45. Based on the histological and immunohistochemical features, we diagnosed the lesion as LCH of the urinary bladder. There was no evidence of recurrence of either bladder cancer or LCH after an 18-month follow-up. To avoid misdiagnosis, urologists and pathologists should be aware that LCH may develop in the urinary bladder after intravesical BCG therapy for bladder cancer.

  20. Beware the ‘raised right hemidiaphragm’ in a female patient with previous pneumothorax surgery: liver herniation through a massive endometrosis-related diaphragmatic fenestration

    PubMed Central

    Yu, Peter S. Y.

    2015-01-01

    A 44-year-old non-smoking woman presented with recurrent right spontaneous pneumothorax 9 years after a right-side surgical pleurodesis via a video-assisted thoracic surgery (VATS) approach for suspected primary pneumothorax in another center. Histological examination of tissue excised during the earlier operation confirmed catamenial pneumothorax, but no further treatment was given. During the 9 years since, she had had persistent right lower chest pain and chest X-ray (CXR) had shown a “persistently elevated right diaphragm”, but these had been treated as iatrogenic neuropathic pain and phrenic nerve palsy respectively. A redo right surgical exploration was performed for the current recurrence. Intra-operatively, the right half of the liver was found to have herniated into the chest via a massive fenestration (10 cm × 9 cm) in the right hemidiaphragm. The defect was repaired via a combined thoracotomy and laparotomy approach. This case serves as an advisory that in patients with persistent ipsilateral chest pain and a raised hemidiaphragm following surgery for catamenial pneumothorax, diaphragmatic fenestration and abdominal visceral herniation should be suspected amongst the differential diagnoses. PMID:26101655

  1. Donor Corneal Transplantation vs Boston Type 1 Keratoprosthesis in Patients with Previous Graft Failures: A Retrospective Single Center Study (An American Ophthalmological Society Thesis)

    PubMed Central

    Akpek, Esen K.; Cassard, Sandra D.; Dunlap, Karen; Hahn, Sarah; Ramulu, Pradeep Y.

    2015-01-01

    Purpose: To compare short-term outcomes of repeat penetrating keratoplasty (PK) to those of Boston type 1 keratoprosthesis (KPro). Our hypothesis was that visual outcomes were superior for KPro compared to PK. Methods: This is a retrospective, nonrandomized, intermediate-term case series. Consecutive adults with one or more failed PKs who underwent either PK or KPro between January 2008 and December 2010 were included. Demographics, indication for the initial PK, comorbidities, concomitant procedures, and complications were considered. Only one procedure in each eye was included. All KPro procedures were retained in the analyses. Results: Fifty-three patients underwent PK and 27 received KPro. Mean follow-up was 19.5 months in the PK group and 16.5 months in the KPro group. KPro eyes had worse mean preoperative vision (hand motions vs counting fingers, P=.01) and more comorbidities. In the postoperative period, 35% of PK eyes and 45% of KPro eyes attained best-ever visual acuity of 20/70. Forty-seven percent of PK eyes vs 40% of KPro eyes were able to retain this visual acuity. Two-year rate of failure to retain visual acuity better than the baseline was higher for PK eyes, though not at a statistically significant level (hazard ratio [HR]=1.67; 95% CI, 0.78–3.60; P=.19). Two-year cumulative rate of graft failure (loss of clarity for PK and removal/replacement for KPro) was higher for PK eyes (HR=3.23; 95% CI, 1.12–9.28; P=.03). Retinal detachment, endophthalmitis, and glaucoma rates were similar (P=.6 for all). Conclusions: These results demonstrate less frequent graft failure, greater visual improvement, and greater likelihood of maintaining the visual improvement in KPro eyes vs PK. PMID:26538773

  2. [Autotransfusion of UV-irradiated blood and the morphofunctional status of mononuclear cells in neurodermitis patients].

    PubMed

    Finkel'shteĭn, B B; Zver'kova, F A

    1989-01-01

    Structural changes in the blood mononuclear glycocalyx has been revealed in children suffering from neurodermatitis. These shifts correlated with the cellular ability to respond to mitogenic stimulation. Treatment by UV-irradiated blood autotransfusions normalized the structure and function of mononuclears whereas routine therapy has been ineffective. PMID:2728605

  3. Late neurological complications after prophylactic cranial irradiation in patients with small-cell lung cancer: The Toronto experience

    SciTech Connect

    Lishner, M.; Feld, R.; Payne, D.G.; Sagman, U.; Sculier, J.P.; Pringle, J.F.; Yeoh, J.L.; Evans, W.K.; Shepherd, F.A.; Maki, E. )

    1990-02-01

    We retrospectively analyzed the charts of 58 long-term survivors of small-cell lung cancer (SCLC) (greater than 2 years) for neurological complications and their impact on the well-being of these patients. We also attempted to have patients complete a questionnaire regarding any possible neurological problems. This was done in 14 patients. Metastasis to the CNS occurred significantly less often in patients who received prophylactic cranial irradiation (PCI) in a dose of 20 Gy in five equal fractions (two of 48), compared with patients who did not receive it (four of 10) (P less than .006). Delayed neurological complications occurred in nine of 48 (19%) patients who received PCI. However, in only two patients did PCI appear to be responsible for progressive dementia. In the other seven patients (one with weakness in the arms and legs, one with transient left hemiparesis, two with hearing loss, and three with various visual disturbances), chemotherapeutic agents (mainly cisplatin and vincristine) and underlying diseases probably contributed significantly to the occurrence of these complications. In addition, these neurological disturbances were transient or ran a stable course and did not adversely affect the daily life of these patients. In comparison, among the 10 patients who did not receive PCI one had progressive dementia and another had hemiparesis secondary to probable brain embolism. We conclude that the use of PCI in these doses was effective in reducing the frequency of CNS metastases and had an adverse effect on the daily life and well-being only in a minority of the patients. Until results of controlled randomized studies show otherwise, PCI should continue to be used as a part of the combined modality treatment of completely responding patients with limited SCLC.

  4. Short course prophylactic cranial irradiation for small cell lung cancer

    SciTech Connect

    Feld, R.; Clamon, G.H.; Blum, R.; Moran, E.; Weiner, R.; Kramer, B.; Evans, W.K.; Herman, J.G.; Hoffman, F.; Burmeister, L.

    1985-10-01

    Ninety-one patients with small cell carcinoma of the lung were given a shortened, intensive course of prophylactic cranial irradiation consisting of 2,000 rad in five fractions. The CNS relapse rate was 21%, but in only one of 91 patients was the brain the first and only site of relapse. Acute toxicities consisting of headache (16%) and nausea and vomiting (15%) were observed. Results are compared with previous results from other studies of cranial irradiation.

  5. Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant

    ClinicalTrials.gov

    2015-06-03

    ; Noncontiguous Stage II Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Grade 3 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Polycythemia Vera; Post-transplant Lymphoproliferative Disorder; Previously Treated Myelodysplastic Syndromes; Primary Myelofibrosis; Primary Systemic Amyloidosis; Progressive Hairy Cell Leukemia, Initial Treatment; Prolymphocytic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Refractory Multiple Myeloma; Relapsing Chronic Myelogenous Leukemia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Secondary Myelofibrosis; Splenic Marginal Zone Lymphoma; Stage 0 Chronic Lymphocytic Leukemia; Stage I Adult

  6. Improved Posttreatment Functional Outcome is Associated with Better Survival in Patients Irradiated for Metastatic Spinal Cord Compression

    SciTech Connect

    Rades, Dirk . E-mail: Rades.Dirk@gmx.net; Veninga, Theo; Stalpers, Lukas J.A.; Basic, Hiba; Hoskin, Peter J.; Karstens, Johann H.; Schild, Steven E.; Dunst, Juergen

    2007-04-01

    Purpose: To evaluate the potential prognostic impact of the effect of radiotherapy (RT) on motor function and of the post-RT ambulatory status on survival in metastatic spinal cord compression (MSCC) patients. Methods and Materials: Of 1,852 patients irradiated for MSCC, 778 patients (42%) received short-course RT and 1,074 (58%) received long-course RT. The effect of RT on motor function (improvement vs. no change vs. deterioration) and the ambulatory status after RT (ambulatory vs. nonambulatory) were evaluated with respect to survival. Results: The actuarial survival rate of the entire cohort was 56% at 6 months, 43% at 12 months, and 32% at 24 months. The patients in whom motor function improved after RT had a significantly better 1-year survival rate than those who had no change or deterioration of motor function (75% vs. 40% and 3%, p < 0.001). The 1-year survival rate of the patients who were ambulatory after RT was significantly better than for those who were not ambulatory (63% vs. 4%, p < 0.001). The results were confirmed in multivariate analysis. Conclusions: The response to RT and the post-RT ambulatory status are important predictors for survival in MSCC patients. This finding can be used by physicians to stratify future studies, plan further therapy, and improve follow-up strategy in these patients.

  7. Hyperparathyroidism after neck irradiation.

    PubMed

    Christmas, T J; Chapple, C R; Noble, J G; Milroy, E J; Cowie, A G

    1988-09-01

    A retrospective review of 1550 cases of hyperparathyroidism (HPT) treated surgically over a 30-year period reveals a past history of exposure to neck irradiation in 10 cases (0.7 per cent). The indication for radiotherapy was benign disease in nine and papillary thyroid carcinoma in one case. The mean interval between radiation exposure and the detection of HPT was 32 years (range 3-63 years). Patients treated with radioactive iodine alone developed HPT after a mean of 5 years while the interval for those treated with external beam therapy alone was a mean of 44 years. The parathyroid histology was adenoma in six cases, carcinoma in three cases and nodular hyperplasia in one case. All patients had coincident benign thyroid disease apart from one that had previously had papillary carcinoma and another with follicular carcinoma. Neck irradiation has been shown to confer an increased risk of HPT due to parathyroid adenoma and carcinoma. Radiotherapy for benign disease has generally been abandoned and these cases demonstrate a further contra-indication for the use of neck irradiation.

  8. A Phase 3, multicenter, open-label, switchover trial to assess the safety and efficacy of taliglucerase alfa, a plant cell-expressed recombinant human glucocerebrosidase, in adult and pediatric patients with Gaucher disease previously treated with imiglucerase.

    PubMed

    Pastores, Gregory M; Petakov, Milan; Giraldo, Pilar; Rosenbaum, Hanna; Szer, Jeffrey; Deegan, Patrick B; Amato, Dominick J; Mengel, Eugen; Tan, Ee Shien; Chertkoff, Raul; Brill-Almon, Einat; Zimran, Ari

    2014-12-01

    Taliglucerase alfa is a β-glucosidase enzyme replacement therapy (ERT) approved in the US and other countries for the treatment of Gaucher disease (GD) in adults and is approved in pediatric and adult patients in Australia and Canada. It is the first approved plant cell-expressed recombinant human protein. A Phase 3, multicenter, open-label, 9-month study assessed safety and efficacy of switching to taliglucerase alfa in adult and pediatric patients with GD treated with imiglucerase for at least the previous 2years. Patients with stable disease were offered taliglucerase alfa treatment using the same dose (9-60U/kg body weight) and regimen of administration (every 2weeks) as imiglucerase. This report summarizes results from 26 adult and 5 pediatric patients who participated in the trial. Disease parameters (spleen and liver volumes, hemoglobin concentration, platelet count, and biomarker levels) remained stable through 9months of treatment in adults and children following the switch from imiglucerase. All treatment-related adverse events were mild or moderate in severity and transient in nature. Exploratory parameters of linear growth and development showed positive outcomes in pediatric patients. These findings provide evidence of the efficacy and safety profile of taliglucerase alfa as an ERT for GD in patients previously treated with imiglucerase. This trial was registered at www.clinicaltrials.gov as # NCT00712348. PMID:24950666

  9. A Phase 3, multicenter, open-label, switchover trial to assess the safety and efficacy of taliglucerase alfa, a plant cell-expressed recombinant human glucocerebrosidase, in adult and pediatric patients with Gaucher disease previously treated with imiglucerase.

    PubMed

    Pastores, Gregory M; Petakov, Milan; Giraldo, Pilar; Rosenbaum, Hanna; Szer, Jeffrey; Deegan, Patrick B; Amato, Dominick J; Mengel, Eugen; Tan, Ee Shien; Chertkoff, Raul; Brill-Almon, Einat; Zimran, Ari

    2014-12-01

    Taliglucerase alfa is a β-glucosidase enzyme replacement therapy (ERT) approved in the US and other countries for the treatment of Gaucher disease (GD) in adults and is approved in pediatric and adult patients in Australia and Canada. It is the first approved plant cell-expressed recombinant human protein. A Phase 3, multicenter, open-label, 9-month study assessed safety and efficacy of switching to taliglucerase alfa in adult and pediatric patients with GD treated with imiglucerase for at least the previous 2years. Patients with stable disease were offered taliglucerase alfa treatment using the same dose (9-60U/kg body weight) and regimen of administration (every 2weeks) as imiglucerase. This report summarizes results from 26 adult and 5 pediatric patients who participated in the trial. Disease parameters (spleen and liver volumes, hemoglobin concentration, platelet count, and biomarker levels) remained stable through 9months of treatment in adults and children following the switch from imiglucerase. All treatment-related adverse events were mild or moderate in severity and transient in nature. Exploratory parameters of linear growth and development showed positive outcomes in pediatric patients. These findings provide evidence of the efficacy and safety profile of taliglucerase alfa as an ERT for GD in patients previously treated with imiglucerase. This trial was registered at www.clinicaltrials.gov as # NCT00712348.

  10. Treatment planning for parotid sparing in the patient requiring bilateral neck irradiation.

    PubMed

    Marsh, L; Eisbruch, A; Watson, B; Martel, M K

    1996-01-01

    The use of three dimensional (3-D) planning techniques for treatment of head and neck cancers has primarily been used in cases which require only unilateral neck irradiation. However, tumors that require bilateral neck irradiation are commonly managed with parallel opposed treatment portals. A common morbidity associated with this standard form of treatment is xerostomia. In an effort to reduce the incidence of this debilitating side effect, a protocol has been developed which attempts to balance effective tumor control with preservation of salivary flow. Key to this protocol is the use of 3-D treatment planning. The close proximity of the targeted tissues to critical structures and the related dose requirements and/or restrictions of these tissues often require the treatment planner to utilize "non-standard" approaches to achieve the unique dose distributions necessary to meet protocol eligibility. This may include treatment planning options such as non-coplanar, non-axial beams; and modulation of beam intensity. PMID:8679070

  11. Golimumab in patients with active rheumatoid arthritis who have previous experience with tumour necrosis factor inhibitors: results of a long-term extension of the randomised, double-blind, placebo-controlled GO-AFTER study through week 160

    PubMed Central

    Smolen, Josef S; Kay, Jonathan; Landewé, Robert B M; Matteson, Eric L; Gaylis, Norman; Wollenhaupt, Jurgen; Murphy, Frederick T; Zhou, Yiying; Hsia, Elizabeth C; Doyle, Mittie K

    2012-01-01

    Objective The aim of this study was to assess long-term golimumab therapy in patients with rheumatoid arthritis (RA) who discontinued previous tumour necrosis factor alpha (TNFα) inhibitor(s) for any reason. Methods Results through week 24 of this multicentre, randomised, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 swollen joints) were previously reported. Patients received placebo (Group 1), 50 mg golimumab (Group 2) or 100 mg golimumab (Group 3) subcutaneous injections every 4 weeks. Patients from Groups 1 and 2 with <20% improvement in tender/swollen joints at week 16 early escaped to golimumab 50 mg and 100 mg, respectively. At week 24, Group 1 patients crossed over to golimumab 50 mg, Group 2 continued golimumab 50/100 mg per escape status and Group 3 maintained dosing. Data through week 160 are reported. Results 459 of the 461 randomised patients were treated; 236/459 (51%) continued treatment through week 160. From week 24 to week 100, ACR20 (≥20% improvement in American College of Rheumatology criteria) response and ≥0.25 unit HAQ (Health Assessment Questionnaire) improvement were sustained in 70–73% and 75–81% of responding patients, respectively. Overall at week 160, 63%, 67% and 57% of patients achieved ACR20 response and 59%, 65% and 64% had HAQ improvement ≥0.25 unit in Groups 1, 2 and 3, respectively. Adjusted for follow-up duration, adverse event incidences (95% CI) per 100 patient-years among patients treated with golimumab 50 mg and 100 mg were 4.70 (2.63 to 7.75) and 8.07 (6.02 to 10.58) for serious infection, 0.95 (0.20 to 2.77) and 2.04 (1.09 to 3.49) for malignancy and 0.00 (0.00 to 0.94) and 0.62 (0.17 to 1.59) for death, respectively. Conclusion In patients with active RA who discontinued previous TNF-antagonist treatment, golimumab 50 and 100 mg injections every 4 weeks yielded sustained improvements in signs/symptoms and physical function in ∼57–67% of patients who continued treatment. Golimumab

  12. Differences in Patterns of Failure in Patients Treated With Accelerated Partial Breast Irradiation Versus Whole-Breast Irradiation: A Matched-Pair Analysis With 10-Year Follow-Up

    SciTech Connect

    Antonucci, J. Vito; Wallace, Michelle; Goldstein, Neal S.; Kestin, Larry; Chen, Peter; Benitez, Pamela; Dekhne, Nayana; Martinez, Alvaro; Vicini, Frank

    2009-06-01

    Purpose: To examine 10-year results of a single institution's experience with radiotherapy limited to the region of the tumor bed (i.e., accelerated partial breast irradiation, [APBI]) in selected patients treated with breast-conserving therapy (BCT) and compare them with results of matched BCT patients who underwent whole-breast irradiation (WBI). Patients and Methods: A total of 199 patients with early-stage breast cancer were treated prospectively with BCT and APBI using interstitial brachytherapy. To compare potential differences in local recurrence rates on the basis of the volume of breast tissue irradiated, patients in the APBI group were matched with 199 patients treated with WBI. Match criteria included tumor size, nodal status, age at diagnosis, margins of excision, estrogen receptor status, and use of adjuvant tamoxifen therapy. Local-regional control, disease-free survival, and overall survival were analyzed between treatment groups. Results: Median follow-up for surviving patients was 9.6 years (range, 0.3-13.6 years). Eight ipsilateral breast tumor recurrences (IBTRs) were observed in patients treated with APBI. The cumulative incidence of IBTR at 10 years was 5%. On matched-pair analysis, the rate of IBTR was not statistically significantly different between the patient groups (4%, 95% confidence interval [CI] 1.3-6.7% for WBI therapy patients vs. 5%, 95% CI 1.5-8.5% for APBI patients; p = 0.48). Conclusions: Radiation therapy limited to the region of the tumor bed (APBI) produced 10-year local control rates comparable to those from WBI in selected low-risk patients.

  13. SU-E-T-404: Simple Field-In-Field Technique for Total Body Irradiation in Large Patients

    SciTech Connect

    Chi, P; Pinnix, C; Dabaja, B; Wang, C; Aristophanous, M; Tung, S

    2014-06-01

    Purpose: A simple Field-in-Field technique for Total Body Irradiation (TBI) was developed for traditional AP/PA TBI treatments to improve dosimetric uniformity in patients with large separation. Methods: TBI at our institution currently utilizes an AP/PA technique at an extended source-to-surface distance (SSD) of 380cm with patients in left decubitus position during the AP beam and in right decubitus during the PA beam. Patients who have differences in thickness (separation) between the abdomen and head greater than 10cm undergo CT simulation in both left and right decubitus treatment positions. One plan for each CT is generated to evaluate dose to patient midline with both AP and PA fields, but only corresponding AP fields will be exported for treatment for patient left decubitus position and PA fields for patient right decubitus position. Subfields are added by collimating with the x-ray jaws according to separation changes at 5–7% steps to minimize hot regions to less than 10%. Finally, the monitor units (MUs) for the plans are verified with hand calculation and water phantom measurements. Results: Dose uniformity (+/−10%) is achieved with field-in-field using only asymmetric jaws. It is dosimetrically robust with respect to minor setup/patient variations inevitable due to patient conditions. MUs calculated with Pinnacle were verified in 3 clinical cases and only a 2% difference was found compared to homogeneous calculation. In-vivo dosimeters were also used to verify doses received by each patient with and confirmed dose variations less than 10%. Conclusion: We encountered several cases with separation differences that raised uniformity concerns — based on a 1% dose difference per cm separation difference assumption. This could Resultin an unintended hot spot, often in the head/neck, up to 25%. This method allows dose modulation without adding treatment complexity nor introducing radiobiological variations, providing a reasonable solution for this unique

  14. Phase 1/2 study of ocaratuzumab, an Fc-engineered humanized anti-CD20 monoclonal antibody, in low-affinity FcγRIIIa patients with previously treated follicular lymphoma.

    PubMed

    Ganjoo, Kristen N; de Vos, Sven; Pohlman, Brad L; Flinn, Ian W; Forero-Torres, Andres; Enas, Nathan H; Cronier, Damien M; Dang, Nam H; Foon, Kenneth A; Carpenter, Susan P; Slapak, Christopher A; Link, Brian K; Smith, Mitchell R; Mapara, Markus Y; Wooldridge, James E

    2015-01-01

    This phase 2 study assessed the safety and efficacy of ocaratuzumab, a humanized anti-CD20 monoclonal antibody. Fifty patients with previously treated follicular lymphoma (FL) and a low-affinity genotype of FcγRIIIa received ocaratuzumab 375 mg/m(2) weekly for 4 weeks. Grade 3/4/5 adverse events (AEs) were reported in 11/1/1 patients, respectively. Serious AEs were reported by 11/50 patients, and three discontinued due to AEs. One patient died from aspiration pneumonia due to possibly drug-related nausea and vomiting. Investigator-assessed response rate was 30% (15/50), including four complete responses (CR), three CR unconfirmed (CRu) and eight partial responses (PR). Investigator-assessed median Progression-free survivial (PFS) was 38.3 weeks. Ocaratuzumab's pharmacokinetic profile was similar to that reported for rituximab. Lymphocyte subset analysis showed significant, selective reduction of B-cells during and after ocaratuzumab treatment. Ocaratuzumab at this dose and schedule is active and well tolerated in patients with previously treated FL with low affinity FcγRIIIa genotypes. ClinTrials registry number: NCT00354926.

  15. Previously unknown species of Aspergillus.

    PubMed

    Gautier, M; Normand, A-C; Ranque, S

    2016-08-01

    The use of multi-locus DNA sequence analysis has led to the description of previously unknown 'cryptic' Aspergillus species, whereas classical morphology-based identification of Aspergillus remains limited to the section or species-complex level. The current literature highlights two main features concerning these 'cryptic' Aspergillus species. First, the prevalence of such species in clinical samples is relatively high compared with emergent filamentous fungal taxa such as Mucorales, Scedosporium or Fusarium. Second, it is clearly important to identify these species in the clinical laboratory because of the high frequency of antifungal drug-resistant isolates of such Aspergillus species. Matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) has recently been shown to enable the identification of filamentous fungi with an accuracy similar to that of DNA sequence-based methods. As MALDI-TOF MS is well suited to the routine clinical laboratory workflow, it facilitates the identification of these 'cryptic' Aspergillus species at the routine mycology bench. The rapid establishment of enhanced filamentous fungi identification facilities will lead to a better understanding of the epidemiology and clinical importance of these emerging Aspergillus species. Based on routine MALDI-TOF MS-based identification results, we provide original insights into the key interpretation issues of a positive Aspergillus culture from a clinical sample. Which ubiquitous species that are frequently isolated from air samples are rarely involved in human invasive disease? Can both the species and the type of biological sample indicate Aspergillus carriage, colonization or infection in a patient? Highly accurate routine filamentous fungi identification is central to enhance the understanding of these previously unknown Aspergillus species, with a vital impact on further improved patient care. PMID:27263029

  16. Clinical significance of the administration of cytarabine or thiotepa in addition to total body irradiation and cyclophosphamide for allogeneic hematopoietic cell transplantation in patients with acute leukemia.

    PubMed

    Tachibana, Takayoshi; Tanaka, Masatsugu; Hagihara, Maki; Kawasaki, Rika; Yamazaki, Etsuko; Koharazawa, Hideyuki; Taguchi, Jun; Tomita, Naoto; Fujimaki, Katsumichi; Sakai, Rika; Fujita, Hiroyuki; Fujisawa, Shin; Maruta, Atsuo; Ishigatsubo, Yoshiaki; Kanamori, Heiwa

    2015-10-01

    A multicenter retrospective study was performed to determine the significance of adding cytarabine (CA) or thiotepa (TT) in the context of total body irradiation (TBI) and cyclophosphamide (CY). A total of 322 patients who underwent allogeneic hematopoietic cell transplantation (HCT) were distributed to the following three groups: TBI/CY (n = 75), TBI/CY/CA (n = 77), and TBI/CY/TT (n = 170). In the TBI/CY/TT group, 164 of patients (96 %) received HCT during the previous year (2000-2005). Multivariate analysis revealed that the TBI/CY/TT group demonstrated a trend of poorer survival rate than the TBI/CY group, [hazard ratio (HR) = 1.49, 95 % confidence interval (CI) 0.99-2.24, P = 0.055] with a higher non-relapse mortality (NRM) (HR = 2.34, 95 % CI 1.35-4.06, P = 0.002) rates, while TBI/CY/CA group demonstrated similar outcomes. Even in the subgroup analyses of disease type or disease risk, the outcomes with intensified conditioning regimens were not superior to those with TBI/CY. In conclusion, although the significant bias has to be carefully considered, the clinical benefit of adding CA or TT to the TBI/CY regimen was not demonstrated.

  17. The relationship between thyroid dose and diagnosis of primary hypothyroidism in pediatric brain tumor patients receiving craniospinal irradiation

    PubMed Central

    Lauro, Christine; Macy, Margaret E.; Zeitler, Philip; Backus, Jennifer; Mettler, Pamela; Foreman, Nicholas; Liu, Arthur K.

    2014-01-01

    Purpose The aim of this work is to determine if a relationship exists between thyroid dose and incidence of primary hypothyroidism (PH) in children undergoing craniospinal irradiation (CSI). Methods A total of 22 patients received CSI with evaluable thyroid dose information. All patients received concurrent chemotherapy and 21 patients (95%) received adjuvant chemotherapy. Median follow-up was 42.9 months. Results The incidence of PH in our cohort was 59% at a median time after radiotherapy of 3.5 years (range: 8 months to 7.5 years). Mean thyroid dose appeared to best predict for PH, with a median of 2080 cGy for patients with PH versus 1736 cGy for children without PH (p=0.057). There was no association between the rate of PH and sex, age, CSI dose, minimum thyroid dose and maximum thyroid dose. Conclusions A relationship may exist between the mean thyroid dose and incidence of PH in patients undergoing CSI. Thus, new strategies to protect the thyroid gland may be warranted. PMID:24057590

  18. Isolating the Role of Bevacizumab in Elderly Patients With Previously Untreated Nonsquamous Non–Small Cell Lung Cancer: Secondary Analyses of the ECOG 4599 and PointBreak Trials

    PubMed Central

    Langer, Corey J.; Socinski, Mark A.; Patel, Jyoti D.; Sandler, Alan B.; Schiller, Joan H.; Leon, Larry; Hazard, Sebastien J.; Ramalingam, Suresh S.

    2016-01-01

    Background Patient-level data from 2 phase III studies in patients with previously untreated, advanced-stage, nonsquamous non–small cell lung cancer (NSCLC) were pooled to examine outcomes with bevacizumab and chemotherapy based on age. Methods Data from patients randomized to paclitaxel–carboplatin (PC) + bevacizumab in the Eastern Cooperative Oncology Group 4599 (E4599) and PointBreak studies were pooled and compared with E4599 patients randomized to PC alone. Patients were grouped by age: <65, 65–74, 70–74, <75, and ≥75 years. A multivariable model was used to calculate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) using time-to-event outcomes. Adverse events (AEs) were assessed by age group in each study. Results The PC + bevacizumab and PC arms comprised 901 and 444 patients, respectively. PC + bevacizumab was associated with significant increases in overall survival relative to PC in patients <65 (HR, 0.75; 95% CI, 0.62–0.89), 65–74 (HR, 0.80; 95% CI, 0.64–1.00), 70–74 (HR, 0.68; 95% CI, 0.48–0.96), and <75 years (HR, 0.78; 95% CI, 0.68–0.89), but not in those ≥75 years (HR, 1.05; 95% CI, 0.70–1.57). Increased incidence of grade ≥3 AEs was reported with PC + bevacizumab vs. PC in patients <75 (63% vs. 48%; P <0.05) and ≥75 years (81% vs. 56%; P <0.05) in E4599. Conclusions This analysis demonstrates that the survival benefits associated with PC + bevacizumab extend to patient subgroups <75 years with advanced-stage NSCLC; no benefit, however, was observed for bevacizumab-eligible patients who were ≥75 years. PMID:25628268

  19. Distinguishing tumor recurrence from irradiation sequelae with positron emission tomography in patients treated for larynx cancer

    SciTech Connect

    Greven, K.M.; Williams, D.W. III; Keyes, J.W. Jr.; McGuirt, W.F.; Harkness, B.A.; Watson, N.E. Jr.; Raben, M.; Frazier, L.C.; Geisinger, K.R.; Capellari, J.O.

    1994-07-01

    Distinguishing persistent or recurrent tumor from postradiation edema, or soft tissue/cartilage necrosis in patients treated for carcinoma of the larynx can be difficult. Because recurrent tumor is often submucosal, multiple deep biopsies may be necessary before a diagnosis can be established. Positron emission tomography with 18F-2-fluro-2-deoxglucose (FDG) was studied for its ability to aid in this problem. Positron emission tomography (18FDG) scans were performed on 11 patients who were suspected of having persistent or recurrent tumor after radiation treatment for carcinoma of the larynx. Patients underwent thorough history and physical examinations, scans with computerized tomography, and pathologic evaluation when indicated. Standard uptake values were used to quantitate the FDG uptake in the larynx. The time between completion of radiation treatment and positron emission tomography examination ranged from 2 to 26 months with a median of 6 months. Ten patients underwent computed tomography (CT) of the larynx, which revealed edema of the larynx (six patients), glottic mass (four patients), and cervical nodes (one patient). Positron emission tomography scans revealed increased FDG uptake in the larynx in five patients and laryngectomy confirmed the presence of carcinoma in these patients. Five patients had positron emission tomography results consistent with normal tissue changes in the larynx, and one patient had increased FDG uptake in neck nodes. This patient underwent laryngectomy, and no cancer was found in the primary site, but nodes were pathologically positive. One patient had slightly elevated FDG uptake and negative biopsy results. The remaining patients have been followed for 11 to 14 months since their positron emission studies and their examinations have remained stable. In patients without tumor, average standard uptake values of the larynx ranged from 2.4 to 4.7, and in patients with tumor, the range was 4.9 to 10.7. 18 refs., 3 figs., 1 tab.

  20. Impaired jun-NH2-terminal kinase activation by ultraviolet irradiation in fibroblasts of patients with Cockayne syndrome complementation group B.

    PubMed

    Dhar, V; Adler, V; Lehmann, A; Ronai, Z

    1996-06-01

    c-jun-NH2 kinases (JNK) are among the UV-activated protein kinases that play an important role in cellular stress response via the phosphorylation of c-jun, ATF2, and p53. Activation of JNK by UV irradiation requires cooperation between membrane and nuclear components, including DNA lesions per se. The role of DNA lesions in JNK activation led us to explore the inducibility of these kinases in cells of repair-deficient patients. Analyses of primary fibroblast cell lines from patients with Cockayne Syndrome of complementation group B (CS-B) revealed poor JNK activation after UV irradiation in four of five cases when compared with three repair-proficient, normal human fibroblast cell lines. Impaired ability to activate JNK persisted at various time points and with different doses of UV irradiation and coincided with failure of in vitro damaged DNA to activate these kinases. In contrast to UV irradiation, other forms of stress, such as H2O2 or heat shock were capable of inducing JNK activation in CS-B cells. Interestingly, when UV irradiation was administered after osmotic shock, it led to JNK activation in CS-B cells, indicating that alternate signal transduction pathways that are activated in response to other forms of stress can potentiate JNK activation by UV irradiation. Unlike CS-B cells, those of other repair-deficient cells, including xeroderma pigmentosum of different complementation groups, revealed proper activation of JNK by UV irradiation. Together, our findings point to deficiency of JNK activation by UV irradiation in CS-B cells, a phenomenon which may be associated with impaired CS-B, the mutant repair gene in these patients. PMID:8780897

  1. Potential Impact of Preoperative Magnetic Resonance Imaging of the Breast on Patient Selection for Accelerated Partial Breast Irradiation

    SciTech Connect

    Kuehr, Marietta; Wolfgarten, Matthias; Stoelzle, Marco; Leutner, Claudia; Hoeller, Tobias; Schrading, Simone; Kuhl, Christiane; Schild, Hans; Kuhn, Walther; Braun, Michael

    2011-11-15

    Purpose: Accelerated partial breast irradiation (APBI) after breast-conserving therapy is currently under investigation in prospective randomized studies. Multifocality and multicentricity are exclusion criteria for APBI. Preoperative breast magnetic resonance imaging (MRI) can detect ipsilateral and contralateral invasive tumor foci or ductal carcinoma in situ in addition to conventional diagnostic methods (clinical examination, mammography, and ultrasonography). The objective of this retrospective study was to evaluate the impact of preoperative MRI on patient selection for APBI. Methods and Materials: From 2002 to 2007, a total of 579 consecutive, nonselected patients with newly diagnosed early-stage breast cancer received preoperative breast MRI in addition to conventional imaging studies at the Bonn University Breast Cancer Center. In retrospect, 113 patients would have met the criteria for APBI using conventional imaging workup (clinical tumor size {<=}3 cm; negative axillary lymph node status; unifocal disease; no evidence of distant metastases; no invasive lobular carcinoma, ductal and lobular carcinoma in situ, or Paget's disease). We analyzed the amount of additional ipsilateral and contralateral tumor foci detected by MRI. Results: MRI detected additional tumor foci in 8.8% of patients eligible for APBI (11 tumor foci in 10 of 113 patients), either ipsilateral (n = 7, 6.2%) or contralateral (n = 4, 3.5%). In 1 patient, MRI helped detect additional tumor focus both ipsilaterally and contralaterally. Conclusions: Preoperative breast MRI is able to identify additional tumor foci in a clinically relevant number of cases in this highly selected group of patients with low-risk disease and may be useful in selecting patients for APBI.

  2. Outcome of treatment of 313 patients with T-1 (UICC) prostate cancer treated with external beam irradiation

    SciTech Connect

    Hanks, G.E.; Krall, J.M.; Martz, K.L.; Diamond, J.J.; Kramer, S.

    1988-02-01

    Three hundred and thirteen patients with UICC T-1 N-0 M-0 prostate cancer were treated with external beam irradiation in 1973 and 1974 or in 1978, and their outcome determined 3-10 years after treatment. Survival over the first 5 years was comparable to that expected for a group of age matched normal males (77% vs. 81%), but during the second 5-year interval, there was a decrease in survival below that expected (51% vs 62%), a reflection of death in patients who developed metastasis as a first recurrence (18%). Overall, 72% of patients were free of any recurrence at 5 years and, 88% free of infield recurrence. The development of metastatic recurrence was significantly related to grade; at 5 years 87% of grade I, 79% of grade II and 69% of grade III patients were free of metastasis. There was a trend for increased local recurrence with increasing grade, but it was not statistically significant. There was a dose/response relation for complications, and radiation doses above 6500 cGy are associated with an increase in complication from 6% to 11% (p = .09). Complications requiring hospitalization for evaluation or management occurred in 30 (10%) of 313 patients. There were no deaths from complications and less than 2% of patients required surgical correction of complications. External beam radiation offers the patient with early prostate cancer a favorable opportunity for cure without the morbidity of impotence, incontinence, and occasional death experienced following LND and radical prostatectomy. Lymph node dissection does not seem necessary for most patients with T-1 prostate cancer as the positive yield in those with Grades I and II cancers is less than the complications of the procedure, and extensive involvement can be detected by non-invasive means. 29 references.

  3. Randomized Phase II Study of Docetaxel plus Personalized Peptide Vaccination versus Docetaxel plus Placebo for Patients with Previously Treated Advanced Wild Type EGFR Non-Small-Cell Lung Cancer.

    PubMed

    Takayama, Koichi; Sugawara, Shunichi; Saijo, Yasuo; Maemondo, Makoto; Sato, Atsushi; Takamori, Shinzo; Harada, Taishi; Sasada, Tetsuro; Kakuma, Tatsuyuki; Kishimoto, Junji; Yamada, Akira; Noguchi, Masanori; Itoh, Kyogo; Nakanishi, Yoichi

    2016-01-01

    Objectives. To evaluate the efficacy and safety of personalized peptide vaccination (PPV) combined with chemotherapy for patients with previously treated advanced non-small-cell lung cancer (NSCLC). Patients and Methods. Previously treated PS0-1 patients with IIIB/IV EGFR (epidermal growth factor receptor) wild genotype NSCLC were randomly assigned to docetaxel (60 mg/m(2) on Day 1) plus PPV based on preexisting host immunity or docetaxel plus placebo. Docetaxel administration was repeated every 3 weeks until disease progression. Personalized peptides or placebo was injected subcutaneously weekly in the first 8 weeks and biweekly in subsequent 16 weeks. The primary efficacy endpoint was progression-free survival (PFS). Results. PPV related toxicity was grade 2 or less skin reaction. The median PFS for placebo arm and PPV arm was 52 days and 59 days, respectively. There was no significant difference between two arms by log-rank test (p = 0.42). Interestingly, PFS and overall survival (OS) in humoral immunological responder were significantly longer than those in nonresponder. Conclusion. PPV did not improve the survival in combination with docetaxel for previously treated advanced NSCLC. However, PPV may be efficacious for the humoral immunological responders and a further clinical investigation is needed. PMID:27274999

  4. Inter- and Intrafraction Target Motion in Highly Focused Single Vocal Cord Irradiation of T1a Larynx Cancer Patients

    SciTech Connect

    Kwa, Stefan L.S. Al-Mamgani, Abrahim; Osman, Sarah O.S.; Gangsaas, Anne; Levendag, Peter C.; Heijmen, Ben J.M.

    2015-09-01

    Purpose: The purpose of this study was to verify clinical target volume–planning target volume (CTV-PTV) margins in single vocal cord irradiation (SVCI) of T1a larynx tumors and characterize inter- and intrafraction target motion. Methods and Materials: For 42 patients, a single vocal cord was irradiated using intensity modulated radiation therapy at a total dose of 58.1 Gy (16 fractions × 3.63 Gy). A daily cone beam computed tomography (CBCT) scan was performed to online correct the setup of the thyroid cartilage after patient positioning with in-room lasers (interfraction motion correction). To monitor intrafraction motion, CBCT scans were also acquired just after patient repositioning and after dose delivery. A mixed online-offline setup correction protocol (“O2 protocol”) was designed to compensate for both inter- and intrafraction motion. Results: Observed interfraction, systematic (Σ), and random (σ) setup errors in left-right (LR), craniocaudal (CC), and anteroposterior (AP) directions were 0.9, 2.0, and 1.1 mm and 1.0, 1.6, and 1.0 mm, respectively. After correction of these errors, the following intrafraction movements derived from the CBCT acquired after dose delivery were: Σ = 0.4, 1.3, and 0.7 mm, and σ = 0.8, 1.4, and 0.8 mm. More than half of the patients showed a systematic non-zero intrafraction shift in target position, (ie, the mean intrafraction displacement over the treatment fractions was statistically significantly different from zero; P<.05). With the applied CTV-PTV margins (for most patients 3, 5, and 3 mm in LR, CC, and AP directions, respectively), the minimum CTV dose, estimated from the target displacements observed in the last CBCT, was at least 94% of the prescribed dose for all patients and more than 98% for most patients (37 of 42). The proposed O2 protocol could effectively reduce the systematic intrafraction errors observed after dose delivery to almost zero (Σ = 0.1, 0.2, 0.2 mm). Conclusions: With

  5. Hyperfractionated Accelerated Radiotherapy for Rectal Cancer in Patients With Prior Pelvic Irradiation

    SciTech Connect

    Das, Prajnan; Delclos, Marc E.; Skibber, John M.; Rodriguez-Bigas, Miguel A.; Feig, Barry W.; Chang, George J.; Eng, Cathy; Bedi, Manpreet; Krishnan, Sunil; Crane, Christopher H.

    2010-05-01

    Purpose: To retrospectively determine rates of toxicity, freedom from local progression, and survival in rectal cancer patients treated with reirradiation. Methods and Materials: Between February 2001 and February 2005, 50 patients with a history of pelvic radiotherapy were treated with hyperfractionated accelerated radiotherapy for primary (n = 2 patients) or recurrent (n = 48 patients) rectal adenocarcinoma. Patients were treated with 150-cGy fractions twice daily, with a total dose of 39 Gy (n = 47 patients) if the retreatment interval was >=1 year or 30 Gy (n = 3) if the retreatment interval was <1 year. Concurrent chemotherapy was administered to 48 (96%) patients. Eighteen (36%) patients underwent surgical resection following radiotherapy. Results: Two patients had grade 3 acute toxicity and 13 patients had grade 3 to 4 late toxicity. The 3-year rate of grade 3 to 4 late toxicity was 35%. The 3-year rate of freedom from local progression was 33%. The 3-year freedom from local progression rate was 47% in patients undergoing surgery and 21% in those not undergoing surgery (p = 0.057). The 3-year overall survival rate was 39%. The 3-year overall survival rate was 66% in patients undergoing surgery and 27% in those not undergoing surgery (p = 0.003). The 3-year overall survival rate was 53% in patients with a retreatment interval of >2 years and 21% in those with a retreatment interval of <=2 years (p = 0.001). Conclusions: Hyperfractionated, accelerated reirradiation was well tolerated, with low rates of acute toxicity and moderate rates of late toxicity. Reirradiation may help improve pelvic control in rectal cancer patients with a history of pelvic radiotherapy.

  6. Screening, detecting and enhancing the yield of previously undiagnosed hepatitis B and C in patients with acute medical admissions to hospital: A pilot project undertaken at the Vancouver General Hospital

    PubMed Central

    Kapeluto, Jordanna E; Kadatz, Matthew; Wormsbecker, Andrew; Sidhu, Kiran; Yoshida, Eric M

    2014-01-01

    BACKGROUND: Hepatitis B virus (HBV) and hepatitis C virus (HCV) represent an increasing health burden and morbidity in Canada. Viral hepatitis, specifically HCV, has high prevalence among persons born between 1945 and 1965, with 45% to 85% of infected adults asymptomatic and unaware of their infection. Screening has been shown to be cost effective in the detection and treatment of viral hepatitis. OBJECTIVE: To quantify incidence and identify undocumented HBV and HCV infection in hospitalized patients at a single centre with secondary analysis of risk factors as part of a quality improvement initiative. METHODS: A one-time antibody test was conducted in patients admitted to the acute medicine and gastroenterology services. RESULTS: Over a 12-week period, hospital screening for HBV and HCV was performed in 37.3% of 995 admitted patients. There was identification of 15 previously undiagnosed cases of HCV (4%) and 36 undocumented cases of occult (ie, antihepatitis B core antigen seropositive) or active (ie, hepatitis B surface antigen seropositive) HBV (9.7%). Among patients with positive screens, 60% of seropositive HCV patients had no identifiable risk factors. CONCLUSIONS: The prevalence of HBV and HCV infection among hospitalized patients in Vancouver was higher than that of the general population. Risk factors for contraction are often not identified. These results can be used as part of an ongoing discussion regarding a ‘seek and treat’ approach to the detection and treatment of chronic blood-borne viral illnesses. PMID:24945186

  7. The Ability of Lumbar Spine DXA and Phalanx QUS to Detect Previous Fractures in Young Thalassemic Patients With Hypogonadism, Hypothyroidism, Diabetes, and Hepatitis-B: A 2-Year Subgroup Analysis From the Taranto Area of Apulia Region

    PubMed Central

    Neglia, Cosimo; Peluso, Angelo; di Rosa, Salvatore; Ferrarese, Antonio; Di Tanna, Gianluca; Caiaffa, Vincenzo; Benvenuto, Marco; Cozma, Alexandru; Chitano, Giovanna; Agnello, Nadia; Paladini, Daniele; Baldi, Nicola; Distante, Alessandro; Piscitelli, Prisco

    2013-01-01

    Background: Osteoporosis is a leading cause of morbidity in patients affected by β-thalassemia major or intermediate; we aimed to assess the association between demineralization observed in young thalassemic patients. Methods: A total of 88 patients with β-thalassemia were recruited at Microcitemia Center of Taranto Hospital under the Prevention Osteoporosis and Fractures research project from 2008 to 2010. All the patients were screened with both dual energy x-ray absorptiometry (DXA) and quantitative ultrasound (QUS). T score and Z score values were obtained for each subject. Results: The overall prevalence of demineralization was 84% with DXA and 70% with QUS, whereas normality was found in 16% of patients screened with DXA and in 30% of cases with QUS. Hypogonadism, hypothyroidism, diabetes mellitus, hepatitis-B, and the presence of previous fragility fractures were significantly associated with the demineralization status (lower T scores values) both with DXA and QUS. Conclusion: Our data confirm that DXA and QUS examinations are both useful for detecting bone demineralization in thalassemic patients. PMID:23652868

  8. Carcinoma of the base of the tongue: results of radical irradiation with surgery reserved for irradiation failure

    SciTech Connect

    Parsons, J.T.; Million, R.R.; Cassisi, N.J.

    1982-06-01

    Between 1964 and 1977, 95 previously untreated patients with squamous cell carcinoma of the base of the tongue received treatment with curative intent at the University of Florida. Eighty-six of the 95 patients (91%) had Stage III or IV disease at presentation. Eighty-nine patients received radical courses of irradiation to the primary with or without neck dissection(s), with surgery reserved for salvage of irradiation failure. Six patients underwent planned combined treatment of the primary lesion. Of the 89 patients whose primary lesions were radically irradiated, failure at the primary site occurred in 24% of those with T1-3 lesions and 78% with T4 lesions. Control results were related to irradiation treatment technique. None of the 9 patients with Stage I-II disease died of the cancer. Actuarial survival at 5 years for Stage III patients was 46%. Within the Stage IV population there is a subgroup of patients with highly treatable and curable disease. The addition of a neck dissection following irradiation of N2-N3 neck disease decreased the incidence of failure in the neck. No patient developed severe soft tissue necrosis or required mandibulectomy for bone exposure following irradiation.

  9. The effect of carvedilol in patients with impaired left ventricular systolic function following an acute myocardial infarction. How do the treatment effects on total mortality and recurrent myocardial infarction in CAPRICORN compare with previous beta-blocker trials?

    PubMed

    Otterstad, Jan Erik; Ford, Ian

    2002-08-01

    In previous beta-blocker trials, post-myocardial infarction (MI) patients were essentially treated with a beta-blocker or placebo. In the CAPRICORN trial, patients were selected on the basis of a left ventricular (LV) ejection fraction (EF) <40% following the index MI and randomised to carvedilol or placebo, in addition to modern secondary prophylaxis with ACE inhibitors, aspirin and statins. In 1959 patients with a mean LVEF of 33%, treatment with carvedilol over a mean follow-up period of 15 months reduced total mortality from 15.3% with placebo to 11.9% with carvedilol [relative risk reduction (RRR) =23%, absolute risk reduction (ARR) =3.4%]. The incidence of recurrent MI was reduced from 5.8 to 2.3% (RRR 41%, ARR 2.3%). The number needed to treat (NNT) to prevent one death was 28 for the entire study period and 43 for 1 year of treatment. The results of the CAPRICORN trial are compared with three previous beta-blocker post-MI trials: the Gothenburg metoprolol trial (GMT), the Norwegian timolol trial (NTT) and the beta-blocker heart attack trial (BHAT). The RRRs for total mortality were 36% in the GMT and NTT, and 27% in BHAT. The respective NNTs for total mortality were 32, 18 and 38. NNT for 1 year of treatment was 25 in NTT and 80 in BHAT. The RRR for recurrent MIs were 28% in NTT and 16% in BHAT. The reduction of mortality and recurrent MIs in CAPRICORN is within the range of previous post-MI beta-blocker studies. In post-MI patients with LVEF<40%, add-on treatment with a beta-blocker should be given >48 h after initiation with an angiotensin-converting enzyme inhibitor (ACEI) and then with a slow dose escalation as applied in CAPRICORN.

  10. Dose Escalation of Total Marrow Irradiation With Concurrent Chemotherapy in Patients With Advanced Acute Leukemia Undergoing Allogeneic Hematopoietic Cell Transplantation

    SciTech Connect

    Wong, Jeffrey Y.C.; Forman, Stephen; Somlo, George; Liu An; Schultheiss, Timothy; Radany, Eric; Palmer, Joycelynne; Stein, Anthony

    2013-01-01

    Purpose: We have demonstrated that toxicities are acceptable with total marrow irradiation (TMI) at 16 Gy without chemotherapy or TMI at 12 Gy and the reduced intensity regimen of fludarabine/melphalan in patients undergoing hematopoietic cell transplantation (HCT). This article reports results of a study of TMI combined with higher intensity chemotherapy regimens in 2 phase I trials in patients with advanced acute myelogenous leukemia or acute lymphoblastic leukemia (AML/ALL) who would do poorly on standard intent-to-cure HCT regimens. Methods and Materials: Trial 1 consisted of TMI on Days -10 to -6, etoposide (VP16) on Day -5 (60 mg/kg), and cyclophosphamide (CY) on Day -3 (100 mg/kg). TMI dose was 12 (n=3 patients), 13.5 (n=3 patients), and 15 (n=6 patients) Gy at 1.5 Gy twice daily. Trial 2 consisted of busulfan (BU) on Days -12 to -8 (800 {mu}M min), TMI on Days -8 to -4, and VP16 on Day -3 (30 mg/kg). TMI dose was 12 (n=18) and 13.5 (n=2) Gy at 1.5 Gy twice daily. Results: Trial 1 had 12 patients with a median age of 33 years. Six patients had induction failures (IF), and 6 had first relapses (1RL), 9 with leukemia blast involvement of bone marrow ranging from 10%-98%, 5 with circulating blasts (24%-85%), and 2 with chloromas. No dose-limiting toxicities were observed. Eleven patients achieved complete remission at Day 30. With a median follow-up of 14.75 months, 5 patients remained in complete remission from 13.5-37.7 months. Trial 2 had 20 patients with a median age of 41 years. Thirteen patients had IF, and 5 had 1RL, 2 in second relapse, 19 with marrow blasts (3%-100%) and 13 with peripheral blasts (6%-63%). Grade 4 dose-limiting toxicities were seen at 13.5 Gy (stomatitis and hepatotoxicity). Stomatitis was the most frequent toxicity in both trials. Conclusions: TMI dose escalation to 15 Gy is possible when combined with CY/VP16 and is associated with acceptable toxicities and encouraging outcomes. TMI dose escalation is not possible with BU/VP16 due to

  11. Hyperparathyroidism After Irradiation for Childhood Malignancy

    SciTech Connect

    McMullen, Todd; Bodie, Greg; Gill, Anthony; Ihre-Lundgren, Catharina; Shun, Albert; Bergin, Mary; Stevens, Graham; Delbridge, Leigh

    2009-03-15

    Purpose: To examine the occurrence of hyperparathyroidism in a cohort of patients undergoing combined parathyroid and thyroid surgery after previous head-and-neck irradiation for childhood malignancy. Methods and Materials: This is a retrospective cohort study for the years 1996 to 2007. The study group comprised patients undergoing surgery in University of Sydney Endocrine Surgical Unit who had received previous head-and-neck irradiation in childhood and who were identified as having pathologic thyroid and parathyroid characteristics. Results: A total of 53 patients were identified in whom head-and-neck irradiation for the treatment of childhood malignancy had been documented. In each of the cases, thyroid disease was the primary reason for referral for surgery. Five of these patients (10%) were found to exhibit coexisting hyperparathyroidism. The latency period for hyperparathyroidism was less than 20 years in 4 of the 5 cases. There were four conventional parathyroid adenomas and one parathyroid lipoadenoma. All patients exhibited a significant decrease in postoperative calcium levels after surgery. Conclusions: To our knowledge, this is the first study to document the significant risk of hyperparathyroidism after radiation exposure for childhood malignancy. The timeframe for development of disease is much shorter than that published for individuals who have undergone irradiation for benign diseases. High doses of therapeutic radiation at a young age make childhood survivors of malignancy at especially high risk for developing hyperparathyroidism.

  12. Primary angioplasty vs. fibrinolysis in very old patients with acute myocardial infarction: TRIANA (TRatamiento del Infarto Agudo de miocardio eN Ancianos) randomized trial and pooled analysis with previous studies

    PubMed Central

    Bueno, Héctor; Betriu, Amadeo; Heras, Magda; Alonso, Joaquín J.; Cequier, Angel; García, Eulogio J.; López-Sendón, José L.; Macaya, Carlos; Hernández-Antolín, Rosana; Bueno, Héctor; Hernández-Antolín, Rosana; Alonso, Joaquín J.; Betriu, Amadeo; Cequier, Angel; García, Eulogio J.; Heras, Magda; López-Sendón, José L.; Macaya, Carlos; Azpitarte, José; Sanz, Ginés; Chamorro, Angel; López-Palop, Ramón; Sionis, Alex; Arós, Fernando; García-Fernández, Eulogio; Rubio, Rafael; Hernández, Felipe; Tascón, Juan Carlos; Moreu, José; Betriu, Amadeu; Heras, Magda; Hernández-Antolín, Rosana; Fernández-Ortiz, Antonio; Morís, César; de Posada, Ignacio Sánchez; Cequier, Ángel; Esplugas, Enrique; Melgares, Rafael; Bosa, Francisco; García-González, Martín Jesús; Lezáun, Román; Carmona, José Ramón; Vázquez, José Manuel; Castro-Beiras, Alfonso; Picart, Joan García; de Rozas, José Domínguez; Fernández, José Díaz; Vázquez, Felipe Fernández; Alonso, Norberto; Zueco, José Javier; San José, José María; San Román, Alberto; Hernández, Carolina; García, José María Hernández; Alcántara, Ángel García; Bethencourt, Armando; Fiol, Miquel; Mancisidor, Xabier; Mancisidor, Xabier; Ruiz, Rafael; Hidalgo, Rafael; Sobrino, Nicolás; Maqueda, Isidoro González; Torres, Alfonso; Arós, Fernando; Amaro, Antonio; Jaquet, Michel

    2011-01-01

    Aims To compare primary percutaneous coronary intervention (pPCI) and fibrinolysis in very old patients with ST-segment elevation myocardial infarction (STEMI), in whom head-to-head comparisons between both strategies are scarce. Methods and results Patients ≥75 years old with STEMI <6 h were randomized to pPCI or fibrinolysis. The primary endpoint was a composite of all-cause mortality, re-infarction, or disabling stroke at 30 days. The trial was prematurely stopped due to slow recruitment after enroling 266 patients (134 allocated to pPCI and 132 to fibrinolysis). Both groups were well balanced in baseline characteristics. Mean age was 81 years. The primary endpoint was reached in 25 patients in the pPCI group (18.9%) and 34 (25.4%) in the fibrinolysis arm [odds ratio (OR), 0.69; 95% confidence interval (CI) 0.38–1.23; P = 0.21]. Similarly, non-significant reductions were found in death (13.6 vs. 17.2%, P = 0.43), re-infarction (5.3 vs. 8.2%, P = 0.35), or disabling stroke (0.8 vs. 3.0%, P = 0.18). Recurrent ischaemia was less common in pPCI-treated patients (0.8 vs. 9.7%, P< 0.001). No differences were found in major bleeds. A pooled analysis with the two previous reperfusion trials performed in older patients showed an advantage of pPCI over fibrinolysis in reducing death, re-infarction, or stroke at 30 days (OR, 0.64; 95% CI 0.45–0.91). Conclusion Primary PCI seems to be the best reperfusion therapy for STEMI even for the oldest patients. Early contemporary fibrinolytic therapy may be a safe alternative to pPCI in the elderly when this is not available. Clinicaltrials.gov # NCT00257309. PMID:20971744

  13. Comparison of risk of radiogenic second cancer following photon and proton craniospinal irradiation for a pediatric medulloblastoma patient

    NASA Astrophysics Data System (ADS)

    Zhang, Rui; Howell, Rebecca M.; Giebeler, Annelise; Taddei, Phillip J.; Mahajan, Anita; Newhauser, Wayne D.

    2013-02-01

    Pediatric patients who received radiation therapy are at risk of developing side effects such as radiogenic second cancer. We compared proton and photon therapies in terms of the predicted risk of second cancers for a 4 year old medulloblastoma patient receiving craniospinal irradiation (CSI). Two CSI treatment plans with 23.4 Gy or Gy (RBE) prescribed dose were computed: a three-field 6 MV photon therapy plan and a four-field proton therapy plan. The primary doses for both plans were determined using a commercial treatment planning system. Stray radiation doses for proton therapy were determined from Monte Carlo simulations, and stray radiation doses for photon therapy were determined from measured data. Dose-risk models based on the Biological Effects of Ionization Radiation VII report were used to estimate the risk of second cancer in eight tissues/organs. Baseline predictions of the relative risk for each organ were always less for proton CSI than for photon CSI at all attained ages. The total lifetime attributable risk of the incidence of second cancer considered after proton CSI was much lower than that after photon CSI, and the ratio of lifetime risk was 0.18. Uncertainty analysis revealed that the qualitative findings of this study were insensitive to any plausible changes of dose-risk models and mean radiation weighting factor for neutrons. Proton therapy confers lower predicted risk of second cancer than photon therapy for the pediatric medulloblastoma patient.

  14. Enhanced membrane binding of autoantibodies to cultured keratinocytes of systemic lupus erythematosus patients after ultraviolet B/ultraviolet A irradiation.

    PubMed Central

    Golan, T D; Elkon, K B; Gharavi, A E; Krueger, J G

    1992-01-01

    Although sunlight is known to induce skin lesions in patients with systemic lupus erythematosus (SLE) and to exacerbate systemic manifestations, the underlying mechanisms remain obscure. We report experiments that show enhanced binding of IgG autoantibodies to the cell surface membrane of ultraviolet-B (UVB) irradiated (200-1,600 J/m2) cultured SLE keratinocytes in 10 out of 12 such cell strains. The autoantibody probes showing increased binding were directed against the soluble intracellular antigens, Sm, RNP, SSA/Ro, SSB/La, whereas serum with anti-dsDNA activity did not demonstrate such binding. Control keratinocytes from several sources shared low level binding of autoantibodies after ultraviolet light exposure. In addition, 4/6 UVB-sensitive SLE strains showed increased autoantibody binding to the surface of SLE keratinocytes after UVA exposure (50-150 kJ/m2), but of lower magnitude. When UVB-sensitive nonirradiated SLE strains were exposed to autologous serum, 3/8 sera demonstrated a striking increase in IgG binding, which increased further after UVB exposure. Enhanced expression of saline-soluble intracellular antigens on the cell surface membrane of patient, but not control, keratinocytes may, in part, explain the photosensitivity of patients with SLE. Images PMID:1522215

  15. Comparison of risk of radiogenic second cancer following photon and proton craniospinal irradiation for a pediatric medulloblastoma patient

    PubMed Central

    Zhang, Rui; Howell, Rebecca M; Giebeler, Annelise; Taddei, Phillip J; Mahajan, Anita; Newhauser, Wayne D

    2013-01-01

    Pediatric patients who received radiation therapy are at risk of developing side effects like radiogenic second cancer. We compared proton and photon therapies in terms of the predicted risk of second cancers for a 4-year-old medulloblastoma patient receiving craniospinal irradiation (CSI). Two CSI treatment plans with 23.4 Gy or Gy (RBE) prescribed dose were computed: a three-field 6-MV photon therapy plan and a four-field proton therapy plan. The primary doses for both plans were determined using a commercial treatment planning system. Stray radiation doses for proton therapy were determined from Monte Carlo simulations, and stray radiation doses for photon therapy were determined from measured data. Dose-risk models based on the Biological Effects of Ionization Radiation VII report were used to estimate risk of second cancer in eight tissues/organs. Baseline predictions of the relative risk for each organ were always less for proton CSI than for photon CSI at all attained ages. The total lifetime attributable risks of the incidence of second cancer considered after proton CSI and photon CSI were 7.7% and 92%, respectively, and the ratio of lifetime risk was 0.083. Uncertainty analysis revealed that the qualitative findings of this study were insensitive to any plausible changes of dose-risk models and mean radiation weighting factor for neutrons. Proton therapy confers lower predicted risk of second cancer than photon therapy for the pediatric medulloblastoma patient. PMID:23322160

  16. Impact of Incidental Irradiation on Clinically Uninvolved Nodal Regions in Patients With Advanced Non-Small-Cell Lung Cancer Treated With Involved-Field Radiation Therapy: Does Incidental Irradiation Contribute to the Low Incidence of Elective Nodal Failure?

    SciTech Connect

    Kimura, Tomoki; Togami, Taro; Nishiyama, Yoshihiro; Ohkawa, Motoomi; Takashima, Hitoshi

    2010-06-01

    Purpose: To evaluate the incidental irradiation dose to elective nodal regions in the treatment of advanced non-small-cell lung cancer with involved-field radiation therapy (IF-RT) and the pattern of elective nodal failure (ENF). Methods and Materials: Fifty patients with advanced non-small-cell lung cancer, who received IF-RT at Kagawa University were enrolled. To evaluate the dose of incidental irradiation, we delineated nodal regions with a Japanese map and the American Thoracic Society map (levels 1-11) in each patient retrospectively and calculated the dose parameters such as mean dose, D95, and V95 (40 Gy as the prescribed dose of elective nodal irradiation). Results: Using the Japanese map, the median mean dose was more than 40 Gy in most of the nodal regions, except at levels 1, 3, and 7. In particular, each dosimetric parameter of level 1 was significantly lower than those at other levels, and each dosimetric parameter of levels 10 to 11 ipsilateral (11I) was significantly higher than those in other nodal regions. Using the American Thoracic Society map, basically, the results were similar to those of the Japanese map. ENF was observed in 4 patients (8%), five nodal regions, and no mean dose to the nodal region exceeded 40 Gy. On the Japanese map, each parameter of these five nodal region was significantly lower than those of the other nodal regions. Conclusions: These results show that a high dose of incidental irradiation may contribute to the low incidence of ENF in patients who have received IF-RT.

  17. Tolerance and dose-volume relationship of intrathoracic stomach irradiation after esophagectomy for patients with thoracic esophageal squamous cell carcinoma

    PubMed Central

    Fu, Xiao-Long; Chen, Jun-Chao; Xiang, Jia-Qing

    2015-01-01

    Purpose To identify the tolerance of radiation with a high prescribed dose and predictors for the development of intrathoracic stomach toxicity in patients with thoracic esophageal squamous cell carcinoma (SCC) after esophagectomy followed by gastric conduit reconstruction. Methods and Materials From 2011 to 2013, 105 patients after esophagectomy were treated with postoperative radiotherapy. The intrathoracic stomach was outlined with the calculation of a dose-volume histogram (DVH) for the initial intended treatment of 6020 cGy or 6300 cGy. The volume of the intrathoracic stomach receiving each dose was recorded at 10-Gy intervals between 10 and 40 Gy and at 5-Gy intervals between 40 and 60 Gy. The grade of toxicities was defined by the National Cancer Institute Common Toxicity Criteria version 4.0. Results The mean and maximum doses of the intrathoracic stomach were 2449 ± 986 cGy and 6519 ± 406 cGy, respectively. Sixteen (15.2%) and three (2.9%) experienced Common Toxicity Criteria Grade 2 and Grade 3 acute gastric toxicity. There were no Grade 4 toxicities. Fourteen patients (13.3%) exhibited late gastric complications possibly related to radiation. The volume percent of the intrathoracic stomach receiving at least 50 Gy (V50) was strongly associated with the degree of toxicity (p = 0.024, respectively). Multivariate analysis of patient and treatment-related factors revealed no other significant predictors of severe toxicities. Conclusions The intrathoracic stomach is well tolerated with a high-dose irradiation for patients with esophageal SCC receiving radiotherapy after esophagectomy. A strong dose-volume relationship exists for the development of Grade 2 acute intrathoracic stomach toxicity in our study. PMID:26314958

  18. Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma†

    PubMed Central

    Al-Batran, S.-E.; Van Cutsem, E.; Oh, S. C.; Bodoky, G.; Shimada, Y.; Hironaka, S.; Sugimoto, N.; Lipatov, O. N.; Kim, T.-Y.; Cunningham, D.; Rougier, P.; Muro, K.; Liepa, A. M.; Chandrawansa, K.; Emig, M.; Ohtsu, A.; Wilke, H.

    2016-01-01

    Background The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine–platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. Patients and methods Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m2) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. Results Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR < 1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. Conclusion In patients with previously treated advanced gastric

  19. Determining Which Patients Require Irradiation of the Supraclavicular Nodal Area After Surgery for N1 Breast Cancer

    SciTech Connect

    Yu, Jeong Il; Park, Won; Huh, Seung Jae; Choi, Doo Ho; Lim, Young Hyuk; Ahn, Jin Suk; Yang, Jung Hyun; Nam, Suk Jin

    2010-11-15

    Purpose: We designed this study to determine which patients have a high risk of supraclavicular node recurrence in N1 breast cancer previously treated with surgery but not having received supraclavicular radiation therapy (SCRT) and to identify which patients needed SCRT. Methods and Materials: We performed a retrospective review of 448 pathologic N1 breast cancer patients treated with mastectomy or breast-conserving treatment, but without SCRT, between 1994 and 2003. Mastectomy was performed in 302 patients (67.4%). The median number of axillary nodes dissected was 17 (range, 5-53). Systemic chemotherapy was administered in 443 patients (98.9%), and 144 patients received radiation after breast-conserving surgery. The median follow-up was 88 months (range, 15-170 months). Results: At follow-up, the treatment failed in 101 patients (22.5%), and 39 patients (8.7%) had supraclavicular node recurrence. Prognostic factors in supraclavicular node recurrence included lymphovascular invasion (p < 0.0001), extracapsular extension (p < 0.0001), the number of involved axillary nodes (p = 0.0003), and the level of involved axillary nodes (p = 0.012) in univariate and multivariate analyses. The total number of prognostic factors correlated well with supraclavicular node recurrence. In the analysis of 5-year supraclavicular node recurrence-free survival, patients with two or more factors showed a significantly higher recurrence rate than did patients with fewer than two factors (96.8% and 72.9%, respectively; p < 0.0001). Conclusions: The prognostic factors associated with supraclavicular node recurrence were lymphovascular invasion, extracapsular extension, and the number and level of involved axillary nodes. Patients with two or more prognostic factors might benefit from SCRT.

  20. Role of irradiation for patients over 80 years old with glioblastoma: a retrospective cohort study.

    PubMed

    Bracci, Stefano; Laigle-Donadey, Florence; Hitchcock, Kathryn; Duran-Peña, Alberto; Navarro, Soledad; Chevalier, Antoine; Jacob, Julian; Troussier, Idriss; Delattre, Jean-Yves; Mazeron, Jean-Jacques; Hoang-Xuan, Khê; Feuvret, Loïc

    2016-09-01

    To assess efficacy and safety of hypofractionated radiation therapy (HRT) in patients over 80 years old with newly diagnosed glioblastoma (GBM). Between June 2009 and September 2015, patients in this population with a recommendation for radiation therapy from a multidisciplinary tumor board, and a Karnofsky performance status (KPS) ≥60 as assessed by a radiation oncologist, who received HRT (40 Gy/15 fractions) ± concomitant and adjuvant temozolomide (TMZ) were retrospectively analyzed. A total of 21 patients fulfilled the criteria for eligibility. Median KPS was 80 (60-90). After a median follow-up of 5.8 months (IQR 3.7-13.1 months), median overall survival (OS) was 7.5 months (95 % CI 4.5-19.1) and the 1-year and 2-year OS were 39.5 % (95 % CI 21.9-71.2 %) and 6.6 % (95 % CI 1.0- 43.3 %), respectively. Median progression-free survival (PFS) was 5.8 months (95 % CI 3.9-7.7 months), 1-year and 2-year PFS were 15.2 % (95 % CI 4.4-52.4) and 0 %, respectively. Overall, 16 (76.2 %) patients presented a recurrence. Overall seven patients (33.3 %) needed to be hospitalized during treatment. On univariate analysis, hospitalization was the only variable that correlated with less favourable outcome in terms of both OS (12.2 months versus 3.8 months, p < 0.010) and PFS (5.8 months versus 3.4 months, p = 0.002). Our study suggests that HRT is feasible with acceptable tolerance among "very elderly" patients affected by GBM. Patients 80 and older should be considered for management based on RT.

  1. Prophylactic cranial irradiation for preventing brain metastases in patients undergoing radical treatment for non-small-cell lung cancer: A Cochrane Review

    SciTech Connect

    Lester, Jason Francis . E-mail: jason.lester@velindre-tr.wales.nhs.uk; MacBeth, Fergus R.; Coles, Bernadette

    2005-11-01

    Purpose: To investigate whether prophylactic cranial irradiation (PCI) has a role in the management of patients with non-small-cell lung cancer (NSCLC) treated with curative intent. Methods and Materials: A search strategy was designed to identify randomized controlled trials (RCTs) comparing PCI with no PCI in NSCLC patients treated with curative intent. The electronic databases MEDLINE, EMBASE, LILACS, and Cancerlit were searched, along with relevant journals, books, and review articles to identify potentially eligible trials. Four RCTs were identified and reviewed. A total of 951 patients were randomized in these RCTs, of whom 833 were evaluable and reported. Forty-two patients with small-cell lung cancer were excluded, leaving 791 patients in total. Because of the small patient numbers and trial heterogeneity, no meta-analysis was attempted. Results: Prophylactic cranial irradiation did significantly reduce the incidence of brain metastases in three trials. No trial reported a survival advantage with PCI over observation. Toxicity data were poorly collected and no quality of life assessments were carried out in any trial. Conclusion: Prophylactic cranial irradiation may reduce the incidence of brain metastases, but there is no evidence of a survival benefit. It was not possible to evaluate whether any radiotherapy regimen is superior, and the effect of PCI on quality of life is not known. There is insufficient evidence to support the use of PCI in clinical practice. Where possible, patients should be offered entry into a clinical trial.

  2. [Variations of HBD-2 and TLR-2 gene expression in patients presenting with lichen ruber planus under effect of ultraviolet irradiation].

    PubMed

    Shakhnovich, A A; Kruglova, L S

    2011-01-01

    The combination of narrow-band range UV-A (311 nm) and middle/broad-band UV-B (320-400 nm) irradiation was shown to significantly reduce manifestations of objective and subjective symptoms in the patients presenting with lichen ruber planus. Moreover, it promoted elimination ofdisbalance between characteristics of congenital immunity and normalization of HBD-2 and TLR-2 gene expression.

  3. An open-label phase 2 trial of dabrafenib plus trametinib in patients with previously treated BRAF V600E–mutant metastatic non-small cell lung cancer

    PubMed Central

    Planchard, David; Besse, Benjamin; Groen, Harry J M; Souquet, Pierre-Jean; Quoix, Elisabeth; Baik, Christina S; Barlesi, Fabrice; Kim, Tae Min; Mazieres, Julien; Novello, Silvia; Rigas, James R; Upalawanna, Allison; D’Amelio, Anthony M; Zhang, Pingkuan; Mookerjee, Bijoyesh; Johnson, Bruce E

    2016-01-01

    Background BRAF mutations act as an oncogenic driver via the mitogen-activated protein kinase (MAPK) pathway in non-small cell lung cancer (NSCLC). BRAF inhibition has demonstrated antitumor activity in patients with BRAF V600E (Val600Glu)–mutant NSCLC. Dual MAPK pathway inhibition with BRAF and MEK inhibitors in BRAF V600E–mutant NSCLC may improve efficacy over BRAF-inhibitor monotherapy based on observations in BRAF V600–mutant melanoma. Methods In this phase 2, multicenter, nonrandomized, open-label study of patients with pretreated metastatic BRAF V600E–mutant NSCLC, antitumor activity and safety of oral dabrafenib (150 mg twice daily) plus oral trametinib (2 mg once daily) were evaluated. Adult patients (≥ 18 years) with documented progression following at least one prior platinum-based chemotherapy and no more than three prior systemic anticancer therapies were enrolled. Patients with prior BRAF or MEK inhibitor treatment were ineligible. Patients with brain metastases were permitted to enroll only if the lesions were asymptomatic, untreated (or stable > 3 weeks after local therapy if treated), and measured < 1 cm. The primary endpoint was investigator-assessed overall response, which was assessed by intention-to-treat in the protocol-defined population (≥ second-line); safety was also assessed in this population. The study is ongoing but no longer recruiting patients. This trial is registered with ClinicalTrials.gov, number NCT01336634. Findings Fifty-seven patients previously treated with systemic chemotherapy for metastatic BRAF V600E–mutant NSCLC were enrolled. The investigator-assessed overall response was 63·2% (36 of 57; 95% CI 49·3–75·6). Serious adverse events were reported in 32 (56%) of 57 patients and included pyrexia (16%; 9 of 57), anemia (5%; 3 of 57), confusional state (4%; 2 of 57), decreased appetite (4%; 2 of 57), hemoptysis (4%; 2 of 57), hypercalcemia (4%; 2 of 57), nausea (4%; 2 of 57), and cutaneous squamous cell

  4. Vaccination with Irradiated Autologous Melanoma Cells Engineered to Secrete Human Granulocyte--Macrophage Colony-Stimulating Factor Generates Potent Antitumor Immunity in Patients with Metastatic Melanoma

    NASA Astrophysics Data System (ADS)

    Soiffer, Robert; Lynch, Thomas; Mihm, Martin; Jung, Ken; Rhuda, Catherine; Schmollinger, Jan C.; Hodi, F. Stephen; Liebster, Laura; Lam, Prudence; Mentzer, Steven; Singer, Samuel; Tanabe, Kenneth K.; Benedict Cosimi, A.; Duda, Rosemary; Sober, Arthur; Bhan, Atul; Daley, John; Neuberg, Donna; Parry, Gordon; Rokovich, Joseph; Richards, Laurie; Drayer, Jan; Berns, Anton; Clift, Shirley; Cohen, Lawrence K.; Mulligan, Richard C.; Dranoff, Glenn

    1998-10-01

    We conducted a Phase I clinical trial investigating the biologic activity of vaccination with irradiated autologous melanoma cells engineered to secrete human granulocyte--macrophage colony-stimulating factor in patients with metastatic melanoma. Immunization sites were intensely infiltrated with T lymphocytes, dendritic cells, macrophages, and eosinophils in all 21 evaluable patients. Although metastatic lesions resected before vaccination were minimally infiltrated with cells of the immune system in all patients, metastatic lesions resected after vaccination were densely infiltrated with T lymphocytes and plasma cells and showed extensive tumor destruction (at least 80%), fibrosis, and edema in 11 of 16 patients examined. Antimelanoma cytotoxic T cell and antibody responses were associated with tumor destruction. These results demonstrate that vaccination with irradiated autologous melanoma cells engineered to secrete granulocyte--macrophage colony-stimulating factor stimulates potent antitumor immunity in humans with metastatic melanoma.

  5. A Prospective Study of Salivary Gland Function in Lymphoma Patients Receiving Head and Neck Irradiation

    SciTech Connect

    Rodrigues, Neesha A.; Killion, Leah; Hickey, Gail; Silver, Barbara; Martin, Chrystalla; Stevenson, Mary Ann; Mauch, Peter M.; Ng, Andrea K.

    2009-11-15

    Purpose: To determine the radiation dose-response relationship on salivary dysfunction and quality of life (QOL) over time in patients with lymphoma receiving radiation therapy (RT) to the head and neck (H and N). Methods and Materials: We conducted a prospective study on salivary-gland function in lymphoma patients receiving RT to the H and N. Fifteen patients were enrolled on the study. Dose-volume histograms and mean doses to the salivary glands were generated. Radiation-related toxicities and H and N-specific QOL were assessed before treatment and at prespecified time points posttreatment. Factors predicting a decrement in QOL were explored using Fisher's exact test. Results: During RT, 47% of patients experienced Grade >= 2 acute toxicity of the salivary gland, mucous membrane, or both. QOL scores improved over time, but up to one third of patients continued to have persistent oral symptoms at 2 years. At 6 months, a mean dose to at least one of the parotids of > 31 Gy was significantly associated with persistent dry mouth (100% vs. 17%, p = 0.02) and sticky saliva (100% vs. 25%, p = 0.04); a mean dose of > 11 Gy to the minor salivary glands was significantly associated with persistent sticky saliva (100% vs. 25%, p = 0.04), although the difference was no longer significant at 1 year. Conclusions: Limiting the mean parotid dose to <= 31 Gy and mean minor salivary gland dose to <= 11 Gy in lymphoma patients treated to the H and N may help reduce the risk of subacute xerostomia.

  6. A Score Predicting Posttreatment Ambulatory Status in Patients Irradiated for Metastatic Spinal Cord Compression

    SciTech Connect

    Rades, Dirk Rudat, Volker; Veninga, Theo; Stalpers, Lukas J.A.; Basic, Hiba; Karstens, Johann H.; Hoskin, Peter J.; Schild, Steven E.

    2008-11-01

    Purpose: To create a scoring system to predict ambulatory status after radiotherapy (RT) for metastatic spinal cord compression (MSCC). Methods and Materials: On the basis of a multivariate analysis of 2096 MSCC patients, a scoring system was developed. This included the five prognostic factors significantly associated with post-RT ambulatory status: primary tumor type, interval between tumor diagnosis and MSCC, visceral metastases, motor function before RT, and time developing motor deficits before RT. The score for each factor was determined by dividing the post-RT ambulatory rate (as a percentage) by 10. Total scores represented the sum of the scores for each factor and ranged between 21 and 44 points. Patients were divided into five groups according to this score. Results: The post-RT ambulatory rates were 6% (24 of 389) for patients with scores of {<=}28 points, 44% (121 of 278) for those with 29-31 points, 70% (212 of 303) for those with 32-34 points, 86% (315 of 266) for those with 35-37 points, and 99% (750 of 760) for those with {>=}38 points. The 3-month survival rates were 29%, 62%, 77%, 84%, and 98%, respectively. The 6-months survival rates were 6%, 31%, 42%, 61%, and 93%, respectively. Conclusions: Because patients with scores of {<=}28 points had poor functional outcome after RT and extraordinarily poor survival rates, short-course RT to decrease pain or best supportive care may be considered. Patients with scores of 29-37 points should be considered surgical candidates, because RT-alone results were not optimal. Patients with scores of {>=}38 points seem to have excellent results with RT alone.

  7. Successful adalimumab treatment of a psoriasis vulgaris patient with hemodialysis for renal failure: A case report and a review of the previous reports on biologic treatments for psoriasis patients with hemodialysis for renal failure.

    PubMed

    Kusakari, Yoshiyuki; Yamasaki, Kenshi; Takahashi, Toshiya; Tsuchiyama, Kenichiro; Shimada-Omori, Ryoko; Nasu-Tamabuchi, Mei; Aiba, Setsuya

    2015-07-01

    The efficacy and safety of biologic treatments have been established in patients with moderate to severe psoriasis, but there are few reports on biologic therapy for patients with psoriasis complicated by end-stage renal failure on hemodialysis (HD). In this report, we demonstrated the efficacy and safety of adalimumab for patients with severe psoriasis on HD. A 46-year-old Japanese man with a 14-year history of psoriasis was referred to our clinic in September 2009. He had developed hypertension and renal failure during a 7-year history of cyclosporin treatment. With the infliximab treatment, he achieved 75% improvement of the Psoriasis Area and Severity Index (PASI) score within 3 months from the PASI of 42.3 before the treatment. However, his renal failure gradually deteriorated, and HD was initiated at 1 year after the introduction of infliximab. Because of hydration during the i.v. injection of infliximab, he developed pulmonary edema with every infliximab treatment after starting HD. We switched to ustekinumab treatment, but his psoriasis was not improved. Then, we switched to adalimumab and achieved a PASI-100 response within 2 months. The patient received adalimumab treatment for more than a year without any adverse effects. In addition to our case, five articles reported cases of psoriasis patients with renal failure on HD who were treated with biologics. The psoriatic lesions were improved by biologics in these cases, and no severe adverse effects on the renal function were reported. Thus, biologics are a reasonable treatment option for patients with severe psoriasis with renal failure on HD.

  8. Acetabular reconstruction with impaction bone-grafting and a cemented cup in patients younger than fifty years old: a concise follow-up, at twenty to twenty-eight years, of a previous report.

    PubMed

    Busch, Vincent J J F; Gardeniers, Jean W M; Verdonschot, Nico; Slooff, Tom J J H; Schreurs, B Willem

    2011-02-16

    In a previous report, we presented our results of forty-two acetabular reconstructions, performed with use of impaction bone-grafting and a cemented polyethylene cup, in thirty-seven patients who were younger than fifty years and had a minimum of fifteen years of follow-up. The present update study shows the results after twenty to twenty-eight years. Eight additional cups had to be revised--four because of aseptic loosening, three because of wear, and one during a revision of the stem. Three additional cups were considered loose on radiographs. Survivorship of the acetabular reconstructions, with an end point of revision for any reason, was 73% after twenty years and 52% after twenty-five years. With revision for aseptic loosening as the end point, survival was 85% after twenty years and 77% after twenty-five years; for signs of loosening on radiographs, survival was 71% at twenty years and 62% at twenty-five years. In conclusion, our previous results have declined but the technique of using impacted morselized bone graft and a cemented cup is useful for the purpose of restoring bone stock in young patients whose acetabular defects require primary or revision total hip arthroplasty.

  9. Functional outcome of patients with benign meningioma treated by 3D conformal irradiation with a combination of photons and protons

    SciTech Connect

    Noel, Georges . E-mail: noel@ipno.in2p3.fr; Bollet, Marc A.; Calugaru, Valentin; Feuvret, Loic; Haie-Meder, Christine; Dhermain, Frederic; Ferrand, Regis; Boisserie, Gilbert; Beaudre, Anne; Mazeron, Jean-Jacques; Habrand, Jean-Louis

    2005-08-01

    Purpose: To evaluate efficacy and tolerance of external fractionated combination of photon and proton radiation therapy (RT) for intracranial benign meningiomas. Methods and Materials: Between 1994 and 2002, 51 patients with intracranial meningiomas of the base of the skull were treated with a combination of photon and proton RT. Median total dose was 60.6 cobalt Gy equivalent (54-64). One hundred eight eye-related symptoms were collected; 80 other symptoms were noted and followed up. Results: Mean follow-up was 25.4 months. Acute tolerance was excellent. Out of the 108 eye-related symptoms, 106 (96%) were evaluated. Improvements were reported for 73 (68.8%) of them. Out of the 88 other miscellaneous symptoms, 81 (92%) were evaluated. Improvements were reported in 54 cases (67%). Median time to improvement ranged from 1 to 24 months after completion of the radiotherapy, depending on the symptom. We did not observe any worsening of primary clinical signs. Radiologically, 1 patient relapsed 4 months after the end of irradiation. Pathology revealed a malignant (Grade 3) transformation of the initial Grade 1 meningioma. Four-year local control and overall survival rates were, respectively, 98% and 100%. Stabilization of the tumor was observed in 38 cases (72%), volume reduction in 10 cases (20%), and intratumor necrosis in 3 cases. Two patients complained of Grade 3 side effects: 1 unilateral hearing loss requiring aid and 1 case of complete pituitary deficiency. Conclusion: These results stressed the clinical efficacy of fractionated-associated photon-proton RT in the treatment of meningiomas, especially on cranial nerve palsies, without severe toxicity in almost all patients.

  10. Is Regional Lymph Node Irradiation Necessary in Stage II to III Breast Cancer Patients With Negative Pathologic Node Status After Neoadjuvant Chemotherapy?

    SciTech Connect

    Daveau, Caroline; Stevens, Denise; Brain, Etienne

    2010-10-01

    Purpose: Neoadjuvant chemotherapy (NAC) generally induces significant changes in the pathologic extent of disease. This potential down-staging challenges the standard indications of adjuvant radiation therapy. We assessed the utility of lymph node irradiation (LNI) in breast cancer (BC) patients with pathologic N0 status (pN0) after NAC and breast-conserving surgery (BCS). Methods and Materials: Among 1,054 BC patients treated with NAC in our institution between 1990 and 2004, 248 patients with clinical N0 or N1 to N2 lymph node status at diagnosis had pN0 status after NAC and BCS. Cox regression analysis was used to identify factors influencing locoregional recurrence-free survival (LRR-FS), disease-free survival (DFS), and overall survival (OS). Results: All 248 patients underwent breast irradiation, and 158 patients (63.7%) also received LNI. With a median follow-up of 88 months, the 5-year LRR-FS and OS rates were respectively 89.4% and 88.7% with LNI and 86.2% and 92% without LNI (no significant difference). Survival was poorer among patients who did not have a pathologic complete primary tumor response (hazard ratio, 3.05; 95% confidence interval, 1.17-7.99) and in patients with N1 to N2 clinical status at diagnosis (hazard ratio = 2.24; 95% confidence interval, 1.15-4.36). LNI did not significantly affect survival. Conclusions: Relative to combined breast and local lymph node irradiation, isolated breast irradiation does not appear to be associated with a higher risk of locoregional relapse or death among cN0 to cN2 breast cancer patients with pN0 status after NAC. These results need to be confirmed in a prospective study.

  11. A simple method of alignment for pelvic irradiation in obese patients

    SciTech Connect

    Sweigart, Kenneth

    2002-12-31

    Administering radiation therapy to obese pelvic patients can pose a difficult challenge to even the veteran radiation therapist. Daily reproducibility can be achieved with the sacrifice of additional time and filming. We have developed a technique which has shown consistent reproducibility of the radiation treatments with a minimum of inconvenience to busy schedules.

  12. Effect of in vitro irradiation on mitogenic responsiveness of peripheral blood lymphocytes from patients with untreated and cured Hodgkin's Disease. [X ray

    SciTech Connect

    Baral, E.; Blomgren, H.; Johansson, B.

    1980-09-15

    Blood lymphocytes from 10 untreated patients with active Hodgkin's disease were compared with those of 10 cured patients with regard to the responsiveness of the cells to PHA and Con A following in vitro irradiation. Lymphocytes of patients remaining in long-term remission exhibited the same pattern of radiosensitivity as those of healthy donors: there was one relatively radiosensitive cell population and one relatively resistant. The latter cell population was undetectable in patients with an active disease. Reappearance of the radioresistant PHA and Con A reactive cell fractions might thus be associated with remission.

  13. Splenic irradiation in the treatment of patients with chronic myelogenous leukemia or myelofibrosis with myeloid metaplasia. Results of daily and intermittent fractionation with and without concomitant hydroxyurea

    SciTech Connect

    Wagner, H. Jr.; McKeough, P.G.; Desforges, J.; Madoc-Jones, H.

    1986-09-15

    Seventeen patients with either chronic myelogenous leukemia (CML) or myelofibrosis with myeloid metaplasia (MMM) received 24 courses of splenic irradiation at this institution from 1973 to 1982. Eleven of the 17 patients had received prior chemotherapy. Patients were treated with /sup 60/Co gamma rays or 6 MV photons. The fraction size ranged from 15 to 100 rad and the total dose per treatment course from 15 to 650 rad, with the exception of one patient who received 1650 rad. Fourteen of 19 courses (71%) given for splenic pain yielded significant subjective relief while 17 of 26 courses given for splenomegaly obtained at least 50% regression of splenic size. Blood counts were carefully monitored before each treatment to limit hematologic toxicity. From this experience, the authors conclude that splenic irradiation effectively palliates splenic pain and reverses splenomegaly in the majority of patients with CML and MMM. Intermittent fractionation (twice or thrice weekly) is more convenient for the patient, appears to be as effective as daily treatment, and may be associated with less hematologic toxicity. Preliminary results of concurrent treatment with splenic irradiation and oral hydroxyurea show promise and warrant further study.

  14. Previous failure of interferon-based therapy does not alter the frequency of HCV NS3 protease or NS5B polymerase inhibitor resistance-associated variants: longitudinal analysis in HCV/HIV co-infected patients.

    PubMed

    Sede, Mariano M; Laufer, Natalia L; Quarleri, Jorge

    2015-08-01

    Since 2011, treatment of chronic hepatitis C virus (HCV) includes direct-acting antivirals (DAAs) in addition to pegylated interferon-α (peg-IFN) and ribavirin (RBV). IFN-based treatment induces strong cytotoxic T-lymphocyte activity directed to the protease- and polymerase-derived epitopes. This enhanced immunological pressure could favour the emergence of viral epitope variants able to evade immune surveillance and, when resistance-associated variants (RAVs) are implicated, could also be co-selected as a hitchhiking effect. This study analysed the dynamics of the frequency of protease and polymerase inhibitor RAVs that could affect future HCV treatment in human immunodeficiency virus (HIV) co-infected patients on stable antiretroviral therapy with previous IFN-based treatment failure. HCV genotype 1a RNA was extracted from plasma samples of 18 patients prior to and during (24h and 4, 12, 24 and 48 weeks) therapy with peg-IFN+RBV. Next-generation sequencing was performed on HCV-RNA populations using NS3 and NS5B PCR-amplified coding regions. Two measures of genetic diversity were used to compare virus populations: average pairwise nucleotide diversity (π) and Tajima's D statistic. Several protease and polymerase RAVs were detected in all subjects at very low frequencies (<5%), and in most cases their presence was not constant during follow-up. Only samples from two patients for each region exhibited Q80R/K/L and A421V as highly predominant variants. No significant differences were observed among sampling times for either π or D values. In conclusion, previous therapy and failure of peg-IFN+RBV were not associated with an increase in DAA-targeting NS3 or NS5B RAVs that naturally exist in HIV co-infected subjects. PMID:26100213

  15. Image-Guided Total-Marrow Irradiation Using Helical Tomotherapy in Patients With Multiple Myeloma and Acute Leukemia Undergoing Hematopoietic Cell Transplantation

    SciTech Connect

    Wong, Jeffrey Y.C. Rosenthal, Joseph; Liu An; Schultheiss, Timothy; Forman, Stephen; Somlo, George

    2009-01-01

    Purpose: Total-body irradiation (TBI) has an important role in patients undergoing hematopoietic cell transplantation (HCT), but is associated with significant toxicities. Targeted TBI using helical tomotherapy results in reduced doses to normal organs, which predicts for reduced toxicities compared with standard TBI. Methods and Materials: Thirteen patients with multiple myeloma were treated in an autologous tandem transplantation Phase I trial with high-dose melphalan, followed 6 weeks later by total-marrow irradiation (TMI) to skeletal bone. Dose levels were 10, 12, 14, and 16 Gy at 2 Gy daily/twice daily. In a separate allogeneic HCT trial, 8 patients (5 with acute myelogenous leukemia, 1 with acute lymphoblastic leukemia, 1 with non-Hodgkin's lymphoma, and 1 with multiple myeloma) were treated with TMI plus total lymphoid irradiation plus splenic radiotherapy to 12 Gy (1.5 Gy twice daily) combined with fludarabine/melphalan. Results: For the 13 patients in the tandem autologous HCT trial, median age was 54 years (range, 42-66 years). Median organ doses were 15-65% that of the gross target volume dose. Primarily Grades 1-2 acute toxicities were observed. Six patients reported no vomiting; 9 patients, no mucositis; 6 patients, no fatigue; and 8 patients, no diarrhea. For the 8 patients in the allogeneic HCT trial, median age was 52 years (range, 24-61 years). Grades 2-3 nausea, vomiting, mucositis, and diarrhea were observed. In both trials, no Grade 4 nonhematologic toxicity was observed, and all patients underwent successful engraftment. Conclusions: This study shows that TMI using helical tomotherapy is clinically feasible. The reduced acute toxicities observed compare favorably with those seen with standard TBI. Initial results are encouraging and warrant further evaluation as a method to dose escalate with acceptable toxicity or to offer TBI-containing regimens to patients unable to tolerate standard approaches.

  16. Nomogram for Predicting the Risk of Locoregional Recurrence in Patients Treated With Accelerated Partial-Breast Irradiation

    SciTech Connect

    Wobb, Jessica L.; Chen, Peter Y.; Shah, Chirag; Moran, Meena S.; Shaitelman, Simona F.; Vicini, Frank A.; Beitsch, Peter

    2015-02-01

    Purpose: To develop a nomogram taking into account clinicopathologic features to predict locoregional recurrence (LRR) in patients treated with accelerated partial-breast irradiation (APBI) for early-stage breast cancer. Methods and Materials: A total of 2000 breasts (1990 women) were treated with APBI at William Beaumont Hospital (n=551) or on the American Society of Breast Surgeons MammoSite Registry Trial (n=1449). Techniques included multiplanar interstitial catheters (n=98), balloon-based brachytherapy (n=1689), and 3-dimensional conformal radiation therapy (n=213). Clinicopathologic variables were gathered prospectively. A nomogram was formulated utilizing the Cox proportional hazards regression model to predict for LRR. This was validated by generating a bias-corrected index and cross-validated with a concordance index. Results: Median follow-up was 5.5 years (range, 0.9-18.3 years). Of the 2000 cases, 435 were excluded because of missing data. Univariate analysis found that age <50 years, pre-/perimenopausal status, close/positive margins, estrogen receptor negativity, and high grade were associated with a higher frequency of LRR. These 5 independent covariates were used to create adjusted estimates, weighting each on a scale of 0-100. The total score is identified on a points scale to obtain the probability of an LRR over the study period. The model demonstrated good concordance for predicting LRR, with a concordance index of 0.641. Conclusions: The formulation of a practical, easy-to-use nomogram for calculating the risk of LRR in patients undergoing APBI will help guide the appropriate selection of patients for off-protocol utilization of APBI.

  17. Sleep apnea syndrome after irradiation of the neck

    SciTech Connect

    Herlihy, J.P.; Whitlock, W.L.; Dietrich, R.A.; Shaw, T. )

    1989-12-01

    After irradiation of the neck for a squamous cell carcinoma of the tonsillar pillar and vocal cord, a 71-year-old man presented with a rapidly progressive sleep apnea syndrome. Previous reports describe the condition of patients with obstructive sleep apnea that developed after neck irradiation and secondary to supraglottic edema. Our patient had an obstructive component to his apnea similar to that described in previous cases, but, in addition, he had hypothyroidism. Myxedema is a well-described cause of both obstructive and central apnea. We believe both contributed to his condition. He was successfully treated by placement of a tracheostomy and by thyroid supplementation. In patients who present with sleep apnea after neck irradiation, especially with acute or severe symptoms, the differential diagnosis should include both a central cause from hypothyroidism as well as a peripheral obstructive cause from laryngeal edema.

  18. Clinical observations of early and late normal tissue injury in patients receiving fast neutron irradiation

    SciTech Connect

    Ornitz, R.D.; Bradley, E.W.; Mossman, K.L.; Fender, F.M.; Schell, M.C.; Rogers, C.C.

    1980-03-01

    This communication describes early and late normal tissue effects in 177 patients treated totally or in part by 15 MeV neutrons from the Naval Research Laboratory Cyclotron in Washington, D.C. between October 1973 and December 1976. Late normal tissue reactions were found to be greater than would be expected from careful observation of the early clinical responses to neutron treatment. Neutron prescriptions must be written based on the late effect tolerance level experience which is being accumulated at several neutron therapy facilities.

  19. Differential Motion Between Mediastinal Lymph Nodes and Primary Tumor in Radically Irradiated Lung Cancer Patients

    SciTech Connect

    Schaake, Eva E.; Rossi, Maddalena M.G.; Buikhuisen, Wieneke A.; Burgers, Jacobus A.; Smit, Adrianus A.J.; Belderbos, José S.A.; Sonke, Jan-Jakob

    2014-11-15

    Purpose/Objective: In patients with locally advanced lung cancer, planning target volume margins for mediastinal lymph nodes and tumor after a correction protocol based on bony anatomy registration typically range from 1 to 1.5 cm. Detailed information about lymph node motion variability and differential motion with the primary tumor, however, is lacking from large series. In this study, lymph node and tumor position variability were analyzed in detail and correlated to the main carina to evaluate possible margin reduction. Methods and Materials: Small gold fiducial markers (0.35 × 5 mm) were placed in the mediastinal lymph nodes of 51 patients with non-small cell lung cancer during routine diagnostic esophageal or bronchial endoscopic ultrasonography. Four-dimensional (4D) planning computed tomographic (CT) and daily 4D cone beam (CB) CT scans were acquired before and during radical radiation therapy (66 Gy in 24 fractions). Each CBCT was registered in 3-dimensions (bony anatomy) and 4D (tumor, marker, and carina) to the planning CT scan. Subsequently, systematic and random residual misalignments of the time-averaged lymph node and tumor position relative to the bony anatomy and carina were determined. Additionally, tumor and lymph node respiratory amplitude variability was quantified. Finally, required margins were quantified by use of a recipe for dual targets. Results: Relative to the bony anatomy, systematic and random errors ranged from 0.16 to 0.32 cm for the markers and from 0.15 to 0.33 cm for the tumor, but despite similar ranges there was limited correlation (0.17-0.71) owing to differential motion. A large variability in lymph node amplitude between patients was observed, with an average motion of 0.56 cm in the cranial-caudal direction. Margins could be reduced by 10% (left-right), 27% (cranial-caudal), and 10% (anteroposterior) for the lymph nodes and −2%, 15%, and 7% for the tumor if an online carina registration protocol replaced a

  20. Selective use of post-mastectomy flap irradiation in high-risk breast cancer patients.

    PubMed

    Asgeirsson, Kristjan S; Holroyd, Ben; Morgan, David A L; Robertson, John F R; Blamey, Roger W; Pinder, Sarah E; Macmillan, R Douglas

    2005-08-01

    The incidence of local recurrence after mastectomy can be reduced by chest wall radiotherapy. However, only a minority of patients are at substantial risk. No UK national guidelines exist for the use of mastectomy flap radiotherapy. This study evaluated a protocol, whereby only high-risk patients were treated with post-mastectomy flap radiotherapy; identified histologically by grade, vascular invasion and nodal status. All women treated by simple mastectomy for invasive breast cancer at the Nottingham Breast Unit from January 1993 to December 1995 were studied (n=292). Postoperative flap radiotherapy was given to 147 high-risk women (50.3%). Median follow-up was 76 months. Overall, 12 women (4.1%) developed a chest wall recurrence; six were single spot recurrences and the remaining six were either multiple spot (n=3) or field change (field change dermal invasion, n=3). The chest wall recurrence rate was 2.7% in those treated with radiotherapy. A low rate of local recurrence has been achieved with selective use of mastectomy flap radiotherapy.

  1. Re-irradiation alternatives for recurrent high-grade glioma

    PubMed Central

    Dong, Yuanli; Fu, Chengrui; Guan, Hui; Zhang, Tianyi; Zhang, Zicheng; Zhou, Tao; Li, Baosheng

    2016-01-01

    Despite advances in the fields of surgery, chemotherapy and radiotherapy, the prognosis for high-grade glioma (HGG) remains unsatisfactory. The majority of HGG patients experience disease recurrence. To date, no standard treatments have been established for recurrent HGG. Repeat surgery and chemotherapy demonstrate moderate efficacy. As recurrent lesions are usually located within the previously irradiated field, a second course of irradiation was once considered controversial, as it was considered to exhibit unsatisfactory efficacy and radiation-related toxicities. However, an increasing number of studies have indicated that re-irradiation may present an efficacious treatment for recurrent HGG. Re-irradiation may be delivered via conventionally fractionated stereotactic radiotherapy, hypofractionated stereotactic radiation therapy, stereotactic radiosurgery and brachytherapy techniques. In the present review, the current literature regarding re-irradiation treatment for recurrent HGG is summarized with regard to survival outcome and side effects. PMID:27703519

  2. Clinical Use of Deferoxamine in Distraction Osteogenesis of Irradiated Bone.

    PubMed

    Momeni, Arash; Rapp, Scott; Donneys, Alexis; Buchman, Steven R; Wan, Derrick C

    2016-06-01

    The deleterious effects of radiotherapy, including hypovascularity and hypocellularity, have made distraction of irradiated bones challenging. Animal studies, however, have demonstrated adjunctive measures such as the administration of deferoxamine to significantly improve bone regeneration across irradiated distraction gaps. In this report, the authors demonstrate, for the first time, enhanced bone formation following deferoxamine application in a patient following distraction of a previously irradiated maxilla. Computed tomography imaging of the pterygomaxillary buttress on the side of administration revealed significantly increased bone area and density relative to the contralateral buttress. This is the first presentation of clinical deferoxamine use to promote bone formation following irradiated bone distraction and highlights the promise for this adjunctive measure to make outcomes after distraction of irradiated bone more reliable. PMID:27171947

  3. Blood pressure and fasting lipid changes after 24 weeks’ treatment with vildagliptin: a pooled analysis in >2,000 previously drug-naïve patients with type 2 diabetes mellitus

    PubMed Central

    Evans, Marc; Schweizer, Anja; Foley, James E

    2016-01-01

    Introduction We have previously shown modest weight loss with vildagliptin treatment. Since body weight balance is associated with changes in blood pressure (BP) and fasting lipids, we have assessed these parameters following vildagliptin treatment. Methods Data were pooled from all double-blind, randomized, controlled, vildagliptin mono-therapy trials on previously drug-naïve patients with type 2 diabetes mellitus who received vildagliptin 50 mg once daily (qd) or twice daily (bid; n=2,108) and wherein BP and fasting lipid data were obtained. Results Data from patients receiving vildagliptin 50 mg qd or bid showed reductions from baseline to week 24 in systolic BP (from 132.5±0.32 to 129.8±0.34 mmHg; P<0.0001), diastolic BP (from 81.2±0.18 to 79.6±0.19 mmHg; P<0.0001), fasting triglycerides (from 2.00±0.02 to 1.80±0.02 mmol/L; P<0.0001), very low density lipoprotein cholesterol (from 0.90±0.01 to 0.83±0.01 mmol/L; P<0.0001), and low density lipoprotein cholesterol (from 3.17±0.02 to 3.04±0.02 mmol/L; P<0.0001), whereas high density lipoprotein cholesterol increased (from 1.19±0.01 to 1.22±0.01 mmol/L; P<0.001). Weight decreased by 0.48±0.08 kg (P<0.001). Conclusion This large pooled analysis demonstrated that vildagliptin shows a significant reduction in BP and a favorable fasting lipid profile that are associated with modest weight loss. PMID:27574437

  4. Light ion irradiation for unfavorable soft tissue sarcoma

    SciTech Connect

    Linstadt, D.; Castro, J.R.; Phillips, T.L.; Petti, P.L.; Collier, J.M.; Daftari, I.; Schoethaler, R.; Rayner, A.

    1990-09-01

    Between 1978 and 1989, 32 patients with unfavorable soft tissue sarcoma underwent light ion (helium, neon) irradiation with curative intent at Lawrence Berkeley Laboratory. The tumors were located in the trunk in 22 patients and head and neck in 10. Macroscopic tumor was present in 22 at the time of irradiation. Two patients had tumors apparently induced by previous therapeutic irradiation. Follow-up times for surviving patients ranged from 4 to 121 months (median 27 months). The overall 3-year actuarial local control rate was 62%; the corresponding survival rate was 50%. The 3-year actuarial control rate for patients irradiated with macroscopic tumors was 48%, while none of the patients with microscopic disease developed local recurrence (100%). The corresponding 3-year actuarial survival rates were 40% (macroscopic) and 78% (microscopic). Patients with retroperitoneal sarcoma did notably well; the local control rate and survival rate were 64% and 62%, respectively. Complications were acceptable; there were no radiation related deaths, while two patients (6%) required operations to correct significant radiation-related injuries. These results appear promising compared to those achieved by low -LET irradiation, and suggest that this technique merits further investigation.

  5. Irradiated mandibular autografts

    SciTech Connect

    Hamaker, R.C.; Singer, M.I.; Shockley, W.W.; Pugh, N.; Shidnia, H.

    1983-09-15

    The cosmetic and functional disability associated with mandibular resection has been a major problem to the patient with direct invasion of the mandible by oral cancer. Marginal resections with combined postoperative radiation therapy have frequently been substituted for the more preferred segmental resections and resultant deformities. Presented are 15 cases of oral cavity cancer involving resection of the mandible, immediate radiation to 10,000 rad, and primary reconstruction as irradiated mandibular autografts. The longest following is 4 years and 3 months, with a success rate of 66%. Morbidity is minimal as compared to autogenous bone grafting. Tumor size, previous radiation, or use of regional flaps have not been a factor in the success of this method in reconstruction of the mandible primarily.

  6. Local Setup Reproducibility of the Spinal Column When Using Intensity-Modulated Radiation Therapy for Craniospinal Irradiation With Patient in Supine Position

    SciTech Connect

    Stoiber, Eva Maria; Giske, Kristina; Schubert, Kai; Sterzing, Florian; Habl, Gregor; Uhl, Matthias; Herfarth, Klaus; Bendl, Rolf; Debus, Juergen

    2011-12-01

    Purpose: To evaluate local positioning errors of the lumbar spine during fractionated intensity-modulated radiotherapy of patients treated with craniospinal irradiation and to assess the impact of rotational error correction on these uncertainties for one patient setup correction strategy. Methods and Materials: 8 patients (6 adults, 2 children) treated with helical tomotherapy for craniospinal irradiation were retrospectively chosen for this analysis. Patients were immobilized with a deep-drawn Aquaplast head mask. Additionally to daily megavoltage control computed tomography scans of the skull, once-a-week positioning of the lumbar spine was assessed. Therefore, patient setup was corrected by a target point correction, derived from a registration of the patient's skull. The residual positioning variations of the lumbar spine were evaluated applying a rigid-registration algorithm. The impact of different rotational error corrections was simulated. Results: After target point correction, residual local positioning errors of the lumbar spine varied considerably. Craniocaudal axis rotational error correction did not improve or deteriorate these translational errors, whereas simulation of a rotational error correction of the right-left and anterior-posterior axis increased these errors by a factor of 2 to 3. Conclusion: The patient fixation used allows for deformations between the patient's skull and spine. Therefore, for the setup correction strategy evaluated in this study, generous margins for the lumbar spinal target volume are needed to prevent a local geographic miss. With any applied correction strategy, it needs to be evaluated whether or not a rotational error correction is beneficial.

  7. The rainbow cohort: 96 week follow-up of saquinavir-containing regimens in previously antiretroviral therapy (ART)-naïve and pre-treated but protease inhibitor (PI)- naïve hiv-infected patients

    PubMed Central

    2011-01-01

    Objective We have previously reported data from the German cohort of the multinational observational prospective RAINBOW survey which assessed the tolerability and efficacy of ritonavir-boosted saquinavir (SQV/r)-containing regimens over 48 weeks in routine clinical practice. This analysis presents data from antiretroviral (ART)-naïve and pretreated but protease inhibitor (PI)-naïve patients treated in a long-term one line (96 weeks) follow-up of the initial study. Methods All ART-and PI-naïve patients from the initial RAINBOW cohort who had recorded data to one line 96 weeks of treatment were eligible for inclusion in the current analysis. Efficacy assessments included the proportion of patients with HIV-1 RNA < 50 and < 400 copies/mL and changes in CD4 cell count from baseline to week 96. Tolerability assessments included changes in liver enzymes and lipid levels from baseline to week 96. For evaluation of efficacy, intent-to-treat analysis, in which missing values were recorded as failure (ITT), and last-observation-carried-forward (LOCF) analysis were used. Metabolic parameters were assessed using LOCF analysis. Results The analysis included 175 ART-naïve and 109 pretreated but PI-naïve patients. After 96 weeks, a similar proportion of patients in the ART-naïve and in the pretreated but Pi-naïve group had HIV-1 RNA levels < 400 copies/mL (68.0% and 70.6% [ITT], respectively; 96.6% and 90.8% [LOCF], respectively). The proportion of patients with HIV RNA < 50 copies/mL was higher in the ART-naïve group compared with the pretreated but PI-naïve group (61.1% and 56.9% [ITT], respectively; 84.0% and 75.2% [LOCF], respectively). Median change in CD4 cell count from baseline to week 96 was'+263 cells/mm3 (IQR 170; 384. LOCF; p < 0.0001) in the ART-naïve group, and one line +181 cells/mm3 (IQR 60; 309. LOCF; p < 0.0001) in the pretreated but PI-naïve group. Treatment was well tolerated, with only 2.5% of patients withdrawing from treatment due to side

  8. The Sequence of Cyclophosphamide and Myeloablative Total Body Irradiation in Hematopoietic Cell Transplantation for Patients with Acute Leukemia.

    PubMed

    Holter-Chakrabarty, Jennifer L; Pierson, Namali; Zhang, Mei-Jie; Zhu, Xiaochun; Akpek, Görgün; Aljurf, Mahmoud D; Artz, Andrew S; Baron, Frédéric; Bredeson, Christopher N; Dvorak, Christopher C; Epstein, Robert B; Lazarus, Hillard M; Olsson, Richard F; Selby, George B; Williams, Kirsten M; Cooke, Kenneth R; Pasquini, Marcelo C; McCarthy, Philip L

    2015-07-01

    Limited clinical data are available to assess whether the sequencing of cyclophosphamide (Cy) and total body irradiation (TBI) changes outcomes. We evaluated the sequence in 1769 (CyTBI, n = 948; TBICy, n = 821) recipients of related or unrelated hematopoietic cell transplantation who received TBI (1200 to 1500 cGY) for acute leukemia from 2003 to 2010. The 2 cohorts were comparable for median age, performance score, type of leukemia, first complete remission, Philadelphia chromosome-positive acute lymphoblastic leukemia, HLA-matched siblings, stem cell source, antithymocyte globulin use, TBI dose, and type of graft-versus-host disease (GVHD) prophylaxis. The sequence of TBI did not significantly affect transplantation-related mortality (24% versus 23% at 3 years, P = .67; relative risk, 1.01; P = .91), leukemia relapse (27% versus 29% at 3 years, P = .34; relative risk, .89, P = .18), leukemia-free survival (49% versus 48% at 3 years, P = .27; relative risk, .93; P = .29), chronic GVHD (45% versus 47% at 1 year, P = .39; relative risk, .9; P = .11), or overall survival (53% versus 52% at 3 years, P = .62; relative risk, .96; P = .57) for CyTBI and TBICy, respectively. Corresponding cumulative incidences of sinusoidal obstruction syndrome were 4% and 6% at 100 days (P = .08), respectively. This study demonstrates that the sequence of Cy and TBI does not impact transplantation outcomes and complications in patients with acute leukemia undergoing hematopoietic cell transplantation with myeloablative conditioning.

  9. The Sequence of Cyclophosphamide and Myeloablative Total Body Irradiation in Hematopoietic Cell Transplantation for Patients with Acute Leukemia.

    PubMed

    Holter-Chakrabarty, Jennifer L; Pierson, Namali; Zhang, Mei-Jie; Zhu, Xiaochun; Akpek, Görgün; Aljurf, Mahmoud D; Artz, Andrew S; Baron, Frédéric; Bredeson, Christopher N; Dvorak, Christopher C; Epstein, Robert B; Lazarus, Hillard M; Olsson, Richard F; Selby, George B; Williams, Kirsten M; Cooke, Kenneth R; Pasquini, Marcelo C; McCarthy, Philip L

    2015-07-01

    Limited clinical data are available to assess whether the sequencing of cyclophosphamide (Cy) and total body irradiation (TBI) changes outcomes. We evaluated the sequence in 1769 (CyTBI, n = 948; TBICy, n = 821) recipients of related or unrelated hematopoietic cell transplantation who received TBI (1200 to 1500 cGY) for acute leukemia from 2003 to 2010. The 2 cohorts were comparable for median age, performance score, type of leukemia, first complete remission, Philadelphia chromosome-positive acute lymphoblastic leukemia, HLA-matched siblings, stem cell source, antithymocyte globulin use, TBI dose, and type of graft-versus-host disease (GVHD) prophylaxis. The sequence of TBI did not significantly affect transplantation-related mortality (24% versus 23% at 3 years, P = .67; relative risk, 1.01; P = .91), leukemia relapse (27% versus 29% at 3 years, P = .34; relative risk, .89, P = .18), leukemia-free survival (49% versus 48% at 3 years, P = .27; relative risk, .93; P = .29), chronic GVHD (45% versus 47% at 1 year, P = .39; relative risk, .9; P = .11), or overall survival (53% versus 52% at 3 years, P = .62; relative risk, .96; P = .57) for CyTBI and TBICy, respectively. Corresponding cumulative incidences of sinusoidal obstruction syndrome were 4% and 6% at 100 days (P = .08), respectively. This study demonstrates that the sequence of Cy and TBI does not impact transplantation outcomes and complications in patients with acute leukemia undergoing hematopoietic cell transplantation with myeloablative conditioning. PMID:25840335

  10. Results of a conservative treatment combining induction (neoadjuvant) and consolidation chemotherapy, hormonotherapy, and external and interstitial irradiation in 98 patients with locally advanced breast cancer (IIIA-IIIB)

    SciTech Connect

    Jacquillat, C.; Baillet, F.; Weil, M.; Auclerc, G.; Housset, M.; Auclerc, M.; Sellami, M.; Jindani, A.; Thill, L.; Soubrane, C.

    1988-05-15

    Ninety-eight patients with locally advanced breast cancer (Stage IIIA-IIIB) were entered into a pilot study combining intensive induction (neoadjuvant) chemotherapy (VTMFAP) with or without hormonochemotherapy, external and interstitial radiotherapy, and consolidation chemotherapy with or without hormonochemotherapy. Tumor regression over 50% was observed in 91% patients after chemotherapy, and complete clinical remission occurred in 100% patients after irradiation. The rate of local relapse is 13%. The 3-year disease-free survival is 62% and 3-year global survival is 77%. Initial chemotherapeutic tumor regression greater than 75% is the main predictive factor for disease-free survival.

  11. Three-dimensional treatment planning for para-aortic node irradiation in patients with cervical cancer

    SciTech Connect

    Munzenrider, J.E.; Doppke, K.P.; Brown, A.P.; Burman, C.; Cheng, E.; Chu, J.; Chui, C.; Drzymala, R.E.; Goitein, M.; Manolis, J.M. )

    1991-05-15

    Three-dimensional treatment planning has been used by four cooperating centers to prepare and analyze multiple treatment plans on two cervix cancer patients. One patient had biopsy-proven and CT-demonstrable metastasis to the para-aortic nodes, while the other was at high risk for metastatic involvement of para-aortic nodes. Volume dose distributions were analyzed, and an attempt was made to define the role of 3-D treatment planning to the para-aortic region, where moderate to high doses (50-66 Gy) are required to sterilize microscopic and gross metastasis. Plans were prepared using the 3-D capabilities for tailoring fields to the target volumes, but using standard field arrangements (3-D standard), and with full utilization of the 3-D capabilities (3-D unconstrained). In some but not all 3-D unconstrained plans, higher doses were delivered to the large nodal volume and to the volume containing gross nodal disease than in plans analyzed but not prepared with full 3-D capability (3-D standard). The small bowel was the major dose limiting organ. Its tolerance would have been exceeded in all plans which prescribed 66 Gy to the gross nodal mass, although some reduction in small bowel near-maximum dose was achieved in the 3-D unconstrained plans. All plans were able to limit doses to other normal organs to tolerance levels or less, with significant reductions seen in doses to spinal cord, kidneys, and large bowel in the 3-D unconstrained plans, as compared to the 3-D standard plans. A high probability of small bowel injury was detected in one of four 3-D standard plans prescribed to receive 50 Gy to the large para-aortic nodal volume; the small bowel dose was reduced to an acceptable level in the corresponding 3-D unconstrained plan. An optimum beam energy for treating this site was not identified, with plans using 4, 6, 10, 15, 18, and 25 MV photons all being equally acceptable. (Abstract Truncated)

  12. Genetic screening test for psoriatic arthritis and UVB irradiation potential responders: A new tool to identify psoriasis subpopulation patients?

    PubMed

    Lotti, Torello; Tognetti, Linda; Galeone, Massimiliano; Bruscino, Nicola; Moretti, Silvia; Giorgini, Simonetta

    2011-07-01

    Psoriatic arthritis (PsA) is a psoriasis-associated inflammatory disease of the joints and enthuses. The occurrence of PsA is linked to the complex interplay of gene environment, and immune system. Genetic factors have long been recognized to play an important role in PsA. Genes within the major histocompatibility complex (MHC) region have been shown to be associated with PsA. These include genes coded in the HLA region, (especially Class I antigens) and non-HLA genes (i.e., MHC class I chain-related antigen A, MICA, and TNF-α genes). Association studies in PsA have also identified a number of genes outside MHC region, including interleukin-1 (IL-1) gene cluster, killer-cell immunoglobulin-like receptors (KIRs), and IL-23R genes. Established systemic treatments for moderate-severe psoriasis and PsA may be potentially dangerous and usually time consuming for the patient and often expensive for the National Health Systems. Tests which could predict which subset of psoriatic patients could develop the most severe forms of the disease (i.e., PsA) or will respond to well-established (UVB irradiation) or other systemic treatments are now required. The goal of genetic test screening is to rapidly and safely identify subjects for preventive or early treatment or extended surveillance prior to the onset of signs and symptoms. Genetic tests today represent a reliable investigation procedure which could rapidly and consistently improve the diagnostic ability of the dermatologist and contribute to the early and correct treatment of the different subsets of PsA.

  13. Genetic screening test for psoriatic arthritis and UVB irradiation potential responders: A new tool to identify psoriasis subpopulation patients?

    PubMed Central

    Lotti, Torello; Tognetti, Linda; Galeone, Massimiliano; Bruscino, Nicola; Moretti, Silvia; Giorgini, Simonetta

    2011-01-01

    Psoriatic arthritis (PsA) is a psoriasis-associated inflammatory disease of the joints and enthuses. The occurrence of PsA is linked to the complex interplay of gene environment, and immune system. Genetic factors have long been recognized to play an important role in PsA. Genes within the major histocompatibility complex (MHC) region have been shown to be associated with PsA. These include genes coded in the HLA region, (especially Class I antigens) and non-HLA genes (i.e., MHC class I chain-related antigen A, MICA, and TNF-α genes). Association studies in PsA have also identified a number of genes outside MHC region, including interleukin-1 (IL-1) gene cluster, killer-cell immunoglobulin-like receptors (KIRs), and IL-23R genes. Established systemic treatments for moderate-severe psoriasis and PsA may be potentially dangerous and usually time consuming for the patient and often expensive for the National Health Systems. Tests which could predict which subset of psoriatic patients could develop the most severe forms of the disease (i.e., PsA) or will respond to well-established (UVB irradiation) or other systemic treatments are now required. The goal of genetic test screening is to rapidly and safely identify subjects for preventive or early treatment or extended surveillance prior to the onset of signs and symptoms. Genetic tests today represent a reliable investigation procedure which could rapidly and consistently improve the diagnostic ability of the dermatologist and contribute to the early and correct treatment of the different subsets of PsA. PMID:23130225

  14. No Previous Public Services Required

    ERIC Educational Resources Information Center

    Taylor, Kelley R.

    2009-01-01

    In 2007, the Supreme Court heard a case that involved the question of whether a school district could be required to reimburse parents who unilaterally placed their child in private school when the child had not previously received special education and related services in a public institution ("Board of Education v. Tom F."). The Court's 4-4…

  15. Long-term follow-up of cardiac function in patients with Hodgkin's disease treated with mediastinal irradiation and combination chemotherapy including doxorubicin

    SciTech Connect

    LaMonte, C.S.; Yeh, S.D.; Straus, D.J.

    1986-04-01

    Among 41 evaluable patients whose first treatment for advanced Hodgkin's disease had consisted of alternating cycles of mechlorethamine, vincristine, prednisone, and procarbazine (MOPP), and doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD), in addition to low-dose mediastinal irradiation, 19 underwent retrospective cardiac evaluation by routine posteroanterior and lateral chest x-ray, 12-lead ECG, M-mode echocardiogram, and ECG-gated left ventricular blood pool scan at rest and during exercise. Fifteen patients had unequivocally normal left ventricular function by all these parameters. Two patients had minimally reduced left ventricular ejection fraction (LVEF) at rest with a normal increment with exercise. In two other patients with high normal resting LVEF and subnormal increment with exercise, the elevated resting values implied initial measurement in a nonbasal state. A twentieth patient (the oldest; one of two with active Hodgkin's disease at the time of evaluation and the stimulus for this study) had markedly reduced LVEF as determined by radionuclide cardiac angiography and had developed clinical congestive heart failure shortly before evaluation. Despite this patient, the study indicates that treatment with MOPP/ABVD and low-dose mediastinal irradiation entails low risk for cardiac complications.

  16. Tract-based Spatial Statistics and fMRI Analysis in Patients with Small Cell Lung Cancer before Prophylactic Cranial Irradiation

    NASA Astrophysics Data System (ADS)

    Benezi, S.; Bromis, K.; Karavasilis, E.; Karanasiou, I. S.; Koutsoupidou, M.; Matsopoulos, G.; Ventouras, E.; Uzunoglu, N.; Kouloulias, V.; Papathanasiou, M.; Foteineas, A.; Efstathopoulos, E.; Kelekis, N.; Kelekis, D.

    2015-09-01

    Prophylactic cranial irradiation (PCI) is known to increase life expectancy to a significant degree in Small Cell Lung Cancer (SCLC) patients. The overall scope of this research is to investigate changes in structural and functional connectivity between SCLC patients and controls before and after PCI treatment. In the current study specifically we use diffusion tensor imaging (DTI) and functional Magnetic Resonance (fMRI) to identify potential alterations in white matter structure and brain function respectively, in SCLC patients before PCI compared to healthy participants. The results in DTI analysis have showed lower fractional anisotropy (FA) and higher eigenvalues in white matter regions in the patient group. Similarly, in fMRI analysis a lower level of activation in the primary somatosensory cortex was reported. The results presented herein are subject to further investigation with larger patient and control groups.

  17. The Sequence of Cyclophosphamide and Myeloablative Total Body Irradiation in Hematopoietic Cell Transplant for Patients with Acute Leukemia

    PubMed Central

    Holter-Chakrabarty, Jennifer L.; Pierson, Namali; Zhang, Mei-Jie; Zhu, Xiaochun; Akpek, Görgün; Aljurf, Mahmoud D.; Artz, Andrew S.; Baron, Frédéric; Bredeson, Christopher N.; Dvorak, Christopher C.; Epstein, Robert B.; Lazarus, Hillard M.; Olsson, Richard F.; Selby, George B.; Williams, Kirsten M.; Cooke, Kenneth R.; Pasquini, Marcelo C.; McCarthy, Philip L.

    2015-01-01

    Limited clinical data are available to assess whether the sequencing of cyclophosphamide (Cy) and total body irradiation (TBI) changes outcomes. We evaluated the sequence in 1769 (CyTBI N=948, TBICy N=821) recipients of related or unrelated hematopoietic cell transplantation (HCT) who received TBI (1200-1500cGY) for acute leukemia from 2003 to 2010. The two cohorts were comparable for median age, performance score, type of leukemia, first complete remission, Ph+ ALL, HLA matched siblings, stem cell source, anti-thymocyte globulin use, TBI dose, and type of graft-versus-host disease (GVHD) prophylaxis. The sequence of TBI did not significantly affect TRM (24% vs. 23% at 3y, p=0.67; relative risk [RR] 1.01, p=0.91), leukemia relapse (27% vs. 29% at 3y, p=0.34; RR 0.89, p=0.18), leukemia-free survival (49% vs. 48% at3y, p=0.27; RR 0.93, p=0.29), chronic GVHD (45% vs. 47% at 1y, p=0.39; RR 0.9, p=0.11) or overall survival (53% vs. 52% at 3y, p=0.62; RR 0.96, p=0.57) for CyTBI and TBICy respectively. Corresponding cumulative incidences of sinusoidal obstruction syndrome were 4% and 6% at 100 days (p=0.08). This study demonstrates that the sequence of Cy and TBI does not impact transplant outcomes and complications in patients with acute leukemia undergoing HCT with myeloablative conditioning. PMID:25840335

  18. Birth after caesarean study – planned vaginal birth or planned elective repeat caesarean for women at term with a single previous caesarean birth: protocol for a patient preference study and randomised trial

    PubMed Central

    Dodd, Jodie M; Crowther, Caroline A; Hiller, Janet E; Haslam, Ross R; Robinson, Jeffrey S

    2007-01-01

    Background For women who have a caesarean section in their preceding pregnancy, two care policies for birth are considered standard: planned vaginal birth and planned elective repeat caesarean. Currently available information about the benefits and harms of both forms of care are derived from retrospective and prospective cohort studies. There have been no randomised trials, and recognising the deficiencies in the literature, there have been calls for methodologically rigorous studies to assess maternal and infant health outcomes associated with both care policies. The aims of our study are to assess in women with a previous caesarean birth, who are eligible in the subsequent pregnancy for a vaginal birth, whether a policy of planned vaginal birth after caesarean compared with a policy of planned repeat caesarean affects the risk of serious complications for the woman and her infant. Methods/Design Design: Multicentred patient preference study and a randomised clinical trial. Inclusion Criteria: Women with a single prior caesarean presenting in their next pregnancy with a single, live fetus in cephalic presentation, who have reached 37 weeks gestation, and who do not have a contraindication to a planned VBAC. Trial Entry & Randomisation: Eligible women will be given an information sheet during pregnancy, and will be recruited to the study from 37 weeks gestation after an obstetrician has confirmed eligibility for a planned vaginal birth. Written informed consent will be obtained. Women who consent to the patient preference study will be allocated their preference for either planned VBAC or planned, elective repeat caesarean. Women who consent to the randomised trial will be randomly allocated to either the planned vaginal birth after caesarean or planned elective repeat caesarean group. Treatment Groups: Women in the planned vaginal birth group will await spontaneous onset of labour whilst appropriate. Women in the elective repeat caesarean group will have this

  19. Ranibizumab for the Prevention of Radiation Complications in Patients Treated With Proton Beam Irradiation for Choroidal Melanoma (An American Ophthalmological Society Thesis)

    PubMed Central

    Kim, Ivana K.; Lane, Anne Marie; Jain, Purva; Awh, Caroline; Gragoudas, Evangelos S.

    2016-01-01

    Purpose: To investigate the safety and potential efficacy of ranibizumab for prevention of radiation complications in patients treated with proton irradiation for choroidal melanoma Methods: Forty patients with tumors located within 2 disc diameters of the optic nerve and/or macula were enrolled in this open-label study. Participants received ranibizumab 0.5 mg or 1.0 mg at tumor localization and every 2 months thereafter for the study duration of 24 months. The incidence of adverse events, visual acuity, and other measures of ocular morbidity related to radiation complications were assessed. Historical controls with similar follow-up meeting the eligibility criteria for tumor size, location, and baseline visual acuity were assembled for comparison. Results: Fifteen patients with large tumors and 25 patients with small/medium tumors were enrolled. Thirty-two patients completed the month 24 visit. No serious ocular or systemic adverse events related to ranibizumab were observed. At 24 months, the proportion of patients with visual acuity ≥ 20/200 was 30/31 (97%) in the study group versus 92/205 (45%) in historical controls (P < .001). The proportion of patients with visual acuity ≥20/40 was 24/31 (77%) in the study group versus 46/205 (22%) in controls at 24 months (P<.001). Clinical evidence of radiation maculopathy at month 24 was seen in 8/24 (33%) patients with small/medium tumors versus 42/62 (68%) of controls (P = .004). Three patients with large tumors developed metastases. Conclusions: In this small pilot study, prophylactic ranibizumab appears generally safe in patients treated with proton irradiation for choroidal melanoma. High rates of visual acuity retention were observed through 2 years.

  20. Multi-institutional Feasibility Study of a Fast Patient Localization Method in Total Marrow Irradiation With Helical Tomotherapy: A Global Health Initiative by the International Consortium of Total Marrow Irradiation

    SciTech Connect

    Takahashi, Yutaka; Vagge, Stefano; Agostinelli, Stefano; Han, Eunyoung; Matulewicz, Lukasz; Schubert, Kai; Chityala, Ravishankar; Ratanatharathorn, Vaneerat; Tournel, Koen; Penagaricano, Jose A.; Florian, Sterzing; Mahe, Marc-Andre; Verneris, Michael R.; Weisdorf, Daniel J.; and others

    2015-01-01

    Purpose: To develop, characterize, and implement a fast patient localization method for total marrow irradiation. Methods and Materials: Topographic images were acquired using megavoltage computed tomography (MVCT) detector data by delivering static orthogonal beams while the couch traversed through the gantry. Geometric and detector response corrections were performed to generate a megavoltage topogram (MVtopo). We also generated kilovoltage topograms (kVtopo) from the projection data of 3-dimensional CT images to reproduce the same geometry as helical tomotherapy. The MVtopo imaging dose and the optimal image acquisition parameters were investigated. A multi-institutional phantom study was performed to verify the image registration uncertainty. Forty-five MVtopo images were acquired and analyzed with in-house image registration software. Results: The smallest jaw size (front and backup jaws of 0) provided the best image contrast and longitudinal resolution. Couch velocity did not affect the image quality or geometric accuracy. The MVtopo dose was less than the MVCT dose. The image registration uncertainty from the multi-institutional study was within 2.8 mm. In patient localization, the differences in calculated couch shift between the registration with MVtopo-kVtopo and MVCT-kVCT images in lateral, cranial–caudal, and vertical directions were 2.2 ± 1.7 mm, 2.6 ± 1.4 mm, and 2.7 ± 1.1 mm, respectively. The imaging time in MVtopo acquisition at the couch speed of 3 cm/s was <1 minute, compared with ≥15 minutes in MVCT for all patients. Conclusion: Whole-body MVtopo imaging could be an effective alternative to time-consuming MVCT for total marrow irradiation patient localization.

  1. Transient engraftment of syngeneic bone marrow after conditioning with high-dose cyclophosphamide and thoracoabdominal irradiation in a patient with aplastic anemia

    SciTech Connect

    Matsue, K.; Niki, T.; Shiobara, S.; Ueda, M.; Ohtake, S.; Mori, T.; Matsuda, T.; Harada, M. )

    1990-01-01

    We describe the clinical course of a 16 year old girl with aplastic anemia who was treated by syngeneic bone marrow transplantation. Engraftment was not obtained by simple infusion of bone marrow without immunosuppression. The patient received a high-dose cyclophosphamide and thoracoabdominal irradiation, followed by second marrow transplantation from the same donor. Incomplete but significant hematologic recovery was observed; however, marrow failure recurred 5 months after transplantation. Since donor and recipient pairs were genotypically identical, graft failure could not be attributed to immunological reactivity of recipient cells to donor non-HLA antigens. This case report implies that graft failure in some cases of aplastic anemia might be mediated by inhibitory cells resistant to cyclophosphamide and irradiation.

  2. Treatment of refractory chronic demyelinating polyneuropathy with lymphoid irradiation

    SciTech Connect

    Rosenberg, N.L.; Lacy, J.R.; Kennaugh, R.C.; Holers, V.M.; Neville, H.E.; Kotzin, B.L.

    1985-03-01

    Four patients with refractory or poorly responsive chronic progressive demyelinating polyneuropathy (CPDP) were treated with total lymphoid irradiation (total dose, 2000 rad) in an uncontrolled feasibility study. All patients had previously failed conventional therapy for CPDP, as well as other unconventional treatments. During a follow-up period of 7 to 12 months after total lymphoid irradiation, there was a profound and sustained suppression of the absolute lymphocyte count and in vitro lymphocyte function, as well as an increase in the ratio of Leu-2 to Leu-3 T cells in the blood. Three of the four patients demonstrated improvement in distal muscle strength, and this was associated with increased functional capabilities in two patients. In contrast, no clinical improvement in sensation was noted in any patient. Nerve conduction studies showed patchy improvement in three patients. The results of this preliminary uncontrolled study indicate that radiotherapy deserves further study in the treatment of CPDP.

  3. Sequential half-body irradiation in childhood

    SciTech Connect

    Jenkin, R.D.T.; Berry, M.P.

    1983-12-01

    Single-dose half-body irradiation (HBI), introduced for the palliation of pain from widespread bone metastases in adults, has proved to be successful. The dose-limiting toxicity has proved to be acute radiation pneumonitis, with bone marrow tolerance of lesser importance, in spite of the fact that many patients received previous local irradiation and/or chemotherapy. Palliative HBI has not become a valuable treatment in pediatric malignancies, because of a shorter metastatic phase. Results are described in selected institutions, where HBI has been used in the treatment of pediatric malignancies. A single institution plot study was undertaken at the Princess Margaret Hospital involving 17 patients with Ewing's sarcoma of bone, without overt metastases at diagnosis. Results to date have not been obviously different from overall survival in the first intergroup Ewing's sarcoma study. Overall, the treatment has been shown to be well tolerated and can be given entirely on an out-patient basis. When compared on a historical basis with a previous single dose total body irradiation study, the one year survival rate was increased. HBI appears to be tolerable treatment, when given concurrently with or sequential to local and systemic treatment.

  4. Total Gross Tumor Volume Is an Independent Prognostic Factor in Patients Treated With Selective Nodal Irradiation for Stage I to III Small Cell Lung Cancer

    SciTech Connect

    Reymen, Bart; Van Loon, Judith; Baardwijk, Angela van; Wanders, Rinus; Borger, Jacques; Dingemans, Anne-Marie C.; Bootsma, Gerben; Pitz, Cordula; Lunde, Ragnar; Geraedts, Wiel; Lambin, Philippe; De Ruysscher, Dirk

    2013-04-01

    Purpose: In non-small cell lung cancer, gross tumor volume (GTV) influences survival more than other risk factors. This could also apply to small cell lung cancer. Methods and Materials: Analysis of our prospective database with stage I to III SCLC patients referred for concurrent chemo radiation therapy. Standard treatment was 45 Gy in 1.5-Gy fractions twice daily concurrently with carboplatin-etoposide, followed by prophylactic cranial irradiation (PCI) in case of non-progression. Only fluorodeoxyglucose (FDG)-positron emission tomography (PET)-positive or pathologically proven nodal sites were included in the target volume. Total GTV consisted of post chemotherapy tumor volume and pre chemotherapy nodal volume. Survival was calculated from diagnosis (Kaplan-Meier ). Results: A total of 119 patients were included between May 2004 and June 2009. Median total GTV was 93 ± 152 cc (7.5-895 cc). Isolated elective nodal failure occurred in 2 patients (1.7%). Median follow-up was 38 months, median overall survival 20 months (95% confidence interval = 17.8-22.1 months), and 2-year survival 38.4%. In multivariate analysis, only total GTV (P=.026) and performance status (P=.016) significantly influenced survival. Conclusions: In this series of stage I to III small cell lung cancer patients treated with FDG-PET-based selective nodal irradiation total GTV is an independent risk factor for survival.

  5. Longitudinal growth in children with non-Hodgkin's lymphoma and children with acute lymphoblastic leukemia: Comparison between unirradiated and irradiated patients

    SciTech Connect

    Marky, I.; Samuelsson, B.O.; Mellander, L.; Karlberg, J. )

    1991-01-01

    Longitudinal growth was studied in children treated for non-Hodgkin's lymphoma (NHL). The aim of the study was to compare these children's growth velocity with findings in a previous study we performed on age-matched children with acute lymphoblastic leukemia (ALL) who received cranial irradiation. Nine children with NHL with an onset time of treatment between 4 and 9 years of age (mean 6.5 years) were studied with annual body measurements taken from the time of the diagnosis and thereafter annually during the following 4 years. None of the children received cranial irradiation. During the first treatment year a significantly low mean height velocity was observed (-1.4 standard deviation score (SDS)) for the NHL group. The consecutive two 1 year periods showed a normalization of the mean height velocity. For the group of children with ALL, there was a more prominent negative effect on height during the first 2 years of treatment than for the NHL group in the present study. After the cessation of therapy, the children with NHL showed a reduced catch-up growth compared with the children with ALL. The explanation offered is that cranial irradiation has a heavier impact on growth than chemotherapy during the first 2 years of treatment, but an intense chemotherapy during the maintenance period could have a considerable impact in blunting growth.

  6. Modified total body irradiation as a planned second high-dose therapy with stem cell infusion for patients with bone-based malignancies

    SciTech Connect

    Zaucha, Renata E.; Buckner, Dean C.; Barnett, Todd; Holmberg, Leona A.; Gooley, Ted; Hooper, Heather A. P.A.-C.; Maloney, David G.; Appelbaum, Frederick; Bensinger, William I. . E-mail: wbensing@fhcrc.org

    2006-01-01

    Purpose: To estimate the maximum tolerated dose of hyperfractionated total marrow irradiation (TMI) as a second consolidation after high-dose chemotherapy with autologous or syngeneic blood stem cell transfusion for patients with bone/bone marrow-based malignant disease. Patients and Methods: Fifty-seven patients aged 3-65 years (median, 45 years), including 21 with multiple myeloma, 24 with breast cancer, 10 with sarcoma, and 2 with lymphoma, were treated with 1.5 Gy administered twice daily to a total dose of 12 Gy (n = 27), 13.5 Gy (n = 12), and 15 Gy (n = 18). Median time between the 2 transplants was 105 days (range, 63-162 days). Results: All patients engrafted neutrophils (median, Day 11; range, Day 9-23) and became platelet independent (median, Day 9; range, Day 7-36). There were 5 cases of Grade 3-4 regimen-related pulmonary toxicity, 1 at 12 Gy, and 4 at 15 Gy. Complete responses, partial responses, and stabilizations were achieved in 33%, 26%, and 41% of patients, respectively. Kaplan-Meier estimates of 5-year progression-free survival and overall survival for 56 evaluable patients are 24% and 36%, respectively. Median time of follow-up among survivors was 96 months (range, 77-136 months). Conclusion: Total marrow irradiation as a second myeloablative therapy is feasible. The estimated maximum tolerated dose for TMI in a tandem transplant setting was 13.5 Gy. Because 20% of patients are surviving at 8 years free of disease, further studies of TMI are warranted.

  7. Laboratory-Treated T Cells in Treating Patients With High-Risk Relapsed Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Previously Treated With Donor Stem Cell Transplant

    ClinicalTrials.gov

    2016-08-08

    Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Adult Myelodysplastic Syndrome; Childhood Myelodysplastic Syndrome; Previously Treated Myelodysplastic Syndrome; Recurrent Adult Acute Myeloid Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Secondary Acute Myeloid Leukemia; Therapy-Related Acute Myeloid Leukemia

  8. Contrast-Enhanced Ultrasound (CEUS) for Echographic Detection of Hepato Cellular Carcinoma in Cirrhotic Patients Previously Treated with Multiple Techniques: Comparison of Conventional US, Spiral CT and 3-Dimensional CEUS with Navigator Technique (3DNav CEUS).

    PubMed

    Giangregorio, Francesco

    2011-01-01

    A commercially available technique named "NAVIGATOR" (Esaote, Italy) easily enables a 3-D reconstruction of a single 2-D acquisition of Contrast Enhanced Ultrasound (CEUS) imaging of the whole liver (with a volumetric correction thanks to the electromagnetic device of NAVIGATOR). Aim of the study was to evaluate this "panoramic" technique in comparison with conventional US and spiral CT in the detection of new hepatic lesions. 144 cirrhotic patients (previously treated for hepato cellular carcinoma (HCC)) in follow-up with detection of 98 new nodules (N), 28 multinodular (Nmulti), 14 loco-regional regrowth (LR) 94 efficaciously treated without new nodules (neg) and four multinodular without new nodules, were submitted to 200 examinations with this new technique from November 2008 to November 2009. 3DNavCEUS was performed using SonoVue (Bracco), as contrast agent, and a machine (Technos MPX, Esaote). Spiral CT and 3DNav CEUS were performed in the same month during follow up. Sens.,Spec.,diagn.-Acc.,PPV and NPV were evaluated; comparison and differences between the techniques were obtained with chi-square (SPSS release-15). Final diagnosis was: 98 new lesions (N) (one to three), 28 multinodular HCC (Nmulti) and 14 loco-regional regrowth (LR); in 94 no more lesions were observed during follow-up; conventional US obtained: 58 N (+18 multinodularN and 8 LR), 40 false negative (+10 Nmulti and 6 LR) (sens:59.2, spec:100%, Diagn Accur:73.6, PPV:100; NPV:70.1); spiral CT obtained: 84N (+26-multinodularN and 14-LR), 14 false-negative (+2-Nmulti), and one false-positive (sens:85.7, spec:97.9%, Diagn Accur:90.9, PPV:97.7; NPV:86.8); 3DNAV obtained: 92N (+28 multinodularN and 14LR), 6 false-negative, and two false-positives (sens:93.9, spec:97.9%, Diagn Accur:95.6, PPV:97.9; NPV:93.9). 3-DNav CEUS is significantly better than US and almost similar to spiral CT for detection of new HCC. This technique, in particular, showed the presence of lesions even in the cases not detected

  9. Effect of high-intensity pulse irradiation with linear polarized near-infrared rays on muscle tone in patients with cerebrovascular disease: a randomized controlled trial.

    PubMed

    Takeuchi, Nobuyuki; Takezako, Nobuhiro; Shimonishi, Yuko; Usuda, Shigeru

    2015-12-01

    [Purpose] This study evaluated effects of a high-intensity linear polarized near-infrared ray irradiation for mitigation of muscle hypertonia. [Subjects] The subjects were 20 patients with cerebrovascular disease. [Methods] Subjects were randomly allocated to an intervention or control group. The intervention group received irradiation of the triceps surae. Passive range of motion and passive resistive joint torque of ankle dorsiflexion were measured before and after the intervention in knee extended and flexed positions. [Results] In the knee extended position, the mean changes in passive range of motion were 2.70° and -0.50° in the intervention and control groups, respectively, and the mean changes in passive resistive joint torque were -1.42 and -0.26 N·m in the intervention and control groups, respectively. In the knee flexed position, the mean changes in passive range of motion were 3.70° and 0.70° in the intervention and control groups, respectively, and the mean changes in passive resistive joint torque were -2.38 and -0.31 N·m in the intervention and control groups, respectively. In both knee positions, the mean changes in the two indices were greater in the intervention group than in the control group. [Conclusion] High-intensity linear polarized near-infrared ray irradiation increases passive range of motion and decreases passive resistive joint torque.

  10. Effect of high-intensity pulse irradiation with linear polarized near-infrared rays on muscle tone in patients with cerebrovascular disease: a randomized controlled trial

    PubMed Central

    Takeuchi, Nobuyuki; Takezako, Nobuhiro; Shimonishi, Yuko; Usuda, Shigeru

    2015-01-01

    [Purpose] This study evaluated effects of a high-intensity linear polarized near-infrared ray irradiation for mitigation of muscle hypertonia. [Subjects] The subjects were 20 patients with cerebrovascular disease. [Methods] Subjects were randomly allocated to an intervention or control group. The intervention group received irradiation of the triceps surae. Passive range of motion and passive resistive joint torque of ankle dorsiflexion were measured before and after the intervention in knee extended and flexed positions. [Results] In the knee extended position, the mean changes in passive range of motion were 2.70° and −0.50° in the intervention and control groups, respectively, and the mean changes in passive resistive joint torque were −1.42 and −0.26 N·m in the intervention and control groups, respectively. In the knee flexed position, the mean changes in passive range of motion were 3.70° and 0.70° in the intervention and control groups, respectively, and the mean changes in passive resistive joint torque were −2.38 and −0.31 N·m in the intervention and control groups, respectively. In both knee positions, the mean changes in the two indices were greater in the intervention group than in the control group. [Conclusion] High-intensity linear polarized near-infrared ray irradiation increases passive range of motion and decreases passive resistive joint torque. PMID:26834360

  11. Total body irradiation in a patient with fragile X syndrome for acute lymphoblastic leukemia in preparation for stem cell transplantation: A case report and literature review.

    PubMed

    Collins, D T; Mannina, E M; Mendonca, M

    2015-10-01

    Fragile X syndrome (FXS) is a congenital disorder caused by expansion of CGG trinucleotide repeat at the 5' end of the fragile X mental retardation gene 1 (FMR1) on the X chromosome that leads to chromosomal instability and diminished serum levels of fragile X mental retardation protein (FMRP). Afflicted individuals often have elongated features, marfanoid habitus, macroorchidism and intellectual impairment. Evolving literature suggests the condition may actually protect from malignancy while chromosomal instability would presumably elevate the risk. Increased sensitivity to ionizing radiation should also be predicted by unstable sites within the DNA. Interestingly, in this report, we detail a patient with FXS diagnosed with acute lymphoblastic leukemia treated with induction followed by subsequent cycles of hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, dexamethasone) with a complete response who then was recommended to undergo peripheral stem cell transplantation. The patient underwent total body irradiation (TBI) as a component of his conditioning regimen and despite the concern of his clinicians, developed minimal acute toxicity and successful engraftment. The pertinent literature regarding irradiation of patients with FXS is also reviewed.

  12. Total body irradiation in a patient with fragile X syndrome for acute lymphoblastic leukemia in preparation for stem cell transplantation: A case report and literature review.

    PubMed

    Collins, D T; Mannina, E M; Mendonca, M

    2015-10-01

    Fragile X syndrome (FXS) is a congenital disorder caused by expansion of CGG trinucleotide repeat at the 5' end of the fragile X mental retardation gene 1 (FMR1) on the X chromosome that leads to chromosomal instability and diminished serum levels of fragile X mental retardation protein (FMRP). Afflicted individuals often have elongated features, marfanoid habitus, macroorchidism and intellectual impairment. Evolving literature suggests the condition may actually protect from malignancy while chromosomal instability would presumably elevate the risk. Increased sensitivity to ionizing radiation should also be predicted by unstable sites within the DNA. Interestingly, in this report, we detail a patient with FXS diagnosed with acute lymphoblastic leukemia treated with induction followed by subsequent cycles of hyper-CVAD (cyclophosphamide, vincristine, doxorubicin, dexamethasone) with a complete response who then was recommended to undergo peripheral stem cell transplantation. The patient underwent total body irradiation (TBI) as a component of his conditioning regimen and despite the concern of his clinicians, developed minimal acute toxicity and successful engraftment. The pertinent literature regarding irradiation of patients with FXS is also reviewed. PMID:26097012

  13. Prospective computer-assisted voice analysis for patients with early stage glottic cancer: a preliminary report of the functional result of laryngeal irradiation.

    PubMed

    Harrison, L B; Solomon, B; Miller, S; Fass, D E; Armstrong, J; Sessions, R B

    1990-07-01

    In January 1987 we began a prospective study aimed at evaluating objective parameters of vocal function for all patients treated with RT for early glottic cancer. All patients underwent vocal analysis using a voice analyzer interfaced with a computer. This allowed for the determination of percent voicing (%V) (normal = presence of phonation = 90-100%V). Other parameters such as breathiness (air turbulence or hoarseness) and strain (vocal cord tension) were also measured. Patients were recorded before RT, weekly during RT, and at set intervals after RT. There have been 25 patients studied. Eighteen (18) are evaluable at 9 months after treatment. All patients were male and ranged from 45-84 years old. Fourteen (14) and T1 lesions and received 66 GY/33 fractions to their larynx and 4 had T2 tumors and received 66-70 Gy/33-35 fractions. To date, all patients are locally controlled. Three distinct patterns of %V changes have been encountered. However, all patients demonstrated normal phonation pattern by 3 months after RT, and this is sustained at 9 months follow-up. In addition, 94% of patients have had significant decrease in breathiness after RT, which objectively documents diminished hoarseness. In 83%, breathiness is normal after RT. Most patients have had increased strain after RT, which documents increased vocal cord tension. However, strain remained within normal limits in 89%. Our preliminary analysis suggests that the majority of patients irradiated for early glottic cancer demonstrate a decrease in breathiness and an increase in strain after RT, and enjoy a resultant voice that has normal phonation maintained at 9 months after RT. Our data also demonstrate three distinct phonation patterns. Further follow-up will allow us to determine the prognostic significance, if any, of these patterns, and to continue to follow objective vocal parameters on larger numbers of patient. PMID:2380077

  14. Sarcoma of bone following therapeutic irradiation for breast carcinoma

    SciTech Connect

    Doherty, M.A.; Rodger, A.; Langlands, A.O.

    1986-01-01

    Four patients with sarcoma arising in bone following therapeutic irradiation for breast carcinoma are presented, along with a review of the 40 patients who have been previously reported in the literature. The majority of these lesions arose in the scapula and the most frequently reported histology is osteosarcoma. The incidence of these lesions has been reported as 0.05% to 0.23% in three previous series. The average latent period between irradiation and the diagnosis of the sarcoma is 10.9 years with a range of 4.5-24 years. The average survival following diagnosis in this series was 2.4 months, which is comparable to other series. However, one patient treated by forequarter amputation and another treated by chemotherapy and radiotherapy survived 4 and 3 years, respectively.

  15. [Postoperative radiotherapy in patients with invasive uterine cervix cancer treated previously with simple hysterectomy. Results from the Hospital de Oncología, Centro Médico Nacional SXXI. ].

    PubMed

    Huerta Bahena, Judith; Labastida Almendaro, Sonia; Cortez Arroyo, Héctor; Calva, Angel

    2003-06-01

    Invasive carcinoma found after simple hysterectomy for several causes is an increasing clinical condition. That situation results in the necessity for further therapy: re-operation or radiotherapy. The purpose of this review is to analyze our results with postoperative radiotherapy for these patients. In 1998, 59 patients were submitted to postoperative radiotherapy at the Oncology Hospital, Medical Cancer Center for invasive cervical cancer found after simple hysterectomy for several causes. All patients had postoperative radiotherapy, the dose depended of the magnitude of residual disease after surgery (range 10-80 Gy). After surgery 27 patients had gross residual disease; and no residual disease or microscopic disease was present in 32 patients. Three years overall survival rate was 59% for the whole group. With the results of the univariate analysis, prognostic factors found that significantly affect disease free survival were interval between hysterectomy and radiotherapy of more than 6 months, radiotherapy dose less than 50 Grays and histology. With multivariate analysis only presence of gross residual disease affect significantly disease free survival p = 0.0000. Postoperative radiotherapy results in patients with invasor cervical cancer incidentally found in hysterectomy specimens with minimal residual disease are excellent. However with the presence of more extensive residual disease the results in disease free survival are worse than those obtained in patients with similar stages who had not been treated with hysterectomy. A well established diagnostic procedure must be done in all patients candidates to simple hysterectomy.

  16. Overall Survival and Long-Term Safety of Nivolumab (Anti–Programmed Death 1 Antibody, BMS-936558, ONO-4538) in Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer

    PubMed Central

    Gettinger, Scott N.; Horn, Leora; Gandhi, Leena; Spigel, David R.; Antonia, Scott J.; Rizvi, Naiyer A.; Powderly, John D.; Heist, Rebecca S.; Carvajal, Richard D.; Jackman, David M.; Sequist, Lecia V.; Smith, David C.; Leming, Philip; Carbone, David P.; Pinder-Schenck, Mary C.; Topalian, Suzanne L.; Hodi, F. Stephen; Sosman, Jeffrey A.; Sznol, Mario; McDermott, David F.; Pardoll, Drew M.; Sankar, Vindira; Ahlers, Christoph M.; Salvati, Mark; Wigginton, Jon M.; Hellmann, Matthew D.; Kollia, Georgia D.; Gupta, Ashok K.; Brahmer, Julie R.

    2015-01-01

    Purpose Programmed death 1 is an immune checkpoint that suppresses antitumor immunity. Nivolumab, a fully human immunoglobulin G4 programmed death 1 immune checkpoint inhibitor antibody, was active and generally well tolerated in patients with advanced solid tumors treated in a phase I trial with expansion cohorts. We report overall survival (OS), response durability, and long-term safety in patients with non–small-cell lung cancer (NSCLC) receiving nivolumab in this trial. Patients and Methods Patients (N = 129) with heavily pretreated advanced NSCLC received nivolumab 1, 3, or 10 mg/kg intravenously once every 2 weeks in 8-week cycles for up to 96 weeks. Tumor burden was assessed by RECIST (version 1.0) after each cycle. Results Median OS across doses was 9.9 months; 1-, 2-, and 3-year OS rates were 42%, 24%, and 18%, respectively, across doses and 56%, 42%, and 27%, respectively, at the 3-mg/kg dose (n = 37) chosen for further clinical development. Among 22 patients (17%) with objective responses, estimated median response duration was 17.0 months. An additional six patients (5%) had unconventional immune-pattern responses. Response rates were similar in squamous and nonsquamous NSCLC. Eighteen responding patients discontinued nivolumab for reasons other than progressive disease; nine (50%) of those had responses lasting > 9 months after their last dose. Grade 3 to 4 treatment-related adverse events occurred in 14% of patients. Three treatment-related deaths (2% of patients) occurred, each associated with pneumonitis. Conclusion Nivolumab monotherapy produced durable responses and encouraging survival rates in patients with heavily pretreated NSCLC. Randomized clinical trials with nivolumab in advanced NSCLC are ongoing. PMID:25897158

  17. Patient selection for partial breast irradiation by intraoperative radiation therapy: can magnetic resonance imaging be useful?—perspective from radiation oncology point of view

    PubMed Central

    Pisani, Carla; Deantonio, Letizia

    2016-01-01

    The guidelines of the European and American Societies of Radiation Oncology (GEC-ESTRO and ASTRO) defined the selection criteria to offer partial breast irradiation (PBI) after lumpectomy in patients with low risk breast cancer regardless pre-operative staging. A recent publication by Tallet et al. explored the impact of preoperative magnetic resonance imaging (MRI) on patient eligibility for PBI. From their study, an ipsilateral BC was detected in 4% of patients, excluding these patients from intraoperative radiotherapy (IORT). The authors suggested that preoperative MRI should be used routinely for patient’s candidate to IORT, because of the rate of ipsilateral breast cancer detected. In view of Tallet’s article, we analyzed some aspects of this issue in order to envisage some possible perspective on how to better identify those patients who could benefit from PBI, especially using IORT. From historical studies, the risk of breast cancer recurrence outside index quadrant without irradiation is in the range of 1.5–3.5%. MRI sensitivity for detection of invasive cancer is reported up to 100%, and it is particularly useful in dense breast. Other imaging technique did not achieve the same sensibility and specificity as conventional MRI. Of note, none of randomized trials published and ongoing on PBI included preoperative MRI as part of staging. To perform a preoperative MRI in PBI setting is an interesting issue, but the available data suggest that this issue should be preferably studied in the setting of prospective clinical trials to clarify the role of MRI and the clinical meaning of the discovered additional foci. PMID:27747042

  18. Protocol for PIT: a phase III trial of prophylactic irradiation of tracts in patients with malignant pleural mesothelioma following invasive chest wall intervention

    PubMed Central

    Bayman, N; Ardron, D; Ashcroft, L; Baldwin, D R; Booton, R; Darlison, L; Edwards, J G; Lang-Lazdunski, L; Lester, J F; Peake, M; Rintoul, R C; Snee, M; Taylor, P; Lunt, C

    2016-01-01

    Introduction Histological diagnosis of malignant mesothelioma requires an invasive procedure such as CT-guided needle biopsy, thoracoscopy, video-assisted thorascopic surgery (VATs) or thoracotomy. These invasive procedures encourage tumour cell seeding at the intervention site and patients can develop tumour nodules within the chest wall. In an effort to prevent nodules developing, it has been widespread practice across Europe to irradiate intervention sites postprocedure—a practice known as prophylactic irradiation of tracts (PIT). To date there has not been a suitably powered randomised trial to determine whether PIT is effective at reducing the risk of chest wall nodule development. Methods and analysis In this multicentre phase III randomised controlled superiority trial, 374 patients who can receive radiotherapy within 42 days of a chest wall intervention will be randomised to receive PIT or no PIT. Patients will be randomised on a 1:1 basis. Radiotherapy in the PIT arm will be 21 Gy in three fractions. Subsequent chemotherapy is given at the clinicians’ discretion. A reduction in the incidence of chest wall nodules from 15% to 5% in favour of radiotherapy 6 months after randomisation would be clinically significant. All patients will be followed up for up to 2 years with monthly telephone contact and at least four outpatient visits in the first year. Ethics and dissemination PIT was approved by NRES Committee North West—Greater Manchester West (REC reference 12/NW/0249) and recruitment is currently on-going, the last patient is expected to be randomised by the end of 2015. The analysis of the primary end point, incidence of chest wall nodules 6 months after randomisation, is expected to be published in 2016 in a peer reviewed journal and results will also be presented at scientific meetings and summary results published online. A follow-up analysis is expected to be published in 2018. Trial registration number ISRCTN04240319; NCT01604005; Pre

  19. [Effect of proton irradiation of the hypophysis on its gonadotropic and thyrotropic functions in patients with prolactinoma].

    PubMed

    Isakov, A V; Konnov, B A; Potin, V V; Svechnikova, F A; Tkachenko, N N

    1988-01-01

    In order to study the effect of proton beam irradiation on prolactinoma cells and hypophyseal intact cells tests with i.v. administration of TRH (200 micrograms) and LH-RH (100 micrograms) were performed in 16 women with prolactin-secreting adenomas before and in 2 mos.-2 years after irradiation of the pituitary body with a high energy narrow proton beam (1000 MeV) at a dose of 40-120 Gy. A curative therapeutic effect of proton therapy which was low with respect to reproductive function recovery, was combined with lowered functional reserves of hypophyseal thyrotrophs and gonadotrophs. The informative value of the tests with the releasing hormones was shown for the determination of damage of hypophyseal intact cells. The results suggest refractivity of adenomatous lactotrophs to radiation exposure and the hypothalamic level of disorder of ovarian function regulation in this pathology.

  20. Bendamustine in combination with rituximab for elderly patients with previously untreated B-cell chronic lymphocytic leukemia: A retrospective analysis of real-life practice in Italian hematology departments.

    PubMed

    Laurenti, Luca; Innocenti, Idanna; Autore, Francesco; Vannata, Barbara; Efremov, Dimitar G; Ciolli, Stefania; Del Poeta, Giovanni; Mauro, Francesca Romana; Cortelezzi, Agostino; Borza, Paola Anticoli; Ghio, Francesco; Mondello, Patrizia; Murru, Roberta; Gozzetti, Alessandro; Cariccio, Maria Rosa Lanza; Piccirillo, Nicola; Boncompagni, Riccardo; Cantonetti, Maria; Principe, Maria Ilaria Del; Reda, Gianluigi; Bongarzoni, Velia; Cervetti, Giulia; Pitini, Vincenzo; Foà, Robin; Sica, Simona; D'Arena, Giovanni

    2015-10-01

    The front-line therapy for CLL young and fit patients is chemo-immunotherapy with fludarabine-cyclophosphamide-rituximab (FCR). FCR regimen results in a significant myelosuppression and high rates of early and late infections especially in elderly patients. German CLL study group compared FCR vs. bendamustine-rituximab (BR) in fit untreated patients. The response rates with BR or FCR were comparable, BR could be an alternative 1st-line treatment for elderly patients. Here we report retrospective data of 70 elderly (≥65 years) CLL patients from 12 Italian centers treated with BR as front-line therapy. The primary end points were overall response rate (complete remission/partial remission) and safety. Forty-seven males and 23 females, with a median age of 72 years, were included in the study. Eight patients were unfit for CIRS. The OR rate was 88.6% (31.4% CR and 57.2% PR). Progression free survival, treatment free survival and overall survival rates at 2-years were 79%, 90.3% and 89.6%, respectively. Only del17 was independent unfavorable parameter on the response rate and PFS. Our results indicate that BR front-line at standard dose provides a high response rate with a good safety profile, even if more than 50% of patients experienced a bendamustine dose reduction until 70 mg/m2. PMID:26307523

  1. Radiation Pneumonitis in Association with Internal Mammary Node Irradiation in Breast Cancer Patients: An Ancillary Result from the KROG 08-06 Study

    PubMed Central

    Choi, Jinhyun; Kim, Yong Bae; Shin, Kyung Hwan; Ahn, Sung-Ja; Lee, Hyung-Sik; Park, Won; Kim, Su Ssan; Kim, Jin Hee; Lee, Kyu Chan; Kim, Dong Won; Suh, Hyun Suk; Park, Kyung Ran; Shin, Hyun Soo

    2016-01-01

    Purpose The aim of this study is to present the incidence of radiation pneumonitis (RP) reported within 6 months after treatment for breast cancer with or without internal mammary node irradiation (IMNI). Methods In the Korean Radiation Oncology Group (KROG) 08-06 phase III randomized trial, patients who were node-positive after surgery were randomly assigned to receive radiotherapy either with or without IMNI. A total of 747 patients were enrolled, and three-dimensional treatment planning with computed tomography simulation was performed for all patients. Of the 747 patients, 722 underwent chest X-rays before and within 6 months after radiotherapy. These 722 patients underwent evaluation, and RP was diagnosed on the basis of chest radiography findings and clinical symptoms. The relationship between the incidence of RP and clinical/dosimetric parameters was analyzed. Results RP developed in 35 patients (4.8%), including grade 1 RP in 26 patients (3.6%), grade 2 RP in nine patients (1.2%); there was no incidence of grade 3 or higher RP. Grade 2 RP cases were observed in only the IMNI group. The risk of developing RP was influenced by IMNI treatment; pneumonitis occurred in 6.5% of patients (n=23/356) who underwent IMNI and in 3.3% of patients (n=12/366) who did not (p=0.047). The differences in lung dosimetric parameters (mean lung dose, V10–40) were statistically significant between the two groups. Conclusion IMNI treatment resulted in increased radiation exposure to the lung and a higher rate of RP, but the incidence and severity of RP was minimal and acceptable. This minor impact on morbidity should be balanced with the impact on survival outcome in future analyses. PMID:27721877

  2. Safety and efficacy of total body irradiation, cyclophosphamide, and cytarabine as a conditioning regimen for allogeneic hematopoietic stem cell transplantation in patients with acute lymphoblastic leukemia.

    PubMed

    Mori, Takehiko; Aisa, Yoshinobu; Kato, Jun; Yamane, Akiko; Nakazato, Tomonori; Shigematsu, Naoyuki; Okamoto, Shinichiro

    2012-04-01

    Disease relapse still greatly interferes with the success of allogeneic hematopoietic stem cell transplantation (HSCT) for acute lymphoblastic leukemia (ALL). This study retrospectively evaluated the long-term safety and efficacy of a conditioning regimen consisting of total body irradiation (TBI; 12 Gy), cyclophosphamide (CY; 60 mg kg(-1) , two doses), and high-dose cytarabine (Ara-C; 2 g m(-2) ; four doses) for patients with ALL. Fifty-five patients (median age: 31-years old) were evaluated. Stem cells were from human leukocyte antigen-identical siblings in 22 patients and from alternative donors in 33. There were no cases of early death before engraftment, and 100-day transplant-related mortality was 7.3%. With a median follow-up period of 9.6 years, 5-year overall and disease-free survival were 63.2% (95% CI: 46.5-79.9%) and 63.6% (95% CI: 47.1-80.1%) in patients with complete remission, respectively, both of which were significantly higher than the values of 27.3% (95% CI: 8.7-46.0%) and 22.7% (95% CI: 5.3-40.1%) for patients in advanced stages (P < 0.01). These results suggest that TBI and CY (TBI-CY) plus Ara-C could be a feasible and effective conditioning regimen for adult patients with ALL both in remission and in advanced stages, and a future study to compare this combination therapy with TBI-CY is required.

  3. Interim Cosmetic Results and Toxicity Using 3D Conformal External Beam Radiotherapy to Deliver Accelerated Partial Breast Irradiation in Patients With Early-Stage Breast Cancer Treated With Breast-Conserving Therapy

    SciTech Connect

    Vicini, Frank A. Chen, Peter; Wallace, Michelle; Mitchell, Christina; Hasan, Yasmin; Grills, Inga; Kestin, Larry; Schell, Scott; Goldstein, Neal S.; Kunzman, Jonathan; Gilbert, Sam; Martinez, Alvaro

    2007-11-15

    Purpose: We present our ongoing clinical experience utilizing three-dimensional (3D)-conformal radiation therapy (3D-CRT) to deliver accelerated partial breast irradiation (APBI) in patients with early-stage breast cancer treated with breast-conserving therapy. Methods and Materials: Ninety-one consecutive patients were treated with APBI using our previously reported 3D-CRT technique. The clinical target volume consisted of the lumpectomy cavity plus a 10- to 15 -mm margin. The prescribed dose was 34 or 38.5 Gy in 10 fractions given over 5 consecutive days. The median follow-up was 24 months. Twelve patients have been followed for {>=}4 years, 20 for {>=}3.5 years, 29 for >3.0 years, 33 for {>=}2.5 years, and 46 for {>=}2.0 years. Results: No local recurrences developed. Cosmetic results were rated as good/excellent in 100% of evaluable patients at {>=} 6 months (n = 47), 93% at 1 year (n = 43), 91% at 2 years (n = 21), and in 90% at {>=}3 years (n = 10). Erythema, hyperpigmentation, breast edema, breast pain, telangiectasias, fibrosis, and fat necrosis were evaluated at 6, 24, and 36 months after treatment. All factors stabilized by 3 years posttreatment with grade I or II rates of 0%, 0%, 0%, 0%, 9%, 18%, and 9%, respectively. Only 2 patients (3%) developed grade III toxicity (breast pain), which resolved with time. Conclusions: Delivery of APBI with 3D-CRT resulted in minimal chronic ({>=}6 months) toxicity to date with good/excellent cosmetic results. Additional follow-up is needed to assess the long-term efficacy of this form of APBI.

  4. Lymphoid irradiation in intractable rheumatoid arthritis. Long-term followup of patients treated with 750 rads or 2,000 rads

    SciTech Connect

    Soden, M.; Hassan, J.; Scott, D.L.; Hanly, J.G.; Moriarty, M.; Whelan, A.; Feighery, C.; Bresnihan, B.

    1989-05-01

    Twenty patients with intractable rheumatoid arthritis were randomized to receive 750 or 2,000 rads of lymphoid irradiation (LI) in a double-blind comparative study, and were followed for a maximum of 48 months (mean 40 months) after treatment. During followup, sustained immunomodulation (including lymphopenia, particularly of the T helper cell subset; reduced ratio of helper cells to suppressor cells; and impaired in vitro lymphocyte proliferation in response to phytohemagglutinin and pokeweed mitogen) was observed. Significant improvements in early morning stiffness, Ritchie articular index, pain score, grip strength, and 15-meter walk time were observed in both treatment groups, but these were not sustained through the followup period. Progressive joint damage was observed radiologically in both groups during followup. Thus, LI induced sustained immunosuppression, but resulted in only short-lived clinical improvement and was associated with progressive joint erosion in these patients.

  5. Phase II Trial of Pre-Irradiation and Concurrent Temozolomide in Patients with Newly Diagnosed Anaplastic Oligodendrogliomas and Mixed Anaplastic Oligoastrocytomas: Long Term Results of RTOG BR0131

    PubMed Central

    Vogelbaum, Michael A.; Hu, Chen; Peereboom, David M.; Macdonald, David R.; Giannini, Caterina; Suh, John H.; Jenkins, Robert B.; Laack, Nadia N.; Brachman, David G.; Shrieve, Dennis C.; Souhami, Luis; Mehta, Minesh P.

    2015-01-01

    BACKGROUND We report on the long-term results of a phase II study of pre-irradiation temozolomide followed by concurrent temozolomide and radiotherapy (RT) in patients with newly diagnosed anaplastic oligodendroglioma (AO) and mixed anaplastic oligoastrocytoma (MOA). METHODS Pre-RT temozolomide was given for up to 6 cycles. RT with concurrent temozolomide was administered to patients with less than a complete radiographic response. RESULTS Forty eligible patients were entered and 32 completed protocol treatment. With a median follow-up time of 8.7 years (range: 1.1 to 10.1), median progression-free survival (PFS) is 5.8 years (95% C.I. 2.0, NR) and median overall survival (OS) has not been reached (5.9, NR). 1p/19q data are available in 37 cases; 23 tumors had codeletion while 14 tumors had no loss or loss of only 1p or 19q (non-codeleted). In codeleted patients, 9 patients have progressed and 4 have died; neither median PFS nor OS have been reached and two patients who received only pre-RT temozolomide and no RT have remained progression-free for over 7 years. 3-year PFS and 6-year OS are 78% (95% CI: 61-95%) and 83% (95% CI: 67-98%), respectively. Codeleted patients show a trend towards improved 6-year survival when compared to the codeleted procarbazine/CCNU/vincristrine (PCV) and RT cohort in RTOG 9402 (67%, 95% CI:55-79%). For non-codeleted patients, median PFS and OS are 1.3 and 5.8 years, respectively. CONCLUSIONS These updated results suggest that the regimen of dose intense, pre-RT temozolomide followed by concurrent RT/temozolomide has significant activity, particularly in patients with 1p/19q codeleted AOs and MAOs. PMID:26088460

  6. Similar Survival for Patients Undergoing Reduced-Intensity Total Body Irradiation (TBI) Versus Myeloablative TBI as Conditioning for Allogeneic Transplant in Acute Leukemia

    SciTech Connect

    Mikell, John L.; Waller, Edmund K.; Switchenko, Jeffrey M.; Rangaraju, Sravanti; Ali, Zahir; Graiser, Michael; Hall, William A.; Langston, Amelia A.; Esiashvili, Natia; Khoury, H. Jean; Khan, Mohammad K.

    2014-06-01

    Purpose: Hematopoietic stem cell transplantation (HSCT) is the mainstay of treatment for adults with acute leukemia. Total body irradiation (TBI) remains an important part of the conditioning regimen for HCST. For those patients unable to tolerate myeloablative TBI (mTBI), reduced intensity TBI (riTBI) is commonly used. In this study we compared outcomes of patients undergoing mTBI with those of patients undergoing riTBI in our institution. Methods and Materials: We performed a retrospective review of all patients with acute leukemia who underwent TBI-based conditioning, using a prospectively acquired database of HSCT patients treated at our institution. Patient data including details of the transplantation procedure, disease status, Karnofsky performance status (KPS), response rates, toxicity, survival time, and time to progression were extracted. Patient outcomes for various radiation therapy regimens were examined. Descriptive statistical analysis was performed. Results: Between June 1985 and July 2012, 226 patients with acute leukemia underwent TBI as conditioning for HSCT. Of those patients, 180 had full radiation therapy data available; 83 had acute lymphoblastic leukemia and 94 had acute myelogenous leukemia; 45 patients received riTBI, and 135 received mTBI. Median overall survival (OS) was 13.7 months. Median relapse-free survival (RFS) for all patients was 10.2 months. Controlling for age, sex, KPS, disease status, and diagnosis, there were no significant differences in OS or RFS between patients who underwent riTBI and those who underwent mTBI (P=.402, P=.499, respectively). Median length of hospital stay was shorter for patients who received riTBI than for those who received mTBI (16 days vs 23 days, respectively; P<.001), and intensive care unit admissions were less frequent following riTBI than mTBI (2.22% vs 12.69%, respectively, P=.043). Nonrelapse survival rates were also similar (P=.186). Conclusions: No differences in OS or RFS were seen between

  7. Phase III, Randomized, Open-Label Study of Daily Imatinib Mesylate 400 mg Versus 800 mg in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase Using Molecular End Points: Tyrosine Kinase Inhibitor Optimization and Selectivity Study

    PubMed Central

    Cortes, Jorge E.; Baccarani, Michele; Guilhot, François; Druker, Brian J.; Branford, Susan; Kim, Dong-Wook; Pane, Fabrizio; Pasquini, Ricardo; Goldberg, Stuart L.; Kalaycio, Matt; Moiraghi, Beatriz; Rowe, Jacob M.; Tothova, Elena; De Souza, Carmino; Rudoltz, Marc; Yu, Richard; Krahnke, Tillmann; Kantarjian, Hagop M.; Radich, Jerald P.; Hughes, Timothy P.

    2010-01-01

    Purpose To evaluate the safety and efficacy of initial treatment with imatinib mesylate 800 mg/d (400 mg twice daily) versus 400 mg/d in patients with newly diagnosed chronic myeloid leukemia in chronic phase. Patients and Methods A total of 476 patients were randomly assigned 2:1 to imatinib 800 mg (n = 319) or 400 mg (n = 157) daily. The primary end point was the major molecular response (MMR) rate at 12 months. Results At 12 months, differences in MMR and complete cytogenetic response (CCyR) rates were not statistically significant (MMR, 46% v 40%; P = .2035; CCyR, 70% v 66%; P = .3470). However, MMR occurred faster among patients randomly assigned to imatinib 800 mg/d, who had higher rates of MMR at 3 and 6 months compared with those in the imatinib 400-mg/d arm (P = .0035 by log-rank test). CCyR also occurred faster in the 800-mg/d arm (CCyR at 6 months, 57% v 45%; P = .0146). The most common adverse events were edema, gastrointestinal problems, and rash, and all were more common in patients in the 800-mg/d arm. Grades 3 to 4 hematologic toxicity also occurred more frequently in patients receiving imatinib 800 mg/d. Conclusion MMR rates at 1 year were similar with imatinib 800 mg/d and 400 mg/d, but MMR and CCyR occurred earlier in patients treated with 800 mg/d. Continued follow-up is needed to determine the clinical significance of earlier responses on high-dose imatinib. PMID:20008622

  8. Relationship between HER2 expression and efficacy with first-line trastuzumab emtansine compared with trastuzumab plus docetaxel in TDM4450g: a randomized phase II study of patients with previously untreated HER2-positive metastatic breast cancer

    PubMed Central

    2014-01-01

    Introduction The purpose of this study was to retrospectively explore the relationship between human epidermal growth factor receptor 2 (HER2) messenger RNA (mRNA) expression and efficacy in patients receiving trastuzumab plus docetaxel (HT) or trastuzumab emtansine (T-DM1). Methods Patients with HER2-positive, locally advanced or metastatic breast cancer (MBC) were randomly assigned to HT (n = 70) or T-DM1 (n = 67). HER2 status was assessed locally using immunohistochemistry or fluorescence in situ hybridization and confirmed retrospectively by central testing. HER2 mRNA expression was assessed using quantitative reverse transcriptase polymerase chain reaction. Results HER2 mRNA levels were obtained for 116/137 patients (HT = 61; T-DM1 = 55). Median pretreatment HER2 mRNA was 8.9. The risk of disease progression in the overall population was lower with T-DM1 than with HT (hazard ratio (HR) = 0.59; 95% confidence interval (CI) 0.36 to 0.97). This effect was more pronounced in patients with HER2 mRNA ≥ median (HR = 0.39; 95% CI 0.18 to 0.85) versus < median (HR = 0.85; 95% CI 0.44 to 1.67). In the T-DM1 arm, median progression-free survival (PFS) was not reached in patients with HER2 mRNA ≥ median and was 10.6 months in patients with HER2 mRNA < median. In the HT arm, PFS was 8.8 versus 9.8 months in patients with HER2 mRNA ≥ median versus < median, respectively. The effect of HER2 mRNA expression on objective response rates was less pronounced. Conclusions This exploratory analysis suggests that while overall, patients with HER2-positive MBC show improved PFS with T-DM1 relative to HT, the effect is enhanced in patients with tumor HER2 mRNA ≥ median. Trial registration ClinicalTrials.gov NCT00679341 PMID:24887458

  9. Comparison of two treatment strategies for irradiation of regional lymph nodes in patients with breast cancer: Lymph flow guided portals versus standard radiation fields

    PubMed Central

    Novikov, Sergey Nikolaevich; Kanaev, Sergey Vasilevich; Semiglazov, Vladimir Fedorovich; Jukova, Ludmila Alekseevna; Krzhivitckiy, Pavel Ivanovich

    2014-01-01

    Aim and Background Radiotherapy being an essential part of breast cancer treatment, we evaluate various radiotherapy strategies in patients with breast cancer. Materials and methods Lymph node (LN) scintigraphy was performed in 172 primary patients with BC. LN visualization started 30–360 min after intratumoral injection of 75–150 MBq of 99mTc-nanocolloids. Our standard recommendation for postoperative radiotherapy in patients with LN invasion by BC were as follows: for patients with external localization of tumour – breast + axillary (Ax) + sub-supraclavicular (SSCL) regions; with internal localization – all above + internal mammary nodes (IM). Proposed strategy of lymph flow guided radiotherapy is based on the assumption that only regions that contain ‘hot’ LNs must be included in a treatment volume. Results Among 110 patients with external localization of BC, Ax LNs were visualized in all cases and in 62 patients it was the only region with ‘hot’ LN. Twenty-three patients (20.9%) had drainage to Ax + SSCL, 12 (10.9%) – Ax + IM, 13 (11.8%) – Ax + SSCL + IM regions. After the visualization of lymph flow patterns, standard treatment volume was changed in 87/110 cases (79.1%): in 56.4%, reduced, in 22.7%, enlarged or changed. In 62 patients with tumours in internal quadrants, we revealed the following patterns of lymph-flow: only to the Ax region in 23 (37.1%); Ax + IM, 13 (21%); Ax + SSCL, 15 (24.2%); Ax + IM + ISSCL, 11 (17.7%) cases. After lymph-flow visualization, the standard irradiation volume was reduced in 53/62 (85.5%) cases. Conclusion Visualization of an individual lymph flow pattern from BC can be used for the optimization of standard fields used for irradiation of regional LNs. PMID:25535581

  10. Transforming Growth Factor β-1 (TGF-β1) Is a Serum Biomarker of Radiation Induced Fibrosis in Patients Treated With Intracavitary Accelerated Partial Breast Irradiation: Preliminary Results of a Prospective Study

    SciTech Connect

    Boothe, Dustin L.; Coplowitz, Shana; Greenwood, Eleni; Barney, Christian L.; Christos, Paul J.; Parashar, Bhupesh; Nori, Dattatreyudu; Chao, K. S. Clifford; Wernicke, A. Gabriella

    2013-12-01

    Purpose: To examine a relationship between serum transforming growth factor β -1 (TGF-β1) values and radiation-induced fibrosis (RIF). Methods and Materials: We conducted a prospective analysis of the development of RIF in 39 women with American Joint Committee on Cancer stage 0-I breast cancer treated with lumpectomy and accelerated partial breast irradiation via intracavitary brachytherapy (IBAPBI). An enzyme-linked immunoassay (Quantikine, R and D, Minneapolis, MN) was used to measure serum TGF-β1 before surgery, before IBAPBI, and during IBAPBI. Blood samples for TGF-β1 were also collected from 15 healthy, nontreated women (controls). The previously validated tissue compliance meter (TCM) was used to objectively assess RIF. Results: The median time to follow-up for 39 patients was 44 months (range, 5-59 months). RIF was graded by the TCM scale as 0, 1, 2, and 3 in 5 of 20 patients (25%), 6 of 20 patients (30%), 5 of 20 patients (25%), and 4 of 20 patients (20%), respectively. The mean serum TGF-β1 values were significantly higher in patients before surgery than in disease-free controls, as follows: all cancer patients (30,201 ± 5889 pg/mL, P=.02); patients with any type of RIF (32,273 ± 5016 pg/mL, P<.0001); and women with moderate to severe RIF (34,462 ± 4713 pg/mL, P<0.0001). Patients with moderate to severe RIF had significantly elevated TGF-β1 levels when compared with those with none to mild RIF before surgery (P=.0014) during IBAPBI (P≤0001), and the elevation persisted at 6 months (P≤.001), 12 months (P≤.001), 18 months (P≤.001), and 24 months (P=.12). A receiver operating characteristic (ROC) curve of TGF-β1 values predicting moderate to severe RIF was generated with an area under the curve (AUC){sub ROC} of 0.867 (95% confidence interval 0.700-1.000). The TGF-β1 threshold cutoff was determined to be 31,000 pg/mL, with associated sensitivity and specificity of 77.8% and 90.0%, respectively. Conclusions: TGF-β1 levels correlate with

  11. Increased Detection of Lymphatic Vessel Invasion by D2-40 (Podoplanin) in Early Breast Cancer: Possible Influence on Patient Selection for Accelerated Partial Breast Irradiation

    SciTech Connect

    Debald, Manuel; Poelcher, Martin; Flucke, Uta; Walgenbach-Bruenagel, Gisela

    2010-07-15

    Purpose: Several international trials are currently investigating accelerated partial breast irradiation (APBI) for patients with early-stage breast cancer. According to existing guidelines, patients with lymphatic vessel invasion (LVI) do not qualify for APBI. D2-40 (podoplanin) significantly increases the frequency of LVI detection compared with conventional hematoxylin and eosin (HE) staining in early-stage breast cancer. Our purpose was to retrospectively assess the hypothetical change in management from APBI to whole breast radiotherapy with the application of D2-40. Patients and Methods: Immunostaining with D2-40 was performed on 254 invasive breast tumors of 247 patients. The following criteria were used to determine the eligibility for APBI: invasive ductal adenocarcinoma of {<=}3 cm, negative axillary node status (N0), and unifocal disease. Of the 247 patients, 74 with available information concerning LVI, as detected by D2-40 immunostaining and routine HE staining, formed our study population. Results: Using D2-40, our results demonstrated a significantly greater detection rate (p = .031) of LVI compared with routine HE staining. LVI was correctly identified by D2-40 (D2-40-positive LVI) in 10 (13.5%) of 74 tumors. On routine HE staining, 4 tumors (5.4%) were classified as HE-positive LVI. Doublestaining of these specimens with D2-40 unmasked false-positive LVI status in 2 (50%) of the 4 tumors. According to the current recommendations for APBI, immunostaining with D2-40 would have changed the clinical management from APBI to whole breast radiotherapy in 8 (10.8%) of 74 patients and from whole breast radiotherapy to APBI in 2 patients (2.7%). Conclusion: These data support the implementation of D2-40 immunostaining in the routine workup to determine a patient's eligibility for APBI.

  12. Sequential hemibody and local irradiation with combination chemotherapy for small cell lung carcinoma: a preliminary analysis

    SciTech Connect

    Powell, B.L.; Jackson, D.V. Jr.; Scarantino, C.W.; Pope, E.; Choplin, R.; Craig, J.B.; Atkins, J.N.; Cooper, M.R.; Hopkins, J.O.; McMahan, R.

    1985-03-01

    Sequential hemibody irradiation (SHB) was integrated with combination chemotherapy and local irradiation (LRT) in the induction and consolidation phases of a therapeutic protocol for small cell lung carcinoma (SCLC). Forty-one previously untreated patients were entered into this program. Among 38 evaluable patients (20 with limited disease (LD) and 18 with extensive disease (ED)), the overall response rate was 63% (90% in LD and 33% in ED patients). The estimated overall survival is 8.1 months. The major toxicity has been myelosuppression - especially thrombocytopenia. The frequency of previously described acute radiation syndromes and radiation pneumonitis associated with hemibody irradiation have been substantially decreased at the current dosage with premedication and shielding techniques.

  13. Impact of the use of autologous stem cell transplantation at first relapse both in naïve and previously rituximab exposed follicular lymphoma patients treated in the GELA/GOELAMS FL2000 study

    PubMed Central

    Le Gouill, Steven; De Guibert, Sophie; Planche, Lucie; Brice, Pauline; Dupuis, Jehan; Cartron, Guillaume; Van Hoof, Achiel; Casasnovas, Olivier; Gyan, Emmanuel; Tilly, Hervé; Fruchart, Christophe; Deconinck, Eric; Fitoussi, Olivier; Gastaud, Lauris; Delwail, Vincent; Gabarre, Jean; Gressin, Rémy; Blanc, Michel; Foussard, Charles; Salles, Gilles

    2011-01-01

    Background We analyzed detailed characteristics and salvage treatment in 175 follicular lymphoma patients from the FL2000 study who were in progression after first-line therapy with or without addition of rituximab to chemotherapy and interferon. Design and Methods The impact of using autologous stem cell transplantation and/or rituximab administration at first progression was investigated, taking into account initial therapy. With a median follow up of 31 months, 3-year event free and overall survival rates after progression were 50% (95%CI 42–58%) and 72% (95%CI 64–78%), respectively. Results The 3-year event free rate of rituximab re-treated patients (n=112) was 52% (95%CI 41–62%) versus 40% (95%CI 24–55%) for those not receiving rituximab second line (n=53) (P=0.075). There was a significant difference in 3-year overall survival between patients receiving autologous stem cell transplantation and those not: 92% (95%CI 78–97%) versus 63% (95%CI 51–72%) (P=0.0003), respectively. In multivariate analysis, both autologous stem cell transplantation and period of progression/relapse affected event free and overall survival. Conclusions Regardless of front-line rituximab exposure, this study supports incorporating autologous stem cell transplantation in the therapeutic approach at first relapse for follicular lymphoma patients. PMID:21486862

  14. Primary Malignant Tumours of Bone Following Previous Malignancy

    PubMed Central

    Patton, J. T.; Sommerville, S. M. M.; Grimer, R. J.

    2008-01-01

    Destructive bone lesions occurring in patients who have previously had a malignancy are generally assumed to be a metastasis from that malignancy. We reviewed 60 patients with a previous history of malignancy, who presented with a solitary bone lesion that was subsequently found to be a new and different primary sarcoma of bone. These second malignancies occurred in three distinct groups of patients: (1) patients with original tumours well known to be associated with second malignancies (5%); (2) patients whose second malignancies were likely to be due to the previous treatment of their primary malignancy (40%); (3) patients in whom there was no clearly defined association between malignancies (55%). The purpose of this study is to emphasise the necessity for caution in assuming the diagnosis of a metastasis when a solitary bone lesion is identified following a prior malignancy. Inappropriate biopsy and treatment of primary bone sarcomas compromises limb salvage surgery and can affect patient mortality. PMID:18414590

  15. Prognostic Impact of Erythropoietin Expression and Erythropoietin Receptor Expression on Locoregional Control and Survival of Patients Irradiated for Stage II/III Non-Small-Cell Lung Cancer

    SciTech Connect

    Rades, Dirk; Setter, Cornelia; Dahl, Olav; Schild, Steven E.; Noack, Frank

    2011-06-01

    Purpose: Prognostic factors can guide the physician in selecting the optimal treatment for an individual patient. This study investigates the prognostic value of erythropoietin (EPO) and EPO receptor (EPO-R) expression of tumor cells for locoregional control and survival in non-small-cell lung cancer (NSCLC) patients. Methods and Materials: Fourteen factors were investigated in 62 patients irradiated for stage II/III NSCLC, as follows: age, gender, Karnofsky performance score (KPS), histology, grading, TNM/American Joint Committee on Cancer (AJCC) stage, surgery, chemotherapy, pack years (average number of packages of cigarettes smoked per day multiplied by the number of years smoked), smoking during radiotherapy, hemoglobin levels during radiotherapy, EPO expression, and EPO-R expression. Additionally, patients with tumors expressing both EPO and EPO-R were compared to those expressing either EPO or EPO-R and to those expressing neither EPO nor EPO-R. Results: On univariate analysis, improved locoregional control was associated with AJCC stage II cancer (p < 0.048), surgery (p < 0.042), no smoking during radiotherapy (p = 0.024), and no EPO expression (p = 0.001). A trend was observed for a KPS of >70 (p = 0.08), an N stage of 0 to 1 (p = 0.07), and no EPO-R expression (p = 0.10). On multivariate analysis, AJCC stage II and no EPO expression remained significant. No smoking during radiotherapy was almost significant. On univariate analysis, improved survival was associated with N stage 0 to 1 (p = 0.009), surgery (p = 0.039), hemoglobin levels of {>=}12 g/d (p = 0.016), and no EPO expression (p = 0.001). On multivariate analysis, N stage 0 to 1 and no EPO expression maintained significance. Hemoglobin levels of {>=}12 g/d were almost significant. On subgroup analyses, patients with tumors expressing both EPO and EPO-R had worse outcomes than those expressing either EPO or EPO-R and those expressing neither EPO nor RPO-R. Conclusions: EPO expression of tumor cells

  16. Total lymphoid irradiation

    SciTech Connect

    Sutherland, D.E.; Ferguson, R.M.; Simmons, R.L.; Kim, T.H.; Slavin, S.; Najarian, J.S.

    1983-05-01

    Total lymphoid irradiation by itself can produce sufficient immunosuppression to prolong the survival of a variety of organ allografts in experimental animals. The degree of prolongation is dose-dependent and is limited by the toxicity that occurs with higher doses. Total lymphoid irradiation is more effective before transplantation than after, but when used after transplantation can be combined with pharmacologic immunosuppression to achieve a positive effect. In some animal models, total lymphoid irradiation induces an environment in which fully allogeneic bone marrow will engraft and induce permanent chimerism in the recipients who are then tolerant to organ allografts from the donor strain. If total lymphoid irradiation is ever to have clinical applicability on a large scale, it would seem that it would have to be under circumstances in which tolerance can be induced. However, in some animal models graft-versus-host disease occurs following bone marrow transplantation, and methods to obviate its occurrence probably will be needed if this approach is to be applied clinically. In recent years, patient and graft survival rates in renal allograft recipients treated with conventional immunosuppression have improved considerably, and thus the impetus to utilize total lymphoid irradiation for its immunosuppressive effect alone is less compelling. The future of total lymphoid irradiation probably lies in devising protocols in which maintenance immunosuppression can be eliminated, or nearly eliminated, altogether. Such protocols are effective in rodents. Whether they can be applied to clinical transplantation remains to be seen.

  17. SU-E-J-172: Bio-Physical Effects of Patients Set-Up Errors According to Whole Breast Irradiation Techniques

    SciTech Connect

    Lee, S; Suh, T; Park, S; Kim, M; Lee, M; Park, J

    2015-06-15

    Purpose: The dose-related effects of patient setup errors on biophysical indices were evaluated for conventional wedge (CW) and field-in-field (FIF) whole breast irradiation techniques. Methods: The treatment plans for 10 patients receiving whole left breast irradiation were retrospectively selected. Radiobiological and physical effects caused by dose variations were evaluated by shifting the isocenters and gantry angles of the treatment plans. Dose-volume histograms of the planning target volume (PTV), heart, and lungs were generated, and conformity index (CI), homogeneity index (HI), tumor control probability (TCP), and normal tissue complication probability (NTCP) were determined. Results: For “isocenter shift plan” with posterior direction, the D95 of the PTV decreased by approximately 15% and the TCP of the PTV decreased by approximately 50% for the FIF technique and by 40% for the CW; however, the NTCPs of the lungs and heart increased by about 13% and 1%, respectively, for both techniques. Increasing the gantry angle decreased the TCPs of the PTV by 24.4% (CW) and by 34% (FIF). The NTCPs for the two techniques differed by only 3%. In case of CW, the CIs and HIs were much higher than that of the FIF in all cases. It had a significant difference between two techniques (p<0.01). According to our results, however, the FIF had more sensitive response by set up errors rather than CW in bio-physical aspects. Conclusions: The radiobiological-based analysis can detect significant dosimetric errors then, can provide a practical patient quality assurance method to guide the radiobiological and physical effects.

  18. Scoring Systems to Estimate Intracerebral Control and Survival Rates of Patients Irradiated for Brain Metastases;Brain metastases; Radiation therapy; Local control; Survival; Prognostic scores

    SciTech Connect

    Rades, Dirk; Dziggel, Liesa; Haatanen, Tiina; Veninga, Theo; Lohynska, Radka; Dunst, Juergen; Schild, Steven E.

    2011-07-15

    Purpose: To create and validate scoring systems for intracerebral control (IC) and overall survival (OS) of patients irradiated for brain metastases. Methods and Materials: In this study, 1,797 patients were randomly assigned to the test (n = 1,198) or the validation group (n = 599). Two scoring systems were developed, one for IC and another for OS. The scores included prognostic factors found significant on multivariate analyses. Age, performance status, extracerebral metastases, interval tumor diagnosis to RT, and number of brain metastases were associated with OS. Tumor type, performance status, interval, and number of brain metastases were associated with IC. The score for each factor was determined by dividing the 6-month IC or OS rate (given in percent) by 10. The total score represented the sum of the scores for each factor. The score groups of the test group were compared with the corresponding score groups of the validation group. Results: In the test group, 6-month IC rates were 17% for 14-18 points, 49% for 19-23 points, and 77% for 24-27 points (p < 0.0001). IC rates in the validation group were 19%, 52%, and 77%, respectively (p < 0.0001). In the test group, 6-month OS rates were 9% for 15-19 points, 41% for 20-25 points, and 78% for 26-30 points (p < 0.0001). OS rates in the validation group were 7%, 39%, and 79%, respectively (p < 0.0001). Conclusions: Patients irradiated for brain metastases can be given scores to estimate OS and IC. IC and OS rates of the validation group were similar to the test group demonstrating the validity and reproducibility of both scores.

  19. SU-E-T-340: Use of Intensity Modulated Proton Therapy (IMPT) for Reducing the Dose to Cochlea in Craniospinal Irradiation (CSI) of Pediatric Patients

    SciTech Connect

    Dormer, J; Kassaee, A; Lin, H; Ding, X; Lustig, R

    2014-06-01

    Purpose: To evaluate use of intensity modulated proton therapy (IMPT) and number of beams for sparing cochlea in treatment of whole brain for pediatric medulloblastoma patients. Methods: In our institution, craniospinal irradiation patients are treated in supine position on our proton gantries using pencil beam scanning with each beam uniformly covering the target volume (SFUD). Each treatment plan consists of two opposed lateral whole brain fields and one or two spinal fields. For sparing the cochlea for the whole brain treatment, we created three different plans using IMPT for five pediatric patients. The first plan consisted of two lateral fields, the second two lateral fields and a superior-inferior field, and the third two lateral fields and two superior oblique fields. Optimization was performed with heavy weights applied to the eye, lens and cochlea while maintaining a dose prescription of 36 Gy to the whole brain. Results: IMPT plans reduce the dose to the cochlea. Increasing the number of treatment fields was found to lower the average dose to the cochlea: 15.0, 14.5 and 12.5 Gy for the two-field, three-field, and four-field plans respectively. The D95 for the two-field plan was 98.2%, compared to 100.0% for both the three-field and four-field plan. Coverage in the mid-brain was noticeably better in the three- and four-field plans, with more dose conformality surrounding the cochlea. Conclusion: IMPT plans for CSI and the whole brain irradiations are capable of sparing cochlea and reduce the dose considerably without compromising treating brain tissues. The reduction in average dose increases with three and four field plans as compared to traditional two lateral beam plans.

  20. A phase I study with an expanded cohort to assess feasibility of intravenous docetaxel, intraperitoneal carboplatin and intraperitoneal paclitaxel in patients with previously untreated ovarian, fallopian tube or primary peritoneal carcinoma: A Gynecologic Oncology Group Study

    PubMed Central

    Gould, Natalie; Sill, Michael W.; Mannel, Robert S.; Thaker, Premal H.; DiSilvestro, Paul A.; Waggoner, Steven E.; Yamada, S. Diane; Armstrong, Deborah K.; Fracasso, Paula M.; Walker, Joan L.

    2015-01-01

    Objective To define the maximum tolerated dose (MTD) and assess the feasibility of intravenous (IV) docetaxel, intraperitoneal (IP) carboplatin and IP paclitaxel in women with Stage II-IV untreated ovarian, fallopian tube or primary peritoneal carcinoma. Methods Patients received docetaxel (55-75 mg/m2) IV and carboplatin (AUC 5-7) IP on day 1 and paclitaxel 60 mg/m2 IP on day 8. A standard 3+3 design was used in the dose escalation phase. A 2-stage group sequential design with 20 patients at the MTD was used in the feasibility phase. Results The MTD determined during the dose escalation phase was day 1 docetaxel 75 mg/m2 IV, carboplatin AUC 6 IP and day 8 IP paclitaxel 60 mg/m2. Forty-six patients were enrolled in the feasibility portion at this dose level. Six were unevaluable. Fifteen evaluable patients had dose-limiting toxicities (DLTs) within the first four cycles. These DLTs were prolonged neutropenia (2), neutropenic fever (7), grade 4 thrombocytopenia (1), grade 4 dehydration (1), grade 3 infection (2), grade 3 oral mucositis (1) and pulmonary embolism (1). Conclusions Docetaxel 75 mg/m2 IV, carboplatin AUC 6 IP administered on day 1, and paclitaxel 60 mg/m2 IP administered on day 8, is the MTD when considering one cycle of treatment but was not feasible over four cycles due to bone marrow toxicity. We recommend reduction of carboplatin to AUC 5 should this regimen be considered for treatment in women with newly diagnosed advanced ovarian cancer. PMID:22943879

  1. Prospective evaluation of pulmonary function in cancer patients treated with total body irradiation, high-dose melphalan, and autologous hematopoietic stem cell transplantation

    SciTech Connect

    Gandola, L.; Siena, S.; Bregni, M.; Sverzellati, E.; Piotti, P.; Stucchi, C.; Gianni, A.M.; Lombardi, F. )

    1990-09-01

    Pulmonary function tests (standard vital capacity, SVC; total lung capacity, TLC; forced expiratory volume in 1 second-forced vital capacity ratio, FEV1/FVC; carbon monoxide transfer factor, DLCO) were prospectively evaluated in patients (median age 25 years, 13-52 years; median follow-up 20 months, 6-51 months) with Hodgkin's disease (15 patients), non-Hodgkin's lymphoma (9 patients), and inflammatory breast cancer (3 patients) treated with sequential high-dose therapy comprising the following phases over approximately 2 months: (a) cyclophosphamide (7 g/m2); (b) vincristine (1.4 mg/m2), methotrexate (8 g/m2), and cisplatinum (120 mg/m2) or etoposide (2 g/m2); (c) total body irradiation (TBI; 12.5 gy, 5 fractions over 48 hours), intravenous melphalan (120-180 mg/m2), and transplantation of autologous peripheral blood and/or bone marrow hematopoietic stem cells. Within 2 months after transplantation, 12 patients also received 25 Gy radiotherapy boost to mediastinum and clavicular regions. In vivo dosimetry evaluations of fractionated TBI treatments showed that mean radiation dose absorbed by lungs was 12.18 Gy (97.4% of TBI dose). Despite such a high radiation dose, we observed only transient and subclinical decrease of SVC, TLC, and DLCO. The decrease of SVC, TLC, and DLCO was more evident and prolonged in patients receiving radiotherapy boost. All parameters progressively recovered to normal values within 2 years after transplantation. In contrast, FEV1/FVC remained within normal limits in all patients, thus demonstrating the absence of obstructive ventilatory changes. In addition, no interstitial pneumonia was observed.

  2. Studies of DNA and chromosome damage in skin fibroblasts and blood lymphocytes from psoriasis patients treated with 8-methoxypsoralen and UVA irradiation

    SciTech Connect

    Bredberg, A.; Lambert, B.; Lindblad, A.; Swanbeck, G.; Wennersten, G.

    1983-08-01

    Exposure of human lymphocytes and skin fibroblasts in vitro to a single, clinically used dose of PUVA, i.e., 0.1 micrograms/ml of 8-methoxypsoralen (8-MOP) plus 0.9-4 J/cm2 of longwave ultraviolet radiation (UVA), lead to the formation of DNA damage as determined by alkaline elution, and to chromosome aberrations and sister chromatid exchanges (SCE). When lymphocyte-enriched plasma was obtained from psoriasis patients 2 h after oral intake of 8-MOP and then UVA irradiated (1.8-3.6 J/cm2) in vitro, an increased frequency of chromosome aberrations and SCE was observed. Normal levels of chromosome aberrations and SCE were found in lymphocytes of psoriasis patients after 3-30 weeks of PUVA treatment in vivo. A small but statistically significant increase in the SCE frequency was observed in the lymphocytes of psoriasis patients treated for 1-6 years with PUVA (mean 18.0 SCE/cell) as compared with before PUVA (mean 15.8, p less than 0.05). Skin fibroblasts of psoriasis patients analyzed 5 years after the start of PUVA treatment showed a normal number of SCE but a high fraction of filter-retained DNA in the alkaline elution assay, suggesting the presence of cross-linked DNA.

  3. Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids.

    PubMed

    Nathan, Robert A; Nolte, Hendrik; Pearlman, David S

    2010-01-01

    Asthma is a heterogeneous condition characterized by reduced lung function, chronic inflammation, and periodic asthma deteriorations. This study was performed to evaluate the effect of mometasone furoate (MF)/formoterol (F) combination, 200/10 microg, administered twice daily (b.i.d.) on asthma deteriorations and pulmonary function in patients with asthma uncontrolled on medium-dose inhaled corticosteroid (ICS). After 2- to 3-week open-label run-in with MF 200 microg b.i.d., patients (>or=12 years) were randomized to 26 weeks of treatment with MF/F 200/10 microg, MF 200 microg, F 10 microg, or placebo b.i.d. Coprimary end points were time to first asthma deterioration (MF/F versus F) and bronchodilation, assessed by the area under the curve of the change in forced expiratory volume in 1 second 0-12 hours (FEV(1) AUC(0-12h); MF/F versus MF). A total of 781 patients were randomized. Treatment with MF/F 200/10 microg reduced asthma deteriorations and clinically judged deteriorations (i.e., deterioration resulting in emergency treatment, hospitalization, or treatment with additional excluded asthma medication [i.e., systemic corticosteroids]). The proportion of patients experiencing asthma deteriorations was MF/F, 30.4%; MF, 33.9%; F, 54.0%; placebo, 55.6% (p < 0.001, MF/F versus F and placebo). There was a sixfold reduction in clinically judged deteriorations with MF/F versus F and placebo (p < 0.001). Lung function improved more rapidly with MF/F than MF and placebo. Mean change from baseline FEV(1) AUC(0-12h) at week 12 was MF/F, 11.7% versus MF, 5.7%; F, 8.5%; and placebo, 3.9% (p < 0.001). Treatment-related AEs were rare and similar across groups. Treatment with MF/F 200/10 microg was effective in reducing the risk of asthma deteriorations. MF/F was safe and provided rapid and sustained bronchodilation in patients with asthma.

  4. Long-term normal-appearing brain tissue monitoring after irradiation using proton magnetic resonance spectroscopy in vivo: Statistical analysis of a large group of patients

    SciTech Connect

    Matulewicz, Lukasz . E-mail: lukasz.matulewicz@io.gliwice.pl; Sokol, Maria; Michnik, Anna; Wydmanski, Jerzy

    2006-11-01

    Purpose: The aim of this study was to detect the non-neoplastic white-matter changes vs. time after irradiation using {sup 1}H nuclear magnetic resonance (NMR) spectroscopy in vivo. Methods and Materials: A total of 394 {sup 1}H MR spectra were acquired from 100 patients (age 19-74 years; mean and median age, 43 years) before and during 2 years after radiation therapy (the mean absorbed doses calculated for the averaged spectroscopy voxels are similar and close to 20 Gy). Results: Ocilations were observed in choline-containing compounds (Cho)/creatine and phosphocreatine (Cr), Cho/N-acetylaspartate (NAA), and center of gravity (CG) of the lipid band in the range of 0.7-1.5 ppm changes over time reveal oscillations. The parameters have the same 8-month cycle period; however the CG changes precede the other by 2 months. Conclusions: The results indicate the oscillative nature of the brain response to irradiation, which may be caused by the blood-brain barrier disruption and repair processes. These oscillations may influence the NMR results, depending on the cycle phase in which the NMR measurements are performed in. The earliest manifestation of radiation injury detected by magnetic resonance spectroscopy is the CG shift.

  5. Morbidity of radical retropubic prostatectomy following previous prostate resection.

    PubMed

    Ramon, J; Rossignol, G; Leandri, P; Gautier, J R

    1994-01-01

    A total of 153 patients with prior prostate surgery underwent a radical retropubic prostatectomy for carcinoma of the prostate. Ninety-seven patients had undergone transurethral resection of the prostate (TURP), and 56 patients had undergone suprapubic transvesical prostatectomy (SPP). In 115 patients, the diagnosis of malignancy was made at the time of transurethral resection or enucleation. No perioperative deaths occurred and no patient suffered rectal injury or ureteral transection. Operative time and blood loss were similar between the TURP and SPP groups and were not different in a group of patients who had not had prior prostate surgery. Early and late complications occurred in eight patients (5.2%), of whom seven had had previous TURP. Complete urinary control was achieved in 96% (147) of the patients; stress incontinence was present in 4% (6 patients); and no patient was totally incontinent. Postoperative complications and the occurrence of stress incontinence were not related to the time elapsed between the previous prostate surgery and the radical prostatectomy. Sexual function was preserved in 32 (71%) of the 45 patients in whom we performed a nerve-sparing radical prostatectomy. Residual cancer was found in the radical prostatectomy specimen in 77 (67%) of the stage A patients. Twenty-nine (25%) of the stage A and 13 (34%) of the stage B patients had pathological evidence of disease extension beyond the confined prostate. Follow-up was 6-92 months, with a mean of 32 months. Four patients died of prostatic cancer, two patients died without cancer, and five have evidence of disease progression; 142 (93%) are alive without evidence of disease. Although radical prostatectomy sometimes is more difficult after previous prostate surgery, operative complication rates, patient morbidity, and the opportunity for surgical cure are not different from those seen in patients with no history of previous prostate operations.

  6. Successful radiofrequency catheter ablation of a right posterolateral bypass tract in a patient with Wolff-Parkinson-White syndrome after a previous failed ablative procedure: taking the high road.

    PubMed

    Cohen, T J

    2000-07-01

    A 16-year-old high school basketball player with symptomatic Wolff-Parkinson-White syndrome underwent an unsuccessful radiofrequency catheter ablative procedure from the femoral venous approach. During this procedure, the patient received 30 applications of radiofrequency energy without injury to the accessory pathway. The patient was treated with flecinide 100 mg orally twice daily and rescheduled for a second ablative procedure via the right internal jugular venous approach. At the second session, prior to any right internal jugular venous applications, 3 additional applications were delivered via the right femoral venous approach using a different catheter, without success. A single radiofrequency energy application from the right internal jugular venous approach eliminated the bypass tract in approximately 2 seconds. The superior approach achieved a more stable catheter position thereby eliminating the bypass tract. In conclusion, an alternative plan of attack should be considered after multiple failures from a given approach. In other words, take the high road if you can't take the low road.

  7. Need for High Radiation Dose (>=70 Gy) in Early Postoperative Irradiation After Radical Prostatectomy: A Single-Institution Analysis of 334 High-Risk, Node-Negative Patients

    SciTech Connect

    Cozzarini, Cesare; Montorsi, Francesco; Fiorino, Claudio; Alongi, Filippo; Bolognesi, Angelo; Da Pozzo, Luigi Filippo; Guazzoni, Giorgio; Freschi, Massimo; Roscigno, Marco; Scattoni, Vincenzo; Rigatti, Patrizio; Di Muzio, Nadia

    2009-11-15

    Purpose: To determine the clinical benefit of high-dose early adjuvant radiotherapy (EART) in high-risk prostate cancer (hrCaP) patients submitted to radical retropubic prostatectomy plus pelvic lymphadenectomy. Patients and Methods: The clinical outcome of 334 hrCaP (pT3-4 and/or positive resection margins) node-negative patients submitted to radical retropubic prostatectomy plus pelvic lymphadenectomy before 2004 was analyzed according to the EART dose delivered to the prostatic bed, <70.2 Gy (lower dose, median 66.6 Gy, n = 153) or >=70.2 Gy (median 70.2 Gy, n = 181). Results: The two groups were comparable except for a significant difference in terms of median follow-up (10 vs. 7 years, respectively) owing to the gradual increase of EART doses over time. Nevertheless, median time to prostate-specific antigen (PSA) failure was almost identical, 38 and 36 months, respectively. At univariate analysis, both 5-year biochemical relapse-free survival (bRFS) and disease-free survival (DFS) were significantly higher (83% vs. 71% [p = 0.001] and 94% vs. 88% [p = 0.005], respectively) in the HD group. Multivariate analysis confirmed EART dose >=70 Gy to be independently related to both bRFS (hazard ratio 2.5, p = 0.04) and DFS (hazard ratio 3.6, p = 0.004). Similar results were obtained after the exclusion of patients receiving any androgen deprivation. After grouping the hormone-naive patients by postoperative PSA level the statistically significant impact of high-dose EART on both 5-year bRFS and DFS was maintained only for those with undetectable values, possibly owing to micrometastatic disease outside the irradiated area in case of detectable postoperative PSA values. Conclusion: This series provides strong support for the use of EART doses >=70 Gy after radical retropubic prostatectomy in hrCaP patients with undetectable postoperative PSA levels.

  8. Full-term newborn after repeated ovarian tissue transplants in a patient treated for Ewing sarcoma by sterilizing pelvic irradiation and chemotherapy

    PubMed Central

    Rodriguez-Wallberg, Kenny A; Karlström, Per-Olof; Rezapour, Masoumeh; Castellanos, Enrique; Hreinsson, Julius; Rasmussen, Carsten; Sheikhi, Mona; Ouvrier, Bettina; Bozóky, Béla; Olofsson, Jan I; Lundqvist, Monalill; Hovatta, Outi

    2015-01-01

    We report the first successful transplantation of cryopreserved ovarian cortical tissue into heavily irradiated tissues in a patient who had received sterilizing pelvic radiotherapy (54 Gy) and 40 weeks of intensive high-dose chemotherapy for the treatment of Ewing’s sarcoma 14 years earlier. Repeated transplantation procedures were required to obtain fully functional follicular development. Enlargement of the transplants over time and increase of the size of the uterus were demonstrated on sequential ultrasonographic examinations. Eggs of good quality that could be fertilized in vitro were obtained only after a substantial incremental increase of the amount of ovarian tissue transplanted. Single embryo replacement resulted in a normal pregnancy and the birth of a healthy child by cesarean section at full-term. No neonatal or maternal postoperative complications occurred. Women facing high-dose pelvic radiotherapy should not be systematically excluded from fertility preservation options, as is currently the trend. PMID:25545009

  9. Tissue irradiator

    DOEpatents

    Hungate, F.P.; Riemath, W.F.; Bunnell, L.R.

    1975-12-16

    A tissue irradiator is provided for the in-vivo irradiation of body tissue. The irradiator comprises a radiation source material contained and completely encapsulated within vitreous carbon. An embodiment for use as an in- vivo blood irradiator comprises a cylindrical body having an axial bore therethrough. A radioisotope is contained within a first portion of vitreous carbon cylindrically surrounding the axial bore, and a containment portion of vitreous carbon surrounds the radioisotope containing portion, the two portions of vitreous carbon being integrally formed as a single unit. Connecting means are provided at each end of the cylindrical body to permit connections to blood- carrying vessels and to provide for passage of blood through the bore. In a preferred embodiment, the radioisotope is thulium-170 which is present in the irradiator in the form of thulium oxide. A method of producing the preferred blood irradiator is also provided, whereby nonradioactive thulium-169 is dispersed within a polyfurfuryl alcohol resin which is carbonized and fired to form the integral vitreous carbon body and the device is activated by neutron bombardment of the thulium-169 to produce the beta-emitting thulium-170.

  10. Post-irradiation effects in polyethylenes irradiated under various atmospheres

    NASA Astrophysics Data System (ADS)

    Suljovrujic, E.

    2013-08-01

    If a large amount of polymer free radicals remain trapped after irradiation of polymers, the post-irradiation effects may result in a significant alteration of physical properties during long-term shelf storage and use. In the case of polyethylenes (PEs) some failures are attributed to the post-irradiation oxidative degradation initiated by the reaction of residual free radicals (mainly trapped in crystal phase) with oxygen. Oxidation products such as carbonyl groups act as deep traps and introduce changes in carrier mobility and significant deterioration in the PEs electrical insulating properties. The post-irradiation behaviour of three different PEs, low density polyethylene (LDPE), linear low density polyethylene (LLDPE) and high density polyethylene (HDPE) was studied; previously, the post-irradiation behaviour of the PEs was investigated after the irradiation in air (Suljovrujic, 2010). In this paper, in order to investigate the influence of different irradiation media on the post-irradiation behaviour, the samples were irradiated in air and nitrogen gas, to an absorbed dose of 300 kGy. The annealing treatment of irradiated PEs, which can substantially reduce the concentration of free radicals, is used in this study, too. Dielectric relaxation behaviour is related to the difference in the initial structure of PEs (such as branching, crystallinity etc.), to the changes induced by irradiation in different media and to the post-irradiation changes induced by storage of the samples in air. Electron spin resonance (ESR), differential scanning calorimetry (DSC), infra-red (IR) spectroscopy and gel measurements were used to determine the changes in the free radical concentration, crystal fraction, oxidation and degree of network formation, respectively.

  11. Pharmacokinetics of High-Dose Lopinavir-Ritonavir with and without Saquinavir or Nonnucleoside Reverse Transcriptase Inhibitors in Human Immunodeficiency Virus-Infected Pediatric and Adolescent Patients Previously Treated with Protease Inhibitors▿ †

    PubMed Central

    Robbins, Brian L.; Capparelli, Edmund V.; Chadwick, Ellen G.; Yogev, Ram; Serchuck, Leslie; Worrell, Carol; Smith, Mary Elizabeth; Alvero, Carmelita; Fenton, Terence; Heckman, Barbara; Pelton, Stephen I.; Aldrovandi, Grace; Borkowsky, William; Rodman, John; Havens, Peter L.

    2008-01-01

    Human immunodeficiency virus (HIV)-infected children and adolescents who are failing antiretrovirals may have a better virologic response when drug exposures are increased, using higher protease inhibitor doses or ritonavir boosting. We studied the pharmacokinetics and safety of high-dose lopinavir-ritonavir (LPV/r) in treatment-experienced patients, using an LPV/r dose of 400/100 mg/m2 orally every 12 h (p.o. q12h) (without nonnucleoside reverse transcriptase inhibitor [NNRTI]), or 480/120 mg/m2 p.o. q12h (with NNRTI). We calculated the LPV inhibitory quotient (IQ), and when the IQ was <15, saquinavir (SQV) 750 mg/m2 p.o. q12h was added to the regimen. We studied 26 HIV-infected patients. The median age was 15 years (range, 7 to 17), with 11.5 prior antiretroviral medications, 197 CD4 cells/ml, viral load of 75,577 copies/ml, and a 133-fold change in LPV resistance. By treatment week 2, 14 patients had a viral-load decrease of >0.75 log10, with a median maximal decrease in viral load of −1.57 log10 copies/ml at week 8. At week 2, 19 subjects showed a median LPV area under the concentration-time curve (AUC) of 157.2 (range, 62.8 to 305.5) μg·h/ml and median LPV trough concentration (Ctrough) of 10.8 (range, 4.1 to 25.3) μg/ml. In 16 subjects with SQV added, the SQV median AUC was 33.7 (range, 4.4 to 76.5) μg·h/ml and the median SQV Ctrough was 2.1 (range, 0.2 to 4.1) μg/ml. At week 24, 18 of 26 (69%) subjects remained in the study. Between weeks 24 and 48, one subject withdrew for nonadherence and nine withdrew for persistently high virus load. In antiretroviral-experienced children and adolescents with HIV, high doses of LPV/r with or without SQV offer safe options for salvage therapy, but the modest virologic response and the challenge of adherence to a regimen with a high pill burden may limit the usefulness of this approach. PMID:18625762

  12. Multimodality image guided total marrow irradiation and verification of the dose delivered to the lung, PTV, and thoracic bone in a patient: a case study.

    PubMed

    Hui, Susanta K; Verneris, M R; Froelich, Jerry; Dusenbery, K; Welsh, James S

    2009-02-01

    This work reports our initial experience using multimodality image guidance to improve total marrow irradiation (TMI) using helical tomotherapy. We also monitored the details of the treatment delivery to glean information necessary for the implementation of future adaptive processes. A patient with metastatic Ewing's sarcoma underwent MRI, and bone scan imaging prior to TMI. A whole body kilovoltage CT (kVCT) scan was obtained for intensity modulated TMI treatment planning, including a boost treatment to areas of bony involvement. The delivered dose was estimated by using MVCT images from the helical tomotherapy treatment unit, compared to the expected dose distributions mapped onto the kVCT images. Clinical concerns regarding patient treatment and dosimetric uncertainties were also evaluated. A small fraction of thoracic bone volume received lower radiation dose than the prescribed dose. Reconstructed planned treatment volume (PTV) and the dose delivered to the lung were identical to planned dose. Bone scan imaging had a higher sensitivity for detecting skeletal metastasis compared to MR imaging. However the bone scan lacked sufficient specificity in three dimensions to be useful for planning conformal radiation boost treatments. Inclusion of appropriate imaging modalities improves detection of metastases, which allows the possibility of a radiation dose boost to metastases during TMI. Conformal intensity modulated radiation therapy via helical tomotherapy permitted radiation delivery to metastases in the skull with reduced dose to brain in conjunction with TMI. While TMI reduces irradiation to the lungs, onboard megavoltage computed tomography (MVCT) to verify accurate volumetric dose coverage to marrow-containing thoracic bones may be essential for successful conformal TMI treatment.

  13. Effect of adjuvant chemotherapy on cosmesis and complications in patients with breast cancer treated by definitive irradiation

    SciTech Connect

    Danoff, B.F.; Goodman, R.L.; Glick, J.H.; Haller, D.G.; Pajak, T.F.

    1983-11-01

    From 1978 to 1981, 46 patients received primary radiotherapy following excisional biopsy and axillary staging procedure for Stages I and II carcinoma of the breast. The patients were divided into 2 groups: 27 patients who received radiation and completed 12 cycles of adjuvant chemotherapy (CMF or CMFP) and 19 patients who received radiation alone. All patients received radiation to the breast and regional nodes (4600 to 5000 rad) and a boost to the site of the primary tumor (1500 to 2000 rad). Median follow-up from completion of radiation was 26 months in the non-adjuvant and 24 months in the adjuvant group with a range of 12 to 49 months. Cosmesis was judged to be good to excellent in 89% (17/19) of the patients receiving radiation alone and 81% (22/27) of the patients receiving adjuvant chemotherapy. Fair to poor cosmesis in the adjuvant group was attributed primarily to increased fibrosis and reduction of breast size. The single complication for which there was an increased incidence in the adjuvant group was arm edema (22 vs. 0%). The incidence of arm edema was unrelated to T stage, type of axillary surgical procedure, number of positive nodes, addition of prednisone or sequencing of chemotherapy.

  14. Optimal management of the elderly patient with head and neck cancer: Issues regarding surgery, irradiation and chemotherapy

    PubMed Central

    Mountzios, Giannis

    2015-01-01

    Head and neck cancer (HNC) represents the sixth most common malignancy and accounts for approximately 6% of new cancer cases annually worldwide. As life expectancy constantly increases, the onset of HNC in patients older than 65 years of age at diagnosis is not rare and up to one fourth of cases occurs in patients older that 70 years at age. Because elderly cancer patients are severely under-represented in clinical trials, there is a clear need to address the particular aspects of this specific patient group, especially in the context of novel multidisciplinary therapeutic approaches. The frailty of elderly patients with HNC is attributed to the high incidence of smoking and alcohol abuse in this malignancy and the presence of substantial cardiovascular, respiratory or metabolic comorbidities. In the current work, I provide an overview of current and emerging treatment approaches, in elderly patients with HNC. In particular, I discuss modern surgical approaches that improve radical excision rates while preserving functionality, the incorporation of modern radiotherapeutic techniques and the introduction of novel chemotherapeutic combinations and molecular targeted agents in an effort to reduce toxicity without compromising efficacy. Finally, there is an urgent need to increase accrual and active participation of elderly patients with HNC in clinical trials, including biomarker evaluation in biopsy specimens towards an individualized therapeutic approach. PMID:25667910

  15. Extracranial chordoma: Outcome in patients treated with function-preserving surgery followed by spot-scanning proton beam irradiation

    SciTech Connect

    Rutz, Hans Peter . E-mail: hanspeter.rutz@psi.ch; Weber, Damien C.; Sugahara, Shinji; Timmermann, Beate; Lomax, Antony J.; Bolsi, Alessandra; Pedroni, Eros; Coray, Adolf; Jermann, Martin M.S.; Goitein, Gudrun

    2007-02-01

    Purpose: To evaluate the use of postoperative proton therapy (PT) in extracranial chordoma. Patients and Methods: Twenty-six patients were treated. Gross total resection was achieved in 18 patients. Nine patients had cervical, 2 had thoracic, 8 had lumbar, and 7 had sacro-coccygeal chordomas. Thirteen patients had implants. PT was administered after function-preserving surgery, using a gantry and spot scanning, without or with intensity modulation (IMPT; 6 patients), and/or photon-based radiotherapy (RT, 6 patients). Median total dose was 72 cobalt Gray equivalent (CGE; range, 59.4-74.4), with means of 70.5 and 73.2 CGE for patients with and without implants. Median follow-up time was 35 months (range, 13-73 months). Adverse events were scored using the Common Terminology Criteria for Adverse Events grading system (version 3.0). Results: At 3 years, actuarial overall survival (OS) and progression-free survival (PFS) rates were 84% and 77%, respectively. One patient each died of local failure (LF), distant failure (DF), suicide, and secondary tumor. We observed 5 LFs and 3 DFs; 3-year LF-free and DF-free survival rates were 86%. We observed four radiation-induced late adverse events (Grade 2 sensory neuropathy; Grade 3 subcutaneous necrosis, and osteonecrosis; and Grade 5 secondary cancer). In univariate analysis, implants were associated with LF (p = 0.034). Gross residual tumor above 30 mL was negatively associated with OS (p = 0.013) and PFS (p = 0.025). Conclusions: Postoperative PT for extracranial chordomas delivered with spot scanning offers high local control rates. Toxicity was acceptable. Implants were significantly associated with LF. Residual tumor above 30 mL impacted negatively on OS and PFS.

  16. Robot-assisted laparoscopic radical prostatectomy after previous cancer surgery.

    PubMed

    Kim, Kwang Hyun; Lorenzo, Enrique Ian S; Jeong, Wooju; Oh, Cheol Kyu; Yu, Ho Song; Rha, Koon Ho

    2010-01-01

    Robot-assisted laparoscopic radical prostatectomy has become a frequently used alternative treatment option in the management of prostate cancer. As more operations are performed, more challenging patient conditions are encountered, for example those with previous abdominal cancer surgery. We present our experience of robot-assisted laparoscopic radical prostatectomy (RALP) in patients with previous cancer surgery. Seven patients with a history of previous surgery for malignancy underwent RALP. All the prostatectomies were performed using the da Vinci™ S surgical system by a single surgeon. All operations were approached transperitoneally. We reviewed perioperative data and surgical outcomes retrospectively. The mean age at surgery was 68.43 years (range 63-82). The mean operative time was 214 ± 47.32 min, and the median estimated blood loss was 500 ml (range 200-1,300). The mean hospital stay was 6.57 ± 2.15 days, and the mean duration of catheterization was 8.29 ± 3.09 days. Nerve-sparing procedure and pelvic lymph node dissection were performed in six patients. Rectal injury occurred in one patient who had undergone hemi-colectomy 15 years previously and was resolved by primary closure. Positive surgical margin was found in three patients. Although one patient had an intraoperative rectal injury, RALP in a patient with previous cancer surgery seems to be feasible and safe in experienced hands. PMID:27628634

  17. DNA damage and apoptosis in mononuclear cells from glucose-6-phosphate dehydrogenase-deficient patients (G6PD Aachen variant) after UV irradiation.

    PubMed

    Efferth, T; Fabry, U; Osieka, R

    2001-03-01

    Patients affected with X chromosome-linked, hereditary glucose-6-phosphate dehydrogenase (G6PD) deficiency suffer from life-threatening hemolytic crises after intake of certain drugs or foods. G6PD deficiency is associated with low levels of reduced glutathione. We analyzed mononuclear white blood cells (MNC) of three males suffering from the German G6PD Aachen variant, four heterozygote females of this family, one G6PD-deficient male from another family coming from Iran, and six healthy male volunteers with respect to their DNA damage in two different genes (G6PD and T-cell receptor-delta) and their propensity to enter apoptosis after UV illumination (0.08-5.28 J/cm2). As determined by PCR stop assays, there was more UV-induced DNA damage in MNC of G6PD-deficient male patients than in those of healthy subjects. MNC of G6PD-deficient patients showed a higher rate of apoptosis after UV irradiation than MNC of healthy donors. MNC of heterozygote females showed intermediate rates of DNA damage and apoptosis. It is concluded that increased DNA damage may be a result of deficient detoxification of reactive oxygen species by glutathione and may ultimately account for the higher rate of apoptosis in G6PD-deficient MNC.

  18. NSUF Irradiated Materials Library

    SciTech Connect

    Cole, James Irvin

    2015-09-01

    The Nuclear Science User Facilities has been in the process of establishing an innovative Irradiated Materials Library concept for maximizing the value of previous and on-going materials and nuclear fuels irradiation test campaigns, including utilization of real-world components retrieved from current and decommissioned reactors. When the ATR national scientific user facility was established in 2007 one of the goals of the program was to establish a library of irradiated samples for users to access and conduct research through competitively reviewed proposal process. As part of the initial effort, staff at the user facility identified legacy materials from previous programs that are still being stored in laboratories and hot-cell facilities at the INL. In addition other materials of interest were identified that are being stored outside the INL that the current owners have volunteered to enter into the library. Finally, over the course of the last several years, the ATR NSUF has irradiated more than 3500 specimens as part of NSUF competitively awarded research projects. The Logistics of managing this large inventory of highly radioactive poses unique challenges. This document will describe materials in the library, outline the policy for accessing these materials and put forth a strategy for making new additions to the library as well as establishing guidelines for minimum pedigree needed to be included in the library to limit the amount of material stored indefinitely without identified value.

  19. Intraocular inflammation after proton beam irradiation for uveal melanoma

    PubMed Central

    Lumbroso, L.; Desjardins, L.; Levy, C.; Plancher, C.; Frau, E.; D'Hermies, F.; Schlienger, P.; Mammar, H.; Delacroix, S.; Nauraye, C.; Ferrand, R.; Desblancs, C.; Mazal, A.; Asselain, B.

    2001-01-01

    AIM—To describe the inflammatory reaction that can occur following proton beam irradiation of uveal melanomas based on a large series of patients and to try to determine the risk factors for this reaction.
METHODS—Data from a cohort of patients with uveal melanoma treated by proton beam irradiation between 1991 and 1994 were analysed. The presence of inflammation was recorded and evaluated. Kaplan-Meier estimates and statistical analysis of general and tumour related risk factors were performed.
RESULTS—28% of patients treated during this period presented with ocular inflammation (median follow up 62 months). Risks factors were essentially tumour related and were correlated with larger lesions (height > 5 mm, diameter > 12 mm, volume > 0.4 cm3). Multivariate analysis identified initial tumour height and irradiation of a large volume of the eye as the two most important risk factors. Ocular inflammation usually consisted of mild anterior uveitis, resolving rapidly after topical steroids and cycloplegics. The incidence of inflammation after proton beam irradiation of melanomas seems higher than previously reported and is related to larger lesions. Evidence of inflammation associated with uveal melanoma has been described and seems to be associated with tumour necrosis (spontaneous or after irradiation). The appearance of transient inflammation during the follow up of these patients may be related to the release of inflammatory cytokines during tumour necrosis.
CONCLUSION—Inflammation following proton beam irradiation is not unusual. It is correlated with larger initial tumours and may be related to tumour necrosis.

 PMID:11673294

  20. Infratentorial craniospinal irradiation for von Hippel-Lindau: a retrospective study supporting a new treatment for patients with CNS hemangioblastomas.

    PubMed

    Simone, Charles B; Lonser, Russell R; Ondos, John; Oldfield, Edward H; Camphausen, Kevin; Simone, Nicole L

    2011-09-01

    Patients with von Hippel-Lindau (VHL) syndrome with diffuse CNS hemangioblastomas have morbidity related to their disease and require a lifetime of surgical resections. Ninety-seven percent of tumors progress, and 5-year surgery rates are 20%-60%. Stereotactic radiosurgery and fractionated radiotherapy have had limited success. For the first time, we have used infratentorial craniospinal radiation therapy (ICSRT) for VHL patients with CNS hemangioblastomas. Consecutive VHL patients treated at the National Institutes of Health with radiographic evidence of hemangioblastomas were included if they received ICSRT. Patients underwent neurologic examinations and imaging at 3- to 12-month intervals. Seven patients with 84 hemangioblastomas met eligibility criteria. ICSRT was commonly administered to 43.2 Gy in 24 fractions. Mean pre-ICSRT tumor volume was 5.48 cm(3). At a mean follow-up of 73.8 months, mean post-ICSRT tumor volume was 6.87 cm(3), and 91 tumors were identified. Complete radiographic resolution was achieved in 17.9% of lesions. Although many patients were no longer optimal surgical candidates, only 4 surgeries were needed for symptomatic lesions after ICSRT, compared with 33 prior. Acute toxicity was mild and no patient developed grade ≥1 late spinal cord toxicity according to the criteria of the Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer, despite the high dose that the entire spinal cord received. Clinical and radiographic stability or resolution was demonstrated in the majority of tumors. Tumor growth rate in this study was less than reported in natural history studies, and the rate of surgical intervention was reduced. ICSRT was well tolerated, can decrease hemangioblastoma growth rate, and is a potential therapeutic option for VHL patients that warrants further investigation.

  1. [Clinical value of the sequential study of the uric acid in CSF in patients with cerebral diseases: Part I. Brain tumor and the effect of irradiation].

    PubMed

    Ueda, T; Wakisaka, S; Kinoshita, K; Adachi, H

    1984-03-01

    Uric acid is the end product of the purine metabolism in the human and is mainly excreted to the urine. The studies on cerebrospinal fluid (CSF) uric acid in patients with various neurological diseases were reported in the literature. In the present study the authors discussed the clinical value of the sequential study of the CSF uric acid content in patients with brain tumors. CSF was investigated for uric acid in 23 controls and 30 cases of brain tumor. The results were as follows: The mean value and standard deviation of the uric acid in CSF in controls was 0.23 +/- 0.13 mg/dl. The uric acid in CSF increased in patients with malignant brain tumor (0.49 +/- 0.22 mg/dl, p less than 0.005), but was in normal range in patients with benign brain tumor (0.32 +/- 0.13 mg/dl, 0.10 less than p less than 0.25). There was no significant correlation between CSF uric acid and CSF protein contents. Uric acid in the lumbar CSF was approximately 4 times higher than in the ventricular CSF in patients with brain tumor. The CSF uric acid had progressively increased during irradiation to the whole brain. The factors contributing to increase of the uric acid in CSF were thought to be increased permeability of blood-CSF barrier, global damage of brain tissue, increased nucleic acid catabolism in the central nervous system (CNS) for example in tumor, inflammation or immunoreaction, increased of xanthine, hypoxanthine or xanthine oxidase activity in the CNS, directly increased of plasma components into the CSF due to such as subarachnoid hemorrhage, intraventricular hemorrhage, bleeding in the tumor or surgical operation, dysfunction of the CSF dynamics.(ABSTRACT TRUNCATED AT 250 WORDS)

  2. Improvement of registration accuracy in accelerated partial breast irradiation using the point-based rigid-body registration algorithm for patients with implanted fiducial markers

    SciTech Connect

    Inoue, Minoru; Yoshimura, Michio Sato, Sayaka; Nakamura, Mitsuhiro; Yamada, Masahiro; Hirata, Kimiko; Ogura, Masakazu; Hiraoka, Masahiro; Sasaki, Makoto; Fujimoto, Takahiro

    2015-04-15

    Purpose: To investigate image-registration errors when using fiducial markers with a manual method and the point-based rigid-body registration (PRBR) algorithm in accelerated partial breast irradiation (APBI) patients, with accompanying fiducial deviations. Methods: Twenty-two consecutive patients were enrolled in a prospective trial examining 10-fraction APBI. Titanium clips were implanted intraoperatively around the seroma in all patients. For image-registration, the positions of the clips in daily kV x-ray images were matched to those in the planning digitally reconstructed radiographs. Fiducial and gravity registration errors (FREs and GREs, respectively), representing resulting misalignments of the edge and center of the target, respectively, were compared between the manual and algorithm-based methods. Results: In total, 218 fractions were evaluated. Although the mean FRE/GRE values for the manual and algorithm-based methods were within 3 mm (2.3/1.7 and 1.3/0.4 mm, respectively), the percentages of fractions where FRE/GRE exceeded 3 mm using the manual and algorithm-based methods were 18.8%/7.3% and 0%/0%, respectively. Manual registration resulted in 18.6% of patients with fractions of FRE/GRE exceeding 5 mm. The patients with larger clip deviation had significantly more fractions showing large FRE/GRE using manual registration. Conclusions: For image-registration using fiducial markers in APBI, the manual registration results in more fractions with considerable registration error due to loss of fiducial objectivity resulting from their deviation. The authors recommend the PRBR algorithm as a safe and effective strategy for accurate, image-guided registration and PTV margin reduction.

  3. Risk Factors of Ototoxicity After Cisplatin-Based Chemo-Irradiation in Patients With Locally Advanced Head-and-Neck Cancer: A Multivariate Analysis

    SciTech Connect

    Zuur, Charlotte L. . E-mail: cl.zuur@vumc.nl; Simis, Yvonne J.; Lansdaal, Pauline E.; Hart, Augustinus A.; Rasch, Coen R.; Schornagel, Jan H.; Dreschler, Wouter A.; Balm, Alfons J.

    2007-08-01

    Purpose: Cisplatin chemo-irradiation is increasingly used in locally advanced squamous cell carcinoma of the head and neck. The objective of this study is to determine risk factors of ototoxicity due to intra-arterial high-dose cisplatin chemoradiation. Methods and Materials: A prospective analysis of hearing thresholds at low and (ultra) high frequencies obtained before, during, and after treatment in 146 patients. Treatment consisted of intra-arterial infusion of high-dose cisplatin (150 mg/m{sup 2}, four courses) with sodium thiosulfate rescue and concurrent radiation therapy (70 Gy). Patient and chemoradiation variables were studied in a multivariate analysis. Results: After treatment, 23% of the ears were under consideration for hearing aids because of therapy. Twenty-two percent of the patients developed an increase in air-bone gap >10 dB during or after therapy. In the multivariate explanatory analysis, cumulative dose of cisplatin and radiation therapy, and young age displayed a causal relationship with increased sensorineural hearing loss during and after therapy (p < 0.001). In the multivariate prediction analysis, pretreatment hearing level of the concerning ear was identified as an independent predictive factor for hearing capability after therapy (p < 0.0001). Conclusions: Both cisplatin and radiation therapy were proven to induce sensorineural hearing loss, in this study with short-term follow-up. Of all patient and treatment variables studied, the patients pretreatment hearing level appeared to be the main predictive factor for hearing capability after high-dose intra-arterial cisplatin chemoradiation.

  4. Factors Associated With Optimal Long-Term Cosmetic Results in Patients Treated With Accelerated Partial Breast Irradiation Using Balloon-Based Brachytherapy

    SciTech Connect

    Vicini, Frank A.; Keisch, Martin; Shah, Chirag; Goyal, Sharad; Khan, Atif J.; Beitsch, Peter D.; Lyden, Maureen; Haffty, Bruce G.

    2012-06-01

    Purpose: To evaluate factors associated with optimal cosmetic results at 72 months for early-stage breast cancer patients treated with Mammosite balloon-based accelerated partial breast irradiation (APBI). Methods and Materials: A total of 1,440 patients (1,449 cases) with early-stage breast cancer undergoing breast-conserving therapy were treated with balloon-based brachytherapy to deliver APBI (34 Gy in 3.4-Gy fractions). Cosmetic outcome was evaluated at each follow-up visit and dichotomized as excellent/good (E/G) or fair/poor (F/P). Follow-up was evaluated at 36 and 72 months to establish long-term cosmesis, stability of cosmesis, and factors associated with optimal results. Results: The percentage of evaluable patients with excellent/good (E/G) cosmetic results at 36 months and more than 72 months were 93.3% (n = 708/759) and 90.4% (n = 235/260). Factors associated with optimal cosmetic results at 72 months included: larger skin spacing (p = 0.04) and T1 tumors (p = 0.02). Using multiple regression analysis, the only factors predictive of worse cosmetic outcome at 72 months were smaller skin spacing (odds ratio [OR], 0.89; confidence interval [CI], 0.80-0.99) and tumors greater than 2 cm (OR, 4.96, CI, 1.53-16.07). In all, 227 patients had both a 36-month and a 72-month cosmetic evaluation. The number of patients with E/G cosmetic results decreased only slightly from 93.4% at 3 years to 90.8% (p = 0.13) at 6 years, respectively. Conclusions: APBI delivered with balloon-based brachytherapy produced E/G cosmetic results in 90.4% of cases at 6 years. Larger tumors (T2) and smaller skin spacing were found to be the two most important independent predictors of cosmesis.

  5. Tracking the dynamic seroma cavity using fiducial markers in patients treated with accelerated partial breast irradiation using 3D conformal radiotherapy

    SciTech Connect

    Yue, Ning J.; Haffty, Bruce G.; Goyal, Sharad

    2013-02-15

    Purpose: The purpose of the present study was to perform an analysis of the changes in the dynamic seroma cavity based on fiducial markers in early stage breast cancer patients treated with accelerated partial breast irradiation (APBI) using three-dimensional conformal external beam radiotherapy (3D-CRT). Methods: A prospective, single arm trial was designed to investigate the utility of gold fiducial markers in image guided APBI using 3D-CRT. At the time of lumpectomy, four to six suture-type gold fiducial markers were sutured to the walls of the cavity. Patients were treated with a fractionation scheme consisting of 15 fractions with a fractional dose of 333 cGy. Treatment design and planning followed NSABP/RTOG B-39 guidelines. During radiation treatment, daily kV imaging was performed and the markers were localized and tracked. The change in distance between fiducial markers was analyzed based on the planning CT and daily kV images. Results: Thirty-four patients were simulated at an average of 28 days after surgery, and started the treatment on an average of 39 days after surgery. The average intermarker distance (AiMD) between fiducial markers was strongly correlated to seroma volume. The average reduction in AiMD was 19.1% (range 0.0%-41.4%) and 10.8% (range 0.0%-35.6%) for all the patients between simulation and completion of radiotherapy, and between simulation and beginning of radiotherapy, respectively. The change of AiMD fits an exponential function with a half-life of seroma shrinkage. The average half-life for seroma shrinkage was 15 days. After accounting for the reduction which started to occur after surgery through CT simulation and treatment, radiation was found to have minimal impact on the distance change over the treatment course. Conclusions: Using the marker distance change as a surrogate for seroma volume, it appears that the seroma cavity experiences an exponential reduction in size. The change in seroma size has implications in the size of

  6. Preseason Perceived Physical Capability and Previous Injury

    PubMed Central

    Sciascia, Aaron; Haegele, Lauren E.; Lucas, Jean; Uhl, Timothy L.

    2015-01-01

    Context  Patient opinion about the ability to perform athletic maneuvers is important after injury; however, prospective assessment of self-perceived physical capability for athletes before the beginning of a season is lacking. Objective  To perform a descriptive analysis of knee, shoulder, and elbow self-perceived measures of physical capability specific to athletics and to compare the measures between athletes with and without a history of injury. Design  Cross-sectional study. Setting  Preparticipation physical examinations. Patients or Other Participants  A total of 738 collegiate athletes (486 men, 251 women; age = 19 ± 1 years) were administered questionnaires after receiving medical clearance to participate in their sports. Of those athletes, 350 reported a history of injury. Main Outcome Measure(s)  Athletes self-reported a history of knee, shoulder, or elbow injury. Perceived physical capability of the 3 joints was evaluated using the Knee Injury and Osteoarthritis Outcome Score Sport and Recreation Function and Knee-Related Quality of Life subscales and the Kerlan-Jobe Orthopaedic Clinic Shoulder and Elbow Score. We conducted nonparametric analysis to determine if scores differed between athletes with and without a history of injury. Results  Median values for the Knee Injury and Osteoarthritis Outcome Score Sports and Recreation Function and Knee-Related Quality of Life subscales and the Kerlan-Jobe Orthopaedic Clinic Shoulder and Elbow Score for all athletes were 100. Median values for perceived physical capability of athletes with a history of injury were 3 to 12 points lower for each questionnaire before the start of the season (P < .001). Conclusions  Our study provided descriptive values for individual perceived knee, shoulder, and elbow physical capability of collegiate athletes participating in 19 sports. Athletes who did not report previous injuries perceived their physical capabilities to be nearly perfect, which could set the

  7. Total Marrow and Lymphoid Irradiation and Chemotherapy Before Donor Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Leukemia

    ClinicalTrials.gov

    2016-08-10

    Adult Acute Lymphoblastic Leukemia in Complete Remission; Acute Myeloid Leukemia in Remission; Previously Treated Myelodysplastic Syndrome; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Childhood Acute Lymphoblastic Leukemia in Complete Remission

  8. Conventional Craniospinal Irradiation with Patient Supine and Source-Skin Distance (SSD) 100 cm for Spinal Field

    SciTech Connect

    Liu Xijun; Yu Jinming; Yu Yonghua; Yin Yong; Wang Bing; Zhang Yong; Kong Lei; Han Dali; Huo Zhijun; Fu Lei

    2011-01-01

    We describe a method of craniospinal irradiation (CSI) in the supine position and at a source-skin distance (SSD) of 100 cm for the spinal fields. The procedure is carried out with a 100-cm isocenter linear accelerator and conventional simulator, and the treatment is delivered with 2 opposed lateral cranial fields at source-axis distance (SAD) of 100 cm and 1 or 2 direct posterior spinal fields at SSD, 100 cm. The half beam-blocked cranial fields with a collimator rotation is used to match the superior border of the spinal field at the level of C2 vertebral body. The length of the spinal field is fixed, and is the same if 2 spinal fields are used. The position of the isocenter of the spine field is defined by longitudinally moving the couch a distance from the isocenter of the cranial fields and adjusting the SSD = 100 cm to the surface of the couch with the gantry rotated to the angle of 180 Degree-Sign (posteroanterior position), and the distance can be calculated easily according to a few parameters. It only needs a simple calculation without couch rotation, extended SSD, or markers. The inferior and superior borders of the spinal field do not require visualization under fluoroscopy when it is beyond the visual field of the simulator. The entire simulation takes no more than 20 minutes. Supine craniospinal treatment using this technique may substitute the traditional prone position as a potentially beneficial alternative to CSI.

  9. Irradiation as an etiologic factor in tumours of the thyroid, parathyroid and salivary glands.

    PubMed

    Palmer, J A; Mustard, R A; Simpson, W J

    1980-01-01

    Irradiation to the head and neck region, usually of low dosage, results in an increased frequency of thyroid, parathyroid and salivary gland tumours. The authors have reviewed their experience with these tumours. Fifty of 475 patients with carcinoma of the thyroid had received previous irradiation. Papillary or mixed papillar-follicular carcinoma occurred most commonly. Eleven of 100 patients with primary hyperparathyroidism had been irradiated and had a parathyroid adenoma. Twenty of 662 patients with salivary gland tumours had previously been irradiated. Mucoepidermoid carcinoma was the most common tumour. Patients who have been irradiated and have a palpable abnormality of the thyroid or the salivary glands should be treated surgically. The various noninvasive tests are of little value in distinguishing between a benign and a malignant tumour. Those with hypercalcemia, considered to be due to primary hyperparathyroidism, should be treated by exploration of the neck, identification of the four parathyroid glands and excision of an adenoma with biopsy of the three remaining glands. If more than one gland is abnormal, a subtotal parathyroidectomy is recommended.

  10. Irradiation subassembly

    DOEpatents

    Seim, O.S.; Filewicz, E.C.; Hutter, E.

    1973-10-23

    An irradiation subassembly for use in a nuclear reactor is described which includes a bundle of slender elongated irradiation -capsules or fuel elements enclosed by a coolant tube and having yieldable retaining liner between the irradiation capsules and the coolant tube. For a hexagonal bundle surrounded by a hexagonal tube the yieldable retaining liner may consist either of six segments corresponding to the six sides of the tube or three angular segments each corresponding in two adjacent sides of the tube. The sides of adjacent segments abut and are so cut that metal-tometal contact is retained when the volume enclosed by the retaining liner is varied and Springs are provided for urging the segments toward the center of the tube to hold the capsules in a closely packed configuration. (Official Gazette)

  11. Immunochemoradiotherapy for patients with oral squamous cell carcinoma: augmentation of OK-432-induced helper T cell 1 response by 5-FU and X-ray irradiation.

    PubMed

    Tano, Tomoyuki; Okamoto, Masato; Kan, Shin; Bando, Takashi; Goda, Hiroyuki; Nakashiro, Koh-ichi; Shimodaira, Shigetaka; Koido, Shigeo; Homma, Sadamu; Fujita, Tomonobu; Sato, Mitsunobu; Yamashita, Naomi; Hamakawa, Hiroyuki; Kawakami, Yutaka

    2013-07-01

    Eighty-one patients with oral squamous cell carcinoma (OSCC) received oral fluoropyrimidine UFT and radiotherapy (RT) with or without an immunotherapeutic agent OK-432. Both overall survival and progression-free survival of patients who received RT + UFT + OK-432 were significantly longer than those of patients who received RT + UFT (P = .0075 and P = .0175, respectively). Clinical response was also more favorable in RT + UFT + OK-432 group than in RT + UFT group (P = .0066). Next, in vitro experiments were conducted to examine the effect of 5-fluorouracil (5-FU) and X-ray irradiation in OK-432-induced immunity. Human peripheral blood mononuclear cells stimulated with OK-432 produced helper T cell 1 (Th1)-type cytokines as well as interleukin-10 (IL-10) and transforming growth factor-β (TGF-β), which are produced by Th2 and regulatory T cells (Tregs), respectively, and are inhibitory in antitumor immunity. OK-432-induced IL-10 and TGF-β but not Th1 cytokines were significantly inhibited by 5-FU and/or X-ray. 5-FU and X-ray also inhibited the expression of mRNAs for GATA-3 and Foxp3, which are transcription factors for Th2 and Tregs, respectively, but not for T-bet, a transcription factor for Th1. In addition, 5-FU and X-ray decreased the expression of mRNAs for suppressor of cytokine signaling 1 (SOCS1) and SOCS3. Antisense oligonucleotides for SOCS1 and SOCS3 markedly reduced OK-432-induced IL-10 and TGF-β. This is the first report clearly demonstrating that OK-432-based immunotherapy significantly enhanced the therapeutic effects of chemoradiotherapy in patients with OSCC as well as elucidating the mechanism of the synergistic effect of immunochemoradiotherapy in which 5-FU and radiation enhanced OK-432-induced Th1 response mediated by the inhibition of SOCS1 and SOCS3 gene expression.

  12. EGFR mutations are associated with favorable intracranial response and progression-free survival following brain irradiation in non-small cell lung cancer patients with brain metastases

    PubMed Central

    2012-01-01

    Background The presence of epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC) is associated with increased radiosensitivity in vitro. However, the results from clinical studies regarding the radiosensitivity in NSCLC with mutant EGFR are inconclusive. We retrospectively analyzed our NSCLC patients who had been regularly followed up by imaging studies after irradiation for brain metastases, and investigated the impact of EGFR mutations on radiotherapy (RT). Methods Forty-three patients with brain metastases treated with RT, together with EGFR mutation status, demographics, smoking history, performance status, recursive partitioning analysis (RPA) class, tumor characteristics, and treatment modalities, were included. Radiological images were taken at 1 to 3 months after RT, and 3 to 6 months thereafter. Radiographic response was evaluated by RECIST criteria version 1.1 according to the intracranial images before and after RT. Log-rank test and Cox regression model were used to correlate EGFR mutation status and other clinical features with intracranial radiological progression-free survival (RPFS) and overall survival (OS). Results The median follow-up duration was 15 months. Patients with mutant EGFR had higher response rates to brain RT than those with wild-type EGFR (80% vs. 46%; p = 0.037). Logistic regression analysis showed that EGFR mutation status is the only predictor for treatment response (p = 0.032). The median intracranial RPFS was 18 months (95% CI = 8.33-27.68 months). In Cox regression analysis, mutant EGFR (p = 0.025) and lower RPA class (p = 0.026) were associated with longer intracranial RPFS. EGFR mutation status (p = 0.061) and performance status (p = 0.076) had a trend to predict OS. Conclusions Mutant EGFR in NSCLC patients is an independent prognostic factor for better treatment response and longer intracranial RPFS following RT for brain metastases. PMID:23110940

  13. Influence of Irradiated Lung Volumes on Perioperative Morbidity and Mortality in Patients After Neoadjuvant Radiochemotherapy for Esophageal Cancer

    SciTech Connect

    Daehn, Doreen; Martell, Joachim; Vorwerk, Hilke; Hess, Clemens F.; Becker, Heinz; Jung, Klaus; Hilgers, Reinhard; Wolff, Hendrik Andreas; Hermann, Robert Michael; Christiansen, Hans

    2010-05-01

    Purpose: In some randomized trials, the treatment outcome of locally advanced esophageal cancer has been significantly improved by neoadjuvant radiochemotherapy (RCT). However, increased perioperative pulmonary toxicity in terms of acute respiratory distress syndrome (ARDS) has been linked to radiation exposure of the lungs. In our study we evaluated perioperative morbidity and mortality in patients with cancer Stages IIA-IVA treated with curative intent either with surgery alone (S) or with neoadjuvant RCT followed by surgery (RCTS). Patients and Methods: Between 1996 and 2003, 55 patients received S, and 98 received RCTS. In the RCTS group, most patients received two cycles of 5-fluorouracil plus cisplatinum simultaneously with normofractionated radiotherapy (40Gy). Four weeks later they underwent surgery. Endpoints were the incidence of acute lung injury (ALI), ARDS, other postoperative complications, and mortality within 31 days. Results: Between both groups there were no significant differences between the incidence and severity of ALI and ARDS (RCTS: 42.9%, 42.9%; S: 45.5%, 38.2%). Furthermore, there were no significant differences in the incidences of pneumonia, pleural effusion, and pneumothorax (RCTS 29.6% vs. S 16.4%, p = 0.07). Perioperative complication rates and mortality did not vary significantly (mortality after RCTS 5.1% vs. S 3.6%). A detailed analysis of 54 RCTS patients according to lung dose-volume histograms did not show any correlation between ARDS and pulmonary exposure. In univariate analysis, only respiratory comorbidity correlated with ARDS. Conclusion: Neoadjuvant cisplatinum and 5-fluorouracil-based RCT apparently has no detrimental impact on the postoperative course.

  14. Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies

    ClinicalTrials.gov

    2016-09-30

    Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia

  15. Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematologic Disease

    ClinicalTrials.gov

    2016-10-04

    Acute Biphenotypic Leukemia; Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Acute Myeloid Leukemia in Remission; Adult Acute Lymphoblastic Leukemia in Complete Remission; Aggressive Non-Hodgkin Lymphoma; Burkitt Lymphoma; Childhood Acute Lymphoblastic Leukemia in Complete Remission; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Lymphoblastic Lymphoma; Mantle Cell Lymphoma; Myelofibrosis; Pancytopenia; Plasma Cell Myeloma; Prolymphocytic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Follicular Lymphoma; Recurrent Lymphoplasmacytic Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Refractory Anemia With Excess Blasts

  16. Clinical outcomes of patients treated with the cutting balloon and Sr-90 {beta}-irradiation for instent restenosis

    SciTech Connect

    Almeda, Francis Q.; Chua, David Y.; Nathan, Sandeep; Kim, Susie; Meyer, Peter M.; Thew, Stephen T.; Nguyen, Cam; Chu, James C.H.; Kavinsky, Clifford J.; Schaer, Gary L.; Snell, R. Jeffrey

    2002-03-01

    Background: The cutting balloon (CB) is an emerging therapy for the treatment of instent restenosis (ISR), but its impact on the clinical outcomes of patients treated with intracoronary radiation therapy (IRT) with Sr-90 compared with conventional PTCA and IRT is not clearly defined. Methods: We compared the baseline demographics, angiographic characteristics and clinical outcomes of 102 consecutive patients with ISR treated either with CB+IRT (n=45) or with conventional PTCA+IRT (n=57). The combined endpoint was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of death, myocardial infarction (MI) or target vessel revascularization (TVR) at 6 months. Results: The CB+IRT group had a shorter mean lesion length (14.3{+-}6.5 vs. 21.1{+-}15.7, P=.009), and greater utilization of glycoprotein IIb/IIIa inhibitors during the procedure (48.9% vs. 26.3%, P=.02) compared to the PTCA+IRT group. There were no significant differences in the baseline demographics, angiographic and procedural results, or subsequent MACE at 6 months between the two groups. Conclusion: The strategy of CB+IRT using Sr-90 for ISR is associated with similar procedural and clinical outcomes compared to conventional PTCA+IRT. Further study is warranted to determine which patient subgroups would derive the most benefit from this approach.

  17. Irradiated foods

    MedlinePlus

    ... it reduces the risk of food poisoning . Food irradiation is used in many countries. It was first approved in the U.S. to prevent sprouts on white potatoes, and to control insects on wheat and in certain spices and seasonings.

  18. Long-Term Follow-Up of Preoperative Pelvic Radiation Therapy and Concomitant Boost Irradiation in Locally Advanced Rectal Cancer Patients: A Multi-Institutional Phase II Study (KROG 04-01)

    SciTech Connect

    Lee, Jong Hoon; Kim, Dae Yong; Nam, Taek-Keun; Yoon, Sei-Chul; Lee, Doo Seok; Park, Ji Won; Oh, Jae Hwan; Chang, Hee Jin; Yoon, Mee Sun; Jeong, Jae-Uk; Jang, Hong Seok

    2012-11-15

    Purpose: To perform a prospective phase II study to investigate the efficacy and safety of preoperative pelvic radiation therapy and concomitant small-field boost irradiation with 5-fluorouracil and leucovorin for 5 weeks in locally advanced rectal cancer patients. Methods and Materials: Sixty-nine patients with locally advanced, nonmetastatic, mid-to-lower rectal cancer were prospectively enrolled. They had received preoperative chemoradiation therapy and total mesorectal excision. Pelvic radiation therapy of 43.2 Gy in 24 fractions plus concomitant boost radiation therapy of 7.2 Gy in 12 fractions was delivered to the pelvis and tumor bed for 5 weeks. Two cycles of 5-fluorouracil and leucovorin were administered for 3 days in the first and fifth week of radiation therapy. The pathologic response, survival outcome, and treatment toxicity were evaluated for the study endpoints. Results: Of 69 patients, 8 (11.6%) had a pathologically complete response. Downstaging rates were 40.5% for T classification and 68.1% for N classification. At the median follow-up of 69 months, 36 patients have been followed up for more than 5 years. The 5-year disease-free survival (DFS) and overall survival rates were 66.0% and 75.3%, respectively. Higher pathologic T (P = .045) and N (P = .032) classification were significant adverse prognostic factors for DFS, and high-grade histology was an adverse prognostic factor for both DFS (P = .025) and overall survival (P = .031) on the multivariate analysis. Fifteen patients (21.7%) experienced grade 3 or 4 acute toxicity, and 7 patients (10.1%) had long-term toxicity. Conclusion: Preoperative pelvic radiation therapy with concomitant boost irradiation with 5-fluorouracil and leucovorin for 5 weeks showed acceptable acute and long-term toxicities. However, the benefit of concomitant small-field boost irradiation for 5 weeks in rectal cancer patients was not demonstrated beyond conventional irradiation for 6 weeks in terms of tumor response and

  19. Total Body Irradiation-Based Myeloablative Haploidentical Stem Cell Transplantation Is a Safe and Effective Alternative to Unrelated Donor Transplantation in Patients Without Matched Sibling Donors.

    PubMed

    Solomon, Scott R; Sizemore, Connie A; Sanacore, Melissa; Zhang, Xu; Brown, Stacey; Holland, H Kent; Morris, Lawrence E; Bashey, Asad

    2015-07-01

    We enrolled 30 patients on a prospective phase II trial utilizing a total body irradiation (TBI)-based myeloablative preparative regimen (fludarabine 30 mg/m2/day × 3 days and TBI 150 cGy twice per day on day -4 to -1 [total dose 1200 cGy]) followed by infusion of unmanipulated peripheral blood stem cells from a haploidentical family donor (haplo). Postgrafting immunosuppression consisted of cyclophosphamide 50 mg/kg/day on days 3 and 4, mycophenolate mofetil through day 35, and tacrolimus through day 180. Median patient age was 46.5 years (range, 24 to 60). Transplantation diagnosis included acute myelogenous leukemia (n = 16), acute lymphoblastic leukemia (n = 6), chronic myelogenous leukemia (n = 5), myelodysplastic syndrome (n = 1), and non-Hodgkin's lymphoma (n = 2). Using the Dana Farber/Center for International Blood and Marrow Transplant Research/Disease Risk Index (DRI), patients were classified as low (n = 4), intermediate (n = 12), high (n = 11), and very high (n = 3) risk. All patients engrafted with a median time to neutrophil and platelet recovery of 16 and 25 days, respectively. All evaluable patients achieved sustained complete donor T cell and myeloid chimerism by day +30. Acute graft-versus-host disease (GVHD) grades II to IV and III and IV was seen in 43% and 23%, respectively. The cumulative incidence of chronic GVHD was 56% (severe in 10%). After a median follow-up of 24 months, the estimated 2-year overall survival (OS), disease-free survival (DFS), nonrelapse mortality, and relapse rate were 78%, 73%, 3%, and 24%, respectively. Two-year DFS and relapse rate in patients with low/intermediate risk disease was 100% and 0%, respectively, compared with 39% and 53% for patients with high/very high risk disease. When compared with a contemporaneously treated cohort of patients at our institution receiving myeloablative HLA-matched unrelated donor (MUD) transplantation (acute myelogenous leukemia [n = 17], acute lymphoblastic leukemia [n = 15

  20. The treatment of tumors by the induction of anemia and irradiation in hyperbaric oxygen

    SciTech Connect

    Sealy, R.; Jacobs, P.; Wood, L.; Levin, W.; Barry, L.; Boniaszczuk, J.; Blekkenhorst, G.

    1989-08-01

    Because increased effects have been achieved when murine tumors are irradiated after a period of hypoxia and because of anecdotal clinical experiences of an improved result after irradiation of previously anemic patients