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  1. Spontaneous monitoring of adverse reactions to drugs by Italian dermatologists: a pilot study. Gruppo Italiano Studi Epidemiologici in Dermatologia.

    PubMed

    1991-01-01

    During 1988, the Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED) coordinated a pilot study aimed at evaluating the feasibility of a system for spontaneous monitoring of adverse drug reactions in dermatological practice in Italy. Approximately 400 dermatologists were asked to collaborate, and 141 agreed to the study. Procedures similar to those well established in other surveillance programs (including the use of standard forms and standardized assessment procedure) were adopted. In a 2-month period 775 reports were collected, of which 711 were maintained after careful evaluation. The general profile of the adverse reactions reported was in accordance with the experience derived by other spontaneous surveillance programs. The main purpose of spontaneous reporting systems is the identification of new reactions, and a model analysis was proposed, in our study, with reference to skin reactions to bamifylline. The demonstration of the feasibility of a drug-monitoring program in Italy, where little tradition exists in the area, is the most important result of our study.

  2. The management of hip fracture in the older population. Joint position statement by Gruppo Italiano Ortogeriatria (GIOG).

    PubMed

    Pioli, Giulio; Barone, A; Mussi, C; Tafaro, L; Bellelli, G; Falaschi, P; Trabucchi, M; Paolisso, G

    2014-10-01

    This document is a Joint Position Statement by Gruppo Italiano di OrtoGeriatria (GIOG) supported by Società Italiana di Gerontologia e Geriatria (SIGG), and Associazione Italiana Psicogeriatria (AIP) on management of hip fracture older patients. Orthogeriatric care is at present the best model of care to improve results in older patients after hip fracture. The implementation of orthogeriatric model of care, based on the collaboration between orthopaedic surgeons and geriatricians, must take into account the local availability of resources and facilities and should be integrated into the local context. At the same time the programme must be based on the best available evidences and planned following accepted quality standards that ensure the efficacy of the intervention. The position paper focused on eight quality standards for the management of hip fracture older patients in orthogeriatric model of care. The GIOG promotes the development of a clinic database with the aim of obtaining a qualitative improvement in the management of hip fracture.

  3. Lichen planus and liver diseases: a multicentre case-control study. Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED).

    PubMed

    1990-01-27

    To assess the association of lichen planus with liver complaints and with known aetiological factors of liver diseases. Multicentre case-control study. Interviews were conducted by trained medical investigators on the basis of a structured questionnaire. At the interview patients and controls were asked for consent to blood samples being taken to determine transaminase activities and the presence of hepatitis B virus surface antigen. Outpatient departments of 27 Italian general and teaching hospitals that were collaborating in the Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED). Incident cases and controls were eligible. A total of 577 patients with lichen planus and 1031 controls with dermatological diseases other than lichen planus were interviewed. Less than 1% of the people contacted refused to participate. Patients and controls were matched for sex and age in five year intervals. The risk of lichen planus was higher in patients with a history of liver diseases requiring hospital admission or specialist consultation (relative risk = 1.6; 95% confidence interval = 1.2 to 2.2), those who had had liver biopsy (5.5; 1.9 to 15.6), and those with a history of viral hepatitis (1.9; 1.1 to 3.1). High activities of liver enzymes and positive results of tests for hepatitis B virus surface antigen were also associated with lichen planus. The association with alcohol consumption was not clearly confirmed by a dose-risk relation. This study adds quantitative epidemiological evidence to the clinical observation that liver disease is a risk factor for lichen planus although not a specific marker of it.

  4. Cutaneous reactions to analgesic-antipyretics and nonsteroidal anti-inflammatory drugs. Analysis of reports to the spontaneous reporting system of the Gruppo Italiano Studi Epidemiologici in Dermatologia.

    PubMed

    1993-01-01

    We analyzed the cutaneous reactions to systemic analgesic-antipyretics and non-steroidal anti-inflammatory drugs reported to the spontaneous reporting system of the Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED). The system has been active since 1988, with periodic intensive surveillance exercises, and 202 dermatologists have collaborated. Up to December 1991, 2,137 reactions had been collected, of which 713 were reactions to systemic analgesic-antipyretics and nonsteroidal anti-inflammatory drugs. A general profile of the reactions was identifiable. It included, in order of frequency, urticaria/angioedema, fixed eruptions, exanthemas, erythema multiforme and Stevens Johnson syndrome. Fixed eruptions and Stevens Johnson syndrome were reported with exceedingly high frequency in association with feprazone. Our system also revealed previously unreported reactions, including fixed eruption to nimesulide, fixed eruption to piroxicam and fixed eruption to flurbiprofen.

  5. Epidemiological evidence of the association between lichen planus and two immune-related diseases. Alopecia areata and ulcerative colitis. Gruppo Italiano Studi Epidemiologici in Dermatologia.

    PubMed

    1991-05-01

    Between September 1986 and February 1988, a case-control study involving 27 Italian dermatological centers collaborating in the Gruppo Italiano Studi Epidemiologici in Dermatologia was conducted, concerning the relationship between history of several medical conditions and exposures to drugs and the risk of lichen planus. The cases were all consecutive patients with a new diagnosis of lichen planus, and the controls were patients under dermatological care observed under the same conditions. A total of 711 cases and 1395 controls met the admission criteria and were interviewed by trained investigators. Patients with histories of alopecia areata were found to be at risk for lichen planus (relative risk = 2.7; 95% confidence interval, 1.1 to 6.5). Five patients (0.7%) in the group with lichen planus had a history of ulcerative colitis, while none of the controls had this disease. The risk of lichen planus was also increased in patients with a history of chronic active hepatitis, but this increase was not statistically significant (relative risk = 4.7; 95% confidence interval, 0.7 to 29.4).

  6. Primary prophylaxis of invasive fungal diseases in allogeneic stem cell transplantation: revised recommendations from a consensus process by Gruppo Italiano Trapianto Midollo Osseo (GITMO).

    PubMed

    Girmenia, Corrado; Barosi, Giovanni; Piciocchi, Alfonso; Arcese, William; Aversa, Franco; Bacigalupo, Andrea; Bandini, Giuseppe; Bosi, Alberto; Busca, Alessandro; Castagnola, Elio; Caselli, Desiree; Cesaro, Simone; Ciceri, Fabio; Locasciulli, Anna; Locatelli, Franco; Mikulska, Malgorzata; Pagano, Livio; Prete, Arcangelo; Raiola, Anna Maria; Rambaldi, Alessandro

    2014-08-01

    This document updates and expands the recommendations on primary prophylaxis of invasive fungal diseases (IFD) in allogeneic hematopoietic stem cell transplantation (allo-HSCT) recipients, published in 2009 by the Gruppo Italiano Trapianto Midollo Osseo (GITMO). A consensus process was undertaken to describe and evaluate current information and practice regarding risk stratification and primary antifungal prophylaxis during the pre-engraftment and postengraftment phases after allo-HSCT. The revised recommendations were based on the evaluation of recent literature including a large, prospective, multicenter epidemiological study of allo-HSCT recipients conducted among the GITMO transplantation centers during the period of 2008 to 2010. It is intended as a guide for the identification of types and phases of transplantation at low, standard, and high risk for IFD, according to the underlying disease, transplantation, and post-transplantation factors. The risk stratification was the critical determinant of the primary antifungal approach for allo-HSCT recipients. Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  7. Factors predicting outcome after allogeneic transplant in refractory acute myeloid leukemia: a retrospective analysis of Gruppo Italiano Trapianto di Midollo Osseo (GITMO).

    PubMed

    Todisco, E; Ciceri, F; Boschini, C; Giglio, F; Bacigalupo, A; Patriarca, F; Donnini, I; Alessandrino, E P; Arcese, W; Iori, A P; Marenco, P; Cavattoni, I; Chiusolo, P; Terruzzi, E; Castagna, L; Santoro, A; Bosi, A; Oldani, E; Bruno, B; Bonifazi, F; Rambaldi, A

    2017-07-01

    The clinical outcome of primary refractory (PRF) AML patients is poor and only a minor proportion of patients is rescued by allogenic hematopoietic stem cell transplantation (HSCT). The identification of pre-HSCT variables may help to determine PRF AML patients who can most likely benefit from HSCT. We analyzed PRF AML patients transplanted between 1999 and 2012 from a sibling, unrelated donor or a cord blood unit. Overall, 227 patients from 26 Gruppo Italiano Trapianto di Midollo Osseo e Terapia cellulare centers were included in the analysis. At 3 years, the overall survival was 14%. By multivariate analysis, the number of chemotherapy cycles, (hazard ratio (HR): 1.87; 95% confidence interval (CI): 1.24-2.85; P=0.0028), the percentage of bone marrow or peripheral blood blasts (HR: 1.75; 95% CI: 1.16-2.64; P=0.0078), the adverse cytogenetic (HR: 1.44; 95% CI: 1.00-2.07; P=0.0508) and the age of patients (HR: 1.77; 95% CI: 1.08-2.88; P=0.0223) remained significantly associated with survival. Thus, we set up a new score predicting at 3 years after transplantation, an overall survival probability of 32% for patients with score 0 (no or 1 prognostic factor), 10% for patients with score 1 (2 prognostic factors) and 3% for patients with score 2 (3 or 4 prognostic factors).

  8. Incidence and outcome of invasive fungal diseases after allogeneic stem cell transplantation: a prospective study of the Gruppo Italiano Trapianto Midollo Osseo (GITMO).

    PubMed

    Girmenia, Corrado; Raiola, Anna Maria; Piciocchi, Alfonso; Algarotti, Alessandra; Stanzani, Marta; Cudillo, Laura; Pecoraro, Clara; Guidi, Stefano; Iori, Anna Paola; Montante, Barbara; Chiusolo, Patrizia; Lanino, Edoardo; Carella, Angelo Michele; Zucchetti, Elisa; Bruno, Benedetto; Irrera, Giuseppe; Patriarca, Francesca; Baronciani, Donatella; Musso, Maurizio; Prete, Arcangelo; Risitano, Antonio Maria; Russo, Domenico; Mordini, Nicola; Pastore, Domenico; Vacca, Adriana; Onida, Francesco; Falcioni, Sadia; Pisapia, Giovanni; Milone, Giuseppe; Vallisa, Daniele; Olivieri, Attilio; Bonini, Alessandro; Castagnola, Elio; Sica, Simona; Majolino, Ignazio; Bosi, Alberto; Busca, Alessandro; Arcese, William; Bandini, Giuseppe; Bacigalupo, Andrea; Rambaldi, Alessandro; Locasciulli, Anna

    2014-06-01

    Epidemiologic investigation of invasive fungal diseases (IFDs) in allogeneic hematopoietic stem cell transplantation (allo-HSCT) may be useful to identify subpopulations who might benefit from targeted treatment strategies. The Gruppo Italiano Trapianto Midollo Osseo (GITMO) prospectively registered data on 1858 consecutive patients undergoing allo-HSCT between 2008 and 2010. Logistic regression analysis was performed to identify risk factors for proven/probable IFD (PP-IFD) during the early (days 0 to 40), late (days 41 to 100), and very late (days 101 to 365) phases after allo-HSCT and to evaluate the impact of PP-IFDs on 1-year overall survival. The cumulative incidence of PP-IFDs was 5.1% at 40 days, 6.7% at 100 days, and 8.8% at 12 months post-transplantation. Multivariate analysis identified the following variables as associated with PP-IFDs: transplant from an unrelated volunteer donor or cord blood, active acute leukemia at the time of transplantation, and an IFD before transplantation in the early phase; transplant from an unrelated volunteer donor or cord blood and grade II-IV acute graft-versus-host disease (GVHD) in the late phase; and grade II-IV acute GVHD and extensive chronic GVHD in the very late phase. The risk for PP-IFD was significantly higher when acute GVHD was followed by chronic GVHD and when acute GVHD occurred in patients undergoing transplantation with grafts from other than matched related donors. The presence of PP-IFD was an independent factor in long-term survival (hazard ratio, 2.90; 95% confidence interval, 2.32 to 3.62; P < .0001). Our findings indicate that tailored prevention strategies may be useful in subpopulations at differing levels of risk for PP-IFDs. Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  9. A multicenter retrospective study of chemotherapy for recurrent intracranial ependymal tumors in adults by the Gruppo Italiano Cooperativo di Neuro-Oncologia.

    PubMed

    Brandes, Alba A; Cavallo, Giovanna; Reni, Michele; Tosoni, Alicia; Nicolardi, Linda; Scopece, Luciano; Franceschi, Enrico; Sotti, Guido; Talacchi, Andrea; Turazzi, Sergio; Ermani, Mario

    2005-07-01

    No data on the role of chemotherapy in recurrent ependymal tumors are available in adults. The aim of the current study was to investigate outcomes after salvage chemotherapy in this setting. A retrospective review was made of the charts of 28 adults (> or = 18 years) with progressive or recurrent ependymal tumors after surgery and radiotherapy, who received chemotherapy between 1993 and 2003 in 3 institutions of the Gruppo Italiano Cooperativo di Neuro-Oncologia network. Thirteen patients (46.3%) received cisplatin-based chemotherapy (Group A) and 15 (53.7%) received regimens without cisplatin (Group B). Platinum-based chemotherapy yielded 2 complete responses (CR) (15.4%) and 2 (15.4%) partial responses (PR), whereas 7 patients (53.8%) remained stable (SD). After regimens without cisplatin, there were no CR, 2 PR (13.3%), and 11 SD (73.3%). The overall median time to progression was 9.9 months (95% confidence interval [95% CI], 7.5-21.7 months), 9.9 months (5.2-not reached) for Group A and 10.9 months (95% CI, 7.17-23.9 months) for Group B. The overall median survival (OS) was 40.7 months (95% CI, 16-not reached), 31 months (21-not reached) for Group A and 40.7 months (13.4-not reached) for Group B. Cisplatin-based chemotherapy achieved a higher response rate, but did not prolong disease progression-free survival or OS. More active regimens for the salvage treatment of ependymal tumors have yet to be found.

  10. Renal vascular lesions as a marker of poor prognosis in patients with lupus nephritis. Gruppo Italiano per lo Studio della Nefrite Lupica (GISNEL).

    PubMed

    Banfi, G; Bertani, T; Boeri, V; Faraggiana, T; Mazzucco, G; Monga, G; Sacchi, G

    1991-08-01

    The frequency of renal vascular lesions (RVL) and their relevance in the progression of renal damage were evaluated by the Pathology Group of the "Gruppo Italiano per lo Studio della Nefrite Lupica" (GISNEL). Of 285 patients with lupus nephritis collected from 20 nephrology centers in Italy and classified according to World Health Organization (WHO) criteria, 79 cases (27.7%) with RVL were identified and classified as follows: (1) lupus vasculopathy (n = 27); (2) hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP) malignant hypertension-like lesions (n = 24); (3) vasculitis (n = 8); (4) arterio-arteriosclerosis (n = 20). At the time of renal biopsy, patients with RVL had mean serum creatinine levels significantly higher than patients without RVL (201.8 +/- 195.9 mumol/L [2.2 +/- 2.2 mg/dL] v 108.1 +/- 108.0 mumol/L [1.2 +/- 1.2 mg/dL]; P less than 0.01). Hypertension was more frequent in patients with RVL than in those without (68.4% v 30.5%; P less than 0.01). The probability of kidney survival assessed according to the Kaplan-Meier method at 5 and 10 years was, respectively, 74.3% +/- 5.9% and 58.0% +/- 8.9% in patients with RVL, compared with 89.6% +/- 2.7% and 85.9% +/- 3.7% in patients without RVL. However, the two groups did not differ significantly as regards overall survival, the probability of survival at 5 and 10 years being 86.5% +/- 4.5% and 78.8% +/- 6.6% in patients with RVL and 92.2% +/- 2.2% and 83.3% +/- 4.4% in patients without RVL.(ABSTRACT TRUNCATED AT 250 WORDS)

  11. Efficacy of FOLFOXIRI plus bevacizumab in liver-limited metastatic colorectal cancer: A pooled analysis of clinical studies by Gruppo Oncologico del Nord Ovest.

    PubMed

    Cremolini, Chiara; Casagrande, Mariaelena; Loupakis, Fotios; Aprile, Giuseppe; Bergamo, Francesca; Masi, Gianluca; Moretto R, Roberto; Pietrantonio, Filippo; Marmorino, Federica; Zucchelli, Gemma; Tomasello, Gianluca; Tonini, Giuseppe; Allegrini, Giacomo; Granetto, Cristina; Ferrari, Laura; Urbani, Lucio; Cillo, Umberto; Pilati, Pierluigi; Sensi, Elisa; Pellegrinelli, Alessio; Milione, Massimo; Fontanini, Gabriella; Falcone, Alfredo

    2017-03-01

    Secondary resection is a chance of cure for a subgroup of metastatic colorectal cancer (mCRC) patients with unresectable liver-limited disease. Medical treatment has a dual goal: to induce tumour shrinkage and to prevent disease relapse. The aims of the present analysis were to assess the efficacy of FOLFOXIRI plus bevacizumab in this setting, and to investigate whether this regimen could revert the poor prognosis of high-risk patients defined by clinical and molecular factors. We performed a pooled analysis of patients with unresectable and liver-limited mCRC, treated with first-line FOLFOXIRI plus bevacizumab in three prospective clinical trials by Gruppo Oncologico del Nord Ovest. 205 (37.9%) patients with liver-limited disease were selected, out of 541 treated patients. Liver metastases were synchronous, ≥4 and bilobar in 90%, 61%, and 79% of cases, respectively. The largest diameter was >5 cm in 42% of cases, and ≥6 segments were involved in 25%. Seventy-four patients (36.1%) underwent R0 or R1 resection of metastases. R2 resections were performed in 17 cases (8.3%). Having <6 involved segments (p < 0.001) and achieving RECIST response (p = 0.019) were associated with higher chances of resection. R0/R1 resected patients had significantly longer median progression-free survival (PFS) (18.1 versus 10.7 months, HR: 0.48 [0.35-0.66], p < 0.001) and overall survival (OS) (44.3 versus 24.4 months, HR: 0.32 [0.22-0.48], p < 0.001) compared with other patients, both in the univariate and multivariate analyses (PFS p = 0.025; OS p < 0.001). The 5-year PFS and OS rate in R0 resected patients were 12% and 43%, respectively. Neither negative baseline characteristics nor high clinical risk scores or RAS/BRAF mutations were associated with poor post-resection outcomes. In conclusion, FOLFOXIRI plus bevacizumab demonstrates efficacy in the conversion setting with considerable long-term outcome results independent of clinical and molecular prognostic

  12. [Appropriateness of indicating aortocoronary bypass and coronary angioplasty: results of an observational prospective study in the Lombardy region. Gruppo Interdisciplinare Valutazione Appropriatezza Rivascolarizzazione Coronarica].

    PubMed

    Valagussa, F; Maggioni, A P; Valagussa, L; Filardo, G; Mura, G; Liberati, A

    1997-12-01

    Most studies on the appropriateness of cardiac revascularization procedures have been aimed at detecting "overuse" (ie when patients get a procedure without a clear indication), while little attention has been paid yet to "underuse" (when patients who could benefit from a procedure do not get it). This study was planned to assess the extent of over- and underuse of revascularization procedures in northern Italy. A multidisciplinary panel of experts convened by the Italian Association of Hospital Cardiologists (ANMCO) rated the appropriateness of 898 "theoretical indications" for coronary artery by-pass grafting (CABG) and percutaneous transluminal angioplasty (PTCA) using the RAND Corporation methodology. Standardized information has been collected on a consecutive sample of patients in the Lombardy region and identified during performance of a coronary angiogram at one of the services belonging to the GISE (Gruppo Italiano Studi Emodinamica) network. Out of the 2718 consecutive patients undergoing a coronary angiogram during the recruitment period (February-May 1995), a total of 1821 (70%) were eligible for the appropriateness study. Indication for CABG were appropriate in 565 (80%) patients, uncertain in 111 (16%) and inappropriate in 25 (4%). Corresponding values for PTCA were: 40% (n = 262), 46% (n = 300) and 14% (n = 90). Among the 394 to whom a medical therapy was recommended after angiography, the indication was considered appropriated in only 14% (n = 57) and uncertain for 30% (n = 117). For the remaining 220, the indication was considered inappropriate, suggesting that according to the panel criteria, 56% of the patients should have received a revascularization procedure (either a CABG or PTCA) instead. These results suggest that underuse of revascularization procedures represents a substantial health care problem in Lombardy region, at least with reference to the period covered by this study. The study in itself does not make it possible to understand

  13. A multicenter phase III prospective randomized trial of high-dose epirubicin in combination with cyclophosphamide (EC) versus docetaxel followed by EC in node-positive breast cancer. GOIM (Gruppo Oncologico Italia Meridionale) 9902 study.

    PubMed

    Vici, P; Brandi, M; Giotta, F; Foggi, P; Schittulli, F; Di Lauro, L; Gebbia, N; Massidda, B; Filippelli, G; Giannarelli, D; Di Benedetto, A; Mottolese, M; Colucci, G; Lopez, M

    2012-05-01

    The Gruppo Oncologico Italia Meridionale 9902 trial compared four cycles of high-dose epirubicin plus cyclophosphamide (EC) with four cycles of docetaxel (Taxotere, D) followed by four cycles of EC as adjuvant treatment of node-positive breast cancer. Patients were randomly assigned to EC (E 120 mg/m(2), C 600 mg/m(2), arm A) for four cycles or four cycles of D (100 mg/m(2)) followed by four cycles of EC (arm B), both regimens every 21 days. Hormone receptor-positive patients were given hormonal therapy for 5 years. Primary end point was 5-year disease-free survival (DFS). Secondary objectives were overall survival (OS) and safety. There were 750 patients enrolled. With a median follow-up of 64 months, 5-year DFS was 73.4% in both arms, and 5-year OS was 89.5% versus 90.7% in arm A and B [hazard ratio was 0.99 (95% confidence interval for DFS 0.75-1.31; P = 0.95)], respectively. Grade 3-4 toxicity was more common in arm B. This study did not show advantages from the addition of docetaxel to high-dose EC as adjuvant chemotherapy in node-positive breast cancer. The small sample size and low number of DFS events may have limited the ability to observe statistically significant difference between the two arms.

  14. A multicenter phase III prospective randomized trial of high-dose epirubicin in combination with cyclophosphamide (EC) versus docetaxel followed by EC in node-positive breast cancer. GOIM (Gruppo Oncologico Italia Meridionale) 9902 study

    PubMed Central

    Vici, P.; Brandi, M.; Giotta, F.; Foggi, P.; Schittulli, F.; Di Lauro, L.; Gebbia, N.; Massidda, B.; Filippelli, G.; Giannarelli, D.; Di Benedetto, A.; Mottolese, M.; Colucci, G.; Lopez, M.

    2012-01-01

    Background: The Gruppo Oncologico Italia Meridionale 9902 trial compared four cycles of high-dose epirubicin plus cyclophosphamide (EC) with four cycles of docetaxel (Taxotere, D) followed by four cycles of EC as adjuvant treatment of node-positive breast cancer. Patients and methods: Patients were randomly assigned to EC (E 120 mg/m2, C 600 mg/m2, arm A) for four cycles or four cycles of D (100 mg/m2) followed by four cycles of EC (arm B), both regimens every 21 days. Hormone receptor-positive patients were given hormonal therapy for 5 years. Primary end point was 5-year disease-free survival (DFS). Secondary objectives were overall survival (OS) and safety. Results: There were 750 patients enrolled. With a median follow-up of 64 months, 5-year DFS was 73.4% in both arms, and 5-year OS was 89.5% versus 90.7% in arm A and B [hazard ratio was 0.99 (95% confidence interval for DFS 0.75–1.31; P = 0.95)], respectively. Grade 3–4 toxicity was more common in arm B. Conclusions: This study did not show advantages from the addition of docetaxel to high-dose EC as adjuvant chemotherapy in node-positive breast cancer. The small sample size and low number of DFS events may have limited the ability to observe statistically significant difference between the two arms. PMID:21965475

  15. Best practice for peripheral blood progenitor cell mobilization and collection in adults and children: results of a Società Italiana Di Emaferesi e Manipolazione Cellulare (SIDEM) and Gruppo Italiano Trapianto Midollo Osseo (GITMO) consensus process.

    PubMed

    Pierelli, Luca; Perseghin, Paolo; Marchetti, Monia; Accorsi, Patrizia; Fanin, Renato; Messina, Chiara; Olivieri, Attilio; Risso, Marco; Salvaneschi, Laura; Bosi, Alberto

    2012-04-01

    A large heterogeneity in current mobilization and collection practices is perceived. Moreover, recent evidence introduced novel issues into some specific topics. Optimization of the clinical practice, through the adoption of clinical practice guidelines, previously proved to reduce health care resource use. Two Italian scientific societies, Società Italiana Di Emaferesi e Manipolazione Cellulare (SIDEM) and Gruppo Italiano Trapianto Midollo Osseo (GITMO), perceived the need of hematologists and transfusionists to share a common paradigm in the setting of hematopoietic stem cell transplantation (SCT). The aim of the current position paper is to provide common definitions and criteria for mobilization and collection of peripheral blood stem cells both in autologous and in the allogeneic setting. Current international and national standards (i.e., International Society of Hematotherapy and Graft Engineering) and recommendations (i.e., European Group for Blood and Marrow Transplantation) were harmonized with the Panel recommendations. The Expert Panel consisted of nine members (five transfusionists and four hematologists with both clinical and scientific experience of SCT in both pediatric and adult setting) and one methodologist and first convened on April 19, 2010: they in turn agreed on the questions to be answered by the project. Available literature was reviewed by one expert and the methodologist and presented to the other members. Statements were then formulated. SIDEM and GITMO planned an informal meeting of the Panel every 2 years to discuss relevant updates and possible changes to the recommendations. The efforts of the expert panel members allowed to set up and share a common approach to the mobilization, enumeration, and collection issues in the field of both autologous and allogeneic peripheral blood SCT. © 2011 American Association of Blood Banks.

  16. Revised International Prognostic Scoring System (IPSS) predicts survival and leukemic evolution of myelodysplastic syndromes significantly better than IPSS and WHO Prognostic Scoring System: validation by the Gruppo Romano Mielodisplasie Italian Regional Database.

    PubMed

    Voso, Maria Teresa; Fenu, Susanna; Latagliata, Roberto; Buccisano, Francesco; Piciocchi, Alfonso; Aloe-Spiriti, Maria Antonietta; Breccia, Massimo; Criscuolo, Marianna; Andriani, Alessandro; Mancini, Stefano; Niscola, Pasquale; Naso, Virginia; Nobile, Carolina; Piccioni, Anna Lina; D'Andrea, Mariella; D'Addosio, Ada; Leone, Giuseppe; Venditti, Adriano

    2013-07-20

    The definition of disease-specific prognostic scores plays a fundamental role in the treatment decision-making process in myelodysplastic syndrome (MDS), a group of myeloid disorders characterized by a heterogeneous clinical behavior. We applied the recently published Revised International Prognostic Scoring System (IPSS-R) to 380 patients with MDS, registered in an Italian regional database, recruiting patients from the city of Rome (Gruppo Romano Mielodisplasie). Patients were selected based on the availability of IPSS-R prognostic factors, including complete peripheral-blood and bone marrow counts, informative cytogenetics, and follow-up data. We validated the IPSS-R score as a significant predictor of overall survival (OS) and leukemia-free survival (LFS) in MDS (P < .001 for both). When comparing the prognostic value of the International Prognostic Scoring System (IPSS), WHO Prognostic Scoring System (WPSS), and IPSS-R, using the Cox regression model and the likelihood ratio test, a significantly higher predictive power for LFS and OS became evident for the IPSS-R, compared with the IPSS and WPSS (P < .001 for both). The multivariate analysis, including IPSS, WPSS, age, lactate dehydrogenase, ferritin concentration, Eastern Cooperative Oncology Group performance status, transfusion dependency, and type of therapy, confirmed the significant prognostic value of IPSS-R subgroups for LFS and OS. Treatment with lenalidomide and erythropoiesis-stimulating agents was shown to be an independent predictor of survival in the multivariate analysis. Our data confirm that the IPSS-R is an excellent prognostic tool in MDS in the era of disease-modifying treatments. The early recognition of patients at high risk of progression to aggressive disease may optimize treatment timing in MDS.

  17. Prognostic Impact of Diabetes and Prediabetes on Survival Outcomes in Patients With Chronic Heart Failure: A Post-Hoc Analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) Trial.

    PubMed

    Dauriz, Marco; Targher, Giovanni; Temporelli, Pier Luigi; Lucci, Donata; Gonzini, Lucio; Nicolosi, Gian Luigi; Marchioli, Roberto; Tognoni, Gianni; Latini, Roberto; Cosmi, Franco; Tavazzi, Luigi; Maggioni, Aldo Pietro

    2017-07-05

    The independent prognostic impact of diabetes mellitus (DM) and prediabetes mellitus (pre-DM) on survival outcomes in patients with chronic heart failure has been investigated in observational registries and randomized, clinical trials, but the results have been often inconclusive or conflicting. We examined the independent prognostic impact of DM and pre-DM on survival outcomes in the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) trial. We assessed the risk of all-cause death and the composite of all-cause death or cardiovascular hospitalization over a median follow-up period of 3.9 years among the 6935 chronic heart failure participants of the GISSI-HF trial, who were stratified by presence of DM (n=2852), pre-DM (n=2013), and non-DM (n=2070) at baseline. Compared with non-DM patients, those with DM had remarkably higher incidence rates of all-cause death (34.5% versus 24.6%) and the composite end point (63.6% versus 54.7%). Conversely, both event rates were similar between non-DM patients and those with pre-DM. Cox regression analysis showed that DM, but not pre-DM, was associated with an increased risk of all-cause death (adjusted hazard ratio, 1.43; 95% CI, 1.28-1.60) and of the composite end point (adjusted hazard ratio, 1.23; 95% CI, 1.13-1.32), independently of established risk factors. In the DM subgroup, higher hemoglobin A1c was also independently associated with increased risk of both study outcomes (all-cause death: adjusted hazard ratio, 1.21; 95% CI, 1.02-1.43; and composite end point: adjusted hazard ratio, 1.14; 95% CI, 1.01-1.29, respectively). Presence of DM was independently associated with poor long-term survival outcomes in patients with chronic heart failure. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00336336. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  18. Risk of Stroke in Chronic Heart Failure Patients Without Atrial Fibrillation: Analysis of the Controlled Rosuvastatin in Multinational Trial Heart Failure (CORONA) and the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca-Heart Failure (GISSI-HF) Trials.

    PubMed

    Abdul-Rahim, Azmil H; Perez, Ana-Cristina; Fulton, Rachael L; Jhund, Pardeep S; Latini, Roberto; Tognoni, Gianni; Wikstrand, John; Kjekshus, John; Lip, Gregory Y H; Maggioni, Aldo P; Tavazzi, Luigi; Lees, Kennedy R; McMurray, John J V

    2015-04-28

    Our aim was to describe the incidence and predictors of stroke in patients who have heart failure without atrial fibrillation (AF). We pooled 2 contemporary heart failure trials, the Controlled Rosuvastatin in Multinational Trial Heart Failure (CORONA) and the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza cardiaca-Heart Failure trial (GISSI-HF). Of the 9585 total patients, 6054 did not have AF. Stroke occurred in 165 patients (4.7%) with AF and in 206 patients (3.4%) without AF (rates 16.8/1000 patient-years and 11.1/1000 patient-years, respectively). Using Cox proportional-hazards models, we identified the following independent predictors of stroke in patients without AF (ranked by χ(2) value): age (hazard ratio, 1.34; 95% confidence interval, 1.18-1.63 per 10 years), New York Heart Association class (1.60, 1.21-2.12 class III/IV versus II), diabetes mellitus treated with insulin (1.87, 1.22-2.88), body mass index (0.74, 0.60-0.91 per 5 kg/m(2) up to 30), and previous stroke (1.81, 1.19-2.74). N-terminal pro B-type natriuretic peptide (available in 2632 patients) was also an independent predictor of stroke (hazard ratio, 1.31; 1.11-1.57 per log unit) when added to this model. With the use of a risk score formulated from these predictors, we found that patients in the upper third of risk had a rate of stroke that approximated the risk in patients with AF. A small number of demographic and clinical variables identified a subset of patients who have heart failure without AF at a high risk of stroke. © 2015 American Heart Association, Inc.

  19. Red blood cell oleic acid levels reflect olive oil intake while omega-3 levels reflect fish intake and the use of omega-3 acid ethyl esters: The Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Heart Failure trial.

    PubMed

    Harris, William S; Masson, Serge; Barlera, Simona; Milani, Valentina; Pileggi, Silvana; Franzosi, Maria Grazia; Marchioli, Roberto; Tognoni, Gianni; Tavazzi, Luigi; Latini, Roberto

    2016-09-01

    The Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Heart Failure (GISSI-HF) study reported benefits of n-3 fatty acid (FA) treatment on cardiovascular (CV) events, but the effects of treatment on a putative CV disease risk factor, the red blood cell (RBC) n-3 FA level (the omega-3 index), have not been examined in this context. We hypothesized that treatment with prescription omega-3 acid ethyl esters (O3AEE) would increase the omega-3 index to the proposed cardioprotective value of 8%. RBCs were collected from a subset of patients participating in the GISSI-HF study (n=461 out of 6975 randomized), at baseline and after 3 months of treatment with either an olive oil placebo or O3AEE (1 g/d). RBC FA levels were expressed as a percentage of total FA. Patients also reported their typical olive oil and fish intakes. RBC oleic acid levels were directly correlated with reported frequency of olive oil consumption, and the omega-3 index was correlated with reported fish intake (P for trends <0.001 for both). After treatment, the omega-3 index increased from 4.8±1.7% to 6.7±1.9% but was unchanged in the placebo group (4.7±1.7 to 4.8±1.5%) (P<.0001 for changes between groups). At 3 months, more patients reached the proposed target omega-3 index level of 8%-12% in the treated vs placebo group (22.6% vs. 1.3%, P<.0001), however, what omega-3 index levels were ultimately achieved after four years in this trial are unknown. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. La relatività debole. La fisica dello spazio e del tempo senza paradossi

    NASA Astrophysics Data System (ADS)

    Selleri, Franco

    2011-06-01

    Secondo Einstein e Poincaré la simultaneità di eventi che hanno luogo in punti diversi dello spazio può essere definita solo per convenzione. Dal punto di vista matematico si dimostra, quindi, che due diverse definizioni di simultaneità corrispondono a due diversi valori del coefficiente e1 della variabile spaziale x presente nelle trasformazioni di Lorentz. A partire da premesse normalmente accettate otterremo diverse dimostrazioni della necessità di reintrodurre il concetto di simultaneità assoluta. Le conseguenze cosmologiche della nuova struttura dello spazio e del tempo andranno contro la cosmologia del Big Bang. Inoltre, dopo questi risultati, il relativismo sopravviverà in una forma meno aspra ("relatività debole") perché risulter privo di quel campionario di paradossi portato dalla teoria della Relatività Speciale.

  1. Capodanno Senza Danno: the effects of an intervention program on fireworks injuries in Naples.

    PubMed Central

    D'Argenio, P; Cafaro, L; Santonastasi, F; Taggi, F; Binkin, N

    1996-01-01

    To study the effects of a comprehensive, multifaceted intervention program to reduce fireworks-related injuries during the Italian New Year's holiday season, active surveillance was conducted in the 18 public emergency rooms of Naples, Italy, before and after implementation of the program. Preintervention data collected between December 24, 1992, and January 6, 1993, were compared with data collected during the same period in 1993-1994. The number of injuries decreased by 48% from 353 to 183, with the greatest declines seen among 10- to 12-year-olds. The broad-based intervention implemented during the 1993-1994 holiday season appears to have substantially reduced the number of injuries. PMID:8561250

  2. The effects of lauromacrogol on thyroid tissue in rabbits. Is this a safe option for the treatment of nodular thyroid disease?

    PubMed

    Idiz, Ufuk Oguz; Aysan, Erhan; Can, Ismail; Buyukpinarbasili, Nur; Yardimci, Erkan Yardimci; Bektasoglu, Huseyin

    2016-01-01

    Lo studio è finalizzato al rilevamento degli effetti del lauromacroglo, un agente sclerosante, sul tessuto tiroideo del coniglio, utilizzando 12 conigli divisi in due gruppi di sei ciascuno. Nel gruppo di studio è stato iniettato nel tessuto tiorideo 0,1 ml di lauromacrogolo, ed in quello di controllo lo stesso volume di soluzione fisiologica. Al controllo postoperatorio sono stati valutati il tasso di FT3, FT4, TSH, la presenza di aderenze e le differenze istopatologiche dei tessuti tiroidei. Non sono risultate differenza significative nel livelli di FT3, FT4, TSH (p>0,05) ma i livelli di , la presenza di aderenze e le differenze istopatologiche dei tessuti tiroidei. Ai controlli i valori di FT3, FT4 ed TSH non sono risultati significativamente differenti (p>0,05), mentre i livelli di FT3 sono stati significativamente differenti all’interno dei due gruppi (p=0,20). Non sono state riscontrate differenze macroscopicamente significative delle aderenze postoperatorie (p>0,05), ma flogosi e fibrosi sono risultate istologicamente più elevate nel gruppo di studio (p=0,003). Due sono i risultati importanti dello studio: la differenza non signifcativa dei test di funzione tiroidea tra i due gruppi, suggerendo che il lauromacrogol può essere usato con sicurezza senza rischi di ipo- o ipertiroidismo; la valutazione istopatologica su modello Erlich-Hunt ha dimostrato che flogosi e fibrosi sono significativamente accresciute nel gruppo di studio, indicando che il lauromacrogol più essere usato efficacemente e con sicurezza per il trattamento dei noduli tiroidei per provocare fibrosi, senza significative aderenze peritiroidee e differenze della funzione.

  3. PPH vs Milligan-Morgan: early and late complications in the treatment of haemorrhoidal disease with circumferential prolapse.

    PubMed

    Sammarco, Giuseppe; Ferrari, Francesco; Carpino, Antonio; Russo, Emilio; Vescio, Giuseppina; Ammendola, Michele; Sacco, Rosario

    2013-07-23

    In questo studio osservazionale retrospettivo abbiamo confrontato le complicanze post-operatorie tardive e precoci di pazienti affetti da malattia emorroidaria con prolasso circonferenziale (P4-E4 secondo la classificazione PATE 2000) sottoposti ad intervento chirurgico con tecnica Milligan-Morgan (variante laser a fibre ottiche) e con tecnica PPH-Stapler. Nello studio sono stati inclusi 160 pazienti sottoposti a trattamento chirurgico tra gli anni 2001 e 2007. Il gruppo A è composto da 80 pazienti (50 maschi; 30 femmine; età media di 39; range 23-57 anni) trattati con tecnica Milligan-Morgan (variante laser a fibre ottiche); il gruppo B composto da 80 pazienti (58 maschi; 22 femmine; età media di 40; range 23-60 anni) trattati con tecnica PPH-Stapler. Le complicanze precoci sono state eventi trombotici (6 casi in M-M vs 1 in PPH) e ritenzione urinaria (13 MM vs 5 PPH) senza casi di sepsi. Le complicanze tardive invece sono state: sanguinamento occasionale del 13.5 % nel gruppo M-M vs 10 % nel gruppo PPH; incontinenza alla defecazione 2.5 % (M-M-group) vs 5% (PPH-group) con p < 0.1; dolore persistente 2.5 % (MM) vs 5 % (PPH) con p < 0.1; soiling 18.75 % (MM) vs 0 % (PPH) con p < 0.001; eventi ricorrenti 5 % nel gruppo PPH vs 0 % in M-M (p < 0.05); residuo di malattia 7.5 % nel gruppo M-M vs 0 % in PPH con p < 0.01. In conclusione, dai nostri dati osservati, la tecnica PPHStapler risulta essere più indicata della tecnica Milligan- Morgan per il trattamento chirurgico del prolasso emorroidario nonostante possa essere seguita da gravi complicanze con una specifica indicazione però nella malattia emorroidaria con prolasso circonferenziale tipo P4- E4. Nella malattia emorroidaria con uno o più noduli invece, crediamo sia più indicato un trattamento chirurgico con tecnica Milligan-Morgan (variante laser a fibre ottiche).

  4. [Assessing the effectiveness of Gelclair® in the prevention and therapy of stomatitis in patients undergoing hematopoietic stem-cell transplantation: a randomized trial].

    PubMed

    Rasero, Laura; Marsullo, Mauro; Dal Molin, Alberto

    2014-01-01

    Introduzione: La stomatite da farmaci chemioterapici è un importante effetto collaterale del trattamento. I protocolli per la cura del cavo orale, si basano su due livelli di intervento: senza e con uso di medicamenti . La letteratura descrive numerosi interventi di profilassi e terapia ma ad oggi non esiste ancora un intervento considerato gold standard. Obiettivo: Valutare l’efficacia del Gelclair® nella prevenzione e trattamento di pazienti sottoposti a trapianto di cellule staminali emopoietiche. Materiale metodi: 57 pazienti (28 gruppo di controllo e 29 gruppo sperimentale ) hanno utilizzato i colluttori 3 volte al giorno, la valutazione è stata effettuata con i seguenti strumenti: scala di valutazione della stomatite (WHO), scala VAS per dolore e Likert per gradimento. I pazienti sono stati osservati mediamente per 17 giorni. Risultati: 38/57 pazienti osservati (61%) hanno manifestato stomatiti .Non è stata rilevata differenza tra i due gruppi in termine di grado di stomatite p= 0.75 in tutto il periodo di osservazione. Il dolore è stato registrato in 31 soggetti su 57 (54%). Non si sono registrate differenze tra i due gruppi per quanto riguarda il valore medio di dolore riferito prima dell’utilizzo dei colluttori per tutti i giorni di osservazione p=0,06, gli utenti del gruppo sperimentale hanno dimostrato una riduzione del grado di dolore dopo l’utilizzo del collutorio p=0,04. Conclusioni: Gelclair® non influenza i tempi di insorgenza e l’andamento della stomatite. E’ in grado di ridurre il dolore, sono necessari però ulteriori studi multicentrici per confermare la reale utilità di utilizzo nei pazienti sottoposti a Trapianto.

  5. Nonmyeloablative allografting for newly diagnosed multiple myeloma: the experience of the Gruppo Italiano Trapianti di Midollo

    PubMed Central

    Rotta, Marcello; Patriarca, Francesca; Mattei, Daniele; Allione, Bernardino; Carnevale-Schianca, Fabrizio; Sorasio, Roberto; Rambaldi, Alessandro; Casini, Marco; Parma, Matteo; Bavaro, Pasqua; Onida, Francesco; Busca, Alessandro; Castagna, Luca; Benedetti, Edoardo; Iori, Anna Paola; Giaccone, Luisa; Palumbo, Antonio; Corradini, Paolo; Fanin, Renato; Maloney, David; Storb, Rainer; Baldi, Ileana; Ricardi, Umberto; Boccadoro, Mario

    2009-01-01

    Despite recent advances, allografting remains the only potential cure for myeloma. From July 1999 to June 2005, 100 newly diagnosed patients younger than 65 years were enrolled in a prospective multicenter study. First-line treatment included vincristin, adriamycin, and dexamethasone (VAD)–based induction chemotherapy, a cytoreductive autograft (melphalan 200 mg/m2) followed by a single dose of nonmyeloablative total body irradiation and allografting from an human leukocyte antigen (HLA)–identical sibling. Primary end points were the overall survival (OS) and event-free survival (EFS) from diagnosis. After a median follow-up of 5 years, OS was not reached, and EFS was 37 months. Incidences of acute and chronic graft-versus-host disease (GVHD) were 38% and 50%, respectively. Complete remission (CR) was achieved in 53% of patients. Profound cytoreduction (CR or very good partial remission) before allografting was associated with achievement of posttransplantation CR (hazard ratio [HR] 2.20, P = .03) and longer EFS (HR 0.33, P < .01). Conversely, development of chronic GVHD was not correlated with CR or response duration. This tandem transplantation approach allows prolonged survival and long-term disease control in patients with reduced tumor burden at the time of allografting. We are currently investigating the role of “new drugs” in intensifying pretransplantation cytoreduction and posttransplantation graft-versus-myeloma effects to further improve clinical outcomes. (http://ClinicalTrials.gov; NCT-00702247.) PMID:19064724

  6. Prognostic factors in advanced epithelial ovarian cancer. (Gruppo Interregionale Cooperativo di Oncologia Ginecologica (GICOG)).

    PubMed Central

    Marsoni, S.; Torri, V.; Valsecchi, M. G.; Belloni, C.; Bianchi, U.; Bolis, G.; Bonazzi, C.; Colombo, N.; Epis, A.; Favalli, G.

    1990-01-01

    The data on 914 patients enrolled in four randomised trials in advanced ovarian cancer, consecutively conducted by the same cooperative group between 1978 and 1986, were analysed with the aims of: (1) determining the impact of selected prognostic variables on survival; (2) finding, from the interaction of favourable prognostic factors and treatment, an approximate estimate of the magnitude of the survival advantage associated with the use of platinum-based combination chemotherapy. The overall 3-year survival in this series of patients is twice that reported historically (22%; 95% CL 18.7-25.4). The proportional hazard regression model was used to perform the analysis on survival. Residual tumour size, age, FIGO stage and cell type were all independent determinants of survival. Differences in survival from the various prognostic groups were impressive with 5-year survival rates ranging from 7 to 62%. However, these differences were not qualitative (i.e. the kinetics of survival were similar for the best and the worst groups) suggesting that current prognostic factors are of little use for selecting 'biologically' different sub-populations. Platinum-based regimens were associated to an overall prolonged median survival, but this benefit was not observable in the subgroup with most favourable prognosis (less than 2 cm residual tumour size). The implications of these observations for clinical research and ovarian cancer patients care are discussed. PMID:2119684

  7. Low-dose aspirin in polycythaemia vera: a pilot study. Gruppo Italiano Studio Policitemia (GISP).

    PubMed

    1997-05-01

    In this pilot study, aimed at exploring the feasibility of a large-scale trial of low-dose aspirin in polycythaemia vera (PV), 112 PV patients (42 females, 70 males. aged 17-80 years) were selected for not having a clear indication for, or contraindication to, aspirin treatment and randomized to receive oral aspirin (40 mg/d) or placebo. Follow-up duration was 16 +/- 6 months. Measurements of thromboxane A2 production during whole blood clotting demonstrated complete inhibition of platelet cyclooxygenase activity in patients receiving aspirin. Aspirin administration was not associated with any bleeding complication. Within the limitations of the small sample size, this study indicates that a biochemically effective regimen of antiplatelet therapy is well tolerated in patients with polycythaemia vera and that a large-scale placebo-controlled trial is feasible.

  8. Microbial monitoring and methods of sample collection: a GITMO survey (Gruppo Trapianto di Midollo Osseo)

    PubMed Central

    Gori, Erica; Callea, Emanuela; Alberani, Francesca; Orlando, Laura

    2014-01-01

    The collection of microbiological samples represents an important aspect of care both for doctors as well as nurses. It is important to recognise and identify some key points, to avoid performing ‘unnecessary’ or ‘incorrect’ sampling, which may give useless or even misleading results, these are: the moment at which the sample is collected, the collection method and timing (if indicated). The comparison between the various nursing members of the Italian National bone marrow transplant group (GITMO), showed diversity of practice across all fields. A formal survey was therefore conducted within GITMO centres looking at the methods of microbiological sample collection. These results were compared with the literature, and in addition to the lack of homogeneity of practice within the centres, a lack of compliance with the recommendations was also observed. To evaluate the effectiveness of this survey in highlighting awareness of this issue and the presence of relevant guidelines, the questionnaire was repeated (with the same centres responding), which demonstrated no major changes in care practices. Conclusion: The survey has allowed us to highlight many critical issues regarding common procedures which are not commonly discussed. Considerable differences were noted between different transplant centres, which may be attributable to the lack of Italian guidelines that can be used as a starting point for clinical practice. The plenary discussion allowed for an exchange of findings with the medical staff, who are usually responsible for requesting microbiological samples. The ideal solution would be a unique field-based training programme, associated with the dissemination of a common procedural document for ensuring evidence-based practice. PMID:24834116

  9. Bone anchored hearing implants without skin thinning: the Gruppo Otologico surgical and audiological experience.

    PubMed

    Caruso, Antonio; Giannuzzi, Anna Lisa; Sozzi, Valerio; Sanna, Mario

    2017-02-01

    To investigate the surgical and audiological outcomes of an installation of a bone-anchored hearing system (BAHS) procedure without tissue reduction using Ponto implants and abutments. Retrospective consecutive case series. Forty-nine patients, 18 years or older and eligible for treatment with a bone-anchored hearing system with tissue preservation surgery, were included in the study. Following a systematic scheme for medical outcomes, we collected the data regarding surgical intervention, quality of life (GBI), skin and soft tissue reactions (Holgers grading system), pain and numbness (VAS). Hearing performance (aided thresholds and speech recognition in noise) was recorded in 20 patients. No implants were lost, skin, and soft tissue reactions were mild in 96 % of the all visits. Quality of life (GBI) generally improved in the aided condition compared to prior to implantation. Audiologically, 100 % of the 20 patients examined showed improvement of speech reception and sound field thresholds comparing aided to unaided. An average improvement of 33 dB on PTA was recorded. The study, presenting data on a large population, treated with tissue preservation and modern titanium implants, shows that this treatment is a viable solution that results in fewer complications, high degree of predictability and good audiological results.

  10. [Emergencies (outpatients) in cardiosurgery: national multicenter study. Gruppo di Studio SIAARTI "Anestesia e Rianimazione in Cardiochirurgia"].

    PubMed

    1997-11-01

    Heart Surgery Italian Centres participated in this study to define the rate and the outcome of outpatients' cardiovascular emergencies. Hospital patients and heart and/or lung transplants were excluded. Data were prospectively collected over 6 months (from April 1 through September 30, 1996) and analyzed using SPSS stat programme. 731 emergencies (5.8% of 12551 cardiosurgical procedures) have been recorded. 85.8% of the patients were admitted to the surgical units, coming from other hospitals. 31.6% of emergencies were admitted in the night. 37.2% of the patients were admitted because of myocardial infarction or unstable angina in spite of e.v. drugs; 28.3% because of dissection of thoracic aorta; 18.2% were congenital heart diseases; 9.2% valvular or valve prosthesis dysfunctions; 7.1% were affected by other cardiovascular diseases. On admission, 48.7% of the patients were in cardiogenic shock or severe heart failure, 27.9% presented respiratory failure, 11.8% renal failure, 5.1% brain injury (coma and/or plegia or paresis). 500 (68.4%) patients needed invasive and or not invasive diagnostic procedures. 33 (4.5%) patients died early after admission to the hospital. 30 patients, who did not need surgery, were discharged few days after admission. 668 (91.4%) patients underwent surgery. Overall perioperative mortality was 21.7%: 31.6% in the aortic group, 21.6% in the congenital heart disease group, 24.6% in the valve group, 15.2% in the coronary group. The cost of outpatients' cardiovascular emergencies is very high. First of all, overall mortality and perioperative mortality are greater when compared to elective surgical procedures; moreover expensive tools and continuous availability of skilled anaesthesiologists, cardiologists and surgeons are mandatory. In order to optimize results (cost/benefit) and looking for lowering mortality, the approach to outpatients' cardiovascular emergencies in Italy must be reorganized, in order to refer emergencies to few, high qualified, "ad hoc" organized Centres properly placed on the national territory.

  11. Facial reanimation after facial nerve injury using hypoglossal to facial nerve anastomosis: the gruppo otologico experience.

    PubMed

    Tanbouzi Husseini, Sami; Kumar, David Victor; De Donato, Giuseppe; Almutair, Tamama; Sanna, Mario

    2013-12-01

    To evaluate the results of facial nerve reanimation after facial nerve injury by means of hypoglossal to facial nerve anastomosis. Retrospective case review. Private neuro-otologic and cranial base quaternary referral center. Sixty patients underwent hypoglossal to facial nerve anastomosis for facial nerve reanimation between April 1987 and December 2010. Only forty patients completed a minimal follow up of 24 months at the time of evaluation and were included in the study population. Facial nerve paralysis was present for a mean duration of 11.3 months (range 2-42 months) and all the patients had a HB grade VI prior their surgery. Final facial nerve motor function. The most common cause of facial paralysis was vestibular Schwannoma surgery. All the patients achieved a postoperative HB grade III or IV after a mean follow-up time of 20 months. The facial movements were detected after a period that ranged from ranged from 5 to 9 months. Only 4 patients suffered from difficulties during eating and drinking and three of them had associated lower cranial nerve deficit. Despite the various techniques in facial reanimation following total facial nerve paralysis, the end to end of hypoglossal to facial nerve anastomosis remains one of the best treatments in cases of viable distal facial stump and nonatrophic musculature.

  12. Cochlea size variability and implications in clinical practice.

    PubMed

    Pelliccia, P; Venail, F; Bonafé, A; Makeieff, M; Iannetti, G; Bartolomeo, M; Mondain, M

    2014-02-01

    Gli obbiettivi di questo studio sono stati: 1) lo studio della variabilità delle dimensioni cocleari in relazione all'età e al grado di ipoacusia; 2) calcolare la lunghezza dell'elettrodo dell'impianto cocleare richiesta per ottenere l'angolo ideale d'inserzione profonda di 270°. Per raccogliere i dati riguardanti le ossa temporali sono stati inclusi nello studio 241 pazienti (482 ossa temporali) che hanno ricevuto una Tomografia Computerizzata a alta risoluzione (HRCT) dell'orecchio nel nostro Policlinico Universitario tra il 2003 e il 2008; i pazienti sono stati divisi in 3 Gruppi: 97 (194 orecchie) aventi una ipoacusia neurosensoriale severa o profonda bilaterale (Gruppo A), 70 (140 orecchie) aventi una ipoacusia neurosensoriale moderata bilaterale (Gruppo B), 74 pazienti (148 orecchie) senza ipoacusia neurosensoriale o mista (gruppo C). In ciascuno dei 3 gruppi, sono stati identificati 5 sottogruppi in base all'età: 1) sottogruppo 1: soggetti ≤ 5 anni, 2) sottogruppo 2: soggetti da 6 a 10 anni; 3) sottogruppo 3: pazienti da 11 a 15 anni, 4) sottogruppo 4: pazienti da 16 a 20 anni, 5) sottogruppo 5: soggetti >; 20 anni. Sono stati misurati la lunghezza della coclea (L), l'altezza della coclea (H), il diametro del lume del giro basale (BTLD) e il Volume della coclea (V). Il Test di Mann-Whitney è stato utilizzato per verificare l'ipotesi alternativa che a livello di queste dimensioni esiste una differenza statisticamente significativa tra i differenti gruppi e sottogruppi. La seguente equazione è stata adottata per calcolare la Lunghezza di un elettrodo rettilineo che segue la parete esterna della scala timpani necessaria per ottenere l'angolo ideale di inserzione profonda di 270° (LIC): [Formula: see text]. Secondo i nostri risultati alla nascita la coclea è completamente sviluppata e ha già raggiunto le dimensioni dell'adulto. Il Grado di ipoacusia non influenza la Lunghezza (L) e il Volume (V) della coclea, mentre può influenzare la sua altezza (H

  13. Feasibility of a registry of pemphigus in Italy: two years experience. Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED)

    PubMed

    Naldi, L; Bertoni, M; Cainelli, T

    1993-06-01

    There are still unanswered questions about optimal treatment strategies and long-term prognosis of pemphigus. The Italian Group for Epidemiologic Research in Dermatology (GISED) started to register pemphigus in March 1990. The registry is hospital-based, covering newly diagnosed cases referred to 33 dermatologic centers in the north and the middle-south of Italy. Serum samples were collected at the time of diagnosis, for centralized storage. In the period between March 1990 and December 1991, 110 cases were collected, with 105 retained. Median age at diagnosis was 54, and the man to woman ratio was 0.7. The median lag of diagnosis was 4 months. Seventy-four of 79 patients with pemphigus vulgaris/vegetans and 24 of the 26 with pemphigus erythematosus/foliaceus were given corticosteroid treatment. A hospital-based registry is feasible and provides useful information about both clinical aspects and management of pemphigus, serving as a basis for developing ad hoc research programs (e.g., formal epidemiologic studies and clinical research).

  14. Functional status in patients with spinal cord injury: a new standardized measurement scale. Gruppo Interdisciplinare Valutazione Interventi Riabilitativi.

    PubMed

    Taricco, M; Apolone, G; Colombo, C; Filardo, G; Telaro, E; Liberati, A

    2000-09-01

    To report on the validation process of a new functional assessment scale (Valutazione Funzionale Mielolesi [VFM]) for patients with spinal cord injury (SCI). Prospective study testing for the VFM in a sample of patients with SCI to evaluate the scale characteristics in terms of psychometric and clinical validity. Eight SCI units located in northern Italy. One hundred patients were recruited and followed up for 18 months. Seventy-seven subjects were men, subjects' mean age was 37 years, 67 were paraplegic, and for 81 their SCI was of traumatic etiology. VFM's characteristics are described using estimates of construct and criterion validity (estimates of the strength and direction of associations between different VFM tasks and between VFM and other medical and nonmedical variables). The Barthel index was used as concurrent and independent measure. VFM met all psychometric criteria usually recommended and, at least in the current sample, was found to be strongly correlated with independent clinical variables (diagnosis and lesion level) and with the Barthel index. Moreover, most of the domains were able to document large and significant changes over time. VFM is a reliable and valid tool that can be used confidently in the rehabilitation setting for patients with SCI to screen for functional problems and monitor changes in patients' functional status and impact of rehabilitation.

  15. Hepatitis B virus related cryoglobulinemic vasculitis: A multicentre open label study from the Gruppo Italiano di Studio delle Crioglobulinemie - GISC.

    PubMed

    Mazzaro, Cesare; Dal Maso, Luigino; Urraro, Teresa; Mauro, Endri; Castelnovo, Laura; Casarin, Pietro; Monti, Giuseppe; Gattei, Valter; Zignego, Anna Linda; Pozzato, Gabriele

    2016-07-01

    Cryoglobulinemic vasculitis (CV) related to Hepatitis-B Virus (HBV) is rare and its treatment is ill-defined. To describe clinical and treatment characteristics of HBV-related CV patients. In addition, the efficacy of treatment with antiviral agent nucleotide (NUC), including Entecavir, Adefovir, and Lamivudine, was explored. In four Italian centres, 17 HBV-positive CV patients (median age 56 years, range 45-70) were enrolled. The extrahepatic manifestations were: purpura (100%), arthralgias (71%), peripheral neuropathy (29%), chronic hepatitis (47%), liver cirrhosis (29%), and glomerulonephritis (18%). Mixed cryoglobulinemias were type II (88%) and type III (12%). The median cryocrit was 3% (range 1-14), rheumatoid factor was 200U/L (range 20-5850), C4 was 12mg/dl (range 2-31), ALT 71U/L (range 36-114). All patients were HBsAg-positive and 80% anti-HbeAg-positive. At enrollment, they were treated with steroids (eight), Entecavir (five), Alpha-IFN (two), Adefovir and Lamivudine (one each). After NUC treatment, no disease progression was observed and, in all patients, HBV-DNA became undetectable. Moreover, a regression of purpura and a reduction of cryocrit were observed. Four patients died during therapy, two of kidney failure and two of liver cirrhosis. NUC therapy appeared to be safe and effective in CV-related HBV. Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  16. Allogeneic hematopoietic stem cell transplantation in myelofibrosis: the 20-year experience of the Gruppo Italiano Trapianto di Midollo Osseo (GITMO).

    PubMed

    Patriarca, Francesca; Bacigalupo, Andrea; Sperotto, Alessandra; Isola, Miriam; Soldano, Franca; Bruno, Barbara; van Lint, Maria Teresa; Iori, Anna Paola; Santarone, Stella; Porretto, Ferdinando; Pioltelli, Pietro; Visani, Giuseppe; Iacopino, Pasquale; Fanin, Renato; Bosi, Alberto

    2008-10-01

    Allogeneic stem cell transplantation is a potentially curative treatment for myelofibrosis, although its use is limited by a high rate of transplant-related mortality. In this study, we evaluated the outcome of patients with myelofibrosis who underwent allogeneic stem cell transplantation, and the impact of prognostic factors. One hundred patients were transplanted in 26 Italian centers between 1986 and 2006. We analyzed the influence of the patients' characteristics and the clinical features of their disease before stem cell transplantation and of transplant procedures on transplant-related mortality, overall survival, and relapse-free survival by means of univariate and multivariate analyses. The median age of the patients at the time of stem cell transplantation was 49 years (range, 21-68) and 90% of them had an intermediate or high Dupriez score. Forty-eight percent received a myeloablative conditioning regimen and 78% received stem cells from matched sibling donors. The cumulative incidence of engraftment at day 90 after transplant was 87% (95% CI, 0.87-0.97). The cumulative 1-year and 3-year incidences of transplant-related mortality were 35% and 43%, respectively. The estimated 3-year overall and relapse-free survival rates after stem cell transplantation were 42% and 35%, respectively. In multivariate analysis, negative predictors of transplant-related mortality were year of stem cell transplantation before 1995, unrelated donor, and a long interval between diagnosis and transplantation. There was a trend towards longer overall and relapse-free survival in patients receiving peripheral blood stem cells rather than bone marrow as the source of their graft (p=0.070 and p=0.077, respectively). The intensity of the conditioning regimen (myeloablative versus reduced intensity regimens) did not significantly influence the outcome. We conclude that the outcome of myelofibrosis patients who underwent allogeneic stem cell transplantation significantly improved after 1996 due to the reduction in transplant-related mortality. We observed that a reduction in transplant-related mortality was associated with the choice of a matched sibling donor, whereas longer overall survival was associated with the use of peripheral blood as the source of stem cells.

  17. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial.

    PubMed

    Kapural, Leonardo; Yu, Cong; Doust, Matthew W; Gliner, Bradford E; Vallejo, Ricardo; Sitzman, B Todd; Amirdelfan, Kasra; Morgan, Donna M; Brown, Lora L; Yearwood, Thomas L; Bundschu, Richard; Burton, Allen W; Yang, Thomas; Benyamin, Ramsin; Burgher, Abram H

    2015-10-01

    Current treatments for chronic pain have limited effectiveness and commonly known side effects. Given the prevalence and burden of intractable pain, additional therapeutic approaches are desired. Spinal cord stimulation (SCS) delivered at 10 kHz (as in HF10 therapy) may provide pain relief without the paresthesias typical of traditional low-frequency SCS. The objective of this randomized, parallel-arm, noninferiority study was to compare long-term safety and efficacy of SCS therapies in patients with back and leg pain. A total of 198 subjects with both back and leg pain were randomized in a 1:1 ratio to a treatment group across 10 comprehensive pain treatment centers. Of these, 171 passed a temporary trial and were implanted with an SCS system. Responders (the primary outcome) were defined as having 50% or greater back pain reduction with no stimulation-related neurological deficit. At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P < 0.001 for both back and leg pain comparisons). The relative ratio for responders was 1.9 (95% CI, 1.4 to 2.5) for back pain and 1.5 (95% CI, 1.2 to 1.9) for leg pain. The superiority of HF10 therapy over traditional SCS for leg and back pain was sustained through 12 months (P < 0.001). HF10 therapy subjects did not experience paresthesias. HF10 therapy promises to substantially impact the management of back and leg pain with broad applicability to patients, physicians, and payers.

  18. Irinotecan plus bolus/infusional 5-Fluorouracil and leucovorin in patients with pretreated advanced pancreatic carcinoma: a multicenter experience of the Gruppo Oncologico Italia Meridionale.

    PubMed

    Gebbia, Vittorio; Maiello, Evaristo; Giuliani, Francesco; Borsellino, Nicolò; Arcara, Carlo; Colucci, Giuseppe

    2010-10-01

    Patients with advanced pancreatic cancer failing gemcitabine-based first-line chemotherapy are still in relatively good clinical conditions and may still require second-line chemotherapy, which is frequently administered in daily clinical practice given to without solid scientific support. A retrospective survey was carried out including 40 patients with stage III or IV gemcitabine-refractory pancreatic carcinoma. Patients received standard FOLFIRI regimen biweekly until progression or unacceptable toxicity. Response evaluation criteria in solid tumors and National Cancer Institute common toxicity criteria were employed respectively for response and toxicity assessment. Six partial responses (15%) and 14 stabilizations of disease (35%) were recorded for a tumor growth control rate of 50%. The median time to progression was 3.7 (range, 1-6.5 months), and median overall survival was 6 months (range, 2-8.2 months). A stabilization of performance status and a subjective improvement of cancer-related symptoms were recorded in 21 patients (52.5%). No correlation has been found between length of time to progression during first-line chemotherapy and length of that reported in the second-line setting or objective response. Grade 3-4 diarrhea and mucositis was observed in 15% and 10% of cases, respectively. Data presented in this article demonstrate that the second-line FOLFIRI regimen are able to induce an objective response in a relatively small fraction of patients with gemcitabine-refractory adenocarcinoma of the pancreas. The use of second-line chemotherapy should be carefully proposed to patients with good performance status or those who had a good response to first-line therapy.

  19. Hematopoietic stem cell transplantation for paroxysmal nocturnal hemoglobinuria: long-term results of a retrospective study on behalf of the Gruppo Italiano Trapianto Midollo Osseo (GITMO)

    PubMed Central

    Santarone, Stella; Bacigalupo, Andrea; Risitano, Antonio M.; Tagliaferri, Elena; Di Bartolomeo, Erminia; Iori, Anna Paola; Rambaldi, Alessandro; Angelucci, Emanuele; Spagnoli, Alessandra; Papineschi, Federico; Tamiazzo, Stefania; Di Nicola, Marta; Di Bartolomeo, Paolo

    2010-01-01

    Background Paroxysmal nocturnal hemoglobinuria is an acquired clonal disorder of the hemopoietic stem cells for which the only curative treatment is allogeneic hematopoietic stem cell transplantation. Design and Methods The aim of this retrospective study was to assess the long-term clinical and hematologic results in 26 paroxysmal nocturnal hemoglobinuria patients who received hematopoietic stem cell transplantation in Italy between 1988 and 2006. The patients were aged 22 to 60 years (median 32 years). Twenty-three donors were HLA-identical (22 siblings and one unrelated) and 3 were HLA-mismatched (2 related and one unrelated). Results Fifteen patients received a myeloablative conditioning consisting of busulfan and cyclophosphamide (in all cases from identical donor) and 11 were given a reduced intensity conditioning (8 from identical donor and 3 from mismatched donor). The cumulative incidence of graft failure was 8% (4% primary and 4% secondary graft failure). Transplant-related mortality for all patients was 42% (26% and 63% for patients transplanted following myeloablative or reduced intensity conditioning, respectively). As of October 31, 2009, 15 patients (11 in the myeloablative conditioning group and 4 in the reduced intensity conditioning group) are alive with complete hematologic recovery and no evidence of paroxysmal nocturnal hemoglobinuria following a median follow-up of 131 months (range 30–240). The 10-year Kaplan-Meier probability of disease-free survival was 57% for all patients: 65% for 23 patients transplanted from identical donor and 73% for 15 patients transplanted with myeloablative conditioning. No thromboembolic event nor recurrence of the disease were reported following transplant. Conclusions The findings of this study confirm that most patients with paroxysmal nocturnal hemoglobinuria may be definitively cured with hematopoietic stem cell transplantation. PMID:20007144

  20. Prevalence of bands other than 160 and 130 kDa in pemphigus sera (a multicenter immunoblotting study). Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED).

    PubMed

    Cozzani, E; Parodi, A; Rebora, A

    1998-05-01

    Patients with pemphigus may produce antibodies against molecules other than the classical transmembranal ones. Recently, for example antibodies to 230 kDa antigens have been found in association with antibodies to intercellular substance. To better understand their prevalence, clinical correlates and prognostic significance of bands other than 130 and 160 kDa, we studied 67 pemphigus sera. About one-fourth of patients revealed multiple heterogeneous bands and 13% the 230 kDa band. When challenged with the recombinant protein rBP55, the carbossiterminal portion of bullous pemphigoid major antigen, all 230 kDa-positive-sera proved negative. Caution is to be recommended in interpreting pemphigus sera with a band migrating at the 230 kDa level.

  1. Cutaneous reactions to alimentary tract medications: results of a seven-year surveillance program and review of the literature. Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED).

    PubMed

    1996-01-01

    No systemic review of skin reactions to alimentary tract medications is available in the literature. We reviewed the reactions to alimentary tract medications reported to the surveillance system of the Italian Group for Epidemiologic Research in Dermatology (GISED). Between January 1988 and December 1994, 202 dermatologists in Italy reported to the coordinating center for GISED all the adverse reactions they observed during prespecified 2-month monitoring periods. Reactions classified under ATC codes A02-A04, A06, A07 and A09 were used for this analysis. Of 2,789 reactions, 48 were attributed to alimentary tract medications. Urticaria/angioedema and exanthemas accounted for about 70% of these reactions. Fixed eruptions and lichenoid dermatitis accounted for a large part of the remaining reactions. Antiulcers and antiemetics appeared remarkably safe. Our data are reassuring with regard to the cutaneous reaction profile of several drugs taken for diseases of the alimentary tract.

  2. Nutritional support in patients undergoing haematopoietic stem cell transplantation: a multicentre survey of the Gruppo Italiano Trapianto Midollo Osseo (GITMO) transplant programmes.

    PubMed

    Botti, Stefano; Liptrott, Sarah Jayne; Gargiulo, Gianpaolo; Orlando, Laura

    2015-01-01

    A survey within Italian haematopoietic stem cell transplant (HSCT) programmes was performed, in order to obtain a snapshot of nutritional support (NS) in patients undergoing HSCT. The primary objective was to verify whether an evidence-based practice (EBP) approach to NS was implemented in HSCT centres. A multicentre survey was performed by questionnaire, covering the main areas of NS (screening, treatment planning, monitoring, nutritional counselling, and methods of nutritional support). The results indicated a significant variation between clinical practice and evidence-based guidelines in terms of clinical pathways, decision-making, and care provision regarding NS. Further research is required to identify reasons for the limited application of EBP and measures that may be undertaken to address such issues. Development of a multidisciplinary educational programme in order to raise awareness of the issue should be undertaken.

  3. Randomised comparison of cisplatin with cyclophosphamide/cisplatin and with cyclophosphamide/doxorubicin/cisplatin in advanced ovarian cancer. Gruppo Interegionale Cooperativo Oncologico Ginecologia.

    PubMed

    1987-08-15

    565 patients with stage III-IV epithelial ovarian cancer were randomly assigned to receive cisplatin (P), cyclophosphamide and cisplatin (CP), or cyclophosphamide, doxorubicin, and cisplatin (CAP). Data on 531 patients were analysed. Treatment with CAP resulted in a significantly higher overall (complete and partial) response rate (66 vs 56 vs 49% for CAP, CP, and P, respectively), but the rate of complete surgical response for the three treatment arms was similar (26, 21, and 20%). Size of residual tumour after first surgery and Karnofsky index were the best predictors of complete remission. Survival and disease-free survival were not significantly different in the three arms, although progression-free survival was significantly longer after CAP. However, tumour size, cell type, and Karnofsky index, but not therapy, were independent predictors for survival. Haematological toxicity was highest with CAP. The addition of cyclophosphamide or doxorubicin and cyclophosphamide to cisplatin does not substantially increase the number of potentially curable, advanced ovarian cancer patients.

  4. Oral vinorelbine plus capecitabine (oral vincap) combination in patients with advanced breast cancer (ABC). A phase II study of the GOIM (Gruppo Oncologico dell'Italia Meridionale).

    PubMed

    Lorusso, V; Spada, M; Giampaglia, M; Misino, A; Calabrese, R; Latorre, A; Monticelli, G; Guida, M; Sambiasi, D; Colucci, G

    2006-06-01

    Vinorelbine i.v. and capecitabine are two of the most effective single agents in previously treated advanced breast cancer (ABC). A number of studies have been reported with the combination of these agents. Actually, the availability of oral formulation for vinorelbine allows a full oral combination of the two agents. The aim of this study was to evaluate the activity and toxicity of this novel combination. Thirty-eight advanced breast cancer patients refractory to anthracyclines and taxanes were included in this study. Treatment consisted of vinorelbine 60 mg/m(2) (days 1 + 8), and capecitabine 2000 mg/m(2) (days 2-7 and 9-16) every 3 weeks. A total of 228 courses were given with a mean of three cycles/patient (range 1-12). Five patients (13.1%) had no toxicity at all. Hematologic side-effects were: neutropenia grade 2-3 in seven patients (18.9%) and grade 4 in one patient (2.7%), anemia grade 1 in 11 patients (29.7%), grade 2-3 in five patients (13.5%), thrombocytopenia grade 1 in six patients (16.2%) and grade 3 in one patient (2.7%). Non-hematologic side-effects were: fatigue grade 1 in five patients (13.5%), hand-foot syndrome grade 1 in two patients (5.4%) and grade 2 in two patients (5.4%), nausea/vomiting grade 1 in two patients (5.4%), grade 2 in three patients (8.1%) and grade 3 in one patient (2.7%), constipation grade 1 in two patients (5.4%), peripheral neurotoxicity grade 1 in three patients (8.1%) and grade 2 in one patient (2.7%), gastric pain grade 1 in two patients (5.4%), stomatitis grade 1 in three patients (8.1%) and grade 2 in one patient (2.7%). Out of 38 patients assessable, we observed two (5.4%) CR, 13 (34 %) PR, 14 (37.8%) SD and nine (26.3%) PD. The median time to progression was 4.5 months (range 1-18 months), the median response duration was 7 months (range 2-18 months) and the median survival duration was 10 months (range 2-26+). The oral vincap should be considered as an alternative to single agent capecitabine or vinorelbine in ABC refractory to antra-taxane combination.

  5. Ruxolitinib in clinical practice for primary and secondary myelofibrosis: an analysis of safety and efficacy of Gruppo Laziale of Ph-negative MPN.

    PubMed

    Breccia, Massimo; Andriani, Alessandro; Montanaro, Marco; Abruzzese, Elisabetta; Buccisano, Francesco; Cedrone, Michele; Centra, Antonietta; Villivà, Nicoletta; Celesti, Francesca; Trawinska, Malgorzata Monica; Massaro, Fulvio; Di Veroli, Ambra; Anaclerico, Barbara; Colafigli, Gioia; Molica, Matteo; Spadea, Antonio; Petriccione, Luca; Cimino, Giuseppe; Latagliata, Roberto

    2017-03-01

    Ruxolitinib, a JAK1 and JAK2 inhibitor, has been tested and approved for the treatment of primary and secondary myelofibrosis (MF). Aim of our study is to report safety and efficacy of ruxolitinib in 98 patients affected by MF treated outside clinical trials and collected and treated consecutively by the Lazio Cooperative Group for Ph negative myeloproliferative diseases.There were 45 males and 53 females; median age was 61.8 years (range 35.3-88). Forty-five patients were diagnosed as primary MF and 53 as secondary MF. Seventy-seven patients (78.5%) experienced constitutional symptoms at baseline, and out of 94 patients tested, 66 (70%) were JAK2(V617F) mutated. Overall, 40 patients received hydroxyurea as firstline treatment, 30 patients received other chemotherapeutic approaches, whereas 28 were treated with ruxolitinib frontline. Median time from diagnosis to start of ruxolitinib in the whole cohort was 34.6 months. Fifty-eight patients (59%) required a dose reduction during the first 3 months due to hematological toxicity in the majority of cases. At 48 weeks, 52% of patients obtained a clinical benefit: of them 7 patients (7%) had a CR, 10 (10%) a PR, 6 patients (6%) a CI, and 28 patients (28.5%) a spleen response. Overall, 66% of patients had disappearance of baseline symptoms burden. After 1 year, of 72 evaluable patients, 52% achieved and maintained a clinical benefit. Adverse events of special interest at any grade included anemia (39.7%), thrombocytopenia (25.5%), infections (16.3%, of which 10 were bronchopneumonia), fluid retention (3%), diarrhea (2%) and abdominal pain (2%). After a median follow-up of 16 months from start of ruxolitinib, median daily dose decreased to 10 mg BID and 21 patients (21%) discontinued the drug. The results of this retrospective multicentric analysis confirmed the efficacy of ruxolitinib outside clinical trials with more than half of treated patients achieving and maintaining a clinical benefit and most of them reporting relief from symptoms.

  6. [Evidence-based medicine. 2. Research of clinically relevant biomedical information. Gruppo Italiano per la Medicina Basata sulle Evidenze--GIMBE].

    PubMed

    Cartabellotta, A

    1998-05-01

    Evidence-based Medicine is a product of the electronic information age and there are several databases useful for practice it--MEDLINE, EMBASE, specialized compendiums of evidence (Cochrane Library, Best Evidence), practice guidelines--most of them free available through Internet, that offers a growing number of health resources. Because searching best evidence is a basic step to practice Evidence-based Medicine, this second review (the first one has been published in the issue of March 1998) has the aim to provide physicians tools and skills for retrieving relevant biomedical information. Therefore, we discuss about strategies for managing information overload, analyze characteristics, usefulness and limits of medical databases and explain how to use MEDLINE in day-to-day clinical practice.

  7. Hydroxyurea with or without imatinib in the treatment of recurrent or progressive meningiomas: a randomized phase II trial by Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO).

    PubMed

    Mazza, Elena; Brandes, Alba; Zanon, Silvia; Eoli, Marika; Lombardi, Giuseppe; Faedi, Marina; Franceschi, Enrico; Reni, Michele

    2016-01-01

    Hydroxyurea (HU) is among the most widely used salvage therapies in progressive meningiomas. Platelet-derived growth factor receptors are expressed in virtually all meningiomas. Imatinib sensitizes transformed cells to the cytotoxic effects of chemotherapeutic agents that interfere with DNA metabolism. The combination of HU with imatinib yielded intriguing results in recurrent malignant glioma. The current trial addressed the activity of this association against meningioma. Patients with recurrent or progressive WHO grade I-III meningioma, without therapeutic indication for surgery, radiotherapy, or stereotactic radiosurgery, aged 18-75 years, ECOG performance status 0-2, and not on enzyme-inducing anti-epileptic drugs were randomized to receive HU 500 mg BID ± imatinib 400 mg QD until progression, unacceptable toxicity, or patient's refusal. The primary endpoint was progression-free survival rate at 9 months (PFS-9). Between September 2009 and February 2012, 15 patients were randomized to receive HU + imatinib (N = 7; Arm A) or HU alone (N = 8; Arm B). Afterward the trial was prematurely closed due to slow enrollment rate. PFS-9 (A/B) was 0/75%, and median PFS was 4/19.5 months. Median and 2-year overall survival (A/B) rates were: 6/27.5 months; 28.5/75%, respectively. Main G3-4 toxicities were: G3 neutropenia in 1/0, G4 headache in 1/1, and G3 vomiting in 1/0. The conduction of a study in recurrent or progressive meningioma remains a challenge. Given the limited number of patients enrolled, no firm conclusions can be drawn about the combination of imatinib and HU. The optimal systemic therapy for meningioma failing surgery and radiation has yet to be identified.

  8. Weekly paclitaxel as first-line chemotherapy in elderly advanced breast cancer patients: a phase II study of the Gruppo Italiano di Oncologia Geriatrica (GIOGer).

    PubMed

    Del Mastro, L; Perrone, F; Repetto, L; Manzione, L; Zagonel, V; Fratino, L; Marenco, D; Venturini, M; Maggi, E; Bighin, C; Catzeddu, T; Venturino, A; Rosso, R

    2005-02-01

    First-line chemotherapy regimens suitable for elderly advanced breast cancer patients are still not defined. Women with stage III or IV breast cancer aged > or =70 years were enrolled in a phase II study aimed to evaluate both activity and toxicity of weekly paclitaxel. Among 46 planned patients, at least 18 responses and not more than seven unacceptable toxic events are required for a favourable conclusion. Paclitaxel 80 mg/m(2) was administered weekly for 3 weeks every 28 days. Unacceptable toxicity occurred in seven out of 46 patients evaluated for toxicity [15.2%; exact 95% confidence interval (CI) 7.6% to 28.2%] and was represented by one case of febrile neutropenia, one case of severe allergic reaction and five cases of cardiac toxicity. Among 41 patients evaluated for response, a complete response occurred in two (4.9%) patients and a partial response in 20 (48.8%), with an overall response rate of 53.7% (exact 95% CI 38.7% to 67.9%). The median progression-free survival was 9.7 months (95% CI 8.5-18.7) and median survival was 35.8 months (95% CI 19-not defined). Weekly paclitaxel is highly active in elderly advanced breast cancer patients. Data on cardiovascular complications, however, indicate the need for a careful monitoring of cardiac function before and during chemotherapy.

  9. Treatment of cancer of the base of the tongue and glosso-epiglottic region: a multicenter Italian survey. GLOCC Group. Gruppo di Lavoro in Oncologia Cervico Cefalica.

    PubMed

    Grandi, C; Guzzo, M; Cavina, R; Gardani, G; Tana, S; Licitra, L; Rossi, N; Barbaccia, C; Mingardo, M; Fallahdar, D; Bruno, P; Molinari, R

    2000-01-01

    The current treatment options for cancer of the base of the tongue and glosso-epiglottic region are surgery, radiotherapy, or a combination of both modalities. Comparisons between different modalities are not common in the literature, and a real standard of treatment has not yet been established. The purpose of our study was to evaluate the results of treatment in a large series of patients from 18 Italian institutions in relation to the main treatment adopted. The present study is a retrospective survey. The series was divided into a combined surgery group and a radiotherapy group. The Kaplan-Meier method and the log-rank test were used for survival calculations and comparisons. Eight hundred patients were registered (25.7% stage III and 62% stage IV), 336 in the surgery and 372 in the radiotherapy group. Conventional fractionation was adopted in almost all cases. The five-year overall and disease free survival of the whole series was 32% and 38%, respectively. Survival was slightly better for patients with tumors of the glosso-epiglottic region than for those with a tumor of the base of the tongue. Five-year disease-free survival was 55% for patients treated with surgery +/- radiochemotherapy and 26% for those submitted to radiotherapy alone or in combination with chemotherapy. As far as the total dose and the treatment duration were concerned, only 26% of the patients of the radiotherapy group met the established criteria of adequacy, but in patients with adequate radiation the control rate was better only for small tumors (T1-T2). The results in patients treated with surgery +/- postoperative radiotherapy were similar to or better than those reported in the best series in the literature. By contrast, the survival rate of irradiated patients was lower than those reported by other centers.

  10. Gefitinib in patients with progressive high-grade gliomas: a multicentre phase II study by Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO).

    PubMed

    Franceschi, E; Cavallo, G; Lonardi, S; Magrini, E; Tosoni, A; Grosso, D; Scopece, L; Blatt, V; Urbini, B; Pession, A; Tallini, G; Crinò, L; Brandes, A A

    2007-04-10

    To investigate the role of gefitinib in patients with high-grade gliomas (HGGs), a phase II trial (1839IL/0116) was conducted in patients with disease recurrence following surgery plus radiotherapy and first-line chemotherapy. Adult patients with histologically confirmed recurrent HGGs following surgery, radiotherapy and first-line chemotherapy, were considered eligible. Patients were treated with gefitinib (250 mg day(-1)) continuously until disease progression. The primary end point was progression-free survival at 6 months progression-free survival at 6 months (PFS-6). Tissue biomarkers (epidermal growth factor receptor (EGFR) gene status and expression, phosphorylated Akt (p-Akt) expression) were assessed. Twenty-eight patients (median age, 55 years; median ECOG performance status, 1) were enrolled; all were evaluable for drug activity and safety. Sixteen patients had glioblastoma, three patients had anaplastic oligodendrogliomas and nine patients had anaplastic astrocytoma. Five patients (17.9%, 95% CI 6.1-36.9%) showed disease stabilisation. The overall median time to progression was 8.4 (range 2-104+) weeks and PFS-6 was 14.3% (95% CI 4.0-32.7%). The median overall survival was 24.6 weeks (range 4-104+). No grade 3-4 gefitinib-related toxicity was found. Gefitinib showed limited activity in patients affected by HGGs. Epidermal growth factor receptor expression or gene status, and p-Akt expression do not seem to predict activity of this drug.

  11. First-line chemotherapy with cisplatin plus fractionated temozolomide in recurrent glioblastoma multiforme: a phase II study of the Gruppo Italiano Cooperativo di Neuro-Oncologia.

    PubMed

    Brandes, Alba A; Basso, Umberto; Reni, Michele; Vastola, Francesca; Tosoni, Alicia; Cavallo, Giovanna; Scopece, Luciano; Ferreri, Andres J; Panucci, Maria G; Monfardini, Silvio; Ermani, Mario

    2004-05-01

    Cisplatin and temozolomide (TMZ) are active in glioblastoma multiforme (GBM), with different profiles of toxicity. A bid regimen of TMZ achieves a strong inhibition of O(6)-alkylguanine DNA-alkyl transferase (AGAT), and cisplatin reduces AGAT activity in vitro, suggesting a possible synergic interaction. The primary end point of the present multicenter phase II study was progression-free survival (PFS) at 6 months (PFS-6); secondary end points included response, toxicity, and overall survival. Chemotherapy-naive patients with GBM who experienced disease recurrence or progression after surgery and standard radiotherapy were eligible. Chemotherapy cycles consisted of cisplatin 75 mg/m(2) on day 1, TMZ 130 mg/m(2) bolus followed by nine doses of 70 mg/m(2) every 12 hours (total of 5 days) from day 2 every 4 weeks. In the absence of hematologic toxicity, TMZ was escalated to 1,000 mg/m(2) in 5 days. A total of 50 patients (median age, 53.4 years; range, 27 to 70 years; median Karnofsky performance status, 80; range, 60 to 100) were accrued in the study. PFS-6 was 34% (95% CI, 23% to 50%), and PFS-12 was 4% (95% CI, 0.3% to 16%). Median PFS was 18.4 weeks (95% CI, 13 to 25.9 weeks). Among 49 assessable patients, one complete response and nine partial responses were obtained, with an overall response rate of 20.4% (95% CI, 7.7% to 33%). Among 203 treatment cycles delivered, the most common grade 3 or grade 4 events included granulocytopenia in 7.9% of cycles, thrombocytopenia in 4%, and neurologic toxicity in three patients (6%). The new cisplatin plus bid TMZ regimen appears active in chemotherapy-naive patients with recurrent GBM and incurs an acceptable toxicity.

  12. Temozolomide 3 weeks on and 1 week off as first-line therapy for recurrent glioblastoma: phase II study from gruppo italiano cooperativo di neuro-oncologia (GICNO).

    PubMed

    Brandes, A A; Tosoni, A; Cavallo, G; Bertorelle, R; Gioia, V; Franceschi, E; Biscuola, M; Blatt, V; Crinò, L; Ermani, M

    2006-11-06

    The efficacy of temozolomide strongly depends on O(6)-alkylguanine DNA-alkyl transferase (AGAT), which repairs DNA damage caused by the drug itself. Low-dose protracted temozolomide administration can decrease AGAT activity. The main end point of the present study was therefore to test progression-free survival at 6 months (PFS-6) in glioblastoma patients following a prolonged temozolomide schedule. Chemonaïve glioblastoma patients with disease recurrence or progression after surgery and standard radiotherapy were considered eligible. Chemotherapy cycles consisted of temozolomide 75 mg/m(2)/daily for 21 days every 28 days until disease progression. O(6)-methyl-guanine-DNA-methyl-tranferase (MGMT) was determined in 22 patients (66.7%). A total of 33 patients (median age 57 years, range 31-71) with a median KPS of 90 (range 60-100) were accrued. The overall response rate was 9%, and PFS-6 30.3% (95% CI:18-51%). No correlation was found between the MGMT promoter methylation status of the tumours and the overall response rate, time to progression and survival. In 153 treatment cycles delivered, the most common grade 3/4 event was lymphopoenia. The prolonged temozolomide schedule considered in the present study is followed by a high PFS-6 rate; toxicity is acceptable. Further randomised trials should therefore be conducted to confirm the efficacy of this regimen.

  13. Unrelated donor marrow transplantation in childhood: a report from the Associazione Italiana Ematologia e Oncologia Pediatrica (AIEOP) and the Gruppo Italiano per il Trapianto Midollo Osseo (GITMO).

    PubMed

    Dini, Giorgio; Cancedda, Roberta; Giorgiani, Giovanna; Porta, Fulvio; Messina, Chiara; Uderzo, Cornelio; Pession, Andrea; Fagioli, Franca; La Nasa, Giorgio; Arcese, William; Pollichieni, Simona; Zecca, Marco; Lanino, Edoardo; Mazzolari, Evelina; Cesaro, Simone; Balduzzi, Adriana; Rondelli, Roberto; Vassallo, Elena; Cappelli, Barbara; Locatelli, Franco

    2002-08-01

    Unrelated donor bone marrow transplant (UD-BMT) has become an attractive, alternative source of hematopoietic cells for patients lacking a matched sibling. The aim of this paper is to report on 520 patients below 19 years of age undergoing UD BMT in 31 Italian centers between September 1989 and December 2001, and to focus on the results achieved in the 423 patients grafted before December 2000. In 1989 the Italian Bone Marrow Transplant Group (GITMO) and the Italian Association for Pediatric Hematology and Oncology (AIEOP) established the Italian Bone Marrow Donor Registry (IBMDR) to facilitate donor search and marrow procurement for patients lacking an HLA identical sibling. By the end of December 2001, 296,720 HLA-A, B typed volunteer donors had been cumulatively registered and 3,411 searches had been activated for Italian patients. At least one HLA-A, B, DRB1 matched donor was found for 54% of the patients and 520 UD BMTs were performed in patients below 19 years of age before December 2001. Since 1999 more than 90% of the patients < or = 14 years old, and more than 50% of the patients 15-18 years old undergoing UD BMT have been treated in AIEOP institutions. In 50% of the cases donors were found in the IBMDR, and in 50% they were found in 14 other Registries. The average time from search activation to transplant was 6 months for diseases other than chronic myeloid leukemia (CML), while for CML it was 8.7 months. Actuarial 100-day transplant-related mortality (TRM) was 32% in patients grafted between 1989 and 1997, and 21% for patients grafted after 1998 (p = 0.003). Twenty-eight per cent of the patients developed grade III or IV acute graft-versus-host disease (GvHD), and 20% developed extensive chronic GvHD. The rate of disease-free survival at three years was 37% for patients with acute lymphoblastic leukemia, 38% for acute myeloid leukemia or myelodysplastic syndrome patients, 59% for patients with inborn errors, and 51% for patients with CML. We conclude that the IBMDR has benefited a substantial number of patients lacking a matched sibling and has facilitated the recruitment of UDs into the international donor pool. Results show a positive trend after 1998, mainly due to a decrease in transplant-related-mortality.

  14. Determinants of response to intracervical prostaglandin E2 for cervical ripening. Gruppo di Studio sull'Induzione del Travaglio di Parto.

    PubMed

    Bortolus, R

    1999-12-01

    To analyze the determinants of response to intracervical prostaglandin E2 (PGE2) in cervical ripening. A total of 250 women with normal pregnancy, parae three or less, with intact membranes between 40 and 42 weeks of gestation and Bishop's score < or = 4 were treated with 0.5 mg PGE2 intracervical repeated after 12 hours if cervical Bishop's score was still < or = 4. After the first administration of PGE2, labor was induced in 106 (42.4%) women. Nulliparae had a significant longer interval from the first PGE2 dose to delivery and more failures of treatment and caesarean sections than parae. There was a tendency towards a shorter interval between the first administration and delivery and a decrease in the frequency of treatment failures with increasing Bishop's score, but the finding was not statistically significant. No fetal or neonatal death occurred. There were eight neonates at one min and three neonates at five min with an Apgar score less than seven. There were 22 neonates admitted to Neonatal Intensive Care Unit. There were 20 cases of jaundice. The study confirms that the main determinant of treatment failure with PGE2 gel in cervical ripening is nulliparity.

  15. [Management of asthma in a context of ambulatory pediatrics: relevance and possibility to avoid the problems. Gruppo de lavoro pediatri dell'Abruzzo Basilicata e Puglia].

    PubMed

    Misticoni, G; Marchetti, F; D'Andrea, N

    1994-01-01

    41 pediatricians agreed to register on a very simple form, all the cases of children affected by bronchial asthma visited in their clinic during october 1993. The data included basic information related to the therapy prescribed, its duration, a judgement on the efficacy of symptoms control and the main problems encountered with the children and their families. 237 cases were reported (mean age 4.6 year, range 2 months-13 years). 80% of children were monitored by the pediatrician; 47% had allergic reactions. The main drug used for profilaxis is ketotifen, a compound without documented efficacy; the main route for drug administration (especially during acute attacks) is by mouth, instead of by aerosol, evidencing problems in the health education on practical skills. In fact the main problems encountered by doctors are related to the communication with patients and families. This survey represents also a research model for involving health care providers and easily and quickly obtaining a useful, methodologically sound and interesting picture of everyday practice.

  16. Quality of harvest and role of cell dose in unrelated bone marrow transplantation: an Italian Bone Marrow Donor Registry-Gruppo Italiano Trapianto di Midollo Osseo Study.

    PubMed

    Fagioli, Franca; Quarello, Paola; Pollichieni, Simona; Lamparelli, Teresa; Berger, Massimo; Benedetti, Fabio; Barat, Veronica; Marciano, Renato; Rambaldi, Alessandro; Bacigalupo, Andrea; Sacchi, Nicoletta

    2014-01-01

    In this study, we investigated the factors affecting cell dose harvest and the role of cell dose on outcome. We analysed data from a cohort of 703 patients who underwent unrelated bone marrow transplantation facilitated by IBMDR in GITMO centers between 2002 and 2008. The median-infused cell doses is 3.7 × 10(8)/kg, the correlation between the nucleated cells requested from transplant centers and those harvested by collection centers was adequate. A harvested/requested cells ratio lower than 0.5 was observed only in 3% of harvests. A volume of harvested marrow higher than the median value of 1270 ml was related to a significant lower infused cell dose (χ(2): 44.4; P < 0.001). No patient- or donor-related variables significantly influenced the cell dose except for the recipient younger age (χ(2): 95.7; P < 0.001) and non-malignant diseases (χ(2): 33.8; P < 0.001). The cell dose resulted an independent predictor factor for a better outcome in patients affected by non-malignant disease (P = 0.05) while early disease malignant patients receiving a lower cell dose showed a higher risk of relapse (P = 0.05).

  17. A hematology consensus agreement on antifungal strategies for neutropenic patients with hematological malignancies and stem cell transplant recipients. Gruppo Italiano Malattie Ematologiche dell'Adulto, Gruppo Italiano Trapianto di Midollo Osseo, Associazione Italiana Ematologia ed Oncologia Pediatrica, Invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer and Sorveglianza Epidemiologica delle Infezioni Fungine nelle Emopatie Maligne.

    PubMed

    Girmenia, Corrado; Aversa, Franco; Busca, Alessandro; Candoni, Anna; Cesaro, Simone; Luppi, Mario; Pagano, Livio; Rossi, Giuseppe; Venditti, Adriano; Nosari, Anna Maria

    2013-09-01

    In the attempt to establish key therapy definitions and provide shared approaches to invasive fungal diseases in neutropenic patients, trials of empiric, preeemptive and targeted antifungal therapy (EAT, PAT and TAT) were reviewed, and a Consensus Development Conference Project was convened. The Expert-Panel concurred that all antifungal treatments, including EAT, should always follow an adequate diagnostic strategy and that the standard definition of PAT may be misleading: being PAT guided by the results of a diagnostic work-up, it should better be termed diagnostic-driven antifungal therapy (DDAT). The Expert-Panel agreed that radiological findings alone are insufficient for the choice of a TAT and that the identification of the etiologic pathogen is needed. The Consensus Agreement proceeded identifying which clinical and microbiological findings were sufficient to start a DDAT and which were not. Finally, an algorithm to rationalize the choice of antifungal drugs on the basis of clinical manifestations, antifungal prophylaxis, instrumental and laboratory findings was drawn up.

  18. Evaluation of surgery risk factor associated to antithrombotic therapy in patients who underwent colorectal surgery.

    PubMed

    Del Rio, Paolo; Sozzi, Francesco; Bertocchi, Elisa; Dell'Abate, Paolo; Perrone, Gennaro; Arcuri, Maria Francesca; Sianesi, Mario

    2016-01-01

    I trattamenti antipiastrinici sono comuni nel mondo occidentale ed il rischio di sanguinamento correlato a procedure chirurgiche o comunque invasive è di conseguenza elevato e pertanto abbiamo volute analizzare la correlazione tra la chirurgia del colon.retto ,la terapia antipiastrinica e le complicanze chirurgiche postoperatorie. Sono stati studiati 176 pazienti operati per tumori del colon-retto considerando i seguenti dati:tipo di intervento xchirurgico,l’indice di massa corporea (BMI), il valore dell’emoglobina (Hb); PT preoperatorio e le trasfusioni di sangue pre epost-operatorie e durante lo stesso intervento chirurgico. L’analisi si è concentrata su due gruppi :pazienti sottoposti a trattamento antipiastrinico (ATterapia antiaggregante) e pazienti non trattati ( NAT: non terapia antiaggregante piastrinica). Nei gruppi di pazienti sottoposti a emicolectomia destra, i valori di emoglobina erano più bassi neri pazienti che hanno ricevuto la terapia antitrombotica rispetto ai pazienti che non hanno ricevuto questa terapia, con una significatività statistica (p <0,05); dati analoghi sono stati osservati nei pazienti sottoposti a emicolectomia sinistra. I pazienti dipeso normale trattati con terapia antiaggregante avevano valori più bassi di emoglobina senza significatività statistica (valore di p non significativo). I pazienti in sovrappeso sottoposti a trattamento antiaggregante hanno presentato valori di Hb inferiori a quelli non trattati (p < 0,05). La percentuale di emotrasfusioneè risultata maggiore nei pazienti sottoposti a trattamento antiaggregante (AT) a prescindere dal tipo di interveno chirurgico rispetto al secondo gruppo con significatività statistica. Tra i pazienti normopeso si è registrata una diversa incidenza di trasfusione di sangue nei pazienti trattati con AT (50%) e quelli non trattati (29%) con un significato statistico (p <0,05), mentre i pazienti in sovrappeso non hanno presenato questa significativa differenza. È stata

  19. First-line cisplatin with docetaxel or vinorelbine in patients with advanced non-small-cell lung cancer: a quality of life directed phase II randomized trial of Gruppo Oncologico Italia Meridionale.

    PubMed

    Gebbia, Vittorio; Lorusso, Vito; Galetta, Domenico; Caruso M, Michele; Palomba, Giuseppe; Riccardi, Fernando; Borsellino, Nicolò; Carrozza, Francesco; Leo, Silvana; Ferraù, Francesco; Cinieri, Saverio; Mancuso, Gianfranco; Mancarella, Sergio; Colucci, Giuseppe

    2010-08-01

    Quality of life (QoL) has gained greater importance in the management of metastatic non-small-cell lung cancer due to the palliative nature of treatment. Docetaxel (DCT) and cisplatin (CDDP) doublet has been reported to be associated to a better QoL than the weekly vinorelbine (VNR) and CDDP regimen. Recently a newer more tolerated schedule of the VNR/CDDP regimen has been published and is widely employed in medical practice. The impact of these regimens on patients' QoL as well as symptoms control and type and grading chemo-related side-effects has been compared prospectically. Patients received CDDP 75 mg/m(2) plus DCT 75 mg/m(2) on day 1 every weeks (arm A) or CDDP 80 mg/m(2) on day 1 plus VNR 30 mg/m(2) day 1 and 8 every 3 weeks (arm B). G-CSF and/or EPO were employed as needed. Health-related QoL was assessed at entry and after every cycle by the EORTC-QLQ-C30 and LC13 questionnaires, toxicity by the NCI-NCCN CTC vs 2, and intent-to-treat objective response by the Recist criteria. The QoL questionnaires were completed by 37 pts (88%) in the DCT/CDDP arm and 39 pts (87%) in the VNR/CDDP one. Baseline mean scores and rates at which pts failed to complete QoL assessment were similar in the two arms. Global health status of the EORTC QLQ-C30 scale and specific symptoms control (LC13 module) improved during treatment without any statistically significant difference between the two arms. Emotional functioning remained stable in both groups during treatment, whereas physical and role improved slightly. In the DCT/CDDP arm 14 pts (33%; 95%CL 24-40%) had PR, and 10 (24%) SD for a 57% TGCR. In the VNR/CDDP arm 12 pts (27%) achieved PR, 18 (41%) SD a 68% TGCR. Differences were not statistically significant. Median time-to-progression was 4.2 months in the DCT/CDDP arm and 4.5 months in the VNR/CDDP one, and median overall survival was 12.1 (range 1-26+ months) and 12.5 months (range 1-28+ months) for DCT/CDDP and VNR/CDDP arms, respectively. Febrile neutropenia rate was higher in the VNR/CDDP arm (p=0.02) as well as G3-4 anemia (p=0.005) and G-CSF/EPO use (p=0.019). Global and specific health-related QoL data similar in both treatment groups with no statistically significant difference. Efficacy measures, overall response rate, time-to-progression and overall survival were equivalent in both arms. However, severe anemia and febrile neutropenia are statistically more frequent in the VNR/CDDP arm than in the DCT/CDDP one. These data should be considered in treatment decision-making for pts with advanced non-small-cell lung cancer and for the design of future trials with chemotherapy plus biologics. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

  20. Adjuvant chemotherapy with epirubicin, leucovorin, 5-fluorouracil and etoposide regimen in resected gastric cancer patients: a randomized phase III trial by the Gruppo Oncologico Italia Meridionale (GOIM 9602 Study).

    PubMed

    De Vita, F; Giuliani, F; Orditura, M; Maiello, E; Galizia, G; Di Martino, N; Montemurro, F; Cartenì, G; Manzione, L; Romito, S; Gebbia, V; Ciardiello, F; Catalano, G; Colucci, G

    2007-08-01

    This randomized, multicenter, phase III trial evaluated the efficacy and safety of the combination of epirubicin, leucovorin, 5-fluorouracil and etoposide (ELFE regimen) as adjuvant therapy for radically resected gastric cancer patients. From June 1996 to June 2001, 228 stage IB-IIIB gastric cancer patients were enrolled. All patients received a total or subtotal gastrectomy with at least a D1 lymphoadenectomy and were randomly assigned to receive surgery alone or surgery followed by chemotherapy. A total number of 630 cycles was delivered with a median number of 5. With a median follow-up of 60 months, the 5-year overall survival (OS) was 48% in the treatment arm and 43.5% in the control arm [hazard ratio (HR) 0.91; 95% confidence interval (CI) 0.69-1.21; P = 0.610); the 5-year disease-free survival (DFS) was 44% in the treatment arm and 39% in the control arm (HR 0.88; 95% CI 0.78-0.91; P = 0.305). In node-positive patients, the 5-year OS was 41% in the treatment arm and 34% in the control arm (HR 0.84; 95% CI 0.69-1.01; P = 0.068), while the 5-year DFS was 39% in the treatment arm and 31% in the control arm (HR 0.88; 95% CI 0.78-0.91; P = 0.051). The most common grade 3-4 toxic effects according to World Health Organization criteria were hematological and gastrointestinal. In radically resected gastric cancer patients, adjuvant chemotherapy with ELFE regimen does not improve OS over surgery alone.

  1. Cisplatin plus weekly vinorelbine versus cisplatin plus vinorelbine on days 1 and 8 in advanced non-small cell lung cancer: a prospective randomized phase III trial of the G.O.I.M. (Gruppo Oncologico Italia Meridionale).

    PubMed

    Gebbia, Vittorio; Galetta, Domenico; Lorusso, Vito; Caruso, Michele; Verderame, Francesco; Pezzella, Giuseppe; Borsellino, Nicolò; Durini, Ernesto; Valenza, Roberto; Agostara, Biagio; Colucci, Giuseppe

    2008-09-01

    A phase III randomized trial was carried out to compare two schedules of the vinorelbine (VNR)-cisplatin (CDDP) regimen in patients with locally advanced unresectable poor prognosis stage IIIB or metastatic stage IV non-small cell lung cancer. The primary endpoints were overall survival (OS) and analysis of toxicity, while secondary endpoints included response rates, time-to-progression (TTP) and quality of life (QoL). Eligible patients were randomized to receive: (a) VNR 25mg/m(2) on day 1, 8 and 15 plus CDDP 100mg/m(2) on day 1 every 4 weeks or (b) VNR 30 mg/m(2) on day 1 and 8 plus CDDP 80 mg/m(2) on day 1 every 3 weeks. All patients were chemotherapy-naïve and had an ECOG performance status (PS) of 0-1. Overall 278 patients were enrolled into the trial. Overall response rate was 34% (95% CL 26-42%) in the weekly VNR/CDDP arm, and 32% (95% CL 24-40%) in patients treated with day 1-8 VNR/CDDP without any statistically significant difference. Median TTP was 4.5 and 4.6 months respectively for weekly VNR/CDDP arm and the day 1-8 VNR/CDDP one. This difference was not statistically significant (log-rank test, p=0.818). Median OS was 9.45 and 10 months respectively for weekly VNR/CDDP arm and the day 1-8 VNR/CDDP one without statistically a significant difference (log-rank test, p=0.259). The 1- and 2-year survival rates were 31 and 36%, and 10 and 11% respectively. The incidence of severe neutropenia (34% versus 68%; p=0.0001) and of febrile neutropenia (5% versus 12%; p=0.026), as well as the rate of therapy omissions (10% versus 24%; p=0.0037) were higher in the weekly VNR/CDDP arm than in the day 1-8 VNR/CDDP one. The weekly VNR/CDDP regimen was associated with a lower received dose intensity in a statistically significant fashion (9% versus 22%; p=0.0001) and with a lower non-statistically significant quality of life score as compared to the day 1-8 VNR/CDDP schedule. The combination of day 1-8 VNR plus CDDP every 3 weeks is less toxic and better tolerated than the regimen of weekly VNR plus CDDP every 4 weeks. The two schedules are equivalent in terms of overall response rate, median time-to-progression and overall survival. The combination of VNR on day 1-8 plus CDDP every 3 weeks may be considered as a reference regimen for the treatment of patients with advanced disease and those who deserve a postoperative therapy, and for future studies.

  2. Vinorelbine and 5-fluorouracil bolus and/or continuous venous infusion plus levofolinic acid as second-line chemotherapy for metastatic breast cancer: an analysis of results in clinical practice of the Gruppo Oncologico Italia Meridionale (GOIM).

    PubMed

    Gebbia, Vittorio; Caruso, Michele; Borsellino, Nicolo; Ajello, Rosanna; Tirrito, Maria Lina; Chiarenza, Maurizio; Valenza, Roberto; Verderame, Francesco; Varvara, Francesca; Marrazzo, Antonio; Bajardi, Eugenia; Ferrao, Francesco; Bordonaro, Roberto; Tralongo, Paolo

    2006-01-01

    This retrospective study evaluated the activity and toxicity profile of a regimen of vinorelbine and 5-fluorouracil with levofolinic acid, given to a large series of patients with recurrent or refractory metastatic breast cancer after first-line chemotherapy. Overall, 286 evaluable patients were included in the analysis. Two chemotherapy schedules were reviewed: a) the bolus regimen consisted of levofolinic acid 100 mg/m2 and 5-fluorouracil 375 mg/m2, both administered i.v. on days 1,2 and 3, plus vinorelbine 25 mg/m2 i.v. bolus on days 1 and 8 every 3 weeks; b) the infusional regimen of levofolinic acid 100 mg/m2 given as a 2-hour infusion, followed by 5-fluorouracil 400 mg/m2 i.v. bolus and by 5-fluorouracil 600 mg/m2 administered as 22-hour continuous venous infusion (c.v.i) for 2 days, plus vinorelbine i.v. bolus on days 1 and 8. Overall, twelve patients achieved a complete response (4%; 95%CL 2%-7%) and 115 patients showed a partial response (40%, 95%CL 34%-46%), for an overall response rate of 44% (95CL 39%-50%). Sixty-one patients had stable disease (21%) and 98 patients progressive disease (34%). The tumor growth control rate was 63% (95%CL 60%-71%). Patients with soft tissue metastases as the dominant disease showed the highest response rate (56%), followed by viscera (48%) and bone (33%). The difference in response rate between patients with dominant visceral disease versus those with dominant bone disease was statistically significant (p=0.038). Patients treated with the bolus schedule achieved a 40% overall response rate with a 5% complete response rate, while those who received the infusional regimen had a 48% overall response rate with a 5% complete response rate. This difference was not statistically significant (p=0.164). The overall median duration of objective responses was 8.3 months (range 4-14 months), median time to progression of the all series was 6.1 months (range 2-24 months) and the median overall survival was 14.6 months (range 3-32). There was a statistically significant difference in survival among responder and non-responder patients (p=0.0009). The results of this large off-trial analysis confirmed the clinical activity and adverse-event profile reported in controlled clinical trials of the vinorelbine/ 5-fluorouracil with levofolinic acid regimen in clinical practice. This combination regimen was active with a low toxicity burden and, therefore, represents a good therapeutic choice for patients who require second-line chemotherapy.

  3. A multicenter phase II randomized trial of docetaxel/gemcitabine versus docetaxel/capecitabine as first-line treatment for advanced breast cancer: a Gruppo Oncologico Italia Meridionale study.

    PubMed

    Vici, P; Giotta, F; Di Lauro, L; Sergi, D; Vizza, E; Mariani, L; Latorre, A; Pizzuti, L; D'Amico, C; Giannarelli, D; Colucci, G

    2011-01-01

    To evaluate two docetaxel-based regimens as first-line treatment in advanced breast cancer patients. Patients were randomly assigned to docetaxel/gemcitabine (arm A: docetaxel 75 mg/m(2) on day 1, gemcitabine 1,000 mg/m(2) on days 1 and 8) or docetaxel/capecitabine (arm B: docetaxel 75 mg/m(2) on day 1, capecitabine 1,250 mg/m(2) twice daily on days 1-14); both chemotherapy regimens were repeated every 21 days. The primary objective of the study was to evaluate the response rate. Seventy-two patients were enrolled (36 each in arms A and B). Responses according to intention-to-treat analysis were as follows: arm A, 41.7% [95% confidence interval (CI) 25.6-57.8]; arm B, 38.9% (95% CI 23-54.8). Median progression-free survival was 10.9 months (95% CI 8.1-13.7) in arm A and 10 months (95% CI 8.8-11.2) in arm B. Overall survival was 26 months (95% CI 22.0-30.0) in arm A and 28 months (95% CI 23.4-32.6) in arm B. Both treatments were well tolerated; myelosuppression was the dose-limiting toxicity, with grade 3-4 neutropenia in 13.8 and 19.4% of the patients in arms A and B, respectively. No relevant differences in other toxicities were observed in the two arms, except for diarrhea (13.9%) and hand-foot syndrome (11.1%), which occurred only in arm B. Both regimens were active and well tolerated in advanced breast cancer. Copyright © 2011 S. Karger AG, Basel.

  4. Cisplatin, fotemustine and whole-brain radiotherapy in non-small cell lung cancer patients with asymptomatic brain metastases: a multicenter phase II study of the Gruppo Oncologico Italia Meridionale (GOIM 2603).

    PubMed

    Galetta, D; Gebbia, V; Silvestris, N; Ferraù, F; Carrozza, F; Cigolari, S; Russo, P; Calista, F; Adamo, V; Colucci, G

    2011-04-01

    More than 50% of brain metastases (BMs) occur in advanced non-small cell lung cancer (NSCLC) patients. Untreated patients with BMs have a poor prognosis with a median survival of 2 months. In most cases BMs are multiple and their optimal therapy is whole-brain radiation therapy (WBRT). The role of systemic therapies for these patients is still a matter for investigation due to concerns about the ability of these drugs to cross the blood-brain barrier (BBB). Cisplatin (CDDP) remains the backbone for medical treatment of NSCLC and fotemustine (FTM) is a nitrosurea able to cross the BBB. Patients with advanced NSCLC, ECOG performance status (PS) 0-1 and multiple BMs not amenable to surgery or stereotactic radiotherapy were treated with 2 cycles of FTM 80 mg/m(2) days 1, 8 and CDDP 80 mg/m(2) day 1, every 3 weeks followed by WBRT 30 Gy (3 Gy daily in 10 fractions). Radiological restaging was performed before WBRT to assess the role of chemotherapy both for cranial and extracranial disease. Patients with disease control (DC: complete response plus partial response) received 4 more cycles. To assess the basic activities of daily living (ADL), the Barthel ADL Index was used to score patients' performance every 2 cycles. The trial design provides a two-step evaluation according to the optimal two-stage design of Simon. In the first phase 29 patients were enrolled in order to verify if this schedule showed more than 25% response rate both for cranial and extracranial disease. If so, enrollment added up to a total of 81 patients. After the first evaluation 4 out of 29 patients were excluded from the study (3 untreated/1 not included for administrative reasons). At the time of the planned interim analysis patient's characteristics were the following: median age 61 years (range 44-70), M/F = 16/9, adenocarcinoma 11, squamous 5, large cell 2, undefined NSCLC 7; PS 0/1 in 11/14 cases, median Barthel Index score was 20 [13-20]. Three (12%) partial responses were observed, 9 subjects (36%) with stable disease and 13 (52%) showing disease progression. These data did not satisfy the pre-planned hypothesis and the study was stopped. At the time of the first evaluation before WBRT 12/25 (48%) patients had a systemic DC in contrast with 15/25 (60%) patients with BMs DC. Chemotherapy was relatively well tolerated with a prevalence of asthenia as the most relevant specific toxicity while the haematological toxicity was mild. CDDP and FTM combined with WBRT do not represent a therapeutic option for patients with NSCLC. Therefore further studies to evaluate the combination of systemic treatments with WBRT are warranted. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  5. Irinotecan (CPT-11) and mitomycin-C (MMC) as second-line therapy in advanced gastric cancer: a phase II study of the Gruppo Oncologico dell' Italia Meridionale (prot. 2106).

    PubMed

    Giuliani, Francesco; Molica, Stefano; Maiello, Evaristo; Battaglia, C; Gebbia, Vittorio; Di Bisceglie, Maurizio; Vinciarelli, Gianluca; Gebbia, Nicola; Colucci, Giuseppe

    2005-12-01

    The aim of this study was to evaluate the activity and toxicity of a combination regimen of CPT-11 and mitomycin-c as second-line chemotherapy for pretreated patients with advanced, metastatic, or both, gastric adenocarcinoma. Patients with pretreated metastatic disease or early relapsed after adjuvant chemotherapy were enrolled. Entry criteria included histologic/cytologic diagnosis of gastric adenocarcinoma, age 18 to 75 years, performance status > or =70 (Karnofsky scale), bi-dimensionally measurable disease. Patients received CPT-11 and mitomycin-c at the dosage of 150 mg/m2 on days 1 and 15, and 8 mg/m2 on day 1, respectively, every 4 weeks. The disease evaluation was done every 3 cycles. Among the 38 patients we observed, 1 (3%) complete response and 11 (29%) partial responses for an overall response rate of 32% according to an intent-to-treat analysis. The median duration of response was 6.5 months. The median time to progression was 4 months with a median overall survival 8 months. All patients were evaluable for toxicity and the only grade 3-4 observed toxicities were leukopenia (8%), neutropenia (21%), and anemia (5%). The combination of CPT-11 and mitomycin-c is an active and well tolerated second-line treatment in pretreated gastric cancer patients. Further studies are needed to test its role in first-line treatment.

  6. Second-line chemotherapy in advanced pancreatic carcinoma: a multicenter survey of the Gruppo Oncologico Italia Meridionale on the activity and safety of the FOLFOX4 regimen in clinical practice.

    PubMed

    Gebbia, V; Maiello, E; Giuliani, F; Borsellino, N; Caruso, M; Di Maggio, G; Ferraù, F; Bordonaro, R; Verderame, F; Tralongo, P; Di Cristina, L; Agueli, R; Russo, P; Colucci, G

    2007-06-01

    In daily clinical practice second-line chemotherapy (SLCT) is frequently given to patients with advanced pancreatic cancer failing gemcitabine-based first-line chemotherapy without solid scientific support. A retrospective survey was carried out including 42 patients. Patients received standard FOLFOX4 regimen biweekly until progression or unacceptable toxicity. Six partial responses (14%) and 16 stabilizations (38%) were recorded for a tumor growth control rate of 57%. The median time to progression (TtP) was 4 months (range 1-7 months), and median overall survival (OS) was 6.7 months (range 2-9 months). A stabilization of performance status (PS) and a subjective improvement of cancer-related symptoms were recorded in 27 patients. Data presented in this paper support the use of FOLFOX4 regimen in the second-line treatment of adenocarcinoma of the pancreas patients. The use of SLCT, however, should be carefully proposed to patients with good PS or those who had a good response to first-line therapy.

  7. Cisplatin/Pemetrexed Followed by Maintenance Pemetrexed Versus Carboplatin/Paclitaxel/Bevacizumab Followed by Maintenance Bevacizumab in Advanced Nonsquamous Lung Cancer: The GOIM (Gruppo Oncologico Italia Meridionale) ERACLE Phase III Randomized Trial.

    PubMed

    Galetta, Domenico; Cinieri, Saverio; Pisconti, Salvatore; Gebbia, Vittorio; Morabito, Alessandro; Borsellino, Nicola; Maiello, Evaristo; Febbraro, Antonio; Catino, Annamaria; Rizzo, Pietro; Montrone, Michele; Misino, Andrea; Logroscino, Antonio; Rizzi, Daniele; Di Maio, Massimo; Colucci, Giuseppe

    2015-07-01

    Cisplatin with pemetrexed (CP) and carboplatin with paclitaxel and bevacizumab (CbTB) are standard first-line treatments for patients with advanced nonsquamous (NS) non-small-cell lung cancer (NSCLC). Quality of life (QoL) is a key objective in the management of advanced NSCLC. Thus, effect on QoL could be an additional factor in the choice of treatment. Patients with untreated stage IIIB/IV NS-NSCLC and Eastern Cooperative Oncology Group performance status of 0 or 1 were randomized to receive first-line chemotherapy with cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2), every 3 weeks, for 6 cycles followed by maintenance pemetrexed; or carboplatin area under the curve 6, paclitaxel 200 mg/m(2), and bevacizumab 15 mg/kg, every 3 weeks, for 6 cycles followed by maintenance bevacizumab. The primary end point was the difference in QoL between the 2 treatment arms after 12 weeks of maintenance, measured using the EuroQoL 5 Dimensions-Index (EQ5D-I) and EQ5D-visual analogue scale (EQ5D-VAS). One hundred eighteen patients were randomized to CP (n = 60) or CbTB (n = 58). Baseline characteristics were well balanced. The proportion of patients evaluable for the primary end point was lower than planned. After 12 weeks of maintenance, the difference between mean changes in EQ5D-I was 0.137, favoring CP (95% confidence interval [CI], -0.02 to 0.29, Wilcoxon P = .078), although not statistically significant; and the difference between mean changes in EQ5D-VAS was 0.97 (95% CI, -9.37 to 11.31, Wilcoxon P = .41). Although the study was underpowered because of a small number of patients evaluable for the primary end point, QoL did not differ between treatment arms. Other factors such as comorbidities and schedule should be used when deciding on first-line treatment. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Serum cholesterol and acute myocardial infarction: a case-control study from the GISSI-2 trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto-Epidemiologia dei Fattori di Rischio dell'Infarto Miocardico Investigators.

    PubMed Central

    Nobili, A.; D'Avanzo, B.; Santoro, L.; Ventura, G.; Todesco, P.; La Vecchia, C.

    1994-01-01

    OBJECTIVE--To examine the role of serum cholesterol in acute myocardial infarction in a population of patients with no history of coronary heart disease and to establish the nature of this association, the degree of risk, and the possible interaction between serum cholesterol and other major risk factors for acute myocardial infarction. DESIGN--Case-control study. SETTING--90 hospitals in northern, central, and southern Italy. PATIENTS--916 consecutive cases of newly diagnosed acute myocardial infarction and 1106 hospital controls admitted to hospital with acute conditions not related to known or suspected risk factors for coronary heart disease. DATA COLLECTION--Data were collected with a structured questionnaire and blood samples were taken by venepuncture as soon as possible after admission to hospital from cases and controls. Blood cholesterol concentrations were available for 614 cases and 792 controls. RESULTS--After adjustment by logistic regression for sex, age, education, geographical area, smoking status, body mass index, history of diabetes and hypertension, and family history of coronary heart disease the estimated relative risks of acute myocardial infarction for quintiles of serum cholesterol (from lowest to highest) were 2.3 (95% confidence interval (CI) 1.6 to 3.4), 3.1 (95% CI 2.1 to 4.6), 4.1 (95% CI 2.8 to 6.0), and 5.2 (95% CI 3.5 to 7.7). The estimated relative risk across selected covariates increased from the lowest to the highest quintile of serum cholesterol particularly for men, patients under 55 years of age, and smokers. When the possible interaction of known risk factors with serum cholesterol was examined, smoking habits, diabetes, and hypertension had approximately multiplicative effects on relative risk. CONCLUSIONS--This study indicates that serum cholesterol was an independent risk factor for acute myocardial infarction. This association was linear, with no threshold level. Moreover, there was a multiplicative effect between cholesterol and other major risk factors on the relative risk of acute myocardial infarction. PMID:8011413

  9. Acute myocardial infarction: association with time since stopping smoking in Italy. GISSI-EFRIM Investigators. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto. Epidemiologia dei Fattori di Rischio dell'Infarto Miocardico.

    PubMed Central

    Negri, E; La Vecchia, C; D'Avanzo, B; Nobili, A; La Malfa, R G

    1994-01-01

    STUDY OBJECTIVE--The study aimed to investigate the relationship between years since stopping smoking and the risk of acute myocardial infarction. DESIGN--This was a hospital based, multicentre, case-control study conducted in Italy between September 1988 and June 1989 within the framework of the GISSI-2 clinical trial. SETTING--Over 80 coronary care units in various Italian regions participated. SUBJECTS--A total of 916 incident cases of acute myocardial infarction, below age 75 years, and with no history of ischaemic heart disease, and 1106 control subjects admitted to the same hospitals for acute, non-neoplastic, cardiovascular or cerebrovascular conditions that were not known or suspected to be related to cigarette smoking took part in the study. MAIN OUTCOME MEASURES AND RESULTS--Measures were relative risk (RR) estimates of acute myocardial infarction according to the time since stopping smoking and adjusted for identified potential confounding factors. Compared with never smokers, the multivariate RRs were 1.6 (95% confidence interval (CI) 0.8,3.2) for subjects who had given up smoking for one year; 1.4 (95% CI 0.9,2.1) for those who had stopped for two to five years; 1.2 (95% CI 0.7,2.1) for six to 10 years; and 1.1 (95% CI 0.8,1.8) for those who had not smoked for over 10 years. The estimated RR for current smokers was 2.9 (95% CI 2.2,3.9). The risks of quitters were higher for heavier smokers and those below age 50 years, while no difference emerged in relation to the duration of smoking, sex, and other risk factors for myocardial infarction. CONCLUSIONS--These results indicate that there is already a substantial drop in the risk of acute myocardial infarction one year after stopping. The risk in ex-smokers, however, seemed higher (although not significantly) than that of those who had never smoked, even more than 10 years after quitting. This could support the existence of at least two mechanisms linking cigarette smoking with acute myocardial infarction--one involving thrombogenesis or spasms that occurs over the short term, and another involving atherosclerosis that is a long term effect. PMID:8189165

  10. Extracorporeal Photopheresis for Treatment of Acute and Chronic Graft Versus Host Disease: An Italian Multicentric Retrospective Analysis on 94 Patients on Behalf of the Gruppo Italiano Trapianto di Midollo Osseo.

    PubMed

    Malagola, Michele; Cancelli, Valeria; Skert, Cristina; Leali, Pierino Ferremi; Ferrari, Emilio; Tiburzi, Alessandra; Sala, Maria Luisa; Donnini, Irene; Chiusolo, Patrizia; Mussetti, Alberto; Battista, Marta; Turra, Alessandro; Cattina, Federica; Rambaldi, Benedetta; Schieppati, Francesca; Polverelli, Nicola; Bernardi, Simona; Perucca, Simone; Marini, Mirella; Laszlo, Daniele; Savignano, Chiara; Patriarca, Francesca; Corradini, Paolo; Piccirillo, Nicola; Sica, Simona; Bosi, Alberto; Russo, Domenico

    2016-12-01

    Extracorporeal photopheresis (ECP) is considered a valid second-line treatment for acute and chronic graft versus host disease (GVHD). Ninety-four patients with acute GVHD (aGVHD) (n = 45) and chronic GVHD (cGVHD) (n = 49), retrospectively recruited in 6 Italian centers, were submitted to ECP for second-line treatment. At the time of ECP, 22 (49%) and 23 (51%) of 45 patients with aGHVD were nonresponsive and in partial remission (PR) after steroids, respectively, and all the 49 patients with cGVHD were steroid refractory. Forty-one (91%) of 45 patients with aGVHD achieved complete remission (CR) after ECP. Fifteen (33%) of 45 patients developed cGVHD. The CR rate in patients who started ECP being nonresponsive and in PR after steroid was 86% and 96%, respectively. After a median follow-up of 20 months (range, 2-72), 15 (33%) of 45 patients developed cGHVD and 16 (35%) of 45 patients died, in 3 cases for aGVHD. A trend for a better survival was seen among patients who started ECP in PR after steroid (80% vs 50% at 2 years; P = 0.07). Overall, 22 (45%) of 49 patients and 17 (35%) of 49 patients with steroid refractory cGHVD achieved CR and PR after ECP, respectively. After a median follow-up of 27 months, 44 (90%) of 49 patients are alive, 21 of whom (48%) are on steroid. Extracorporeal photopheresis is confirmed as an effective second-line treatment in both aGVHD and cGVHD, because it can induce a response in more than 80% of the patients and a long-term survival in at least 50% of the cases.

  11. EXTRACORPOREAL PHOTOPHERESIS (ECP) FOR TREATEMENT OF ACUTE AND CHRONIC GRAFT VERSUS HOST DISEASE: AN ITALIAN MULTICENTRIC RETROSPECTIVE ANALYSIS ON 94 PATIENTS ON BEHALF OF THE GRUPPO ITALIANO TRAPIANTO DI MIDOLLO OSSEO (GITMO).

    PubMed

    Malagola, Michele; Cancelli, Valeria; Skert, Cristina; Leali, Pierino Ferremi; Ferrari, Emilio; Tiburzi, Alessandra; Sala, Maria Luisa; Donnini, Irene; Chiusolo, Patrizia; Muffetti, Alberto; Battista, Marta; Turra, Alessandro; Cattina, Federica; Rambaldi, Benedetta; Schieppati, Francesca; Polverelli, Nicola; Bernardi, Simona; Perucca, Simone; Marini, Mirella; Laszlo, Daniele; Savignano, Chiara; Patriarca, Francesca; Corradini, Paolo; Piccirillo, Nicola; Sica, Simona; Bosi, Alberto; Russo, Domenico

    2016-09-08

    Extracorporeal photopheresis (ECP) is considered a valid second-line treatment for acute and chronic graft versus host disease (GVHD). Ninety-four patients with aGVHD (n=45) and cGVHD (n=49), retrospectively recruited in 6 Italian Centers, were submitted to ECP for second-line treatment. At the time of ECP, 22 (49%) and 23 (51%) out of 45 patients with aGHVD were non responsive (NR) and in partial remission (PR) after steroids, respectively, and all the 49 patients with cGVHD were steroid refractory. Forty-one out of 45 (91%) patients with aGVHD achieved complete remission (CR) after ECP. Fifteen out of 45 (33%) patients developed cGVHD. The CR rate in patients who started ECP being NR and in PR after steroid was 86% and 96%, respectively. After a median follow up of 20 months (range 2-72), 15/45 patients (33%) developed cGHVD and 16/45 patients (35%) died, in 3 cases for aGVHD. A trend for a better survival was seen among patients who started ECP in PR after steroid (80% vs 50% at 2 years; p=0,07). Overall, 22/49 (45%) and 17/49 (35%) patients with steroid refractory cGHVD achieved CR and PR after ECP, respectively. After a median follow up of 27 months, 44/49 patients (90%) are alive, 21 of whom (48%) on steroid. ECP is confirmed as an effective second-line treatment in both acute and chronic GVHD, as it can induce a response in more than 80% of the patients and a long term survival in at least 50% of the cases.

  12. Long-term results of a randomized trial comparing cisplatin with cisplatin and cyclophosphamide with cisplatin, cyclophosphamide, and adriamycin in advanced ovarian cancer. GICOG (Gruppo Interregionale Cooperativo Oncologico Ginecologia), Italy.

    PubMed

    1992-05-01

    We report the long-term results of a randomized trial comparing cisplatin (P) with cisplatin and cyclophosphamide (CP) with cisplatin, cyclophosphamide, and adriamycin (CAP) in advanced ovarian cancer. Overall, this update confirms previously published data on 529 cases. Median survival times for the three treatments--CAP, CP, and P--are, respectively, 23, 20, and 19 months. The differences among the three arms are still nonsignificant and the estimated percentage survival at 7 years and confidence limits are, respectively, 21.7 (14.9-28.4), 17.0 (11.0-22.9), and 12.2 (6.9-17.4). According to the results of the Cox regression model on prognostic factors, higher grading, a larger residual tumor size, and performance status less than 80 (Karnovsky) all were independently associated with a poorer outcome, while a serous histotype was related to a better prognosis. The other variables (age, stage, center, type of surgery) initially included in the model did not appear to be significantly related to prognosis. The implications of these long-terms results relative to the application of combination chemotherapy with CAP or CP are discussed.

  13. Adjuvant treatment for early epithelial ovarian cancer: results of two randomised clinical trials comparing cisplatin to no further treatment or chromic phosphate (32P). G.I.C.O.G.: Gruppo Interregionale Collaborativo in Ginecologia Oncologica.

    PubMed

    Bolis, G; Colombo, N; Pecorelli, S; Torri, V; Marsoni, S; Bonazzi, C; Chiari, S; Favalli, G; Mangili, G; Presti, M

    1995-11-01

    From 1983 to 1990, 271 consecutive patients with stage I ovarian cancer entered two randomised trials, aimed at assessing the role of adjuvant chemotherapy after radical surgery in early stages of ovarian cancer. Trial I compared cisplatin (50 mg/m2 with repeated courses every 28 days for 6 cycles) to no further therapy in F.I.G.O. stage Ia & b Grade II-III patients; trial II compared cisplatin (same dose and schedule) to 32P in Iaii & bii and Ic patients. Both studies were multicentric and centrally randomized. Treatment was allocated by phone and stratified by center. All patients satisfying major eligibility criteria (histological and grade, no previous neoplasms) were analysed according to treatment allocated by randomisation. With a median observation time of 76 months, cisplatin significantly reduced the relapse rate by 65% (HR = 0.35; 95% CI = 0.14-0.89, p = 0.028; Cox Model) in trial I and 61% (HR = 0.39; 95% CI = 0.19-0.77, p = 0.007; Cox Model) in trial II. Survival was not significantly different (trial I - Kaplan-Meier overall 5-year survival: cisplatin = 88%, control = 82%, HR = 1.15; 95% CI = 0.44-2.98; p = 0.773; Cox Model); trial II - overall 5-year survival: cisplatin = 81%, 32P = 79%, HR = 0.72; 95% CI = 0.37-1.43; p = 0.354; Cox model). In both studies the risk of dying after relapse increased for patients originally randomized to the cisplatin arms: in trial I, 6 of 7 patients in the cisplatin relapsed arm and died of tumor compared with 8 of 14 patients in the control arm. In trial II 11 of 12 patients on cisplatin, and 18 of 26 on 32P succumbed to tumor recurrence. Adjuvant cisplatin treatment in early ovarian cancer significantly prevents relapse in comparison to 32P in stage IC patients or to no immediate treatment in earlier stage women. The impact of cisplatin adjuvant treatment on survival remains, however, unclear.

  14. Prognostic significance of heart rate variability in post-myocardial infarction patients in the fibrinolytic era. The GISSI-2 results. Gruppo Italiano per lo Studio della Sopravvivenza nell' Infarto Miocardico.

    PubMed

    Zuanetti, G; Neilson, J M; Latini, R; Santoro, E; Maggioni, A P; Ewing, D J

    1996-08-01

    Studies performed before the introduction of fibrinolysis showed that a low heart rate variability (HRV) is associated with higher mortality in post-myocardial infarction (MI) patients. We evaluated whether HRV adds information relevant to risk stratification in patients treated with fibrinolysis as well. From 24-hour ECG recordings obtained at discharge in patients treated with recombinant tissue-type plasminogen activator or streptokinase, we measured several time-domain indexes of HRV: standard deviation (SDNN), root-mean-square of successive differences (RMSSD), and number of RR interval increases > 50 ms ("NN50+"). The prognostic value of HRV for total and cardiovascular mortality was assessed. Of 567 patients with valid recordings, 52 (9.1%) died during the 1000 days of follow-up, 44 (7.8%) of cardiovascular causes. All indexes of low HRV were able to identify patients (16% to 18% of total population) with a higher total mortality (20.8% to 24.2% versus 6.0% to 6.8%, depending on index used). The independent predictive value of low HRV was confirmed by the adjusted analysis with the following relative risks: NN50+, 3.5 (95% CI, 1.9 to 6.7); SDNN, 3.0 (95% CI, 1.55 to 5.9); and RMSSD, 2.8 (95% CI, 1.5 to 5.3). Advanced age, previous MI, Killip class at entry, and use of digitalis were also independent predictors. Similar data were obtained for cardiovascular mortality. Time-domain indexes of HRV retain their independent prognostic significance even in post-MI patients of all ages treated with fibrinolysis.

  15. Role of interactions between psychological and clinical factors in determining 6-month mortality among patients with acute myocardial infarction. Application of recursive partitioning techniques to the GISSI-2 database. Gruppo Italiano per lo Studio della Sopravvivenza nell' Infarto Miocardico.

    PubMed

    Carinci, F; Nicolucci, A; Ciampi, A; Labbrozzi, D; Bettinardi, O; Zotti, A M; Tognoni, G

    1997-05-01

    Clinical and epidemiological studies support the hypothesis that ischaemic cardiovascular diseases are consistently associated with psychological, social and behavioural factors. Nevertheless, the joint effect of clinical characteristics and psychological variables in determining the prognosis of acute myocardial infarction survivors has been seldom investigated. In the framework of the GISSI-2 trial, the impact of psychological factors on 6-month mortality and their interaction with clinical features was included as an ad hoc research project. Overall, 2449 patients were evaluated, 63 of whom died during the study period. All patients undertook a self-administered questionnaire (Cognitive Behavioural Assessment Hospital Form), investigating 16 psychological dimensions relative to three areas (state variables, vital exhaustion, trait variables). The impact of psychological variables on prognosis and their interaction with clinical variables were investigated by using a tree-growing technique (RECursive Partitioning and AMalgamation-RECPAM) applied to survival analysis. This statistical method allowed the identification of three separate classes, characterized by different prognoses: Class I (presence of vital exhaustion), Class II (concomitance of no vital exhaustion, depression and low levels of anxiety) and Class III (all other patients). After adjusting for the clinical variables, Class I was associated with an intermediate prognosis (hazard ratio [HR] = 2.2; 95% confidence intervals [CI], 1.2-4.0) and Class II to the worst (HR = 3.2; 95% CI = 1.6-6.2), as compared to Class III. High levels of neuroticism and extroversion were associated with a better prognosis. When clinical and psychological variables were simultaneously investigated by RECPAM, Type A behaviour was shown to be an important risk predictor among patients with better clinical conditions, i.e. those eligible for exercise test (HR = 2.6, 95% CI = 1.2-5.5). Finally, a striking difference in the impact of the most predictive clinical variables (exercise test ineligibility, late and early ventricular failure) was found among patients with and without vital exhaustion. This study shows that acute myocardial infarction survivors are heterogeneous with respect to 6-month mortality according to their psychological profile. More important, the impact of these variables appears comparable to that of very well known clinical risk predictors. The availability of a large study population, together with the use of innovative statistical techniques, allowed us to identify subgroups of patients for whom the joint action of clinical and psychological characteristics has been clearly documented. This suggests the need for incorporating psychological evaluation in the care of acute myocardial infarction patients.

  16. [Multicenter study on the treatment and outcome of patients admitted to intensive care units in Italy. Presentation of the research project and the study protocol. GiViTI (Gruppo Italiano per la Valutazione degli interventi in Terapia Intensiva)].

    PubMed

    Apolone, G; Brazzi, L; Pesce, C

    1992-12-01

    Although Intensive Care Units (ICU) are present in most of the Italian Hospitals for acute patients, the heterogeneity of the patients case-mix and the large variation in structural, organizational and staffing arrangements have limited the feasibility and precision of evaluation studies aimed at assessing the quality of health care delivered and its impact on patients outcomes. To our knowledge there has been no nationwide study aimed at assessing the quality and effectiveness of the delivered care in samples of ICUs and patients that are representative of the source populations. To study the effects of variations in health care practices on the outcome of the patients admitted in ICU, we designed a multicentric observational study involving 120 ICUs within the country. The present study is the first part of a project involving a network of Intensive Care Units gathered under the name of GiViTI-Italian Group for the Evaluation of the Interventions in Intensive Care-that is representative of the national Italian reality in the field. The idea of a large collaborative group acting in the field of Intensive Care stands in line with several quality, effectiveness and resource utilization studies that are ongoing in other European countries and is also the result of a series of smaller-scale experiences carried out by other Italian groups eventually emboied in the GiViTI project. In the framework of the ongoing long term, multisite, and multidisciplinary project, the present study calls for the recruitment of all consecutive patients seen at the participant centers during a two months period.(ABSTRACT TRUNCATED AT 250 WORDS)

  17. The performance of SAPS II in a cohort of patients admitted to 99 Italian ICUs: results from GiViTI. Gruppo Italiano per la Valutazione degli interventi in Terapia Intensiva.

    PubMed

    Apolone, G; Bertolini, G; D'Amico, R; Iapichino, G; Cattaneo, A; De Salvo, G; Melotti, R M

    1996-12-01

    To assess the validity of SAPS II (new Simplified Acute Physiology Score) in a cohort of patients admitted to a large sample of Italian intensive care units (ICU). The ability of the SAPS II scoring system to predict the probability of hospital mortality was assessed with calibration and discrimination measures obtained using published coefficients. A new logistic regression equation was then developed and further formal calibration and discrimination measures were estimated for the customized model. From the 2202 consecutive patients recruited during a 1-month period in 99 ICUs, a total of 1393 patients were included in this validation study. When the parameters based on the standard model were applied, the expected probability of mortality did not fit those actually observed in the cohort (p < 0.001), although it showed satisfactory discrimination (area under the receiver operating characteristic curve = 0.80). Such lack of fit yields an overall under prediction of mortality (observed/expected ratio = 1.14) that reflects a uniform pattern across a preselected set of subgroups. Customization allowed new mortality estimates to be calculated, with satisfactory calibration (p = 0.82) and a more uniform pattern across subgroups. SAPS II maintained its validity in an independent sample of patients recruited in a large network of Italian ICUs only after appropriate adaptation (first-level customization). Whether the determinants of this relatively poor performance are related to differences in unmeasured case-mix, methods of application, or quality of care delivered is a matter for discussion that cannot be solved with the data presently available. However, these findings suggest that caution is warranted before implementing the standard SAPS II scoring system parameters outside formal research projects.

  18. Gemcitabine alone or with cisplatin for the treatment of patients with locally advanced and/or metastatic pancreatic carcinoma: a prospective, randomized phase III study of the Gruppo Oncologia dell'Italia Meridionale.

    PubMed

    Colucci, Giuseppe; Giuliani, Francesco; Gebbia, Vittorio; Biglietto, Maria; Rabitti, Piergiorgio; Uomo, Generoso; Cigolari, Silvio; Testa, Antonio; Maiello, Evaristo; Lopez, Massimo

    2002-02-15

    A prospective, randomized Phase III trial was performed to determine whether, compared with gemcitabine (GEM) alone, the addition of cisplatin (CDDP) to GEM was able to improve the time to disease progression and the clinical benefit rate in patients with advanced pancreatic adenocarcinoma. The objective response rate, overall survival rate, and toxicity patterns of patients in the two treatment arms were evaluated as secondary end points. Patients with measurable, locally advanced and/or metastatic pancreatic adenocarcinoma were randomized to receive GEM (Arm A) or a combination of GEM and CDDP (Arm B). In Arm A, a dose of 1000 mg/m(2) GEM per week was administered for 7 consecutive weeks, and, after a 2-week rest, treatment was resumed on Days 1, 8, and 15 of a 28-day cycle for 2 cycles. In Arm B, CDDP was given at a dose of 25 mg/m(2) per week 1 hour before GEM at the same dose that was used in Arm A. On Day 22, only GEM was administered. Patients were restaged after the first 7 weeks of therapy and then again after the other 2 cycles. A total of 107 patients entered the trial: Fifty-four patients were randomized to Arm A, and 53 patients were randomized to Arm B. The median time to disease progression was 8 weeks in Arm A and 20 weeks in Arm B; this difference was statistically significant (P = 0.048). In Arm A, one complete response and four partial responses were recorded on the basis of an intent-to-treat analysis, with an overall response rate of 9.2% (95% confidence interval [95%CI], 3-20%). In Arm B, there were no complete responses, whereas 14 partial responses were achieved, with an overall response rate of 26.4% (95%CI, 15-40%). This difference in the overall response rates was statistically significant (P = 0.02). The tumor growth control rate (i.e., total number of patients who achieved complete responses, partial responses, and stable disease) was 42.6% (95%CI, 29-57%) in Arm A and 56.6% (95%CI, 42-70%) in Arm B. A clinical benefit was observed in 21 of 43 patients (49%) in Arm A and in 20 of 38 patients (52.6%) in Arm B without any significant difference. The median overall survival was 20 weeks for patients in Arm A and 30 weeks for patients in Arm B (P = 0.43). Toxicity was mild in both treatment arms, with no significant differences between the two groups except for the statistically higher incidence of Grade 1-2 asthenia in Arm B (P = 0.046). The addition of CDDP to GEM significantly improved the median time to disease progression and the overall response rate compared with GEM alone. The clinical benefit rate was similar in both arms, whereas the median overall survival rate was more favorable for Arm B, although the difference did not attain statistical significance. The authors conclude that the combination of CDDP and GEM currently may be considered as an optimal treatment for patients with locally advanced and/or metastatic adenocarcinoma of the pancreas. Copyright 2002 American Cancer Society. DOI 10.1002/cncr.10323

  19. Fotemustine as second-line treatment for recurrent or progressive glioblastoma after concomitant and/or adjuvant temozolomide: a phase II trial of Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO).

    PubMed

    Brandes, Alba A; Tosoni, A; Franceschi, E; Blatt, V; Santoro, A; Faedi, M; Amistà, P; Gardiman, M; Labianca, R; Bianchini, C; Ermani, M; Reni, M

    2009-09-01

    Standardized salvage treatment has not yet proved effective in glioblastoma multiforme (GBM) patients who receive prior standard radiotherapy plus concomitant and adjuvant temozolomide. Patients with progressive GBM after radiotherapy plus concomitant and/or adjuvant temozolomide received three-weekly doses (100-75 mg m(2)) of fotemustine followed, after a 5-week rest, by fotemustine (100 mg m(2)) every 3 weeks for < or =1 year. Forty-three patients (29 M, 14 F; median age 51 years, range 34-68; median KPS 90) were enrolled. Progression-free survival at 6 months (PFS-6) was 20.9% (95% CI: 9-33%); three patients (7.1%) had partial response (PR); 15 (34.9%), disease stabilization (SD). The median survival was 6 months (95% CI: 5-7). MGMT promoter status was methylated in 8 (18.6%) and unmethylated in 26 (60.5%) and not assessable in 9 (20.9%) patients, respectively. Disease control was 75% versus 34.6% in methylated and unmethylated MGMT patients (P = 0.044); no significant difference was found between groups for PFS-6 and survival. Grade 3 and 4 thrombocytopenia and neutropenia were observed in 20.9 and 16.3% of patients, during the induction phase, and in 0 and 9.5% patients during the maintenance phase, respectively. The findings of the present trial, that evaluate fotemustine in a homogeneous population, may represent a new benchmark for nitrosourea activity. Moreover, this is the first study to evaluate correlation between MGMT promoter status and outcome of fotemustine for relapsing GBM previously treated with radiotherapy and temozolomide.

  20. Allogeneic bone marrow transplantation versus chemotherapy in high-risk childhood acute lymphoblastic leukaemia in first remission. Associazione Italiana di Ematologia ed Oncologia Pediatrica (AIEOP) and the Gruppo Italiano Trapianto di Midollo Osseo (GITMO).

    PubMed

    Uderzo, C; Valsecchi, M G; Balduzzi, A; Dini, G; Miniero, R; Locatelli, F; Rondelli, R; Pession, A; Arcese, W; Bacigalupo, A; Polchi, P; Andolina, M; Messina, C; Conter, V; Aricó, M; Galimberti, S; Masera, G

    1997-02-01

    We compared the outcome of children with high-risk acute lymphoblastic leukaemia (HR-ALL) in first complete remission (first CR) treated with chemotherapy (CHEMO) or with allogeneic bone marrow transplantation (BMT) in a multicentre study. All children treated by the Italian Paediatric Haematology Oncology Association for HR-ALL in first CR between 1986 and 1994 were eligible for the study. 30 children were given BMT at a median of 4 months from first CR, with preparative regimens including total-body irradiation (n = 25/30). 130 matched controls for BMT patients were identified among 397 HR-ALL CHEMO patients. Matching on main prognostic factors and duration of first CR was adopted to control the selection and time-to-transplant biases. The comparative analysis was based on the results of a stratified Cox model. The estimated hazard ratios of BMT versus CHEMO at 6 months, 1 year and 2 years after CR were 1.38 (CI 0.59-3.24), 0.69 (CI 0.27-1.77) and 0.35 (CI 0.06-1.91), with an overall non-significant difference between the two groups (P = 0.34). With a median follow-up of 4 years, the disease-free survival was 58.5% (SE 9.3) in the BMT group and 47.7% (SE 4.8) in the CHEMO group, at 4 years from CR. Non-leukaemic death occurred in 4% of CHEMO and 10% of BMT patients. In the BMT group the estimated cumulative incidence of relapse at 1.5 years from CR was 31.5% (SE 8.8) and did not change thereafter, whereas in the CHEMO group the corresponding figure was 29.2% (SE 4.1) and the incidence continued to increase thereafter (48.2% (SE 4.8) at 4 years from CR). The results of this study suggest that, with respect to the CHEMO group, the higher risk of early failure in the BMT group is outweighed by the lower risk of relapse after 1 year. Results prompt the need for a prospective study, in order to demonstrate the likely advantage of BMT in HR childhood ALL in first CR.

  1. Second-line chemotherapy with irinotecan plus carmustine in glioblastoma recurrent or progressive after first-line temozolomide chemotherapy: a phase II study of the Gruppo Italiano Cooperativo di Neuro-Oncologia (GICNO).

    PubMed

    Brandes, Alba A; Tosoni, Alicia; Basso, Umberto; Reni, Michele; Valduga, Francesco; Monfardini, Silvio; Amistà, Pietro; Nicolardi, Linda; Sotti, Guido; Ermani, Mario

    2004-12-01

    Glioblastoma multiforme (GBM), the most frequent brain tumor in adults, is not considered chemosensitive. Nevertheless, there is widespread use of first-line chemotherapy, often with temozolomide, as a therapeutic option in patients with progressive disease after surgery and radiotherapy. However, at the time of second recurrence and/or progression, active and noncross-resistant chemotherapy regimens are required. The aim of the present multicenter phase II trial, therefore, was to ascertain the efficacy of second-line carmustine (BCNU) and irinotecan chemotherapy. Patients with histologically confirmed GBM, recurring or progressing after surgery, standard radiotherapy and a first-line temozolomide-based chemotherapy, were considered eligible. The primary end-point was progression-free survival at 6 months (PFS-6), and secondary end-points included response rate, toxicity, and survival. All patients were on enzyme-inducing antiepileptic prophylaxis. Chemotherapy consisted of BCNU (100 mg/m2 on day 1) plus irinotecan (175 mg/m2/weekly for 4 weeks), every 6 weeks, for a maximum of eight cycles. In the absence of grade 2 toxicity, the irinotecan dose was increased to 200 mg/m2. A total of 42 patients (median age, 53.4 years; median Karnofsky performance status, 80; range, 60 to 90) were included in the study. PFS-6 was 30.3% (95% CI, 18.5% to 49.7%). Median time to progression was 17 weeks (95% CI, 11.9 to 23.9). Nine partial responses (21.4%; 95% CI, 9% to 34%) were obtained. Toxicity was manageable. The BCNU plus irinotecan regimen seems active and non-cross-resistant in patients with GBM with recurrence after temozolomide-based chemotherapy.

  2. Allogeneic bone marrow transplantation in children with acute myelogenous leukemia in first remission. Associazione Italiana di Ematologia e Oncologia Pediatrica (AIEOP) and the Gruppo Italiano per il Trapianto di Midollo Osseo (GITMO).

    PubMed

    Dini, G; Boni, L; Abla, O; Uderzo, C; Polchi, P; Locatelli, F; Di Bartolomeo, P; Arcese, W; Iori, A P; Rossetti, F

    1994-06-01

    Fifty-nine children, aged 1-15 years, with acute myelogenous leukemia (AML) received a bone marrow transplant (BMT) from an HLA-identical sibling (n = 57) or from an identical twin (n = 2), while in first remission (CR). These children represent, to the best of our knowledge, all children grafted in first CR in 11 Italian centers between 1980 and 1990. Patients were prepared with total body irradiation (TBI) plus cyclophosphamide (CY) (n = 50) or melphalan (n = 2) or with busulfan plus CY (n = 7). GVHD prophylaxis consisted of cyclosporin A (n = 48), methotrexate (n = 7) or cyclosporin and methotrexate (n = 2). Survivors have been followed for 21-137 months (median 59 months). Actuarial relapse-free survival was 58% at 66-137 months (95% confidence interval (CI) 44-72). Actuarial risk of relapse was 23% at 48 months (95% CI 10.9-34.8). Risk of non-relapse deaths was 33% in the period 1980-87 and 4% in the period 1988-90 (p = 0.02). In multivariate analysis patients with a blood cell count > 14 x 10(9)/l at diagnosis showed a lower relapse-free survival compared with patients with counts < 14 x 10(9)/l (p = 0.006). We could not detect an effect of FAB subtype, patient age, time to achieve remission or transplant-related variables, including year of BMT, on relapse-free survival. In conclusion, allogeneic marrow transplantation can achieve long-term relapse-free survival in over 50% of children with AML and should be considered as consolidation therapy if a matched sibling is available.(ABSTRACT TRUNCATED AT 250 WORDS)

  3. Vinorelbine, gemcitabine, procarbazine and prednisone (ViGePP) as salvage therapy in relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL): results of a phase II study conducted by the Gruppo Italiano per lo Studio dei Linfomi.

    PubMed

    Di Renzo, Nicola; Brugiatelli, Maura; Montanini, Antonella; Vigliotti, Maria Luigia; Cervetti, Giulia; Liberati, Anna Marina; Luminari, Stefano; Spedini, Pierangelo; Giglio, Gianfranco; Federico, Massimo

    2006-03-01

    Patients with aggressive NHL who fail initial treatment or subsequently relapse have a very poor outcome and less than 20-25% achieve a prolonged disease-free interval with salvage therapies. To improve the outcome of patients with refractory aggressive NHL not suitable for High Dose Therapy (HDT) and Autologous Stem Cell Transplant (ASCT), the efficacy of a combination of gemcitabine, vinorelbine, procarbazine and prednisone (ViGePP) were tested. Between November 1999 and September 2002, 69 patients with relapsed or refractory aggressive NHL were treated with ViGePP regimen, every 4 weeks up to six courses. At the end of planned chemotherapy patients could receive additional radiotherapy on residual masses or on sites of previously bulky disease. Sixty-six patients were available for evaluation of study end-points. Thirty patients were refractory to therapy and 36 patients had relapsed after remission obtained with previous therapy. At the end of therapy, complete remission (CR) rate was 23%, 3-year relapse free survival rate was 40% and 3-year overall survival rate was 25% for the whole series (29% and 20% for relapsed and refractory patients, respectively). Patients achieving CR with ViGePP had a significantly better survival as compared with the remaining ones (p = 0.0003). ViGePP as used in the present setting has demonstrated a promising activity, comparable to other conventional dose regimens. Although CR was achieved only in a minority of patients, this was durable in a significant proportion of them. This regimen should be tested in less heavily pre-treated patients and probably in combination with new active agents such Rituximab. Further developments of this combination are warranted.

  4. Neuropsychological assessment of the severely impaired elderly patient: validation of the Italian short version of the Severe Impairment Battery (SIB). Gruppo di Studio sull'Invecchiamento Cerebrale della Società Italiana di Gerontologia e Geriatria.

    PubMed

    Pippi, M; Mecocci, P; Saxton, J; Bartorelli, L; Pettenati, C; Bonaiuto, S; Cucinotta, D; Masaraki, G; Neri, M; Tammaro, A E; Vergani, C; Chionne, F; Senin, U

    1999-08-01

    One hundred and sixty-nine severely demented patients were tested in a multicenter study with the short version of the Severe Impairment Battery which was translated into Italian with the purpose of adapting and validating it for an Italian population. Patients were enrolled in Italian geriatric centers participating in the Study Group on Aging Brain of the Italian Society of Gerontology and Geriatrics. Following thorough clinical and instrumental examinations, they were evaluated with the Mini Mental State Examination, the Clinical Dementia Rating, the Severe Impairment Battery (SIB), the Gottfries-Bråne-Steen Rating Scale for Dementia, the Activity of Daily Living index, and the Bedford Alzheimer Nursing Severity scale (BANS.s). The inter-rater reliability of the SIB was highly significant for the total score and its subtests; test-retest reliability showed the same significance in all items. Also concurrent validity, performed comparing the total SIB score with the total BANS.s score, was significant. The short Italian version of the SIB proved to be a very reliable tool for the evaluation of severely demented patients; it has the advantage of being easy to administer, it evaluates more cognitive domains that, are typically assessed in dementia, and has a wide enough range of scores to detect even small differences in the examined abilities.

  5. Serum cholesterol and acute myocardial infarction: a case-control study from the GISSI-2 trial. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto-Epidemiologia dei Fattori di Rischio dell'Infarto Miocardico Investigators.

    PubMed

    Nobili, A; D'Avanzo, B; Santoro, L; Ventura, G; Todesco, P; La Vecchia, C

    1994-05-01

    To examine the role of serum cholesterol in acute myocardial infarction in a population of patients with no history of coronary heart disease and to establish the nature of this association, the degree of risk, and the possible interaction between serum cholesterol and other major risk factors for acute myocardial infarction. Case-control study. 90 hospitals in northern, central, and southern Italy. 916 consecutive cases of newly diagnosed acute myocardial infarction and 1106 hospital controls admitted to hospital with acute conditions not related to known or suspected risk factors for coronary heart disease. Data were collected with a structured questionnaire and blood samples were taken by venepuncture as soon as possible after admission to hospital from cases and controls. Blood cholesterol concentrations were available for 614 cases and 792 controls. After adjustment by logistic regression for sex, age, education, geographical area, smoking status, body mass index, history of diabetes and hypertension, and family history of coronary heart disease the estimated relative risks of acute myocardial infarction for quintiles of serum cholesterol (from lowest to highest) were 2.3 (95% confidence interval (CI) 1.6 to 3.4), 3.1 (95% CI 2.1 to 4.6), 4.1 (95% CI 2.8 to 6.0), and 5.2 (95% CI 3.5 to 7.7). The estimated relative risk across selected covariates increased from the lowest to the highest quintile of serum cholesterol particularly for men, patients under 55 years of age, and smokers. When the possible interaction of known risk factors with serum cholesterol was examined, smoking habits, diabetes, and hypertension had approximately multiplicative effects on relative risk. This study indicates that serum cholesterol was an independent risk factor for acute myocardial infarction. This association was linear, with no threshold level. Moreover, there was a multiplicative effect between cholesterol and other major risk factors on the relative risk of acute myocardial infarction.

  6. Physical activity and the risk of acute myocardial infarction. GISSI-EFRIM Investigators. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto-Epidemiologia dei Fattori di Rischio dell'Infarto Miocardico.

    PubMed

    D'Avanzo, B; Santoro, L; La Vecchia, C; Maggioni, A; Nobili, A; Iacuitti, G; Franceschi, S

    1993-11-01

    The relationship between physical activity and acute myocardial infarction (AMI) was examined in a case-control study conducted in Italy in 1988 to 1989 within the framework of the GISSI-2 trial of streptokinase versus alteplase and heparin versus no heparin in the treatment of AMI. A total of 916 case patients admitted to coronary care units from various Italian regions for AMI were interviewed. Control subjects were 1106 patients admitted to the same network of hospitals for a broad spectrum of acute diseases not related to known or potential risk factors for myocardial infarction. Among various types of physical activity (occupational activity, walking, stair climbing, and sport and leisure-time physical activity), occupational physical exercise emerged as the most protective. Multivariate odds ratios (ORs) were 1.4 (95% confidence interval (CI), 1.0 to 2.0) and 1.6 (95% CI, 1.2 to 2.1) for the two lowest levels of occupational physical activity. The trends of increasing risk with decreasing activity were consistent, although less strong, when other types of activity were considered. The protection conveyed by occupational physical activity was similar across various strata of sex, age, education, smoking habits, and diabetes, and was not explained by serum cholesterol, body weight, or hypertension. This study therefore confirms that low physical activity is an indicator of subsequent risk of AMI.

  7. Cigarette smoking and acute myocardial infarction. A case-control study from the GISSI-2 trial. GISSI-EFRIM Investigators. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto--Epidemiologia dei Fattori di Rischio dell'infarto Miocardioco.

    PubMed

    Negri, E; La Vecchia, C; Nobili, A; D'Avanzo, B; Bechi, S

    1994-08-01

    To make a further quantitative assessment of the relationship between cigarette smoking and the risk of myocardial infarction, a multicentric case-control study was conducted in Italy between September 1988 and June 1989 within the framework of the GISSI-2 trial. Ninety hospitals in various Italian Regions participated. 916 cases of acute myocardial infarction with no history of ischaemic heart disease and 1106 controls admitted to hospital for acute conditions not related to known or suspected risk factors for ischaemic heart disease were studied. Relative risks (RR) and 95% confidence intervals (CI) of myocardial infarction according to various measures of tobacco smoking, were adjusted for identified potential confounding factors using multiple logistic regression. Compared to lifelong non-smokers, the RR was 1.3 (95% CI 1.0 to 1.9) for ex-smokers, 2.0 (95% CI 1.4 to 2.9) for current smokers of less than 15 cigarettes per day, 3.1 (95% CI 2.2 to 4.2) for 15-24 cigarettes per day and 4.9 (95% CI 3.4 to 7.1) for 25 or more cigarettes per day. No trend in risk was evident for the duration, the RR being around 3 for subsequent categories. There was a significant interaction between smoking and age. Below the age 45, smokers of 25 or more cigarettes per day had a 33 times higher risk than non-smokers, compared to 7.5 at in the age group 45-54, 4.4 between the ages 55-64 and 2.5 at the age of 65 or over. The risk estimates were higher in women (RR for > or = 25 cigarettes per day = 10.1), in subjects in the lowest cholesterol tertile (RR = 11.9), with no history of diabetes (RR = 6.8), hypertension (RR = 9.5), no family history ischaemic heart disease (RR = 9.1) and low body mass index (RR = 9.3). The importance of smoking is confirmed as a cause of acute myocardial infarction: about 50% of all nonfatal infarctions in this Italian population could be attributable to cigarette smoking.(ABSTRACT TRUNCATED AT 250 WORDS)

  8. Attributable risks for nonfatal myocardial infarction in Italy. GISSI-EFRIM investigators. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico. Epidemiologia dei Fattori di Rischio dell'Infarto Miocardico.

    PubMed

    Negri, E; La Vecchia, C; Franzosi, M G; Tognoni, G

    1995-11-01

    The proportions of nonfatal acute myocardial infarctions (AMI) in Italy attributable to cigarette smoking, body mass, serum cholesterol level, hypertension, diabetes, and family history of AMI (attributable risks, AR) were estimated using data from a case-control study on 614 incident cases of AMI before age 75 with no history of ischemic heart disease and 792 control subjects admitted to the same hospitals where cases were identified for acute, nonneoplastic, cardio- or cerebrovascular conditions not known or suspected to be related to cigarette smoking. The study was conducted between September 1988 and June 1989 within the framework of the GISSI-2 clinical trial. We assumed a multiplicative model and thus the risk attributable to several factors combined is not the sum of those attributable to the single factors. Overall the AR of smoking was 49%, and for cholesterol, body mass, family history of AMI, hypertension, and diabetes the AR were 49, 16, 14, 13, and 6%, respectively. Together these factors explained 85% of AMI cases. Though differences emerged for each single factor, the proportion of AMI explained by the six factors together was approximately the same for both sexes, while these factors accounted for 97% of AMI cases before age 50 (and smoking alone for 70%) and for 80% after age 50. This study confirms that interventions on well-defined risk factors could, in principle, lead to the avoidance of the great majority of myocardial infarctions in this population (i.e., about 80% before age 75 and about 95% before age 50).

  9. Coffee consumption and risk of acute myocardial infarction in Italian males. GISSI-EFRIM. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto, Epidemiologia dei Fattori di Rischio del'Infarto Miocardico.

    PubMed

    D'Avanzo, B; La Vecchia, C; Tognoni, G; Franceschi, S; Franzosi, M G; Nobili, A; Santoro, L; Scarsi, G

    1993-11-01

    The relationship between coffee consumption and acute myocardial infarction (AMI) was analyzed using data from a case-control study conducted in 1988 to 1989 within the framework of the GISSI-2 trial on streptokinase versus alteplase and heparin versus no heparin in the treatment of AMI. A total of 801 male patients with AMI and 792 control subjects who were hospitalized in several Italian regions for diseases unrelated to known or potential risk factors for cardiovascular diseases were included. Compared with coffee nondrinkers, the multivariate relative risks (RRs), after allowance for age, education, body mass index, smoking habits, alcohol consumption, family history of AMI, cholesterol level, history of diabetes, and hypertension, were 0.8 (95% confidence interval (CI), 0.5 to 1.2) for consumption of one cup/d, 1.3 (95% CI, 0.9 to 2.0) for two cups/d, 1.8 (95% CI, 1.1 to 2.7) for three cups, 2.5 (95% CI, 1.5 to 4.1) for four cups, and 2.6 (95% CI, 1.6 to 4.2) for five cups or more. The trend in risk with dose was statistically significant (P < 0.001). Duration of coffee consumption was not associated with the risk of AMI. The RRs for daily coffee consumption were elevated across strata of various covariates, including age, smoking habits, cholesterol level, diabetes, and hypertension, with a particularly elevated (although not significantly heterogeneous) estimate in patients younger than 50 years (RR, 5.7; 95% CI, 3.0 to 10.9 for four or more cups/d). The RR in patients who drank four or more cups of coffee per day and were current smokers was 8.1 (95% CI, 5.1 to 13.0), suggesting an unfavorable effect on the combination of cigarette smoking and high coffee intake on the risk of AMI.

  10. Frequency of consumption of selected indicator foods and serum cholesterol. GISSI-EFRIM investigators. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto--Epidemiologia dei Fattori di Rischio dell'Infarto Miocardico.

    PubMed

    D'Avanzo, B; Negri, E; Nobili, A; La Vecchia, C

    1995-06-01

    The relationship between frequency of consumption of eleven indicator foods (milk, meat, liver, carrots, green vegetables, fruit, eggs, ham, fish, cheese and alcohol) and serum cholesterol was investigated in the comparison group of a case-control study of acute myocardial infarction conducted in Italy. Data were collected on 792 subjects from various Italian regions, admitted to hospital for acute conditions unrelated to any known or potential risk factor for myocardial infarction or to long-term modifications in diet. No statistically or epidemiologically meaningful relationship emerged between serum cholesterol level and frequency of consumption of any of these foods. Cholesterol levels rose according to increasing consumption tertiles for most of the indicator foods considered. Higher values for the higher tertile of consumption were observed for meat, ham and eggs, but also for fruit, carrots and green vegetables. However, correlation coefficients between frequency of consumption of various food items and serum cholesterol level were uniformly low for all food items considered, ranging between -0.09 (for milk) and 0.19 (for ham). Although a more comprehensive diet history may lead to different indications, the present data are not suggestive of any major influence of long-term frequency of consumption of a few selected indicator foods on serum cholesterol levels.

  11. Acute myocardial infarction: association with time since stopping smoking in Italy. GISSI-EFRIM Investigators. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto. Epidemiologia dei Fattori di Rischio dell'Infarto Miocardico.

    PubMed

    Negri, E; La Vecchia, C; D'Avanzo, B; Nobili, A; La Malfa, R G

    1994-04-01

    The study aimed to investigate the relationship between years since stopping smoking and the risk of acute myocardial infarction. This was a hospital based, multicentre, case-control study conducted in Italy between September 1988 and June 1989 within the framework of the GISSI-2 clinical trial. Over 80 coronary care units in various Italian regions participated. A total of 916 incident cases of acute myocardial infarction, below age 75 years, and with no history of ischaemic heart disease, and 1106 control subjects admitted to the same hospitals for acute, non-neoplastic, cardiovascular or cerebrovascular conditions that were not known or suspected to be related to cigarette smoking took part in the study. Measures were relative risk (RR) estimates of acute myocardial infarction according to the time since stopping smoking and adjusted for identified potential confounding factors. Compared with never smokers, the multivariate RRs were 1.6 (95% confidence interval (CI) 0.8,3.2) for subjects who had given up smoking for one year; 1.4 (95% CI 0.9,2.1) for those who had stopped for two to five years; 1.2 (95% CI 0.7,2.1) for six to 10 years; and 1.1 (95% CI 0.8,1.8) for those who had not smoked for over 10 years. The estimated RR for current smokers was 2.9 (95% CI 2.2,3.9). The risks of quitters were higher for heavier smokers and those below age 50 years, while no difference emerged in relation to the duration of smoking, sex, and other risk factors for myocardial infarction. These results indicate that there is already a substantial drop in the risk of acute myocardial infarction one year after stopping. The risk in ex-smokers, however, seemed higher (although not significantly) than that of those who had never smoked, even more than 10 years after quitting. This could support the existence of at least two mechanisms linking cigarette smoking with acute myocardial infarction--one involving thrombogenesis or spasms that occurs over the short term, and another involving atherosclerosis that is a long term effect.

  12. Gemcitabine and cisplatin versus vinorelbine and cisplatin versus ifosfamide+gemcitabine followed by vinorelbine and cisplatin versus vinorelbine and cisplatin followed by ifosfamide and gemcitabine in stage IIIB-IV non small cell lung carcinoma: a prospective randomized phase III trial of the Gruppo Oncologico Italia Meridionale.

    PubMed

    Gebbia, Vittorio; Galetta, Domenico; Caruso, Michele; Verderame, Francesco; Pezzella, Giuseppe; Valdesi, Matteo; Borsellino, Nicolò; Pandolfo, Giuseppe; Durini, Ernesto; Rinaldi, Massimo; Loizzi, Michele; Gebbia, Nicola; Valenza, Roberto; Tirrito, Maria Lina; Varvara, Francesca; Colucci, Giuseppe

    2003-02-01

    we carried out a phase III randomized trial to compare vinorelbine-cisplatin regimen to gemcitabine-cisplatin regimen, and to a sequential administration of gemcitabine-ifosfamide followed by vinorelbine-cisplatin or the opposite sequence of vinorelbine-cisplatin followed by ifosfamide-gemcitabine according to the 'worst drug rule' hypothesis in patients with locally advanced unresectable stage IIIB or metastatic stage IV non-small cell lung cancer. The primary endpoint was survival parameters, while secondary endpoints included analysis of response rates and toxicity. patients were randomized to receive: (a) gemcitabine 1000 mg/m(2) on days 1, 8 and 15 plus ifosfamide 1500 mg/m(2) on days 8-12 with mesna uroprotection (GI regimen) followed by vinorelbine 25 mg/m(2) on days 1 and 8 plus cisplatin 100 mg/m(2) on day 1 (GI --> VC regimen); (b) the opposite sequence (VC --> GI); (c) vinorelbine plus cisplatin as above described (VC regimen); or (d) gemcitabine 1400 mg/m(2) on days 1 and 8 plus cisplatin 100 mg/m(2) on day 8 (GC regimen). All regimens were given every 4 weeks. All patients were chemotherapy naive and had a ECOG PS 0-2. 400 patients were enrolled into the trial. Interim analysis after inclusion of 243 patients showed that ORR were 19% in the GI --> VC arm, 32% in the inverse sequence arm (CV --> GI), 42% in the VC arm, and 30% in the GC arm. The VC arm was statistically superior over the GI --> VC arm (p = 0.0074), but not over the other regimens. Median TTP was 3.1 months in the GI --> VC arm versus 5.0 months in the VC --> GI arm (p = 0.014). For these reasons the GI --> VC and VC --> GI arm were closed since the 'worst drug rule' hypothesis was rejected. Accrual in the VC and GC arms continued up to 140 and 138 patients respectively. Final ORR were 44% for the VC regimen (4 CR), and 34% for the GC regimen (1 CR). This difference was statistically significant (p = 0.032). OS was 9.0 and 8.2 months, respectively, with no statistically significant difference. The 1-year survival rate was 24 and 20%, respectively for VC and GC regimens. As expected the incidence of phlebitis was higher in the VC arm, while thrombocytopenia, flu-like syndrome and asthenia were more frequent in the GC arm. the results of this trial indicate that the combination of vinorelbine and cisplatin and that of gemcitabine and cisplatin are equivalent in terms of median TTP and OS, although the vinorelbine-cisplatin regimen is associated with a higher ORR. Both regimens may be considered as reference treatments for future studies. Moreover, our data reject the 'worst drug rule' hypothesis of sequential treatments in NSCCL at least with the combination used in this study. Copyright 2002 Elsevier Science Ireland Ltd.

  13. Predicting poor peripheral blood stem cell collection in patients with multiple myeloma receiving pre-transplant induction therapy with novel agents and mobilized with cyclophosphamide plus granulocyte-colony stimulating factor: results from a Gruppo Italiano Malattie EMatologiche dell'Adulto Multiple Myeloma Working Party study.

    PubMed

    Musto, Pellegrino; Simeon, Vittorio; Grossi, Alberto; Gay, Francesca; Bringhen, Sara; Larocca, Alessandra; Guariglia, Roberto; Pietrantuono, Giuseppe; Villani, Oreste; D'Arena, Giovanni; Cuomo, Carmela; Musto, Clelia; Morabito, Fortunato; Petrucci, Maria Teresa; Offidani, Massimo; Zamagni, Elena; Tacchetti, Paola; Conticello, Concetta; Milone, Giuseppe; Palumbo, Antonio; Cavo, Michele; Boccadoro, Mario

    2015-04-17

    A still not well defined proportion of patients with multiple myeloma (MM) and eligible for autologous stem cell transplantation (AuSCT) fails to mobilize CD34+ peripheral blood stem cells (PBSC) at all or to collect an adequate number for a safe procedure or sufficient for multiple transplants. These so-called "poor-mobilizers" are difficult to be predicted, due to marked difference across previous heterogeneous studies. We aimed to develop a method based on simple clinical parameters for predicting unsuccessful (<2×10(6)/kg) or sub-optimal (<5×10(6)/kg) collections of CD34+ PBSC in newly diagnosed MM patients eligible for AuSCT, treated with novel agents and receiving an homogeneous mobilizing therapy with cyclophosphamide and granulocyte-colony stimulating factor (G-CSF). To this purpose, 1,348 patients enrolled in five consecutive Italian clinical trials were retrospectively analysed. Age, baseline low peripheral blood cell counts, use of lenalidomide, and haematological toxicity developed during induction were taken into account as possible factors associated with poor mobilization. Overall, 280 patients (20.8%) showed either sub-optimal (167 patients, 12.4%) or unsuccessful (113 patients, 8.4%) collections. All analysed parameters negatively influenced the procedure, but only age and haematological toxicity during induction maintained their significance at multivariate analysis. Based on ordinal logistic regression model, we constructed a risk heat-map where the four parameters were pooled and weighted according to their relevance as single or combined variables. This model was predictive for different probabilities of failure, suboptimal or optimal outcomes. We found that about one fifth of newly diagnosed MM fails to collect an adequate number of PBSC. Our model, based on a large group of patients treated frontline with novel agents and receiving the most popular mobilizing approach currently employed in Europe, is applicable in individual subjects and may contribute to the early identification of "poor mobilizer" phenotypes.

  14. Intensive consolidation therapy compared with standard consolidation and maintenance therapy for adults with acute myeloid leukaemia aged between 46 and 60 years: final results of the randomized phase III study (AML 8B) of the European Organization for Research and Treatment of Cancer (EORTC) and the Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) Leukemia Cooperative Groups.

    PubMed

    Hengeveld, Marysia; Suciu, Stefan; Karrasch, Matthias; Specchia, Giorgina; Marie, Jean-Pierre; Muus, Petra; Petti, Maria C; Rotoli, Bruno; Amadori, Sergio; Fioritoni, Guiseppe; Leoni, Pietro; Morra, Enrica; Thaler, Joseph; Resegotti, Luigi; Fazi, Paola; Vignetti, Marco; Mandelli, Franco; Zittoun, Robert; de Witte, Theo

    2012-06-01

    The most effective post-remission treatment to maintain complete remission (CR) in adults aged between 46 and 60 years with acute myeloid leukaemia (AML) is uncertain. Previously untreated patients with AML in CR after induction chemotherapy with daunorubicin and cytarabine were randomized between two intensive courses of consolidation therapy containing high-dose cytarabine, combined with amsacrine or daunorubicin and a standard consolidation and maintenance therapy containing standard dose cytarabine and daunorubicin. One hundred fifty-eight CR patients were assigned to the intensive group and 157 patients to the standard group. After a median follow-up of 7.5 years, the 4-year survival rate was 32 % in the intensive group versus 34 % in the standard group (P = 0.29). In the intensive group, the 4-year relapse incidence was lower than in the standard group: 55 and 75 %, respectively (P = 0.0003), whereas treatment-related mortality incidence was higher: 22 versus 3 % (P < 0.0001). Two intensive consolidation courses containing high-dose cytarabine as post-remission treatment in patients with AML aged between 46 and 60 years old did not translate in better long-term outcome despite a 20 % lower relapse incidence. Better supportive care and prevention of treatment-related complications may improve the overall survival after intensified post-remission therapy in this age group.

  15. Predicting outcome in the intensive care unit using scoring systems: is new better? A comparison of SAPS and SAPS II in a cohort of 1,393 patients. GiViTi Investigators (Gruppo Italiano per la Valutazione degli interventi in Terapia Intensiva). Simplified Acute Physiology Score.

    PubMed

    Bertolini, G; D'Amico, R; Apolone, G; Cattaneo, A; Ravizza, A; Iapichino, G; Brazzi, L; Melotti, R M

    1998-09-01

    This study sought to compare the performance of the old and new versions of the Simplified Acute Physiology Score, SAPS and SAPS II, in classifying patients according to the risk of hospital mortality. To compare the performance of the two systems, measures of association between the scores and observed mortality were adopted, together with discrimination (area under the Receiver Operating Characteristics curve) and calibration (goodness-of-fit statistics) estimates. Subjects were 1,393 eligible patients recruited during 1 month in 1994. The outcome measure was vital status at hospital discharge. SAPS II was associated more strongly with hospital mortality than the earlier version. SAPS II also had better discrimination ability than SAPS (area under Receiver Operating Characteristics curve 0.80 versus 0.74) and predicted an overall number of deaths (416.5) closer to the observed figure (475) than SAPS (267.7). Conversely, neither SAPS nor SAPS II fitted our data. Both P values derived from goodness-of-fit statistics were lower than 0.05. SAPS II offers a real improvement compared with SAPS in its ability to explain hospital mortality, but its standard parameters do not fit our data from Italy. The role and impact of potential determinants of this lack of fit, such as random errors and confounders related to casemix and/or quality of care should be clarified before this scoring system be used outside formal research projects. Special caution is suggested when SAPS II is adopted to predict mortality to compare intensive care unit performance across different countries and systems of care.

  16. Molecular remission in PML/RAR alpha-positive acute promyelocytic leukemia by combined all-trans retinoic acid and idarubicin (AIDA) therapy. Gruppo Italiano-Malattie Ematologiche Maligne dell'Adulto and Associazione Italiana di Ematologia ed Oncologia Pediatrica Cooperative Groups.

    PubMed

    Mandelli, F; Diverio, D; Avvisati, G; Luciano, A; Barbui, T; Bernasconi, C; Broccia, G; Cerri, R; Falda, M; Fioritoni, G; Leoni, F; Liso, V; Petti, M C; Rodeghiero, F; Saglio, G; Vegna, M L; Visani, G; Jehn, U; Willemze, R; Muus, P; Pelicci, P G; Biondi, A; Lo Coco, F

    1997-08-01

    Two hundred fifty-three patients with newly diagnosed acute promyelocytic leukemia (APL) were eligible to enter the multicentric GIMEMA-AIEOP "AIDA" trial during the period July 1993 to February 1996. As a mandatory prerequisite for eligibility, all patients had genetic evidence of the specific t(15;17) lesion in their leukemic cells confirmed by karyotyping or by reverse transcription-polymerase chain reaction (RT-PCR) of the PML/RAR alpha fusion gene (the latter available in 247 cases). Median age was 37.8 years (range, 2.2 to 73.9). Induction treatment consisted of oral all-trans retinoic acid (ATRA), 45 mg/m2/d until complete remission (CR), given with intravenous Idarubicin, 12 mg/m2/d on days 2, 4, 6, and 8. Three polychemotherapy cycles were given as consolidation. Hematologic and molecular response by RT-PCR was assessed after induction and after consolidation. At the time of analysis, 240 of the 253 eligible patients were evaluable for induction. Of these, 11 (5%) died of early complications and 229 (95%) achieved hematologic remission. No cases of resistant leukemia were observed. Of 139 cases studied by RT-PCR after induction, 84 (60.5%) were PCR-negative and 55 (39.5%) PCR-positive. One hundred sixty-two patients were evaluable by RT-PCR at the end of consolidation. Of these, 159 (98%) tested PCR-negative and 3 (2%), PCR-positive. After a median follow up of 12 months (range, 0 to 33), the estimated actuarial event-free survival for the whole series of 253 eligible patients was 83% +/- 2.6% and 79% +/- 3.2% at 1 and 2 years, respectively. This study indicates that the AIDA protocol is a well-tolerated regimen that induces molecular remission in almost all patients with PML/RAR alpha-positive APL. Preliminary survival data suggest that a remarkable cure rate can be obtained with this treatment.

  17. Adjuvant portal-vein infusion of fluorouracil and heparin in colorectal cancer: a randomised trial. European Organisation for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group, the Gruppo Interdisciplinare Valutazione Interventi in Oncologia, and the Japanese Foundation for Cancer Research.

    PubMed

    Rougier, P; Sahmoud, T; Nitti, D; Curran, D; Doci, R; De Waele, B; Nakajima, T; Rauschecker, H; Labianca, R; Pector, J C; Marsoni, S; Apolone, G; Lasser, P; Couvreur, M L; Wils, J

    1998-06-06

    There is conflicting evidence on the efficacy of regional adjuvant chemotherapy, via portal-vein infusion (PVI), after resection of colorectal cancer. We undertook a randomised controlled multicentre trial to investigate the efficacy of PVI (500 mg/m2 fluorouracil plus 5000 IU heparin daily for 7 days). 1235 of about 1500 potentially eligible patients were randomly assigned surgery plus PVI or surgery alone (control). The patients were followed up for a median of 63 months, with yearly screening for recurrent disease. The primary endpoint was survival; analyses were by intention to treat. 619 patients in the control group and 616 in the PVI group met eligibility criteria. 164 (26%) control-group patients and 173 (28%) PVI-group patients died. 5-year survival did not differ significantly between the groups (73 vs 72%; 95% Cl for difference -6 to 4). The control and PVI groups were also similar in terms of disease-free survival at 5 years (67 vs 65%) and the number of patients with liver metastases (79 vs 77%). PVI of fluorouracil, at a dose of 500 mg/m2 for 7 days, cannot be recommended as the sole adjuvant treatment for high-risk colorectal cancer after complete surgical excision. However, these results cannot eliminate a small benefit when PVI is used at a higher dosage or in combination with mitomycin.

  18. GIVIO-SITAC 01: A randomized trial of adjuvant 5-fluorouracil and folinic acid administered to patients with colon carcinoma--long term results and evaluation of the indicators of health-related quality of life. Gruppo Italiano Valutazione Interventi in Oncologia. Studio Italiano Terapia Adiuvante Colon.

    PubMed

    Zaniboni, A; Labianca, R; Marsoni, S; Torri, V; Mosconi, P; Grilli, R; Apolone, G; Cifani, S; Tinazzi, A

    1998-06-01

    In 1989, the authors began a randomized trial to determine whether 5-fluorouracil and high dose folinic acid (HD-FUFA) would increase the event free and overall survival of patients with resectable Dukes B and C (AJCC/UICC Stage II and Stage III) colon carcinoma, and to assess the toxicity of the treatment and its impact on selected health-related quality-of-life indicators. Early results were published as a part of an international multicenter pooled analysis (IMPACT) in 1995. The purpose of this report is to update the survival data for patients enrolled in the trial and describe their reported perceptions of their own health and quality of life. The trial involved multiple treatment centers, with a centralized randomization between surgery alone and surgery with chemotherapy. The HD-FUFA regimen employed consisted of 5-fluorouracil (370 mg/m2) plus folinic acid (200 mg/m2) administered daily for 5 days every 4 weeks for 6 cycles. Patients' perceptions of their own health status were obtained by means of 3 self-administered questionnaires, which were completed by patients at the time of discharge from the treatment center and at 6 and 24 months after randomization. Overall, 888 patients with resected Dukes B2 and C colon carcinoma were enrolled in the trial. HD-FUFA significantly reduced mortality by 25% (95% confidence interval, 5-41%; P=0.02) and events by 31% (95% confidence interval, 14-45%; P < or = 0.001). Compliance with treatment was good; more than 80% of patients completed the planned therapy. Toxicity was mild, and oral mucositis was the main side effect. None of the health-related quality-of-life parameters investigated (emotional status, worry about the future, changes in social life, impact of the disease, follow-up, and global quality of life) seemed to be affected by the treatment to which patients were allocated. A positive trend in the evolution of patients' psychologic status was observed. Long term results of this SITAC study confirm that HD-FUFA is a well-tolerated, effective 6-month adjuvant regimen for patients with colon carcinoma that has no detrimental effect on their quality of life.

  19. Gemtuzumab ozogamicin (Mylotarg) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups.

    PubMed

    Amadori, S; Suciu, S; Stasi, R; Willemze, R; Mandelli, F; Selleslag, D; Denzlinger, C; Muus, P; Stauder, R; Berneman, Z; Pruijt, J; Nobile, F; Cassibba, V; Marie, J-P; Beeldens, F; Baila, L; Vignetti, M; de Witte, T

    2005-10-01

    The therapeutic activity and toxicity profile of gemtuzumab ozogamicin were assessed in 40 patients >60 years of age with acute myeloid leukemia (AML) who were not considered eligible for conventional chemotherapy because of advanced age or poor performance status. The drug was administered at the dose of 9 mg/m2 as a single 2-h i.v. infusion on days 1 and 15. Patients who achieved a complete remission (CR/CRp) were to receive a consolidation with two additional injections of the immunotoxin at the same dose. The overall CR/CRp rate was 17% (95% CI, 8-32%). The CR/CRp rate in patients 61-75 years old was 33% (6/18), and 5% (1/22) in patients older than 75 years. Induction death occurred in seven patients (17%), all aged above 75 years. Overall survival was significantly longer in patients aged 61-75 years than in older individuals (P=0.05), and in CD33+ cases than in CD33- cases (P=0.05). We conclude that the dose/schedule of gemtuzumab ozogamicin used in this trial is too toxic in the age group over 75 years. For these patients, additional studies with reduced doses of the immunotoxin are warranted.

  20. The protective effect of melatonin on remote organ liver ischemia and reperfusion injury following aortic clamping.

    PubMed

    Ozsoy, Mustafa; Gonul, Yucel; Ozkececi, Ziya Taner; Bali, Ahmet; Celep, Ruchan Bahadir; Koçak, Ahmet; Adali, Fahri; Tosun, Murat; Celik, Sefa

    2016-01-01

    Dopo il ripristino della circolazione sanguigna e dell’ossigenazione possono verificarsi gravi danni locali e sistemici ai tessuti temporaneamente ischemici, noti come danni da riperfusione. Lo scopo di questo studio è stato quello di indagare sui possibili effetti protettivi della melatonina nei confronti dei danni sistemici da riperfuzione nel tessuto epatico a seguito dell’occlusione dell’aorta sottorenale. Per questo studio sono stati impiegati un totale di 21 ratti Wistar-albini di sesso maschile, suddivisi in tre gruppi: I gruppo – laparotomia e contemporanea dissezione dell’aorta infrarenale; II gruppo – somministrazione intraperitoneale di circa 1 ml di fisiologica al 0,9% di NaCl 30’ prima e dopo l’operazione di occlusione. Dopo la laparotomia e sua dissezione, l’aorta sottorenale è clampata per 30’ e quindi riabitata al circolo di riperfusione per 2 ore; III gruppo – 30’ prima del clampaggio dell’aorta sottorenale è stata somministrata la malatonina, seguita dal clampaggio aortico per 30’ e un periodo di riperfusione di 2 ore. Sono stati quindi dosati i tassi sierici di aspartate aminotransferasi, alanine aminotransferasi, and lattato dehydrogenase, risultati significativamente più elevate nei gruppi II e III rispetto al gruppo I di controllo. Gli esami di laboratorio sono tornati ai livelli normali nel III gruppo dopo il trattamento. Sebbene si sia avuto un decremento del tasso sierico di IL-1β, IL-6, IL-18, TNF-α, e IFN- γ nel gruppo trattato con melatonina, questo decremento ha assunto valore statisticamente significativo per i livelli sierici di IL- 18, TNF-α, e IFN- γ in paragone con quanto osservato nel II gruppo. I tassi sierici dello stato totale di antiossidanti tissutali (TOC) e dell’indice di stress ossidativo dei tessuti (OSI) sono risultati diminuiti e quelli della capacità antiossidante (TAC) risultano accresciuti dalla melatonina. Il risultato di questo studio suggerisce effetti antiossidanti della

  1. Sonographic examination of epiaortic vessels in patients with peripheral vertigo.

    PubMed

    Salvaggio, G; Gargano, R; Campisi, A; Cantisani, V; Ricci, P; Gallina, S; Midiri, M; Caruso, G

    2010-09-01

    Sommario INTRODUZIONE: Valutare l’utilità dell’eco-color Doppler (CDU) dei vasi epiaortici nei pazienti con vertigine periferica da causa sconosciuta. MATERAILI E METODI: Centocinquantasei pazienti (gruppo studio; 42 uomini e 114 donne; età media 61,86 ± 14,14) e 161 pazienti (gruppo controllo; 80 uomini e 81 donne; età media 62,31 ± 13,69) sono stati sottoposti a CDU dei vasi epiaortici. Sono stati valutati i seguenti parametri: presenza di placche ateromasiche a livello dell’arteria carotide (CA) comune e/o interna; spessore medio intimale (IMT) della CA comune; picco di velocità sistolica (PSV) e indice di resistenza (RI) a livello delle arterie vertebrali (VA).Sono stati utilizzati test parametrici (T-test) e non parametrici (Mann–Whitney U-test e Kolmogorov–Smirnov test). È stata eseguita un’analisi di regressione logistica per fornire un odds ratio indice di grandezza del rischio di vertigine. Sono state considerate variabili indipendenti (età, sesso), fattori di rischio vascolare (ipercolesterolemia, diabete, ipertensione) e variabili CDU (IMT, placche, PSV e RI). RISULTATI: Placche ed IMT > 1 mm sono stati trovati in 31 (19,8%) e 98 (62,8%) pazienti del gruppo di studio e in 43 (26,7%) e 125 (77,6%) pazienti del gruppo controllo. I test statistici, applicati a PSV e RI, non hanno dimostrato differenze significative (p-valore > 0,05). Alla regressione logistica le vertigini sono risultate associate ad età, sesso, ipercolesterolemia, diabete, ipertensione e IMT (p < 0,01), mentre placche, PSV ed RI non erano fattori significativi (p > 0,05). DISCUSSIONE: IMT è la sola variabile CDU significativamente associata alla vertigine, specialmente nelle classi di età inferiore (35-45 e 45-55) del gruppo studio.

  2. Soft dynamics and transverse momenta in QCD

    NASA Astrophysics Data System (ADS)

    Trentadue, L.

    1987-03-01

    We analyze transverse momentum distributions in QCD. We focus on the small and intermediate transverse momentum range where the form factor represents a universal quantity. The relation between the shape of the distributions and the underlying theory is emphasized. Results from analytical and numerical analyses are compared. On leave of absence from Dipartimento di Fisica, Università di Parma, Parma, Italy and Istituto Nazionale di Fisica Nucleare, Gruppo Collegato di Parma, Sezione di Milano, Milan, Italy.

  3. JPRS Report, West Europe, Reference Aid, Glossary of Acronyms and Abbreviations of Italy

    DTIC Science & Technology

    1989-01-27

    Magnetico dgm.oc dragamine oceanico D.G.P.C. Direzione Generale Personale Civile D.G.P.U. Direzione Generale Personale Ufficiali D.G.S. Direzione...d’armata G.A. Giunta Amministrativa Gab. Gabinetto G.A.D. Gruppo d’Arte Drammatica G a F. guardia alia frontiera GAF guardia di finanza gall...comando) genio di divisione di fanteria G.d.F. Guardia di Finanza GDT heavy (caliber) coastal patrol boat corps engineer headquarters

  4. [Attenzione per i dettagli in genitori di nazionalità italiana di donne affette da anoressia nervosa: uno studio comparativo].

    PubMed

    Chinello, Alessandro; Zappa, Luigi; Pastori, Miriam; Crocamo, Cristina; Ricciardelli, Paola; Clerici, Massimo; Carrà, Giuseppe

    2017-01-01

    RIASSUNTO. Scopo. È noto come l'anoressia nervosa (AN) e il disturbo dello spetto autistico (ASD) condividano alcuni tratti, come la rigidità mentale e l'attenzione per i dettagli, che potrebbero essere diffusi a livello familiare. Questo studio ha lo scopo di confrontare la distribuzione di tratti autistici in genitori con figlie affette da disturbo alimentare ED (anoressia - AN o bulimia nervosa - BN) con genitori appartenenti a un gruppo di controllo. Metodi. Sono stati coinvolti 40 genitori con figlie affette da disturbo alimentare (60% con anoressia, 40% con bulimia nervosa) e 33 genitori di controllo. Tutti i genitori hanno compilato questionari specifici riguardanti il quoziente di spettro autistico (AQ) e le stime cognitive (CET). Inoltre, sono stati somministrati EAT-26 e SCL-90-R al fine di escludere la presenza di disturbi psichiatrici o alimentari nel gruppo sperimentale. Risultati. Le analisi su AQ mostrano una differenza tra i due gruppi per un tratto autistico specifico, evidenziando una riduzione significativa dell'attenzione per i dettagli nel gruppo sperimentale (ED), in particolare nei genitori di figlie affette da AN. Discussione. Questi dati suggeriscono una preferenza per un'elaborazione globale delle informazioni nei genitori AN in contrasto a quanto trovato in pazienti con AN. La presenza di aspetti depressivi, ansiosi e di disturbi alimentari è stata esclusa nei genitori nel gruppo sperimentale tramite SCL-90-R e EAT-26. Infine, la capacità di prendere decisioni, misurata dal CET, è stata esclusa dalle nostre analisi. Conclusione. Nei genitori con figlie affette da AN emerge una peculiare preferenza per un'elaborazione cognitiva globale, suggerendo il ruolo dell'attenzione per i dettagli come nuovo fattore da considerare nelle valutazione cliniche di pazienti con AN e nei loro familiari. Considerando i limiti dello studio, ulteriori approfondimenti in merito sono necessari.

  5. Autologous bone grafting with platelet-rich plasma for alveolar cleft repair in patient with cleft and palate.

    PubMed

    Giudice, Giuseppe; Cutrignelli, Daniela Anna; Leuzzi, Sara; Robusto, Fabio; Sportelli, Pasquale; Nacchiero, Eleonora

    2016-01-01

    L’innesto osseo è essenziale nella terapia chirurgica della labiopalatoschisi (LPS), ma i tempi di osteogenesi ed integrazione ossea nella sede ricevente possono procrastinare i successivi interventi di ortodonzia. Nel nostro studio è stata valutata la capacità della PRP (platelet-rich plasma) associata al trapianto osseo nel diminuire il tempo d’attesa e la durata del trattamento ortodontico in una coorte di 8 bambini, confrontandola con 8 controlli sottoposti a semplice innesto osseo. I risultati hanno mostrato come i soggetti sottoposti a trapianto osseo + PRP abbiano avuto la possibilità di essere sottoposti ad un trattamento ortodontico più precoce (155 giorni vs 298) e più breve (295 giorni vs 356) rispetto al gruppo di controllo. Inoltre nel gruppo di controllo si sono verificate con maggiore frequenza complicanze post-chirurgiche (quali fistole oro-nasali, disturbi periodontali, malattie dentali, perdita di spessore, massa o trabecolatura ossea) rispetto al gruppo sottoposto a PRP. Perciò l’associazione della PRP (platelet-rich plasma) al trapianto osseo è una metodica che sembra associarsi ad una diminuzione statisticamente significativa dei tempi di integrazione ossea nei pazienti affetti da LPS, con conseguente anticipazione della ortodonzia e miglioramento degli outcome chirurgici.

  6. Comparison of multiple training models of surgical rotation for third-year medical students A prospective study.

    PubMed

    Magistri, Paolo; Nigri, Giuseppe; Petrucciani, Niccolò; Aurello, Paolo; D'Angelo, Francesco; Ramacciato, Giovanni

    2016-01-01

    Considerata la necessità di elaborare un sistema di rotazione nei reparti di Chirurgia che venga incontro alle necessità degli studenti, abbiamo ideato questo studio prospettico presso la Facoltà di Medicina e Psicologia di “Sapienza, Università di Roma”. Nella nostra Istituzione, gli studenti del terzo anno del corso di laurea di Medicina e Psicologia trascorrono un periodo di 2 mesi presso il reparto di Chirurgia Generale per prepararsi all’esame di Semeiotica Medico-Chirurgica. Spesso i feedback di tale esperienza riportano una certa insoddisfazione, soprattutto per la scarsità dell’attività pratica al letto del paziente. Pertanto, abbiamo deciso di confrontare cinque modelli per stabilire il migliore approccio in termini di apprendimento e soddisfazione degli studenti. 28 studenti sono stati coinvolti nello studio e divisi in cinque gruppi (da A ad E). Il Gruppo A ha eseguito una rotazione standard così come prevista dall’ordine degli studi, 5 accessi in reparto seguiti dal proprio tutor. Gli studenti del gruppo B hanno frequentato il reparto una volta la settimana, arrivando dopo la visita della mattina, trascorrendo un’ora con il tutor ed il resto della mattina con gli specializzandi. Il gruppo C è stato diviso in piccoli gruppi, ciascuno assegnato per 2 volte all’ambulatorio chirurgico, 2 volte in reparto (standard) e 2 volte al servizio di preospedalizzazione. Gli studenti del gruppo D hanno frequentato il reparto una volta la settimana arrivando la mattina presto, trascorrendo 2 ore con il tutor ed il resto della mattina con gli specializzandi. Il gruppo E è stato diviso in 2 gruppi, ciascuno assegnato 3 volte al reparto (standard) e 3 volte alla sala operatoria. Ciascuno studente ha completato un questionario con 20 item di semeiotica all’inizio ed alla fine dello studio per valutare la progressione dell’apprendimento, ed un questionario finale di valutazione della soddisfazione. I risultati hanno dimostrato come tutti i gruppi

  7. Biological and clinical outcomes in the elderly with left ventricular dysfunction: Are there differences between on-pump and off-pump coronary artery bypass grafting?

    PubMed

    Concistrè, Giovanni; Dell'Aquila, Angelo Maria; Piccardo, Alessandro; Pansini, Stefano; Gargiulo, Raffaele; Gallo, Alina; Merlanti, Bruno; Passerone, Giancarlo; Regesta, Tommaso

    2015-01-01

    Il nostro studio ha lo scopo di confrontare gli eventi clinici ed i dati laboratoristici postoperatori di pazienti anziani coronaropatici con disfunzione ventricolare sinistra, sottoposti a rivascolarizzazione miocardica chirurgica eseguita con o senza ausilio della circolazione extracorporea. Studi recenti hanno evidenziato i vantaggi dell’intervento a cuore battente nei pazienti anziani, riportando una riduzione della morbidità postoperatoria e della disfunzione di organo. Tuttavia questi studi non analizzano l’impatto della disfunzione ventricolare sinistra sugli eventi postoperatori precoci e tardivi nei pazienti ad alto rischio. Abbiamo esaminato retrospettivamente 90 pazienti di età superiore ai 75 anni, con frazione di eiezione preoperatoria < 50%, sottoposti a bypass aortocoronarico, senza altre procedure cardiochirurgiche associate, tra Gennaio 2000 e Luglio 2009 presso il nostro Centro. I pazienti sono stati divisi in 2 gruppi: pazienti operati senza ausilio della circolazione extracorporea (a cuore battente) e pazienti operati con l’ausilio della circolazione extracorporea (a cuore fermo). Abbiamo confrontato I livelli sierici postoperatori degli enzimi CK, CK-MB e troponina T, indici di danno miocardico, e gli eventi cerebrovascolari. La mortalità intraospedaliera totale era del 2% (2 pazienti su 90) e simile in entrambi i gruppi (p=0.8336). I livelli medi di troponina T a 6, 24, 48 ore dopo l’intervento erano significativamente più bassi nei pazienti operati a cuore battente (p=0.0001; p=0.0021; p=0.0070). Non c’era una differenza statisticamente significativa nei 2 gruppi in termini di sopravvivenza (p=0.0764) e di eventi cerebrovascolari (p=0.3016) nell’immediato postoperatorio ed a 10 anni. I nostri risultati dunque mostrano che il non utilizzo della circolazione extracorporea nei pazienti ad alto rischio determinerebbe una più bassa incidenza di danno miocardico; tuttavia ciò sembra non influenzare a lungo termine la sopravvivenza

  8. France, Italy and the 2002/2003 Iraq Crisis

    DTIC Science & Technology

    2004-09-01

    13 September 2002. “In questo momento la principale sfida all’Onu e al nostro sistema di valori e di principi è portata dal regime che governa l’Iraq...GovernoInforma.index.html 18 Prime Minister Berlusconi speaks to the House of Deputies, 25 September 2002. “D’altra parte, sul fatto che il regime politico iracheno...coraggio in quello sforzo politico , diplomatico e militare che i nudi fatti, guardati senza fanatismo ma anzi con freddezze, ci impongono come un

  9. Bio-Engineering tissue and V.A.C. therapy: A new method for the treatment of extensive necrotizing infection in the diabetic foot.

    PubMed

    Armenio, Andrea; Cutrignelli, Daniela Anna; Nardulli, Maria Luisa; Maggio, Giulio; Memeo, Giuseppe; De Santis, Valerio; Giudice, Giuseppe; Ressa, Cosmo Maurizio

    2016-12-06

    La prevalenza mondiale del diabete nel 2000 è stata stimata essere del 2.8% con una previsione del 4.4% nel 2030. A causa della neuropatia e dei processi ischemici che ne derivano, i pazienti diabetici sono purtroppo predisposti all’insorgenza di infezioni a carico del piede con un rischio di amputazione molto elevato. A tal proposito, un trattamento rapido ed efficace del processo necrotizzante impedirebbe complicanze maggiori e la stessa amputazione. Il nostro studio consiste in un’analisi retrospettiva condotta su 20 pazienti atta a valutare l’efficacia del sostituto dermico autologo bioingegnerizzato (Hyalograft 3D Autograft) in associazione alla V.A.C (vacuum assisted closure) Therapy per il trattamento delle ulcere diabetiche, rispetto ai metodi sinora impiegati. I pazienti selezionati, a seconda del trattamento eseguito, sono stati suddivisi in due gruppi omogenei di dieci pazienti ciascuno. Il gruppo controllo è stato trattato con il metodo standard, ovvero con debridment chirurgico e innesti cutanei autologhi, mentre il gruppo studio è stato trattato con il metodo in analisi. La raccolta dei dati ha suggerito come l’impiego combinato del sostituto dermico bioingegnerizzato e della pressione negativa determini, rispetto al gruppo controllo, un aumento della percentuale di guarigione, una riduzione del tasso di recidiva di lesioni anche estese e una maggiore ripresa della deambulazione autonoma. In conclusione, la nostra analisi ha evidenziato un metodo sicuro, affidabile e competitivo per il trattamento di ampie lesioni necrotizzanti del piede diabetico. Anche se ulteriori valutazioni sono necessarie, crediamo fortemente che l’associazione del derma bioingegnerizzato e della pressione negativa possa condurre ad una rapida ed efficace guarigione delle ulcere, migliorando la qualità della vita del paziente diabetico.

  10. [Efficacy of educational intervention for patients wearing peripherall inserted central catheter. A pilot study].

    PubMed

    Fusco, Federica; Armando, Tiziana; Storto, Silvana; Mussa, Maria Valentina

    2016-01-01

    Introduzione: Il Peripherally Inserted Central Catheter (PICC) è un catetere venoso centrale adatto per pazienti in regime di Day Hospital. Il suo utilizzo è considerato vantaggioso ma comporta degli oneri di gestione a carico della persona. E' bene formare il paziente ad una corretta gestione domiciliare del presidio attraverso un'educazione strutturata. Obiettivo: In un gruppo di pazienti portatori di PICC, valutare l'efficacia di un intervento educativo mirato attraverso la comparazione di: colloquio informativo, opuscolo cartaceo, video informativo. Metodo: Studio clinico randomizzato e controllato monocentrico, schema comparativo semplice a tre bracci. Popolazione: tutti i pazienti sottoposti all'impianto di PICC nel periodo di osservazione tra Ottobre 2013 e Febbraio 2014 presso l'Unità Operativa Day Hospital Oncologico e Breast Unit, presidio Molinette di Torino. L'intervento educativo standard è erogato attraverso un colloquio con l'infermiere che esegue l'impianto. Il team di impiantatori è costituito da due infermieri con comprovata esperienza in ambito oncologico ed in possesso di Master di I Livello "Gestione degli accessi venosi". I pazienti eleggibili, dopo randomizzazione, sono stati divisi in tre gruppi: gruppo A colloquio informativo; gruppo B opuscolo; gruppo C video. I pazienti dei gruppi B e C hanno ricevuto informazioni standard inte- grate con informazioni audiovisive oppure cartacee, in base al braccio al quale erano stati destinati; il grado di conoscenza raggiunto è stato indagato attraverso la somministrazione di questionari costruiti ad hoc, non vali- dati in quanto non presenti in letteratura. Risultati: Adesione allo studio di 40 pazienti, campione di convenienza costituito da persone di età compresa tra 18 e 75 anni, consenzienti e risiedenti al proprio domicilio. L'analisi delle conoscenze apprese in seguito all'intervento educativo mostra una differenza statisticamente significativa in diversi ambiti necessari per la

  11. [Model of chemical risk assessment (D.L 25/2002), applied in 19 chemical industries of the Province of Bergamo].

    PubMed

    Santini, M; Leghissa, P; Riva, M M; Rosso, G L; Deleidi, G; Mosconi, G

    2007-01-01

    The aim of this work is to describe a model for the evaluation of chemical risk, according to the legislative decree 25/2002, planned by U.O.O.M.L. "Ospedali Riuniti di Bergamo", in collaboration with "Gruppo Industriali Chimici dell'Unione Industriali-Provincia di Bergamo" and applied in 19 Chemical Industries of the Province of Bergamo. The objective of the model is the rationalization of the procedures to ponder the levels of exposure and to value different typologies of risk using and manipulating chemical substances with the purpose to optimize the relationship among the attention for safety, workers health and the employment of resources.

  12. Successful use of rFVIIa for major breast surgery prophylaxis in congenital factor VII deficiency.

    PubMed

    Varricchio, Antonio; Schettino, Michela; Ciampa, Antonio; Iannace, Carlo; Lo Conte, Domenico; Donnarumma, Bernadette; Vigorito, Raffaella; Lepore, Mariolina

    2014-06-24

    emorragiche. In questo articolo descriviamo un caso di una paziente di 46 anni con deficit congenito del fattore VII che si è sottoposta a trattamento chirurgico con successo grazie al trattamento con Novoseven prima della procedura. È stato utilizzato il modello riportato sotto per valutare i livelli di PTT e aPTT nel paziente. Per il prelievo ematico il sangue venoso della paziente è stato raccolto in provette di plastica (0.129 M di citrato di sodio, con sistema Vacutainer). Il tempo di protrombina è stato misurato con Recombiplastin (IL, Milano Italy), l’aPTT è stato misurato con l’APTT-SP (IL, Milano Italy). Come primo approccio profilattico alla paziente è stata utilizzata la vitamina K intramuscolo ma con scarsi risultati, poi si è valutato l’uso del Prothromplex, senza però ottenere un effetto significativo. L’ultimo step è stata la somministrazione di una terapia con Novoseven ® 15μg/kg somministrato 30 minuti prima dell’intervento and 4-5 h dopo la prima infusione. L’infusione del farmaco ha risolto i problemi di coagulazione permettendo il trattamento chirurgico, senza rischio nè emorragico nè trombotico per la paziente.

  13. Long waiting lists and health care spending The example of cholecystectomy.

    PubMed

    Palmisano, Silvia; Benvenuto, Chiara; Casagranda, Biagio; Dobrinja, Chiara; Piccinni, Giuseppe; de Manzini, Nicolò

    2014-05-05

    Lo scopo dello studio è stato valutare l’incidenza di complicanze correlate alla calcolosi della colecisti in pazienti in lista d’attesa per l’intervento di colecistectomia e quantificare le implicazioni economiche di quest’attesa in termini di costi sanitari relativi agli esami ematochimici, strumentali, alla degenza, all’intervento chirurgico e alle terapie somministrate. La popolazione oggetto dello studio è stata di 86 pazienti, 39 uomini e 47 donne, inseriti in lista d’attesa per intervento chirurgico di colecistectomia in un periodo compreso fra aprile 2007 e aprile 2010. Di tali pazienti sono stati raccolti dati anagrafici, la durata del tempo d’attesa, dettagli sugli accessi in PS ed eventuali ricoveri durante l’attesa, esami e terapie eseguite, il tipo di intervento chirurgico effettuato e i giorni di degenza. È stato fatto uno studio comparativo di natura economica tra tre gruppi di pazienti: A: asintomatici durante l’attesa, B: complicati ma non operati in urgenza, C: complicati e operati in regime d’urgenza. Utilizzando il tariffario regionale delle prestazioni di assistenza specialistica ambulatoriale e quello delle prestazioni di assistenza ospedaliera per acuti erogate in regime di ricovero diurno abbiamo stimato che un singolo paziente complicato ma non operato in regime d’urgenza abbia determinato un ingente spesa per il sistema sanitario ( gruppo B: circa 3513,2 €) circa 1.9 volte in più se paragonata a un paziente che durante l’attesa non abbia sviluppato complicanze ( gruppo A: circa 1.849,4 €) o 1.36 volte in più di un paziente precocemente operato in regime d’urgenza (gruppo c: circa 2.584,6 €). Nel nostro limitato, ma a nostro parere esplicativo, campione abbiamo stimato i costi specifici legati alla lunghezza delle liste d’attesa pari a circa 26.112 €. In questo periodo di crisi economica, che ha portato numerosi tagli anche al sistema sanitario, questo significativo ammontare di denaro, a nostro

  14. Long waiting lists and health care spending The example of cholecystectomy.

    PubMed

    Palmisano, Silvia; Benvenuto, Chiara; Casagranda, Biagio; Dobrinja, Chiara; Piccinni, Giuseppe; de Manzini, Nicolò

    2015-01-01

    Lo scopo dello studio è stato valutare l’incidenza di complicanze correlate alla calcolosi della colecisti in pazienti in lista d’attesa per l’intervento di colecistectomia e quantificare le implicazioni economiche di quest’attesa in termini di costi sanitari relativi agli esami ematochimici, strumentali, alla degenza, all’intervento chirurgico e alle terapie somministrate. La popolazione oggetto dello studio è stata di 86 pazienti, 39 uomini e 47 donne, inseriti in lista d’attesa per intervento chirurgico di colecistectomia in un periodo compreso fra aprile 2007 e aprile 2010. Di tali pazienti sono stati raccolti dati anagrafici, la durata del tempo d’attesa, dettagli sugli accessi in PS ed eventuali ricoveri durante l’attesa, esami e terapie eseguite, il tipo di intervento chirurgico effettuato e i giorni di degenza. È stato fatto uno studio comparativo di natura economica tra tre gruppi di pazienti: A: asintomatici durante l’attesa, B: complicati ma non operati in urgenza, C: complicati e operati in regime d’urgenza. Utilizzando il tariffario regionale delle prestazioni di assistenza specialistica ambulatoriale e quello delle prestazioni di assistenza ospedaliera per acuti erogate in regime di ricovero diurno abbiamo stimato che un singolo paziente complicato ma non operato in regime d’urgenza abbia determinato un ingente spesa per il sistema sanitario ( gruppo B: circa 3513,2 €) circa 1.9 volte in più se paragonata a un paziente che durante l’attesa non abbia sviluppato complicanze ( gruppo A: circa 1.849,4 €) o 1.36 volte in più di un paziente precocemente operato in regime d’urgenza (gruppo c: circa 2.584,6 €). Nel nostro limitato, ma a nostro parere esplicativo, campione abbiamo stimato i costi specifici legati alla lunghezza delle liste d’attesa pari a circa 26.112 €. In questo periodo di crisi economica, che ha portato numerosi tagli anche al sistema sanitario, questo significativo ammontare di denaro, a nostro

  15. Long waiting lists and health care spending: the example of cholecystectomy.

    PubMed

    Palmisano, Silvia; Benvenuto, Chiara; Casagranda, Biagio; Dobrinja, Chiara; Piccinni, Giuseppe; de Manzini, Nicolò

    2014-03-28

    Lo scopo dello studio è stato valutare l’incidenza di complicanze correlate alla calcolosi della colecisti in pazienti in lista d’attesa per l’intervento di colecistectomia e quantificare le implicazioni economiche di quest’attesa in termini di costi sanitari relativi agli esami ematochimici, strumentali, alla degenza, all’intervento chirurgico e alle terapie somministrate. La popolazione oggetto dello studio è stata di 86 pazienti, 39 uomini e 47 donne, inseriti in lista d’attesa per intervento chirurgico di colecistectomia in un periodo compreso fra aprile 2007 e aprile 2010. Di tali pazienti sono stati raccolti dati anagrafici, la durata del tempo d’attesa, dettagli sugli accessi in PS ed eventuali ricoveri durante l’attesa, esami e terapie eseguite, il tipo di intervento chirurgico effettuato e i giorni di degenza. È stato fatto uno studio comparativo di natura economica tra tre gruppi di pazienti: A: asintomatici durante l’attesa, B: complicati ma non operati in urgenza, C: complicati e operati in regime d’urgenza. Utilizzando il tariffario regionale delle prestazioni di assistenza specialistica ambulatoriale e quello delle prestazioni di assistenza ospedaliera per acuti erogate in regime di ricovero diurno abbiamo stimato che un singolo paziente complicato ma non operato in regime d’urgenza abbia determinato un ingente spesa per il sistema sanitario ( gruppo B: circa 3513,2 €) circa 1.9 volte in più se paragonata a un paziente che durante l’attesa non abbia sviluppato complicanze ( gruppo A: circa 1.849,4 €) o 1.36 volte in più di un paziente precocemente operato in regime d’urgenza (gruppo c: circa 2.584,6 €). Nel nostro limitato, ma a nostro parere esplicativo, campione abbiamo stimato i costi specifici legati alla lunghezza delle liste d’attesa pari a circa 26.112 €. In questo periodo di crisi economica, che ha portato numerosi tagli anche al sistema sanitario, questo significativo ammontare di denaro, a nostro

  16. Case report: Inflammatory myofibroblastic tumor of pancreatic origin in a patient with down syndrome: The role of diagnostic ultrasound.

    PubMed

    Colangelo, M; Di Renzo, D; Persico, A; Chiesa, P Lelli

    2011-03-01

    Sommario INTRODUZIONE: Il tumore miofibroblastico infiammatorio (TIM) è un tumore solido benigno, di incerta eziologia. MATERIALI E METODI: Riportiamo un case-report di un bambino (4 anni, sindrome di Down), con massa pancreatica identificata all’ultrasonografia (US) e confermata da TC. RISULTATI: Il monitoraggio del TIM è stato effettuato con US seriate. Il follow-up a 4 anni dalla diagnosi è senza recidive. DISCUSSIONE: Il paziente, data l’impossibilità dell’exeresi chirurgica radicale, è stato trattato con successo con terapia medica (FANS). Abbiamo deciso di monitorizzare la lesione con ultrasonografie seriate, riducendo il numero di esami TC ai quali il paziente avrebbe dovuto sottoporsi, evitando così l’esposizione a radiazioni ionizzanti. La letteratura, infatti, riporta ampiamente come l’esecuzione di ripetuti esami TC si accompagni ad una importante radioesposizione con conseguente rischio cancerogeno, dato assolutamente non trascurabile in età pediatrica.

  17. Penetrating cardiac injuries. Two case reports.

    PubMed

    Castriconi, Maurizio; Festa, Patrizio; Bartone, Giovanni; Maglio, Mauro Domenico Natale; Vicenzo, Luciano; Papaleo, Domenico; Severino, Beatrice Ulloa; Clemente, Marco; Martino, Antonio

    2013-04-24

    Presentiamo in questo breve lavoro due casi di ferita penetrante cardiaca in giovani pazienti di sesso maschile trattati chirurgicamente presso il trauma center dell’A.O.R.N. A. Cardarelli di Napoli. La peculiarità di entrambi i casi, più che nel trattamento chirurgico, che segue i canoni prescritti dalla letteratura internazionale, è nel timing. Entrambi I giovani,infatti, hanno ricevuto le prime cure in ospedali periferici per poi essere trasferiti nel nostro centro, lasciando che le cure del caso fossero differite di ore rispetto a ciò che ci si auspica in certi casi. Nonostante ciò i pazienti superano brillantemente l’intervento e vengono dimessi senza sequele. Per completare la discussione dei casi presentiamo una revisione della letteratura a riguardo dal 1986 al 2012.

  18. Bilobate wandering spleen with doble torsion of the vascular pedicle. A case report.

    PubMed

    Barra, Sossio; Lepore, Renata; Cappabianca, Adele; Barra, Floriana

    2017-03-08

    Il trattamento della torsione del peduncolo di milza migrante è generalmente di tipo conservativo e consiste nella splenopessia,la splenectomia è indicata nei casi complicati da ischemia irreversibile dell’organo. Nel caso in oggetto si tratta di un donna adulta che giunge due volte alla nostra osservazione. Al primo accesso in Pronto Soccorso la donna lamenta dolore epigastrico a sbarra che si irradia in regione dorsale da alcuni giorni, alvo regolare non vomito. Addome trattabile dolente all’epigastrio, assenza di masse patologiche palpabili. Sottoposta ad esame radiografico di diretta addome ed esame ecografico dell’addome completo, si reperta l’assenza di milza nella sua sede anatomica e la presenza di essa in fossa iliaca sinistra senza alterazioni focali eco strutturali del parenchima con minima falda fluida perisplenica qualche livello idroaereo in flessura sinistra. La paziente viene sottoposta anche a TC in urgenza senza somministrazione di mdc e.v. che conferma milza migrante con minima falda di versamento perilienale con sospetta anomala rotazione del peduncolo vascolare. In anamnesi la paziente era a conoscenza di essere portatrice di milza ectopica. Migliorata la sintomatologia la paziente rifiuta ricovero. Il giorno successivo ritorna in Pronto Soccorso per dolore non più localizzato all’epigatrio ma diffuso a tutto l’addome .Sulla scorta degli esami precedenti viene sottoposta subito ad esame MSTC con mezzo di contrasto che mostra milza migrante, dismorficabilobata,aumentata notevolmente di volume rispetto al giorno precedente con doppio coiling del peduncolo vascolare completamente avascolarizzata con infarto massivo. Nel caso presentato, l’angio MSTC ha permesso di documentare anche una sottile frattura mediana della milza non sanguinante.Questi reperti hanno orientato al trattamento chirurgico d’urgenza di splenectomia. Il trattamento chirurgico conservativo va effettuato qualora non siano presenti segni di sofferenza vascolare

  19. A giant inguinoscrotal hernia associated with other abdominal wall defects A case report.

    PubMed

    Iovino, Francesco; Auriemma, Pasquale Pio; Dani, Luca; Giordano, Giovanni; Barbarisi, Alfonso

    2016-04-29

    Le ernie giganti sono rare nei Paesi sviluppati ed ancora più raramente sono associate ad altre ernie della parete addominale, come un’ernia inguinale controlaterale o un’ernia ombelicale. La presenza di più difetti di parete facilità il riposizionamento in addome del contenuto di una voluminosa ernia inguinale senza compromettere la funzionalità cardiorespiratoria, ma il rischio di intasamento o strozzamento intestinale negli altri orifizi erniari aumenta. In letteratura non esistono opinioni convergenti se riparare simultaneamente o in maniera sequenziale, cioè in maniera distanziata nel tempo, le diverse ernie di parete, quando sono associate ad un’ernia gigante. Riportiamo in questo lavoro il caso clinico di un uomo di 60 anni, italiano, che si recò nel nostro ambulatorio di chirurgia lamentando da molti anni la presenza di un’ernia inguinale gigante associata ad un’ernia inguinale controlaterale ed un’ernia ombelicale. Il paziente alla visita presentava difficoltà di deambulazione, ma non riferiva disturbi di canalizzazione. Aveva diverse comorbidità e tra queste quella più importante era una insufficienza respiratoria severa. Dopo un accurato studio cardiologico, respiratorio e metabolico il paziente fu sottoposto a riparazione delle ernie a partire da quella gigante, in maniera sequenziale ed in anestesia spinale secondo la tecnica di Lichtenstein. L’ernia ombelicale fu riparata per ultima con tecnica diretta, senza protesi, ed anch’essa in anestesia spinale. Il decorso operatorio fu regolare dopo i tre interventi e non si ebbe alcuna complicanza respiratoria, cardiologica né di canalizzazione. In conclusione riteniamo che nei pazienti con importanti comorbidità la riparazione di un’ernia gigante associata ad altre ernie di parete debba avvenire in maniera sequenziale, monitorando con attenzione la canalizzazione e soprattutto il progressivo adattamento dei visceri in addome attraverso la palpazione degli orifizi erniari. I dati

  20. Improving earthquake hazard assessments in Italy: An alternative to “Texas sharpshooting”

    NASA Astrophysics Data System (ADS)

    Peresan, Antonella; Panza, Giuliano F.

    2012-12-01

    The 20 May 2012 M = 6.1 earthquake that struck the Emilia region of northern Italy illustrates a common problem afflicting earthquake hazard assessment. It occurred in an area classified as "low seismic hazard" based on the current national seismic hazard map (Gruppo di Lavoro, Redazione della mappa di pericolosità sismica, rapporto conclusivo, 2004, http://zonesismiche.mi.ingv.it/mappa_ps_apr04/italia.html) adopted in 2006. That revision of the seismic code was motivated by the 2002 M = 5.7 earthquake that struck S. Giuliano di Puglia in central Italy, also a previously classified low-hazard area, resulting in damage and casualties. Previous code was updated in 1981-1984 after earlier maps missed the 1980 M = 6.5 Irpinia earthquake.

  1. Italian consensus conference for colonic diverticulosis and diverticular disease.

    PubMed

    Cuomo, Rosario; Barbara, Giovanni; Pace, Fabio; Annese, Vito; Bassotti, Gabrio; Binda, Gian Andrea; Casetti, Tino; Colecchia, Antonio; Festi, Davide; Fiocca, Roberto; Laghi, Andrea; Maconi, Giovanni; Nascimbeni, Riccardo; Scarpignato, Carmelo; Villanacci, Vincenzo; Annibale, Bruno

    2014-10-01

    The statements produced by the Consensus Conference on Diverticular Disease promoted by GRIMAD (Gruppo Italiano Malattia Diverticolare, Italian Group on Diverticular Diseases) are reported. Topics such as epidemiology, risk factors, diagnosis, medical and surgical treatment of diverticular disease (DD) in patients with uncomplicated and complicated DD were reviewed by a scientific board of experts who proposed 55 statements graded according to level of evidence and strength of recommendation, and approved by an independent jury. Each topic was explored focusing on the more relevant clinical questions. Comparison and discussion of expert opinions, pertinent statements and replies to specific questions, were presented and approved based on a systematic literature search of the available evidence. Comments were added explaining the basis for grading the evidence, particularly for controversial areas.

  2. Italian consensus conference for colonic diverticulosis and diverticular disease

    PubMed Central

    Barbara, Giovanni; Pace, Fabio; Annese, Vito; Bassotti, Gabrio; Binda, Gian Andrea; Casetti, Tino; Colecchia, Antonio; Festi, Davide; Fiocca, Roberto; Laghi, Andrea; Maconi, Giovanni; Nascimbeni, Riccardo; Scarpignato, Carmelo; Villanacci, Vincenzo; Annibale, Bruno

    2014-01-01

    The statements produced by the Consensus Conference on Diverticular Disease promoted by GRIMAD (Gruppo Italiano Malattia Diverticolare, Italian Group on Diverticular Diseases) are reported. Topics such as epidemiology, risk factors, diagnosis, medical and surgical treatment of diverticular disease (DD) in patients with uncomplicated and complicated DD were reviewed by a scientific board of experts who proposed 55 statements graded according to level of evidence and strength of recommendation, and approved by an independent jury. Each topic was explored focusing on the more relevant clinical questions. Comparison and discussion of expert opinions, pertinent statements and replies to specific questions, were presented and approved based on a systematic literature search of the available evidence. Comments were added explaining the basis for grading the evidence, particularly for controversial areas. PMID:25360320

  3. [Cardiologists and mucopolysaccharidoses. Recommendations of GICEM (Cardiology Experts on Metabolic Disease Italian Group) for diagnosis, follow-up and cardiological management].

    PubMed

    Russo, Pierluigi; Andria, Generoso; Baldinelli, Alessandra; Boffi, Maria Lucia; Cerini, Emma; Della Casa, Roberto; Imperatori, Andrea; Luciani, Giovanni Battista; Morra, Elisa; Parini, Rossella; Pieroni, Maurizio; Prioli, Maria Antonia; Ragni, Luca; Rapezzi, Claudio; Rinelli, Gabriele; Rubino, Marta; Sarais, Cristiano; Sciacca, Pietro; Seddio, Francesco; Limongelli, Giuseppe

    2017-09-01

    Mucopolysaccharidoses (MPS) represent a group of rare lysosomal storage disorders, with a heterogeneous clinical presentation in terms of inheritance (autosomal and X-linked recessive), age of onset (infants, children, and adults), systemic and cardiac manifestations (mild to severe disease forms). Evidence-based recommendations on the diagnosis and management of cardiovascular disease in MPS are scarce. GICEM (Gruppo Italiano Cardiologi Esperti Malattie Metaboliche) is a group of cardiologists, cardiac surgeons and pediatricians with a specific expertise in metabolic diseases including MPS. In this paper, we report our experience and recommendations on the diagnosis and management of cardiovascular aspects in MPS, with a tailored approach based on current evidence, and taking into account MPS phenotype (particularly, I, II, IVa, VI), age at presentation, and severity of systemic and cardiac manifestations.

  4. An Italian Education: IEEE Pulse talks with Riccardo Pietrabissa, president of Italy's National Bioengineering Group, about Italian progress and challenges in biomedical engineering education.

    PubMed

    Pietrabissa, Riccardo; Reynolds, Pamela

    2015-01-01

    From Leonardo da Vinci's designs for ball bearings to the incredible engineering wizardry behind the Ferrari, the inventive, inquisitive, and ingenious spirit of the engineer has always lived--and thrived--in Italy. From education to research to product development, Italy has always been regarded as an engineering leader. But does this apply to biomedical engineering (BME)? Despite many successes, questions loom, as they do at engineering schools worldwide. Concerns such as whether BME programs are providing students with enough focused, practical, hands-on training remain at the forefront, as does the question of whether graduates will be able to find jobs in industry after university studies are over. Here, IEEE Pulse explores these topics with Riccardo Pietrabissa, president of the Gruppo Nazionale di Bioingegneria (National Bioengineering Group) and a full professor in the Department of Chemistry, Materials, and Chemical Engineering at Politecnico di Milano.

  5. Thoracic ultrasonography: A new method for the work-up of patients with dyspnea().

    PubMed

    Vitturi, N; Soattin, M; Allemand, E; Simoni, F; Realdi, G

    2011-09-01

    SommarioLa diagnosi differenziale di dispnea è fondamentale per la gestione dell’insufficienza respiratoria in cui, ai parametri routinari, può essere ora affiancata l’ecografia toracica. L’obiettivo di questo studio è stato valutare la validità e l’accuratezza di questa metodica anche in un reparto di medicina interna. MATERIALI E METODI: 152 pazienti ricoverati conseguentemente con diagnosi di dispnea sono stati esaminati dopo valutazione clinica, radiografia del torace, dosaggi bioumorali (NT-proBNP) e terapia d’emergenza. L’esame ecografico polmonare è stato considerato positivo qualora il numero totale di linee B fosse superiore ad 8. L’esame ecografico e il dosaggio dell’NT-proBNP sono stati ripetuti dopo 48 ore. Il gold standard di riferimento è stato la diagnosi clinica di scompenso cardiaco fatta da medici esperti secondo le linee guida dell’AHA. RISULTATI: Il gruppo di pazienti che mostrava un esame ecografico positivo riceveva in percentuale maggiore la diagnosi finale di insufficienza cardiaca (X 92.5; p < 0.005) e valori significativamente più elevati di NT-proBNP (10,384 ng/l vs 3889 ng/l; p < 0.05). Inoltre la diminuzione delle linee B a 48 ore era significativamente maggiore (p < 0.005) nel gruppo di pazienti trattati per scompenso cardiaco mentre non vi erano cambiamenti significativi nei valori di NT-proBNP (p = 0.37). DISCUSSIONE: In conclusione abbiamo dimostrato che anche in un reparto di medicina interna l’ecografia polmonare è uno strumento diagnostico utile per le gestione dell’insufficienza respiratoria e il suo monitoraggio durante la terapia.

  6. Prolidase activity and oxidative stress in patients with breast carcinoma A prospective randomized case-controlled study.

    PubMed

    Bayhan, Zulfu; Zeren, Sezgin; Kocak, Cengiz; Kocak, Fatma Emel; Duzgun, Sukru Aydin; Algin, Mustafa Cem; Taskoylu, Burcu Yapar; Yaylak, Faik

    2016-09-19

    Lo stress ossidativo gioca un ruolo importante nella patogenesi delle malattie neoplastiche. La prolidasi è un costituente della matrice metalloproteinasica, gioca un ruolo maggiore nel metabolismo del collagene, nell’accrescimento cellulare e nel rimodellamento strutturale. Una elevata attività prolidasica è stata dimostrata in molti casi di carcinomi. Lo scopo del presente studio è quello di indagare sull’attività sierica della prolidasi, dello stato ossidativo (TOS) ed antiossidativo (TAS) totale, e di valutare il loro rapporto con lo stadio del tumore, delle metastasi linfonodali e della massa neoplastica in pazienti con carcinoma mammario. Per lo studio sono state arruolate 35 pazienti con carcinoma della mammella e 40 soggetti di controllo. Sono stati rilevati i livelli di TAS, TOS e dell’attività prolidasica, calcolando gli indici di stress ossidativo (OSI). Come risultato i livelli di TOS, di OSI e dell’attività prolidasica sono risultati significativamente più elevati nelle pazienti con carcinoma mammario rispetto al gruppo di controllo (rispettivamente (P < 0.001, P < 0.001, P = 0.002). I livelli di TAS sono risultati significativamente inferiori nelle pazienti con carcinoma mammario rispetto al gruppo di controllo (P = 0,016). Sono stati rilevate correlazioni positive tra attività prolidasica, ed i livelli di TOS e di OSI con lo stadio tumorale, le metastasi linfoniodali e le dimensioni del tumore. Negativa è risultata la correlazione tra i livelli di TAS e le dimensioni del tunore, ma nessuna correlazione tra i livelli di TAS e lo stadio del tumore, come pure con l’infiltrazione linfonodale. Si conclude che l’elevata attività prolidasica del siero e lo stress ossidativo possono associarsi col carcinoma mammario. L’accresciuta attività prolidasica può essere messa in relazione con lo stadio e la prognosi del carcinoma mammario.

  7. Course of acute pancreatitis in diabetic patients.

    PubMed

    Koziel, Dorota; Gluszek, Stanislaw; Osuch, Martyna Gluszek

    2016-01-01

    Negli anni recenti in molti paesi europei si è dimostrata una crescente incidenza della pancreatite acuta (AP), ed alcuni studi indicano un aumento di rischio di AP nei pazienti diabetici. Questo studio è pertanto finalizzato a valutare il decorso clinico della AP nei pazienti diabetici. Sono stati studiati tutti i pazienti curati in reparto chirurgico per una diagnosi di AP identificando come pazienti diabetici quelli che all’anamnesi hanno confermato essere affetti da diabete di tipo 1 o di tipo 2 prima di essere ricoverati per AP. I pazienti ricoverati per AP, ed arruolati nello studio sono stati 963, e tra essi vi erano 87 (9%) diabetici. Tra questi ultimi erano più numerosi quelli portatori di calcolosi biliare quale causa della pancreatite (46% vs 32%). Nella maggioranza dei casi il decorso della AP è stato di gravità moderata, ma comunque nel 10,3% dei pazienti con diabete il decorso della malattia è stato moderatamente grave, e nel 12,7% decisamente grave. Non sono state osservate differenze nella mortalità da AP in entrambi i gruppi. Insufficienza sistemica è stata osservata più frequentemente nel gruppo dei diabetici di tipo 2 (5,4%) e 23,1% in quelli di tipo 2, a fronte del 5,1% dei pazienti non diabetici, con differenze statisticamente non significative. In conclusione l’incidenza della AP nei pazienti diabetici aumenta con l’età, ed è più spesso correlata con la calcolosi biliare. In questo gruppo di pazienti in decorso clinico è èiù frequentemente grave, con insufficienza sistemica nei diabetici di tipo 1.

  8. The prognostic value of sentinel lymph node micrometastases in patients with invasive breast carcinoma.

    PubMed

    Cipolla, Calogero; Graceffa, Giuseppa; La Mendola, Roberta; Fricano, Salvatore; Fricano, Martina; Vieni, Salvatore

    2015-01-01

    Il significato prognostico delle micrometastasi nel linfonodo sentinella nelle pazienti affette da carcinoma della mammella è ancora ampiamente dibattuto. Anche se, in assenza di univoche linee guida, nella pratica clinica la linfadenectomia ascellare in queste pazienti non viene più eseguita di routine. Abbiamo condotto uno studio retrospettivo su 746 patienti affette da carcinoma invasivo della mammella con linfonodi ascellari negativi, sottoposte a chirurgia conservativa o a mastectomia totale con biopsia del linfonodo sentinella. Le pazienti in cui è stata diagnostica la presenza di micrometastasi del linfonodo sentinella sono state considerate in due diversi gruppi. In un primo gruppo, trattato con linfadenectomia ascellare totale è stata valutata l’incidenza di metastasi a carico dei rimanenti linfonodi ascellari. Un secondo gruppo non ha ricevuto alcun trattamento aggiuntivo dell’ascella e le pazienti sono state seguite con controlli periodici clinico strumentali. In entrambi i gruppi è stata valutata l’incidenza di eventuali recidive ascellari. All’esame istologico estemporaneo ed al successivo esame istologico definitivo del linfonodo sentinella, in 51 pazienti (6,83%) sono state evidenziate micrometastasi, in 8 pazienti (1,07%) erano presenti cellule tumorali isolate. Quindici di queste pazienti sono state sottoposte a linfadenectomia ascellare totale. Solo in 2 casi (13,33%) sono state ritrovate metastasi a carico dei rimanenti linfonodi ascellari. Quarantaquattro pazienti non hanno ricevuto alcun trattamento aggiuntivo dell’ascella. In queste pazienti nessuna recidiva ascellare è stata registrata durante un follow-up medio di 65,3±9,65 mesi (range 42-78 mesi). Sulla base dei risultati ottenuti in questo studio ed in linea con alcuni recenti trials randomizzati si ci sentiamo di concludere che la linfadenectomia ascellare può essere evitata nei casi con micrometastasi nel linfonodo sentinella. Una sua eventuale indicazione può essere

  9. Rare extra-adrenal paraganglioma mimicking a painful Schwannoma: case report.

    PubMed

    Picchetto, Andrea; M Paganini, Alessandro; Balla, Andrea; Quaresima, Silvia; Cantisani, Vito; D'Ambrosio, Giancarlo; Lezoche, Emanuele

    2014-09-26

    I paragangliomi hanno un’incidenza annuale di circa 1/100000; essi originano dai tessuti cromaffini dei corpi di Zurckerkandl. In questo case report riportiamo il caso di un uomo di 53 anni, già trattato e seguito per un precedente limfoma di Hodkin che è stato sottoposta a RMN dell’addome per una lombalgia cronica che durava da due anni e che non riusciva ad alleviare con i FANS. La RMN ha rivelato un’incidentaloma: una massa in regione para-aortica, a livello della loggia surrenalica sinistra con le caratteristiche di una massa nodulare solida (29*25mm), che non sembrava originare direttamente dal surrene. Il pz ha inoltre eseguito un TC dell’addome che ha mostrato una massa localizzata di fronte al surrene di sinistra; il collega radiologo ha definito questa massa come un tumore maligno delle guaine nervose periferiche (Schwannoma) o come un linfonodo colliquato (essendo nota la patologia linfomatosa già descritta in anamnesi). Il paziente non riferiva cefalea, palpitazioni, picchi ipertensivi ne’ altri sintomi sistemici. Durante il suo ricovero, sono stati dosati i marker tumorali cromogranina e l’enolasi neurono-specifica che sono risultati essere rispettivamente 187.00 ng/mL and 7.7 ng/mL. La lombalgia è stata trattata inizialmente con Ketorolac, senza beneficio alcuno, quindi con Ketorolac più Tramadolo in pompa elastomerica, nuovamente senza beneficio per il paziente, infine con infusione continua di Morfina. Dato che l’esatta natura della neoformazione non era nota e che l’esecuzione di una biopsia TC guidata non era tecnicamente possibile, è stata eseguita un’escissione per via laparoscopica della massa, con approccio anteriore submesocolico trans peritoneale, così come gli Autori sono soliti eseguire per la surrenalectomia sinistra. Sin dai primi giorni postoperatori il paziente non ha più necessitato della morfina. Il decorso postoperatorio è stato del tutto regolare. L’esame istologico è risultato essere paraganglioma. I

  10. Malignant transformation in non-recurrent peritoneal cystic mesothelioma Our experience and review of the literature.

    PubMed

    Santangelo, Giuseppe; Accardo, Marina; De Vita, Ferdinando; Del Giudice, Santolo; Gallucci, Federica; Fabozzi, Alessio; De Falco, Massimo

    2016-01-29

    Il mesotelioma peritoneale cistico è un tumore raro. Si tratta di un tumore benigno, che tuttavia va incontro a recidive locali post-chirurgiche in oltre il 50% dei casi. È proprio a seguito di recidive ricorrenti che si possono determinare trasformazioni maligne di questa neoplasia, come descritto in Letteratura. Nel Giugno del 2004 un paziente di 73 anni è giunto presso la nostra struttura con una tumefazione addominale causa di dolore gravativo: si trattava di una massa di 16 cm, la cui struttura, agli esami strumentali (ecografia, TC con m.d.c. e RMN), appariva pluricistica. Attraverso una laparotomia mediana si è provveduto alla sua rimozione e il paziente è stato dimesso in VIII giornata post-operatoria senza complicanze. L’esame istologico, corredato da studio immunoistochimico e di microscopia elettronica, ha consentito di porre diagnosi di mesotelioma peritoneale pluricistico in trasformazione maligna. D’accordo con gli oncologi, in considerazione della scarsa efficacia dei trattamenti adiuvanti e della scarsità dei dati riportati in Letteratura sull’argomento, si è deciso di sottoporre il paziente unicamente ad uno stretto follow-up, con esecuzione di ecografia addominale ogni sei mesi e TC addominale ogni anno. Ad oggi, dieci anni dopo il trattamento, il paziente, di 83 anni, gode di un discreto stato di salute e non si sono verificate riprese o recidive di malattia, né locali, né a distanza. Oltre al fatto di essere risultato maligno alla sua prima manifestazione e non dopo ripetute recidive, il caso presenta altre particolarità: il mesotelioma peritoneale cistico, infatti, solitamente colpisce soggetti di sesso femminile (con un rapporto F:M di 4,5:1) ad un’età media di 60 anni, mentre il caso descritto riguarda un soggetto di sesso maschile di 73 anni. La nostra osservazione dimostra la possibilità che il mesotelioma peritoneale vada incontro a trasformazioni maligne già alla sua prima manifestazione e non esclusivamente dopo

  11. European Collaboration on Low-dose Aspirin in Polycythemia Vera (ECLAP): a randomized trial.

    PubMed

    Landolfi, R; Marchioli, R

    1997-01-01

    Thrombotic complications characterize the clinical course of polycythemia vera (PV) and represent the main cause of morbidity and mortality. However, uncertainty still exists as to the benefit/risk ratio of aspirin prophylaxis in this setting. In vivo platelet biosynthesis of thromboxane A2 is enhanced and can be suppressed by low-dose aspirin in PV, thus providing a rationale for assessing the efficacy and safety of a low-dose aspirin regimen in these patients. The Gruppo Italiano Studio Policitemia Vera has recently performed a pilot study on 112 patients randomized to receive aspirin, 40 mg daily, or placebo and followed for 16 +/- 6 months (mean +/- SD). This study showed that low-dose aspirin is well tolerated in PV patients, and that a large-scale efficacy trial is feasible in this setting. In this article we report the protocol of the European Collaboration on Low-dose Aspirin in Polycythemia Vera (ECLAP) study, which is a randomized trial designed to assess the risk/benefit ratio of low-dose aspirin in PV. To estimate the size and the follow-up duration required for the ECLAP trial, a retrospective analysis of the clinical epidemiology of a large PV population has recently been completed by the Gruppo Italiano Studio Policitemia Vera. On this basis, approximately 3500 patients will be enrolled in the ECLAP study with a follow-up of 3 to 4 years. The uncertainty principle will be used as the main eligibility criterion: Polycythemic patients of any age, having no clear indication for or contraindication to aspirin treatment, will be randomized in a double-blind fashion to receive oral aspirin (100 mg daily) or placebo. According to current therapeutic recommendations, the basic treatment of randomized patients should be aimed at maintaining the hematocrit value < or = 45% in subjects aged < or = 50, and hematocrit < 45% as well as platelet count < 400 x 10(9)/L in patients aged > 50. Randomization will be stratified by participating center. The study is

  12. Coronary artery bypass grafting in the octogenarian. Is complete revascularization always necessary?

    PubMed

    Concistrè, Giovanni; Dell'Aquila, Angelo Maria; Gallo, Alina; Pansini, Stefano; Piccardo, Alessandro; Rapetto, Filippo; Passerone, Giancarlo; Regesta, Tommaso

    2015-01-01

    La rivascolarizzazione miocardica completa è importante nei pazienti giovani sottoposti ad intervento di bypass aortocoronarico (CABG), ma questo principio resta poco chiaro nei pazienti anziani. Lo scopo del nostro studio è valutare se la completezza della rivascolarizzazione influenzi gli outcomes negli ultraottantenni. Abbiamo analizzato retrospettivamente 130 pazienti ultraottantenni (età media: 82 ± 10 anni; range: 80-90 anni) sottoposti presso il nostro Istituto a CABG tra Gennaio 2003 e Settembre 2010. In accordo con la strategia operatoria utilizzata, i pazienti sono stati suddivisi in 2 gruppi: pazienti sottoposti a rivascolarizzazione completa (Gruppo RC) (96 pazienti) e pazienti sottoposti a rivascolarizzazione incompleta (Gruppo RI) (34 pazienti). Per rivascolarizzazione incompleta si è inteso l’assenza di bypass su un territorio miocardico vascolarizzato da una coronaria con una stenosi ≥ 50%. Il follow-up è stato completato al 98% (medio: 30 ± 25 mesi; range: 3 mesi – 7.5 anni). La mortalità intraospedaliera complessiva è stata del 13% ed è stata simile nei 2 gruppi (p=0.0553). L’analisi multivariata ha identificato la frazione di eiezione preoperatoria ≤ 40% (p=0.0060; OR=0.19) e la classe NYHA > II (p=0.0042; OR=0.17) fattori di rischio di mortalità intraospedaliera. L’analisi di Cox non ha identificato la rivascolarizzazione incompleta come fattore di rischio di mortalità precoce e tardiva (p=0.1381 e p=0.8865). Non sono state riscontrate differenze tra i 2 gruppi in termini di sopravvivenza a 5 anni e libertà da eventi cardiaci e cerebrovascolari maggiori (MACCE) (p=0.8865 e p=0.6283). Probabilmente i maggiori benefici di una rivascolarizzazione completa si hanno nei pazienti più giovani, che hanno un’aspettativa di vita maggiore. In conclusione il nostro studio mostra che, seppur con una limitata coorte di pazienti, negli ultraottantenni sottoposti a CABG la rivascolarizzazione incompleta non influenza la sopravvivenza

  13. New "all-in-one" device for mesh plug hernioplasty: the Trabucco repair.

    PubMed

    Gossetti, Francesco; Massa, Salvatore; Abbonante, Francesco; Calabria, Michele; Ceci, Francesca; Viarengo, Maria Antonietta; Manzi, Emy; D'Amore, Linda; Negro, Paolo

    2015-01-01

    Sebbene la tecnica Mesh Plug rappresenti una procedura di indubbia efficacia nel trattamento dell’ernia inguinale, tuttora permangono dubbi in relazione alla storia naturale del plug. In particolare, il plug può andare incontro a coartazione (shrinkage) con formazione di un “meshoma” responsabile di una sintomatologia dolorosa cronica. Più raramente, il plug può migrare e provocare erosione delle strutture anatomiche circostanti. Nel passato sono stati proposti alcuni devices per cercare di risolvere il problema della migrazione; nessuno di questi, tuttavia, ha raggiunto la popolarità dei plug conici o a forma di fiore. Il presente lavoro riporta i risultati di uno studio pilota condotto con l’impiego di un nuovo device tridimensionale, il NeT Plug & Patch. I risultati dopo 12 mesi di follow-up, hanno dimostrato una ridotta incidenza di dolore postoperatorio e cronico, senza rischio di migrazione. Inoltre è stata registrata una compliance soddisfacente sia dei pazienti che degli operatori. La protesi NeT Plug & Patch ha dimostrato di poter realizzare un’ernioplastica semplice ed efficace per la riparazione dell’ernia inguinale.

  14. Multidisciplinary approach to follicular thyroid carcinoma with giant mandibular and multiple sites metastases Case report.

    PubMed

    De Pasquale, Loredana; Rabbiosi, Dimitri; Bardazzi, Alessandro; Autelitano, Luca; Moro, Giacomina Pierina; Ghilardi, Giorgio

    2014-01-01

    I tumori metastatici in genere hanno una cattiva prognosi, con sopravvivenza breve e raramente sono candidabili al trattamento chirurgico. Nel caso dei carcinomi differenziati della tiroide, la prognosi è solitamente migliore, grazie alla possibilità di un approcio multidisciplinare e soprattutto al trattamento radiometabolico dei secodarismi, dopo l’asportazione del tumore primitivo. Il caso presentato riguarda una donna di 65 anni, che è giunta alla nostra osservazione per una tumefazione mandibolare, risultata successivamente una metastasi da carcinoma follicolare della tiroide, a partenza da un voluminoso gozzo cervico-mediastinico normofunzionante, con ulteriori secondarismi a livello polmonare. Dopo un accurato studio pre-operatorio la Paziente è stata sottoposta a resezione della mandibola sinistra con ricostruzione mediante una protesi metallica e a tiroidectomia totale. Successivamente è stata trattata con quattro cicli di terapia radiometabolica con buona risposta. La Paziente è viva, senza ulteriore progressione di malattia a un follow-up di quarantasei mesi. Anche nei casi di tumori differnziati della tiroide in fase metastatica, l’opzione chirurgica va presa in considerazione per consentire alle terapie complementari di migliorare la prognosi in termini di sopravvivenza.

  15. Usefulness of ileostomy defunctioning stoma after anterior resection of rectum on prevention of anastomotic leakage A retrospective analysis.

    PubMed

    Salamone, Giuseppe; Licari, Leo; Agrusa, Antonino; Romano, Giorgio; Cocorullo, Gianfranco; Falco, Nicolò; Tutino, Roberta; Gulotta, Gaspare

    2016-01-01

    Una delle principali e più temute complicanze della resezione anteriore di retto è stata ed è la deiscenza anastomotica. Solitamente, sia essa una scelta di principio od a discrezione del chirurgo operatore, viene confezionata una ileostomia laterale di sicurezza con lo scopo di prevenire tale circostanza. Scopo di tale studio è stato quello di investigare circa la utilità della stomia laterale di sicurezza quale strumento di prevenzione della deiscenza anastomotica, mettendo a paragone il decorso post-operatorio dei paziente con e senza stomia laterale. Le evidenze hanno portato alla conclusione che il confezionamento della stomia laterale di sicurezza è fattore di protezione non tanto dell’evento deiscenza anastomotica in senso stretto, quanto delle complicanze e della evoluzione clinica della stessa, vedasi ad esempio tasso di ricorrenza di deiscenza/quadro clinico in corso di deiscenza/ tempi di degenza, pur rendendosi necessario sottolineare l’assenza di significatività statistica nel tasso di mortalità nei due gruppi in studio. Cosi detto appare dunque sinottico affermare che il confezionamento di ileostomia laterale di sicurezza in corso di resezione anteriore di retto non determina una diretta azione sull’evento “deiscenza anastomotica” né “morte”, purtuttavia modifica certamente in positivo il decorso clinico ed evolutivo dell’evento “deiscenza anastomotica”.

  16. [Malattia di Marchiafava-Bignami con coinvolgimento della corteccia frontale e insorgenza tardiva di sintomi psichiatrici resistenti: un caso clinico].

    PubMed

    Gramaglia, Carla; Feggi, Alessandro; Vecchi, Camilla; Di Marco, Sarah; Venesia, Alessandra; Delicato, Claudia; Chieppa, Nunzia; De Marchi, Fabiola; Cantello, Roberto; Zeppegno, Patrizia

    2016-01-01

    RIASSUNTO. Scopo. Descrivere il management di un paziente con malattia di Marchiafava-Bignami (MBD) associata a lesioni frontali corticali, senza sintomi specifici al primo accesso in Pronto Soccorso, e insorgenza tardiva di sintomi psichiatrici atipici. Metodi. Descriviamo il caso di un paziente di 44 anni con storia di abuso cronico di alcol, a cui è stata diagnosticata la MBD. Risultati. La risonanza magnetica ha evidenziato lesioni nello splenio e corpo del corpo calloso e lesioni bilaterali della corteccia frontale. Il paziente ha sviluppato sintomi psichiatrici atipici a insorgenza tardiva, che sono risultati essere resistenti alle terapie farmacologiche impostate. Discussione. Il caso che descriviamo sembra supportare le attuali, ma ancora scarse evidenze che descrivono il coinvolgimento corticale nella MBD, suggerendone l'associazione con una prognosi peggiore. I sintomi psichiatrici possono risultare difficili da trattare a causa della resistenza alle terapie. Conclusione. Il coinvolgimento di psichiatri, radiologi e neurologi secondo un approccio di consultazione-liaison si è dimostrato di fondamentale importanza per la diagnosi e l'impostazione della terapia adeguata al paziente.

  17. Autotransplantation of pancreatic islets. A single-center first experience.

    PubMed

    Magistri, Paolo; Andreani, Sara; Lo Conte, Domenico; Ferrari, Giovanni Carlo; Forgione, Antonello; Pugliese, Raffaele

    2016-01-01

    L’autotrapianto d’isole pancreatiche (IAT) è una procedura ben nota che consente di migliorare il controllo glicemico dopo una pancreasectomia totale (o completamento di pancreasectomia dopo duodenocefalopancreasectomia) rispetto alla sola terapia insulinica. In questo lavoro presentiamo la nostra esperienza nel campo dell’ IAT riportando il caso clinico di una donna di sessanta anni, sottoposta a completamento di pancreasectomia per episodi ricorrenti di acuzie in un quadro di pancreatite cronica. Il trattamento IAT è stato somministrato mediante iniezione trans-epatica intra-portale. Il recupero post-procedurale è stato ottimale, fatta eccezione per un’infezione di ferita che ha richiesto un trattamento con tecnologia a pressione negativa. La paziente è stata dimessa in ventisettesima giornata postoperatoria, in buone condizioni generali, dopo regolare ripresa dell’alimentazione e della canalizzazione. I dati presenti in letteratura dimostrano che la IAT è una procedura sicura, garantendo nel lungo periodo un vantaggio rispetto alla terapia insulinica in termini di rapporto costo-beneficio. Riguardo alla procedura chirurgica, è qui utile ricordare che la mortalità a 30 giorni dopo pancreasectomia totale associata a IAT è del 5%, ed è pertanto sovrapponibile ai risultati della pancreasectomia totale senza IAT. Riportando questa esperienza intendiamo contribuire alla crescita della casistica chirurgica attuale in questo campo, proponendo nel futuro un più ampio sviluppo e una più estesa applicazione di tale approccio.

  18. Urine albumin excretion, within normal range, reflects increasing prevalence of metabolic syndrome in patients with essential hypertension.

    PubMed

    Vyssoulis, Gregory; Karpanou, Eva; Spanos, Pangiotis; Kyvelou, Stella-Maria; Adamopoulos, Dionysios; Stefanadis, Christodoulos

    2010-08-01

    Microalbuminuria is a prognostic marker of cardiovascular disease and is related to metabolic syndrome (MetS). For this purpose, the authors examined the relationship of low grade albuminuria to MetS, using 4 current definitions and a MetS score. They studied 6650 consecutive, nondiabetic, hypertensive patients with normal microalbumin excretion. MetS was defined by Adult Treatment Panel III, American Heart Association, World Heart Organization, International Diabetes Federation criteria, and MetS Gruppo Italiano per lo Studio della Streptochinasi nell'Infarcto Miocardico (GISSI) score. Urine microalbumin concentration was measured after a 24-hour urine collection by immunonephelometry. By all definitions, hypertensive patients with MetS had higher microalbumin levels. Significantly higher microalbumin levels were observed as the number of metabolic components rose. After adjustment for systolic blood pressure, the strength of this association was reduced to a nonsignificant level. Microalbumin levels, within normal range, are increased in patients with MetS, irrespective of the definition criteria.

  19. Group actions and anomalies in gauge theories

    NASA Astrophysics Data System (ADS)

    Catenacci, R.; Pirola, G. P.; Martellini, Maurizio; Reina, Cesare

    1986-05-01

    The transformation properties are studied of the vacuum functional W(A) for chiral fermions in a gauge potential A under the group A×U(1)×R+ of gauge, chiral and scale transformations. The vacuum functional W is identified with a section of a G×U(1)×R+ line bundle over the space A of all gauge potentials. Known results on bundles carrying group actions give a simple and unifying clue to non-abelian, abelian chiral anomalies, as well as to trace anomalies. While the first are due to the twisting of a line bundle on A/G, the abelian chiral and trace anomalies are related to characters of U(1) and R+ respectively. Characters of U(1) are basically controlled by ``winding numbers'', i.e. again by topology. Opposite to these, trace anomalies seem to have little to do with topology, with the exception of two-dimensional theories. Also at Gruppo Nazionale di Fisica Matematica, CNR.

  20. Veno-occlusive disease nurse management: development of a dynamic monitoring tool by the GITMO nursing group

    PubMed Central

    Botti, Stefano; Orlando, Laura; Gargiulo, Gianpaolo; Cecco, Valentina De; Banfi, Marina; Duranti, Lorenzo; Samarani, Emanuela; Netti, Maria Giovanna; Deiana, Marco; Galuppini, Vera; Pignatelli, Adriana Concetta; Ceresoli, Rosanna; Vedovetto, Alessio; Rostagno, Elena; Bambaci, Marilena; Dellaversana, Cristina; Luminari, Stefano; Bonifazi, Francesca

    2016-01-01

    Veno-occlusive disease (VOD) is a complication arising from the toxicity of conditioning regimens that have a significant impact on the survival of patients who undergo stem cell transplantation. There are several known risk factors for developing VOD and their assessment before the start of conditioning regimens could improve the quality of care. Equally important are early identification of signs and symptoms ascribable to VOD, rapid diagnosis, and timely adjustment of support therapy and treatment. Nurses have a fundamental role at the stages of assessment and monitoring for signs and symptoms; therefore, they should have documented skills and training. The literature defines nurses’ areas of competence in managing VOD, but in the actual clinical practice, this is not so clear. Moreover, there is an intrinsic difficulty in managing VOD due to its rapid and often dramatic evolution, together with a lack of care tools to guide nurses. Through a complex evidence-based process, the Gruppo Italiano per il Trapianto di Midollo Osseo (GITMO), cellule staminali emopoietiche e terapia cellulare nursing board has developed an operational flowchart and a dynamic monitoring tool applicable to haematopoietic stem cell transplantation patients, whether they develop this complication or not. PMID:27594906

  1. Practice guidelines on the use of esophageal manometry - A GISMAD-SIGE-AIGO medical position statement.

    PubMed

    Savarino, Edoardo; de Bortoli, Nicola; Bellini, Massimo; Galeazzi, Francesca; Ribolsi, Mentore; Salvador, Renato; Savarino, Vincenzo; Penagini, Roberto

    2016-10-01

    Patients with esophageal symptoms potentially associated to esophageal motor disorders such as dysphagia, chest pain, heartburn and regurgitation, represent one of the most frequent reasons for referral to gastroenterological evaluation. The utility of esophageal manometry in clinical practice is: (1) to accurately define esophageal motor function, (2) to identify abnormal motor function, and (3) to establish a treatment plan based on motor abnormalities. With this in mind, in the last decade, investigations and technical advances, with the introduction of high-resolution esophageal manometry, have enhanced our understanding and management of esophageal motility disorders. The following recommendations were developed to assist physicians in the appropriate use of esophageal manometry in modern patient care. They were discussed and approved after a comprehensive review of the medical literature pertaining to manometric techniques and their recent application. This position statement created under the auspices of the Gruppo Italiano di Studio per la Motilità dell'Apparato Digerente (GISMAD), Società Italiana di Gastroenterologia ed Endoscopia Digestiva (SIGE) and Associazione Italiana Gastroenterologi ed Endoscopisti Digestivi Ospedalieri (AIGO) is intended to help clinicians in applying manometric studies in the most fruitful manner within the context of their patients with esophageal symptoms.

  2. Passive magnetic attitude stabilization of the UNISAT-4 microsatellite

    NASA Astrophysics Data System (ADS)

    Santoni, Fabio; Zelli, Mauro

    2009-09-01

    UNISAT-4 is the fourth educational microsatellite, completely designed and built by students and professors of the research group GAUSS (Gruppo di Astrodinamica dell'Università degli Studi "la Sapienza") at the Scuola di Ingegneria Aerospaziale of University of Rome "La Sapienza". The spacecraft is stabilized using a passive magnetic attitude stabilization system, based on a permanent magnet and an energy dissipation system, which consists of magnetic hysteresis rods. The main features of passive magnetic stabilization are simplicity and reliability. However, sizing the system parameters, predicting the in-orbit performance and obtainable accuracy of passive magnetic stabilization systems is not trivial. The main problem in the system design is accurate modeling of the hysteresis rods magnetization and the evaluation of the rods magnetic parameters, such as apparent permeability, remanence and coercitive force, which are considerably affected by the rods' manufacturing technological process. In this paper the design and ground test of the UNISAT-4 magnetic attitude stabilization system is described. A method to experimentally determine the hysteresis rod parameters is described and an accurate model of the satellite dynamics is obtained, based on the results of the measurements. One of the main design parameters is the number of hysteresis rods necessary to obtain satellite stabilization. Numerical simulations for two hysteresis rods per axis and eight hysteresis rods per axis are discussed, showing that the satellite stabilizes in about 14 days, with a residual oscillation amplitude of less than 10°, if eight rods are used.

  3. Risk factors and prevention of vascular complications in polycythemia vera.

    PubMed

    Barbui, T; Finazzi, G

    1997-01-01

    Risk factors for vascular complications in polycythemia vera (PV) include laboratory and clinical findings. Among laboratory values, the hematocrit has been clearly associated with thrombosis, particularly in the cerebral circulation. Platelet count is a possible but not yet clearly established predictor of vascular complications. Platelet function tests are of little help in prognostic evaluation because most attempts to correlate these abnormalities with clinical events have been disappointing. Clinical predictors of thrombosis include increasing age and a previous history of vascular events. Identifying risk factors for thrombosis is important to initiate therapy. Phlebotomy is associated with an increased incidence of thrombosis in the first 3 to 5 years, whereas chemotherapy may induce a higher risk of secondary malignancies after 7 to 10 years of follow-up. New cytoreductive drugs virtually devoid of mutagenic risk include interferon-alpha and anagrelide, but their role in reducing thrombotic complications remains to be demonstrated. Antithrombotic drugs, such as aspirin, are frequently used in PV, despite doubts regarding safety and efficacy. Two recent studies from the Gruppo Italiano Studio Policitemia Vera (GISP) assessed the rate of major thrombosis as well as the tolerability of low-dose aspirin in PV patients. These investigations created a favorable scenario for launching a European collaborative clinical trial (ECLAP study) aimed at testing the efficacy of low-dose aspirin in preventing thrombosis and prolonging survival in patients with PV.

  4. Veno-occlusive disease nurse management: development of a dynamic monitoring tool by the GITMO nursing group.

    PubMed

    Botti, Stefano; Orlando, Laura; Gargiulo, Gianpaolo; Cecco, Valentina De; Banfi, Marina; Duranti, Lorenzo; Samarani, Emanuela; Netti, Maria Giovanna; Deiana, Marco; Galuppini, Vera; Pignatelli, Adriana Concetta; Ceresoli, Rosanna; Vedovetto, Alessio; Rostagno, Elena; Bambaci, Marilena; Dellaversana, Cristina; Luminari, Stefano; Bonifazi, Francesca

    2016-01-01

    Veno-occlusive disease (VOD) is a complication arising from the toxicity of conditioning regimens that have a significant impact on the survival of patients who undergo stem cell transplantation. There are several known risk factors for developing VOD and their assessment before the start of conditioning regimens could improve the quality of care. Equally important are early identification of signs and symptoms ascribable to VOD, rapid diagnosis, and timely adjustment of support therapy and treatment. Nurses have a fundamental role at the stages of assessment and monitoring for signs and symptoms; therefore, they should have documented skills and training. The literature defines nurses' areas of competence in managing VOD, but in the actual clinical practice, this is not so clear. Moreover, there is an intrinsic difficulty in managing VOD due to its rapid and often dramatic evolution, together with a lack of care tools to guide nurses. Through a complex evidence-based process, the Gruppo Italiano per il Trapianto di Midollo Osseo (GITMO), cellule staminali emopoietiche e terapia cellulare nursing board has developed an operational flowchart and a dynamic monitoring tool applicable to haematopoietic stem cell transplantation patients, whether they develop this complication or not.

  5. Thrombolysis in acute myocardial infarction: need for a change in strategy and future directions.

    PubMed

    Pitt, B

    1990-01-01

    The results of several major trials of i.v. thrombolysis in patients with acute myocardial infarction have demonstrated the efficacy of the treatment in reducing mortality. Streptokinase and rt-PA have been shown to be effective (APSAC = anisoylated plasminogen streptokinase activator complex; GISSI = Gruppo Italiano per lo Studio della Streptochinasi nell' Infarto miocardico, ASSET = Anglo Scandinavian study of early thrombolysis, rt-PA). This treatment is associated with the potential for cerebral and major bleeding, especially in elderly patients. The benefit of this treatment in patients with cardiogenic shock or hypotension (ISIS-2) is discussed. There is no convincing evidence that patients with ST-segment depression or those with an equivocal electrocardiogram had been benefited from i.v. thrombolysis. Further studies with i.v. thrombolysis and/or other strategies need to be explored. Overall the use of i.v. thrombolytic agents in combination with PTCA in patients with acute myocardial infarction have resulted in improvement in ventricular function and survival in patients eligible for this therapy. However, new techniques and therapeutic approaches to prevent reocclusion, to prevent reperfusion injury, to prevent restenosis after PTCA, to prevent atherosclerosis in the infarct and non-infarct related arteries, and to reduce the potential for ventricular arrhythmias and sudden death as well as the potential for mural thrombi and embolization after infarction are needed. The 1990's will see attempts to determine the optimum adjunctive therapy or "cocktail" of agents to be used with i.v. thrombolysis.

  6. Burning mouth syndrome: the role of contact hypersensitivity.

    PubMed

    Virgili, A; Corazza, M; Trombelli, L; Arcidiacono, A

    1996-11-01

    The burning mouth syndrome is characterized by an unpleasant sensation of burning in the oral cavity, without clinical signs. Causal factors may be psychogenic, systemic or local. The aim of the study was to determine the significance of contact allergy in the pathogenesis of burning mouth syndrome. Fifteen patients with burning mouth syndrome were studied through anamnesis and laboratory analysis. Epicutaneous patch tests were performed with the Italian standard series (GIRDCA - Gruppo Italiano di Ricerca Dermatiti da Contatto ed Ambientali), preservative and dental series. The same tests were carried out in 12 healthy age- and sex-matched subjects. The number of patients affected by burning mouth syndrome with a positive reaction to patchtesting was 6 out of 15, while the number of allergic patients in the control group was 3 out of 12. No association could be found between positive reaction at patchtesting and exposure to allergens. Contact allergy in burning mouth syndrome seems not to play a primary role; nevertheless, it is advisable to perform patch tests in selected patients to identify a possible aetiological agent.

  7. [The difficult start of nephrology in Rome].

    PubMed

    Cagli, V; Cinotti, G A

    2009-01-01

    Nephrology in Rome began in the 1960s with the arrival of Ernico Fiaschi in the wake of Cataldo Cassano at the Institute of Medical Pathology (later on Clinica Medica II). A group of doctors interested in nephrology was set up, with among them Giulio A. Cinotti, who was to become full professor of nephrology at the University of Rome ''La Sapienza'' in 1980. By the end of the 1960s, the renal transplant activity had become an important asset at the Institute of Surgical Pathology (later on Clinica Chirurgica II) thanks to Paride Stefanini. A chair of surgical nephrology was instituted at the Urology Clinics of Ulrico Bracci; the chair was first held by Nicola Cerulli, who developed an intensive hemodialysis program. Around the same time, the Center for the Research and Treatment of Arterial Hypertension and Kidney Diseases became operational at the hospitals of Rome (under the responsibility of Vito Cagli at the Policlinico Umberto I), while a nephrology and dialysis unit, directed by Giancarlo Ruggieri, was set up at the San Giacomo Hospital. Many nephrology-related ''cultural'' activities started to be undertaken thanks to the ''Gruppo Laziale di Nefrologia Medica e Chirurgica'' founded by Drs Cagli, Cerulli, and Cinotti. Two national congresses were organized by Giulio Cinotti in 1979 (Fiuggi) and 1992 (Rome).

  8. Breast cancer screening: characteristics and results of the Italian programmes in the Italian group for planning and evaluating breast cancer screening programmes (GISMa).

    PubMed

    Giordano, L; Giorgi, D; Fasolo, G; Segnan, N; Del Turco, M R

    1996-01-01

    In 1990, GISMa (Italian Group for planning and evaluating Mammographic Screening - Gruppo Italiano per la pianificazione e la valutazione dei programmi di Screening Mammografico), a working group of operators (radiographers, radiologists, epidemiologists, clinicians, surgeons) involved in screening programmes ongoing in Italy, was created within the Italian School of Senology. The aim of this study is to illustrate data, presented at the GISMa meeting held in April 1994, concerning the characteristics of each programme and some early indicators of effectiveness. To assess these parameters (concerning compliance level, recall rate, benign/malignant biopsy ratio, detection rate, stage distribution, nodal involvement and number of cancers with a diameter under 1 cm, rate of cancer, etc.), 'acceptable' and 'desirable' standards obtained from Italian and North-European cancer screening experiences have been adopted. Most programmes have shown an acceptable standard for most of the indicators, and many of them have attained desirable levels. In most screening programmes the occurrence of interval cancers has not yet been measured, but all centres have (or are working to set up) a systematic active procedure to collect the data. The results indicate that common guidelines can be adopted, even when working in very heterogeneous contexts, and that it is possible to achieve a very high effectiveness and efficacy level. As regards quality control and cost/benefit issues, the goal of extending centralised, population-based screening programmes to other Italian regions becomes a priority.

  9. External validation of the Simplified Acute Physiology Score (SAPS) 3 in a cohort of 28,357 patients from 147 Italian intensive care units.

    PubMed

    Poole, Daniele; Rossi, Carlotta; Anghileri, Abramo; Giardino, Michele; Latronico, Nicola; Radrizzani, Danilo; Langer, Martin; Bertolini, Guido

    2009-11-01

    To evaluate the SAPS 3 score predictive ability of hospital mortality in a large external validation cohort. Prospective observational study. A total of 28,357 patients from 147 Italian ICUs joining the Project Margherita national database of the Gruppo italiano per la Valutazione degli interventi in Terapia Intensiva (GiViTI). None. Evaluation of discrimination through ROC analysis and of overall goodness-of-fit through the Cox calibration test. Although discrimination was good, calibration turned out to be poor. The general and the South-Europe Mediterranean countries equations overestimated hospital mortality overall (SMR values 0.73 with 95% CI 0.72-0.75 for both equations) and homogeneously across risk classes. Overprediction was confirmed among important subgroups, with SMR values ranging between 0.47 and 0.82. The result strictly supported by our data is that the SAPS 3 score calibrates inadequately in a large sample of Italian ICU patients and thus should not be used for benchmarking, at least in Italian settings.

  10. Intensive or not surveillance of patients with colorectal cancer after curative resection

    PubMed Central

    Rosati, Gerardo

    2010-01-01

    It is common practice to follow patients with colorectal cancer for some years after resection and/or adjuvant treatment. Data are lacking about how often patients should be seen, what tests should be performed, and what surveillance strategy has a significant impact on patient outcome. Seven randomized trials have addressed this issue, but none had sufficient statistical power. Four published meta-analyses have established that overall survival is significantly improved for patients in the more intensive programs of follow-up. This improvement amounts to a risk difference of 7% (95% CI: 3%-12%, P = 0.002) in 5-year survival. This should be partly attributable to more frequent reoperation for cure of asymptomatic recurrence, or more intense follow-up, as well other factors, such increased psychosocial support and well-being, diet and lifestyle optimization, and/or improved treatment of coincidental diseases. A large-scale multicenter European study [Gruppo Italiano di Lavoro per la Diagnosi Anticipata (GILDA)] is underway to answer the question of what constitutes optimal surveillance for patients after primary therapy, based on an adequately powered study. PMID:20333780

  11. Minimal requirements in prostate cancer irradiation: a consensus document by the AIRO Lombardia Cooperative Group.

    PubMed

    Valdagni, R; Bertoni, F; Bossi, A; Caraffini, B; Corbella, F; Italia, C; Källi, M; Leoni, M; Nava, S; Sarti, E; Vavassori, V; Villa, S

    1999-01-01

    With the aim of establishing clinical and technical criteria to homogenize radiotherapy practice, a working group of AIRO-Lombardia (Associazione Italiana di Radioterapia Oncologica--Gruppo regionale della Lombardia) has tried to define minimal requirements for radical and postoperative irradiation in prostate cancer. The document has been structured in such a way as to be also of interest to the urological and medical oncology communities. The working group, composed of representatives of most of the regional radiotherapy departments in the Lombardy region, had monthly meetings during 1996 and 1997. The document on minimal requirements has been derived from the participants' combined experience and knowledge, from review of the literature, and from a 1995 regional survey on current practice of prostate irradiation. Minimal requirements for radical and postoperative irradiation of prostate cancer have been defined with respect to treatment strategies, pre-treatment diagnostic evaluation and staging, treatment prescription, preparation and execution, and quality assurance procedures. Standards of reference for minimal requirements in prostate cancer irradiation adapted to the regional structures and resources have been defined.

  12. Diagnosis of CCSVI in Meniere syndrome.

    PubMed

    Bruno, Aldo; Quarto, Gennaro; Califano, Luigi; Mastrangelo, Diego; De Vizia, Marcella; Salafia, Francesca; Bernardo, Benedetto

    In questo lavoro gli autori hanno valutato la possibilità di diagnosticare l’insufficienza venosa cronica cerebro-spinale (CCSVI) nei pazienti affetti da sindrome di Meniére resistente alle terapie mediche. Da aprile 2013 al luglio 2014 sono stati valutati 140 pazienti, 85 femmine, 55 maschi di età compresa tra 32 a 68 anni, con un’età media di 46 aa, affetti da sindrome di Meniere clinicamente definita secondo i criteri AAO 1995. I pazienti sono stati sottoposti ad un esame eco-colordoppler delle vene del collo e dei vasi venosi intracranici secondo il metodo di Zamboni. L’esame è stato eseguito anche in 100 pazienti sani, non affetti da malattia neurologica o audiovestibolare, di età simile a quella dei pazienti arruolati nello studio. L’incidenza della CCSVI, diagnosticata secondo il protocollo sviluppato dal Prof. Zamboni, nei pazienti con sindrome di Meniere è stata del 90%, con una presenza di lesioni più gravi sul lato interessato in casi unilaterali. Nella popolazione di controllo sono state rilevate anomalie compatibili con la CCSVI in soli tre pazienti (3%) comunque asintomatici. Vi è un’alta incidenza di CCSVI nei pazienti con malattia di Meniere clinicamente definita, in una percentuale tale da mettere in dubbio un evento casuale, soprattutto data la bassa prevalenza nel gruppo di controllo.

  13. Foundry waste recycling in moulding operations and in the ceramic industry.

    PubMed

    Zanetti, Maria Chiara; Fiore, Silvia

    2003-06-01

    An industrial treatment was performed by the Sasil plant of Brusnengo (Biella, Northern Italy), which is part of the Gruppo Minerali S.p.A. (Novara, Northern Italy), to consider the reclamation of bentonite bonded moulding sands obtained from the Teksid Italia S.p.A. cast iron foundry plant in Crescentino (Vercelli, Northern Italy). An evaluation of the fine particles produced by the wet-mechanical regeneration treatment was made with the purpose of proposing their recycling as binding agents in moulding operations in the cast iron foundry and for the production of tiles in the ceramic industry. The pre-mixed product sold by bentonite suppliers (35% coal dust and 65% bentonite, 0.15 Euro/kg) could be made from the recovered fine fraction below 0.025 mm with the addition of active clay and coal dust, thus obtaining a product that will have physico-chemical properties similar to those of calcic bentonite. The improvements due to the addition of the fine particles to the usually employed clay for tile production were also underlined from the results of several baking tests. The recovery and recycling of sands and fine particles obtained from the reclamation of bentonite moulding sands will lead to a saving of raw materials and landfill space, with economic and environmental advantages.

  14. Audit system on Quality of breast cancer diagnosis and Treatment (QT): results of quality indicators on screen-detected lesions in Italy for 2006 and preliminary results for 2007.

    PubMed

    Tomatis, Mariano; Mano, Maria Piera; Baiocchi, Diego; Barca, Alessandra; Bordon, Rita; Casella, Denise; Donati, Giovanni; Berti, Rosa; Filippini, Luigi; Frigerio, Alfonso; Furini, Alessia; Mantellini, Paola; Naldoni, Carlo; Pagano, Giovanni; Ramera, Deborah; Ravaioli, Alessandra; Sapino, Anna; Taffurelli, Mario; Vettorazzi, Marcello; Zorzi, Manuel; Cataliotti, Luigi; Rosselli Del Turco, Marco; Segnan, Nereo; Ponti, Antonio

    2009-01-01

    Within this survey, conducted by the Italian Breast Screening Network (Gruppo Italiano per lo Screening Mammografico, GISMa), individual data are collected yearly on more than 50% of all screen-detected operated lesions in Italy. In 2006, results showed overall good diagnosis and treatment quality and an improving trend over time. Critical issues were identified in waiting times, compliance with recommendations on not performing frozen section examination on small lesions and on performing specimen X-ray. Pre-operative diagnosis reached the acceptable target, but there is a large variation between Regions and programmes. The sentinel lymph node technique (SLN) was performed on the axilla in more than 70% of screen-detected invasive cancers, avoiding a large number of potentially harmful dissections. On the other hand, potential overuse of SLN in ductal carcinoma in situ deserves further investigation. The detailed results have been distributed to regional and local screening programmes, also by means of an online database, in order to allow multidisciplinary discussion and the identification of appropriate solutions to any problems documented by the data. Specialist Breast Units with adequate case volume and enough resources would provide the best setting for making audit effective in producing quality improvement with a shortening of waiting times.

  15. Intermittent pneumatic compression in laparoscopic surgery for prevention of deep vein thrombosis and cellular damage from iatrogenic compartment syndrome.

    PubMed

    Sederino, Maria Grazia; Casamassima, Giulia; Laforgia, Rita; Balducci, Giovanni; Carbotta, Giuseppe; Tromba, Antonella

    In chirurgia laparoscopica l’induzione del pneumoperitoneo (PNP) realizza una sindrome compartimentale iatrogena con ripercussioni sul circolo venoso profondo degli arti inferiori. In questo studio abbiamo voluto valutare l’incidenza di Trombosi Venosa Profonda (TVP) postoperatoria e del danno cellulare da sindrome compartimentale iatrogena analizzando due gruppi di pazienti, ad uno dei quali è stato applicato un dispositivo Sequential Compression Device (SCD). I pazienti selezionati sono stati suddivisi in due gruppi e sono stati sottoposti a chirurgia laparoscopica con durata non inferiore a 90’. È stato rilevato con metodo ECOCOLOR-DOPPLER il flusso venoso degli arti inferiori e soltanto ad uno dei due gruppi è stato applicato un dispositivo SCD. Da novembre 2006 a ottobre 2007 sono stati valutati 35 pz, 21 pz con dispositivo SCD e 14 pz utilizzati come gruppo controllo, con follow-up a 7 gg, 14 gg, 30 gg, a 3 e 5 anni. L’utilizzo di un dispositivo SCD applicato agli arti inferiori consente un aumento del ritorno venoso dagli arti inferiori diminuendone il rischio di TVP.

  16. [Valutazione delle guardie di sicurezza privata attraverso la Suicide Probability Scale e la Brief Symptom Inventory].

    PubMed

    Dogan, Bulent; Canturk, Gurol; Canturk, Nergis; Guney, Sevgi; Özcan, Ebru

    2016-01-01

    RIASSUNTO. Scopo. Lo scopo di questo studio è stato quello di investigare l'influenza della probabilità di suicidio, con le sue caratteristiche sociodemografiche, e di procurare i dati per la prevenzione del suicidio tra le guardie di sicurezza privata che lavorano in condizioni di stress, essendo a contatto ininterrottamente con eventi negativi e traumatici di vita durante il loro lavoro. Metodi. Hanno partecipato allo studio 200 guardie di sicurezza privata e 200 persone dell'Università di Ankara. Per raccogliere i dati sono stati utilizzati un questionario riguardante le condizioni sociodemografiche dei partecipanti, la Suicide Probability Scale (SPS) e la Brief Symptom Inventory (BSI). Risultati. Genere, stato civile, stipendio, credenze religiose, vivere una situazione di pericolo di vita, passato di tentativi di suicidio, fumare e non avere una malattia cronica hanno causato statisticamente una differenza significativa sui punteggi di SPS tra il gruppo di guardie di sicurezza privata e quello di controllo. In aggiunta, c'è stata una correlazione positiva statisticamente significativa tra i punteggi totali delle sottoscale di SPS e quelli di BSI. Conclusioni. Allo stesso modo degli agenti di polizia e dei gendarmi, le guardie di sicurezza privata sono ad alto rischio di commettere e tentare il suicidio trovandosi in condizioni stressanti di lavoro e anche soffrendo del trauma secondario. È necessario che essi siano consapevoli della propria tendenza al suicidio e avere controlli psichiatrici regolari.

  17. Inner ear extension of vestibular schwannomas.

    PubMed

    Falcioni, Maurizio; Taibah, Abdelkader; Di Trapani, Giuseppe; Khrais, Tarek; Sanna, Mario

    2003-09-01

    Inner ear extension of vestibular schwannomas (VSs) is a rare finding but has important clinical implications. This report reviews the treatment options and presents the experience of the Gruppo Otologico, Piacenza, Italy, in this field. Case report and literature review. Five cases of VSs with inner ear extension were surgically removed. In all of them, the cochlea was partially or completely invaded by the lesion. In 4 cases, the inner ear extension was preoperatively identified on magnetic resonance imaging, and the surgical removal was planned through a transotic approach. In the last case, the cochlear invasion was not detected preoperatively, and the lesion was removed during a second surgery performed to seal a cerebrospinal fluid fistula. VSs with inner ear extension should be distinguished from pure intralabyrinthine schwannomas because of differences in clinical significance. Cochlear involvement is more frequent than vestibular involvement and is often accompanied by a dead ear. Dead ear caused by small VSs should alert the surgeon to the possibility of a cochlear extension. The presence of an intracochlear involvement requires the adoption of an approach that allows control of the cochlear turns, and we found the transotic approach to be the most suitable. Undetected cochlear extensions that are left in place may grow with time.

  18. A History of Streptokinase Use in Acute Myocardial Infarction

    PubMed Central

    Sikri, Nikhil; Bardia, Amit

    2007-01-01

    A serendipitous discovery by William Smith Tillett in 1933, followed by many years of work with his student Sol Sherry, laid a sound foundation for the use of streptokinase as a thrombolytic agent in the treatment of acute myocardial infarction. The drug found initial clinical application in combating fibrinous pleural exudates, hemothorax, and tuberculous meningitis. In 1958, Sherry and others started using streptokinase in patients with acute myocardial infarction and changed the focus of treatment from palliation to “cure.” Initial trials that used streptokinase infusion produced conflicting results. An innovative approach of intracoronary streptokinase infusion was initiated by Rentrop and colleagues in 1979. Subsequently, larger trials of intracoronary infusion achieved reperfusion rates ranging from 70% to 90%. The need for a meticulously planned and systematically executed randomized multicenter trial was fulfilled by the Gruppo Italiano per la Sperimentazione della Streptochinasi nell'Infarto Miocardico (GISSI) trial in 1986, which not only validated streptokinase as an effective therapeutic method but also established a fixed protocol for its use in acute myocardial infarction. Currently, despite the wide use of tissue plasminogen activator in developed nations, streptokinase remains essential to the management of acute myocardial infarction in developing nations. PMID:17948083

  19. Antiarrhythmic effects of omega-3 fatty acids.

    PubMed

    Reiffel, James A; McDonald, Arline

    2006-08-21

    Fish oil, and omega-3 fatty acids in particular, have been found to reduce plasma levels of triglycerides and increase levels of high-density lipoprotein in patients with marked hypertriglyceridemia, and a pharmaceutical-grade preparation has recently received approval from the US Food and Drug Administration to market for this purpose. However, in both bench research studies and clinical trials, evidence for clinically significant antiarrhythmic properties has also been detected in association with omega-3 fatty acid intake. Arguably the most significant finding in this data set was the reduction in the incidence of sudden death in survivors of myocardial infarction in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI)-Prevenzione trial and the subsequent recommendation for administration of fish oil as part of the postinfarction regimen in Europe. This article reviews in detail the basic and clinical research studies of fish oil as an antiarrhythmic entity, the forms of preparation and/or administration that appear to possess these properties and those that do not, the types of arrhythmias (ventricular ectopy and atrial fibrillation as well as ventricular tachyarrhythmias) that have been beneficially affected by fish oil administration, and the presumed and known mechanisms by which the beneficial actions are exerted.

  20. Quality of life in elderly cancer patients.

    PubMed

    Repetto, L; Ausili-Cefaro, G; Gallo, C; Rossi, A; Manzione, L

    2001-01-01

    Increasing age is a major risk factor for developing cancer and the number of older people is rapidly expanding. Therefore, cancer in the geriatric population is becoming an emerging problem. Older patients are extremely heterogeneous. Instruments collecting information related to comorbidity and disability, (which have both been demonstrated to affect the survival of elderly patients) may help treatment decision. The G.I.O.Ger (Gruppo Italiano di Oncologia Geriatrica) has validated a Comprehensive Geriatric Assessment (CGA) scale for geriatric cancer patients, and we recommend its use in clinical practice. Our findings suggest that cancer adversely affects physical performance and psychological status less than other comorbidities. Many aspects of physical limitations are not totally recognised by performance status, in particular those aspects of daily life that require instrumental activities and that may affect adherence to diagnostic or therapeutic protocols. Quality of life as a main objective in the management of elderly cancer patients is now recognized by many clinicians. In clinical practice. quality of life means maintenance of function and symptom control, and quality-of-life instruments rated by the patient rather than by clinicians should be preferred. Whether it is preferable to use cancer-specific or generic instruments is an ongoing debate.

  1. A challenging diagnosis for potential fatal diseases: recommendations for diagnosing acute porphyrias.

    PubMed

    Ventura, Paolo; Cappellini, Maria Domenica; Biolcati, Gianfranco; Guida, Claudio Carmine; Rocchi, Emilio

    2014-07-01

    Acute porphyrias are a heterogeneous group of metabolic disorders resulting from a variable catalytic defect of four enzymes out of the eight involved in the haem biosynthesis pathway; they are rare and mostly inherited diseases, but in some circumstances, the metabolic disturbance may be acquired. Many different environmental factors or pathological conditions (such as drugs, calorie restriction, hormones, infections, or alcohol abuse) often play a key role in triggering the clinical exacerbation (acute porphyric attack) of these diseases that may often mimic many other more common acute medical and neuropsychiatric conditions and whose delayed diagnosis and treatment may be fatal. In order to obtain an accurate diagnosis of acute porphyria, the knowledge and the use of appropriate diagnostic tools are mandatory, even in order to provide as soon as possible the more effective treatment and to prevent the use of potentially unsafe drugs, which can severely precipitate these diseases, especially in the presence of life-threatening symptoms. In this paper, we provide some recommendations for the diagnostic steps of acute porphyrias by reviewing literature and referring to clinical experience of the board members of the Gruppo Italiano Porfiria (GrIP).

  2. Consensus document on controversial issues in the diagnosis and treatment of bloodstream infections and endocarditis.

    PubMed

    Boumis, Evangelo; Gesu, Giovanni; Menichetti, Francesco; Ranieri, Marco; Rinaldi, Mauro; Suter, Fredy; Nicastri, Emanuele; Lauria, Francesco N; Carosi, Giampiero; Moroni, Mauro; Ippolito, Giuseppe

    2010-10-01

    The treatment of severe bloodstream infections (sepsis, endocarditis, and infections of vascular prostheses) caused by Gram-positive microorganisms is made even more difficult by the emergence of resistant strains. The introduction of new antibiotics with activity against these strains has created new opportunities, but many controversial issues remain. The aim of this GISIG (Gruppo Italiano di Studio sulle Infezioni Gravi) working group - a panel of multidisciplinary experts - was to define recommendations for some controversial issues using an evidence-based and analytical approach. The controversial issues concerned the duration of therapy and role of aminoglycosides and teicoplanin in the treatment of Gram-positive bacterial endocarditis, the optimal use of the new antibiotics in the treatment of bloodstream infections caused by resistant Gram-positive strains, and the use of microbiological techniques (i.e., bactericidal serum testing and synergy testing) and of pharmacokinetic data (e.g., monitoring of plasma levels of antibiotics) in the treatment of difficult-to-treat Gram-positive bloodstream infections. A systematic literature search of randomized controlled trials and/or non-randomized studies was performed mainly using the MEDLINE database. A matrix was created to extract evidence from original studies using the CONSORT method to evaluate randomized clinical trials and the Newcastle-Ottawa Quality Assessment Scale for non-randomized studies. The GRADE method for grading the quality of evidence and strength of recommendation was applied. Copyright © 2010 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  3. Imaging detection of new HCCs in cirrhotic patients treated with different techniques: Comparison of conventional US, spiral CT, and 3-dimensional contrast-enhanced US with the Navigator technique (Nav 3D CEUS)().

    PubMed

    Giangregorio, F; Comparato, G; Marinone, M G; Di Stasi, M; Sbolli, G; Aragona, G; Tansini, P; Fornari, F

    2009-03-01

    Sommario INTRODUZIONE: Il sistema “Navigator” di Esaote consente di ottenere ricostruzioni 3-D di tutto il fegato (corrette volumetricamente da un sistema di guida) mediante singola acquisizione con CEUS (mediante scansione perpendicolare all'asse lungo del fegato, per una completa acquisizione 2-D del suo asse corto) e sovrappone tali ricostruzioni 3-D con quelle ottenute con la TC. SCOPO: valutare la capacità di tale sistema di diagnosticare nuovi HCC rispetto all'US e alla TC in una popolazione di HCC su cirrosi precedentemente trattati con varie metodiche. MATERIALI E METODI: Settantadue cirrotici con pregressi HCC (M/F: 38/34; tutti HCV +vi, Child A/B: 58/14, con detection di 49 nuovi noduli (N) in 34 pazienti; 10 nuovi HCC multinodulari (NMulti); 6 riprese locali di malattia (Ri) in 4 pazienti (3 riprese singole, in un paziente tre noduli con ripresa di malattia); 47 HCC trattati efficacemente (neg) in 22 pazienti + 2 pazienti con HCC multinodulare senza segni di ripresa (neg-Multi) sono stati sottoposti a 100 esami (1 esame: 48 pazienti; 2 esami: 20 pazienti; 3 esami: 4 pazienti) dal 1 novembre 2006 al novembre 2007. La Nav 3D CEUS è stata eseguita con SonoVue (BR1; Bracco) e con l'ecografo Esaote MPX collegato a un sistema “Navigator” con software di ricostruzione 3-D dedicato. La TC spirale di controllo è stata eseguita entro 30 giorni dall'esecuzione di Nav 3D CEUS. Sono stati valutati sensibilità, specificità, accuratezza diagnostica (ODA), valore predittivo positivo (PPV) e negativo (NPV). RISULTATI: La diagnosi finale fu: 34 pazienti con 49 nuove lesioni (N), 10 con HCC multiN e 6 recidive loco-regionali in 4 pazienti; 47 noduli in 24 pazienti senza nuove lesioni durante il follow-up. Gli US hanno ottenuto: 29 N (+5 multinodularN e 3 LR), 20 falsi negativi (+5 Nmulti e 3 LR) (sensibilità: 59,2, specificità: 100%; accuratezza diagnostica: 73;6; VPP: 100; VPN: 70, 1); la TC spirale ha ottenuto: 42 N (+9 multinodularN e 7 LR), 7 falsi

  4. Integrated clinical-ultrasonographic diagnosis in acute appendicitis.

    PubMed

    Summa, M; Perrone, F; Priora, F; Testa, S; Quarati, R; Spinoglio, G

    2007-12-01

    Sommario SCOPO: L'appendicite acuta è una delle urgenze chirurgiche addominali più comuni. Se non trattata, può rapidamente progredire verso complicanze severe, quali la perforazione e la peritonite. Spesso i chirurghi optano per un intervento chirurgico precoce anche in caso di diagnosi solo probabile, con il rischio di eseguire una quota importante di appendicectomie inutili. Lo scopo dello studio è di analizzare la nostra esperienza con la diagnosi integrata clinico-ultrasonografica dell'appendicite acuta. MATERIALI E METODI: Durante il periodo gennaio 1999-dicembre 2006 1447 pazienti sono stati sottoposti a valutazione clinica, a conta leucocitaria, dosaggio della proteina C reattiva ed ecografia addominale. È stata utilizzata la tecnica ecografia di compressione graduale, con sonda ad alta frequenza. RISULTATI: È stata formulata diagnosi ecografica di appendicite acuta in 368 pazienti (25%). Ulteriori 8 pazienti sono stati operati sulla base del solo giudizio clinico. Abbiamo osservato 7 casi di falsi positivi ecografici. In 1079 (75% del totale) pazienti è stato espresso un giudizio diagnostico negativo per appendicite acuta: in 173 di essi (12%) è stata formulata una diagnosi diversa. I restanti 906 pazienti sono stati sottoposti a controllo clinico fino alla risoluzione della sintomatologia, senza alcuna complicanza. I nostri risultati hanno dimostrato una sensibilità dell'ecografia del 98%, una specificità del 99%, un valore predittivo positivo del 98% e un valore predittivo negativo del 99%. L'accuratezza diagnostica globale è stata del 99%. CONCLUSIONI: La diagnosi integrata (clinica, di laboratorio ed ecografica) dell'appendicite acuta consente una diagnosi sicura, con risparmio di risorse evitando il ricorso ad appendicectomie inutili.

  5. Diagnostic value of contrast-enhanced ultrasonography in the characterization of ovarian tumors().

    PubMed

    Sconfienza, L M; Perrone, N; Delnevo, A; Lacelli, F; Murolo, C; Gandolfo, N; Serafini, G

    2010-03-01

    Sommario INTRODUZIONE: La ricchezza della componente vascolare dei tumori ginecologici influenza le caratteristiche dell'imaging diretto, utilizzando metodiche che evidenziano la componente macrovascolare delle lesioni (color e power Doppler), e di quello indiretto, mediante somministrazione di mezzi di contrasto (MdC) per lo studio del microcircolo e della perfusione interstiziale. Lo scopo di questo lavoro è di valutare l'aggiunta di informazioni diagnostiche fornite dalla valutazione ecografica con MdC nello studio delle lesioni ovariche. MATERIALI E METODI: Abbiamo valutato 72 lesioni annessiali in 61 pazienti con lesioni ovariche di incerta interpretazione mediante somministrazione di 4,8 ml di MdC ecoamplificatore di II generazione. Per ogni lesione, abbiamo valutato la morfologia basale, quella contrastografica e le curve intensità/tempo. RISULTATI: La valutazione post-contrasto confrontata con la basale non ha apportato informazioni aggiuntive morfovascolari in 8 pazienti (13,1%); in 38 pazienti (62,3%) ha apportato informazioni senza modifiche del comportamento clinico; in 15 soggetti (24,6%) ha apportato elementi che hanno modificato il comportamento clinico. Le lesioni maligne presentavano valori di tempo massimo di enhancement significativamente minori (11,9 ± 3,1 s vs 19,8 ± 4,0 s p < 0,01) e intensità di picco massimo significativamente maggiore (24,7 ± 4,2 dB vs 17,8 ± 3,3 dB p < 0,01) rispetto alle lesioni benigne. CONCLUSIONI: La CEUS consente di migliorare la confidenza diagnostica nelle lesioni liquide corpuscolate in cui l'indagine convenzionale non risulta dirimente, proponendosi nella diagnosi differenziale di un limitato numero di lesioni complesse, in alternativa a TC ed RM. Le informazioni ottenute influenzano tuttavia il successivo iter diagnostico e terapeutico in una limitata percentuale di casi (24,6%).

  6. Influence of fear of movement on total knee arthroplasty outcome.

    PubMed

    Kocic, Mirjana; Stankovic, Anita; Lazovic, Milica; Dimitrijevic, Lidija; Stankovic, Ivona; Spalevic, Marija; Stojiljkovic, Predrag; Milenkovic, Marina; Stojanovic, Zorica; Nikolic, Dejan

    2015-01-01

    RiassuntoLo scopo dello studio è quello di verificare l’incidenza del timore postoperatorio ai movimenti nei pazienti sottoposti ad artroplastica totale del ginocchio (TKA) e di determinare l’associazione di questo timore con i provvedimenti da adottare. Lo studio prospettico riguarda 78 pazienti sottoposti ad TKA primaria per osteoartrite. L’incidenza di timore al movimento è stata detenninata con l’uso della Tampa Scale of Kinesiophobia (TSK). I pazienti sono stati valutati in tre fasi temporali: 2 settimane. 4 settimane e 6 mesi dopo l’intervento chirurgico. In tutte e tre le fasi sono stati valutati il dolore e l’entità della flessione, mentre l’aspetto funzionale è stato preso in considerazione soltanto sei mesi dopo l’intervento, secondo la Oxford knee score 1. Il timore al movimento è stato registrato in 17 pazienti (21,8%). Quelli con maggiore entità di timore hanno dimostrato di conseguire risultati significativamente meno buoni in termini di dolore, grado di flessione e funzionalità rispetto a quelli con limitata paura. Miglioramento del dolore e della flessione sono stati progressivamente conseguiti nel tempo in entrambi i gruppi, ma i risultati migliori vengono raggiunti nel gruppo con minore paura al movimento. Lo studio ha dimostrato che la paura postoperatoria alla motilità si associa significativamente con il dolore, l’entità della flessione e la funzionalità del ginocchio. Altri Autori haImo rilevato che il timore preoperatorio alla motilità del ginocchio fa prevedere limitazioni funzionali postoperatorie. In conclusione il timore della motilità si rileva in una significativa proporzione dei pazienti dopo TKA e si associa con gonalgia, e minore flessione e funzionalità, e dunaue questa paura rappresenta un richio di scarsi risultati dopo artroplastica totale del ginocchio.

  7. Eyelid dermatitis: an evaluation of 447 patients.

    PubMed

    Ayala, Fabio; Fabbrocini, Gabriella; Bacchilega, Roberto; Berardesca, Enzo; Caraffini, Stefano; Corazza, Monica; Flori, Maria Laura; Francalanci, Stefano; Guarrera, Marcella; Lisi, Paolo; Santucci, Baldassarre; Schena, Donatella; Suppa, Francesco; Valsecchi, Rossano; Vincenzi, Colombina; Balato, Nicola

    2003-06-01

    Eyelids can be affected by various types of dermatitis that are often difficult to diagnose. The aim of the study was to establish some guidelines for a correct diagnosis. A total of 447 patients treated at 12 research units for eczema or other inflammatory dermatitis located on the eyelids were invited to complete a questionnaire. When necessary, patch tests with haptens of the standard series from Gruppo Italiano di Ricerca sulle Dermatiti da Contatto e Ambientali della Società Italiana di Dermatologia e Venereologia (SIDEV-GIRDCA) were performed. Of the subjects studied, 50.2 % were diagnosed with allergic contact dermatitis (ACD); 20.9% were affected by irritant contact dermatitis (ICD), 13.5% by atopic dermatitis, 6.3% by seborrheic dermatitis, 6.5% by aspecific xerotic dermatitis, and 2.3% by psoriasis. Approximately 91% of all subjects reported an absence of familial atopy. A significant statistical association between diagnosis type and a personal history of atopy was evident (p <.000001, chi-square test). The results of gradual logistic regression models showed four-eyelid involvement as the main risk factor for ACD (odds ratio [OR] = 3.0; 95% CI, 1.1-8.1); with ICD, the main risk factor was the onset of symptoms at between 2 and 6 months (OR = 2.1; 95% CI, 1.1-4.0), whereas for atopic dermatitis, the main risk factors were the onset of symptoms later than 6 months and a personal history of atopy (OR = 4.9 and 3.6, respectively). Results suggest that many characteristics of the patients examined can be used for the differential diagnosis of palpebral eczematous dermatitis.

  8. WebEQ: a web-GIS System to collect, display and query data for the management of the earthquake emergency in Central Italy

    NASA Astrophysics Data System (ADS)

    Carbone, Gianluca; Cosentino, Giuseppe; Pennica, Francesco; Moscatelli, Massimiliano; Stigliano, Francesco

    2017-04-01

    After the strong earthquakes that hit central Italy in recent months, the Center for Seismic Microzonation and its applications (CentroMS) was commissioned by the Italian Department of Civil Protection to conduct the study of seismic microzonation of the territories affected by the earthquake of August 24, 2016. As part of the activities of microzonation, IGAG CNR has created WebEQ, a management tool of the data that have been acquired by all participants (i.e., more than twenty research institutes and university departments). The data collection was organized and divided into sub-areas, assigned to working groups with multidisciplinary expertise in geology, geophysics and engineering. WebEQ is a web-GIS System that helps all the subjects involved in the data collection activities, through tools aimed at data uploading and validation, and with a simple GIS interface to display, query and download geographic data. WebEQ is contributing to the creation of a large database containing geographical data, both vector and raster, from various sources and types: - Regional Technical Map em Geological and geomorphological maps em Data location maps em Maps of microzones homogeneous in seismic perspective and seismic microzonation maps em National strong motion network location. Data loading is done through simple input masks that ensure consistency with the database structure, avoiding possible errors and helping users to interact with the map through user-friendly tools. All the data are thematized through standardized symbologies and colors (Gruppo di lavoro MS 2008), in order to allow the easy interpretation by all users. The data download tools allow data exchange between working groups and the scientific community to benefit from the activities. The seismic microzonation activities are still ongoing. WebEQ is enabling easy management of large amounts of data and will form a basis for the development of tools for the management of the upcoming seismic emergencies.

  9. Chronic myeloid leukemia: a prospective comparison of interphase fluorescence in situ hybridization and chromosome banding analysis for the definition of complete cytogenetic response: a study of the GIMEMA CML WP.

    PubMed

    Testoni, Nicoletta; Marzocchi, Giulia; Luatti, Simona; Amabile, Marilina; Baldazzi, Carmen; Stacchini, Monica; Nanni, Mauro; Rege-Cambrin, Giovanna; Giugliano, Emilia; Giussani, Ursula; Abruzzese, Elisabetta; Kerim, Simonetta; Grimoldi, Maria Grazia; Gozzetti, Alessandro; Crescenzi, Barbara; Carcassi, Carlo; Bernasconi, Paolo; Cuneo, Antonio; Albano, Francesco; Fugazza, Giuseppina; Zaccaria, Alfonso; Martinelli, Giovanni; Pane, Fabrizio; Rosti, Gianantonio; Baccarani, Michele

    2009-12-03

    In chronic myeloid leukemia, different methods are available to monitor the response to therapy: chromosome banding analysis (CBA), interphase fluorescence in situ hybridization (I-FISH), and real-time quantitative polymerase chain reaction (RT-Q-PCR). The GIMEMA CML WP (Gruppo Italiano Malattie Ematologiche Adulto Chronic Myeloid Leukemia Working Party) has performed a prospective study to compare CBA and I-FISH for the definition of complete cytogenetic response (CCgR). Samples (n = 664) were evaluated simultaneously by CBA and I-FISH. Of 537 cases in CCgR, the number of positive nuclei by I-FISH was less than 1% in 444 cases (82.7%). Of 451 cases with less than 1% positive nuclei by I-FISH, 444 (98.4%) were classified as CCgR by CBA. The major molecular response rate was significantly greater in cases with I-FISH less than 1% than in those with I-FISH 1% to 5% (66.8% vs 51.6%, P < .001) and in cases with CCgR and I-FISH less than 1% than in cases with CCgR and I-FISH 1% to 5% (66.1% vs 49.4%, P = .004). I-FISH is more sensitive than CBA and can be used to monitor CCgR. With appropriate probes, the cutoff value of I-FISH may be established at 1%. These trials are registered at http://www.clinicaltrials.gov as NCT00514488 and NCT00510926.

  10. Optimal distributed control of a diffuse interface model of tumor growth

    NASA Astrophysics Data System (ADS)

    Colli, Pierluigi; Gilardi, Gianni; Rocca, Elisabetta; Sprekels, Jürgen

    2017-06-01

    In this paper, a distributed optimal control problem is studied for a diffuse interface model of tumor growth which was proposed by Hawkins-Daruud et al in Hawkins-Daruud et al (2011 Int. J. Numer. Math. Biomed. Eng. 28 3-24). The model consists of a Cahn-Hilliard equation for the tumor cell fraction φ coupled to a reaction-diffusion equation for a function σ representing the nutrient-rich extracellular water volume fraction. The distributed control u monitors as a right-hand side of the equation for σ and can be interpreted as a nutrient supply or a medication, while the cost function, which is of standard tracking type, is meant to keep the tumor cell fraction under control during the evolution. We show that the control-to-state operator is Fréchet differentiable between appropriate Banach spaces and derive the first-order necessary optimality conditions in terms of a variational inequality involving the adjoint state variables. The financial support of the FP7-IDEAS-ERC-StG #256872 (EntroPhase) and of the project Fondazione Cariplo-Regione Lombardia MEGAsTAR ‘Matematica d’Eccellenza in biologia ed ingegneria come accelleratore di una nuona strateGia per l’ATtRattività dell’ateneo pavese’ is gratefully acknowledged. The paper also benefited from the support of the MIUR-PRIN Grant 2015PA5MP7 ‘Calculus of Variations’ for PC and GG, and the GNAMPA (Gruppo Nazionale per l’Analisi Matematica, la Probabilità e le loro Applicazioni) of INdAM (Istituto Nazionale di Alta Matematica) for PC, GG and ER.

  11. [Valutazione del carico gestionale in un centro diurno psichiatrico: gravosità e recovery style].

    PubMed

    Callegari, Camilla; Caselli, Ivano; Bertù, Lorenza; Berto, Emanuela; Vender, Simone

    2016-01-01

    RIASSUNTO. Scopo. Nella riabilitazione psichiatrica il piano di trattamento individuale può essere formulato a partire da strumenti che offrano una valutazione multidimensionale del paziente. Il lavoro si propone di analizzare il rapporto tra gravosità (distress degli operatori) e stile di recupero (integration e sealing over) dalla patologia psicotica. Ipotizzando che esso influenzi il carico gestionale, lo studio si pone l'ulteriore obiettivo di acquisire maggiori elementi che indirizzino la formulazione di piani terapeutico-riabilitativi più efficaci. Metodi. Lo studio è stato condotto presso un centro diurno psichiatrico, struttura semi-residenziale dei servizi psichiatrici del Sistema Sanitario Nazionale in Italia. 45 pazienti reclutati sono stati valutati mediante la Neuropsychiatric Inventory (NPI - versione italiana) e la Integration/Sealing Over Scale (ISOS - versione italiana), nell'arco di tre mesi (marzo-giugno 2014). Risultati. Nel campione esaminato è emerso che la disinibizione, l'irritabilità e l'apatia sono i sintomi che provocano maggiore distress negli operatori, in senso assoluto. Inoltre, i risultati indicano che depressione e ansia recano un grado maggiore di distress nei pazienti sealer. Discussione e conclusione. Gli aspetti della disinibizione, dell'irritabilità e dell'apatia sono risultati più gravosi per gli operatori in quanto richiedono maggiore coinvolgimento nella relazione terapeutica. Sintomi ansiosi e depressivi risultano più gravosi nel gruppo dei sealer, segnalando minore tenuta della negazione della psicosi. I dati osservati sembrano provare che conoscere, differenziare e approfondire i diversi aspetti dello stile di recupero di ciascun paziente consente di stimare l'impegno gestionale fin dalla presa in carico e di ridurre il distress e il rischio di burnout degli operatori.

  12. Pegfilgrastim administration after 24 or 72 or 96 h to allow dose-dense anthracycline- and taxane-based chemotherapy in breast cancer patients: a single-center experience within the GIM2 randomized phase III trial.

    PubMed

    Lambertini, Matteo; Bruzzi, Paolo; Poggio, Francesca; Pastorino, Simona; Gardin, Giovanni; Clavarezza, Matteo; Bighin, Claudia; Pronzato, Paolo; Del Mastro, Lucia

    2016-03-01

    To evaluate the safest timing of pegfilgrastim administration in dose-dense anthracycline- and taxane-based chemotherapy, three different cohorts of patients enrolled in the Gruppo Italiano Mammella (GIM) 2 study and treated at the coordinating center received pegfilgrastim 24 h (cohort A) or 72 h (cohort B) or 96 h (cohort C) after chemotherapy. A total of 41 patients were included. The safety of pegfilgrastim administration in terms of occurrence of early and late leukocytosis and the behavior of white blood cells (WBC) counts in the three cohorts across all chemotherapy cycles were evaluated. Anthracycline and taxane cycles were analyzed separately. The occurrence of early leukocytosis was a more common event in patients in cohort A in both anthracycline and taxane cycles (75 and 66.7%) as compared to cohort B (50 and 60%) and cohort C (66.7 and 33.3%). More patients in cohort C developed late leukocytosis in both anthracycline and taxane cycles (50 and 100%) as compared to cohort A (0 and 66.7%) and cohort B (35.7 and 86.7%). Patients in cohort A experienced the highest median value of WBC count 24 h after pegfilgrastim administration in both anthracycline and taxane cycles (61.2 × 10(3)/μl and 67.8 × 10(3)/μl). Patients in cohort C experienced the highest median value of WBC count at day 13 in both anthracycline and taxane cycles (19.4 × 10(3)/μl and 24.2 × 10(3)/μl). For the prevention of leukocytosis, the safest timing of pegfilgrastim administration based on WBC count in dose-dense anthracycline- and taxane-based regimens seems to be 72 h after chemotherapy. This study is registered with https://clinicaltrials.gov/ct2/show/NCT00433420.

  13. The PAX5 gene is frequently rearranged in BCR-ABL1-positive acute lymphoblastic leukemia but is not associated with outcome. A report on behalf of the GIMEMA Acute Leukemia Working Party

    PubMed Central

    Iacobucci, Ilaria; Lonetti, Annalisa; Paoloni, Francesca; Papayannidis, Cristina; Ferrari, Anna; Storlazzi, Clelia Tiziana; Vignetti, Marco; Cilloni, Daniela; Messa, Francesca; Guadagnuolo, Viviana; Paolini, Stefania; Elia, Loredana; Messina, Monica; Vitale, Antonella; Meloni, Giovanna; Soverini, Simona; Pane, Fabrizio; Baccarani, Michele; Foà, Robin; Martinelli, Giovanni

    2010-01-01

    Background Recently, in genome-wide analyses of DNA copy number abnormalities using single nucleotide polymorphism microarrays, genetic alterations targeting PAX5 were identified in over 30% of pediatric patients with acute lymphoblastic leukemia. So far the occurrence of PAX5 alterations and their clinical correlation have not been investigated in adults with BCR-ABL1-positive acute lymphoblastic leukemia. Design and Methods The aim of this study was to characterize the rearrangements on 9p involving PAX5 and their clinical significance in adults with BCR-ABL1-positive acute lymphoblastic leukemia. Eighty-nine adults with de novo BCR-ABL1-positive acute lymphoblastic leukemia were enrolled into institutional (n=15) or GIMEMA (Gruppo Italiano Malattie EMatologiche dell’Adulto) (n=74) clinical trials and, after obtaining informed consent, their genome was analyzed by single nucleotide polymorphism arrays (Affymetrix 250K NspI and SNP 6.0), genomic polymerase chain reaction analysis and re-sequencing. Results PAX5 genomic deletions were identified in 29 patients (33%) with the extent of deletions ranging from a complete loss of chromosome 9 to the loss of a subset of exons. In contrast to BCR-ABL1-negative acute lymphoblastic leukemia, no point mutations were found, suggesting that deletions are the main mechanism of inactivation of PAX5 in BCR-ABL1-positive acute lymphoblastic leukemia. The deletions were predicted to result in PAX5 haploinsufficiency or expression of PAX5 isoforms with impaired DNA-binding. Deletions of PAX5 were not significantly correlated with overall survival, disease-free survival or cumulative incidence of relapse, suggesting that PAX5 deletions are not associated with outcome. Conclusions PAX5 deletions are frequent in adult BCR-ABL1-positive acute lymphoblastic leukemia and are not associated with a poor outcome. PMID:20534699

  14. Laparoscopic intra-operative ultrasound in liver and pancreas resection: Analysis of 93 cases.

    PubMed

    Piccolboni, D; Ciccone, F; Settembre, A; Corcione, F

    2010-03-01

    Sommario INTRODUZIONE: L’ispezione laparoscopica in chirurgia del pancreas o del fegato è un approccio ampiamente utilizzato. L’aggiunta dell’ecografia intra-operatoria alla laparoscopia ha di recente ulteriormente migliorato la valutazione chirurgica. Lo scopo di questo studio è stato di valutare l’impatto dell’ecografia intra-operatoria open (IOUS) o laparoscopica (LIOUS) in chirurgia del fegato e del pancreas. MATERIALI E METODI: Negli anni 2005–2008, 45 pazienti, di età 42–75 anni, sono stati selezionati per chirurgia epatica resettiva e 48 pazienti, di età 14–72 anni, per resezione parziale del pancreas. L’ecografia intra-operatoria è stata effettuata per mezzo di un apparecchio Aloka SSD-550 (Aloka, Tokyo, Giappone), con sonda lineare laparoscopica a punta flessibile e sonda elettronica lineare a T. RISULTATI: Tra i pazienti epatici, la LIOUS ha evitato inutili laparotomie in sei pazienti (13,3%) ed, insieme alla IOUS, ha consentito di trovare noduli non diagnosticati ed ha cambiato la strategia chirurgica in cinque pazienti (11,1%). Nel gruppo pancreas, la LIOUS ha escluso 7 pazienti (14,4%) dalla chirurgia radicale, per infiltrazione della vena mesenterica, coinvolgimento dei linfonodi celici o para-aortici, micro-metastasi epatiche e peritoneali. In 11 lesioni benigne, ha consentito la definizione dei rapporti con il dotto di Wirsung ed i vasi splenici, in 6 ha guidato l’aspirazione di liquido per analisi chimiche e citologiche. CONCLUSIONI: Nella nostra esperienza la LIOUS e la IOUS hanno avuto la massima importanza sia nella selezione dei pazienti per la chirurgia resettiva e nel pianificare l’approccio chirurgico, influenzando la strategia chirurgica in 11 pazienti epatici (24,4%) e 13 pazienti pancreatici (27%).

  15. Real-world experience of tocilizumab in rheumatoid arthritis: sub-analysis of data from the Italian biologics' register GISEA.

    PubMed

    Iannone, F; Ferraccioli, G; Sinigaglia, L; Favalli, E G; Sarzi-Puttini, P; Atzeni, F; Gorla, R; Bazzani, C; Govoni, M; Farina, I; Gremese, E; Carletto, A; Giollo, A; Galeazzi, M; Foti, R; Bianchino, L; La Grasta, L; Lapadula, G

    2017-10-05

    To assess the long-term effectiveness and safety of tocilizumab, abatacept, and tumor necrosis factor-α inhibitors (TNFi), in the Italian real-world setting of rheumatoid arthritis (RA). The records of adult RA patients from the Italian biologics' registry Gruppo Italiano Studio Early Arthritis (GISEA) were analyzed. Demographic and clinical data were obtained at entry. The disease remission rate (28-joint disease activity score calculated using the erythrocyte sedimentation rate [DAS28-ESR] ≤ 2.6) and frequency of adverse events (AEs) were evaluated at 2 years. From 1999 to 2014, 7539 patients were treated with biologics (61.3% in first- and 22.6% in second-line), 68% of cases received TNFi, 9.1% tocilizumab, and 8.6% abatacept. Treatment groups showed a similar DAS28 at entry. As first-line, tocilizumab induced a significantly higher remission rate than abatacept or TNFi at 6 (51 vs 23.3 and 26.2%, respectively; p < 0.0001) and 24 months (52.3 vs 33.3 and 34.4%, respectively; p < 0.01). A similar pattern was observed in later lines. The most common AEs reported were infections, reactions to biologics (more frequent among TNFi-treated patients), increased transaminase (more frequent among TCZ-treated patients), and cardiovascular events. In clinical practice, TCZ induced a rapid and long-lasting remission and in a higher percentage of patients compared to abatacept and TNFi, with a good safety profile.

  16. Aspirin in polycythemia vera and essential thrombocythemia: current facts and perspectives.

    PubMed

    Landolfi, R; Patrono, C

    1996-09-01

    The role of aspirin in the antithrombotic strategy of patients with polycythemia vera (PV) and essential thrombocythemia (ET) is highly controversial. Long considered unsafe on the basis of a single clinical trial testing very high doses in PV patients, aspirin is being increasingly used at lower dosage. The rationale for the use of aspirin in patients with PV and ET is provided by the efficacy of this agent in the treatment of microcirculatory disturbances of thrombocythemic states associated with myeloproliferative disorders and by recent evidence that asymptomatic PV and ET patients have persistently increased thromboxane (TX) A2-biosynthesis. This increase, which most likely reflects enhanced platelet activation in vivo, is independent of the platelet mass and blood viscosity and largely supressed by a short term low-dose aspirin regimen (50 mg/day for 7 days). Since enhanced TXA2 biosynthesis may play a role in transducing the increased thrombotic risk associated with PV and ET, long-term low-dose aspirin administration has been proposed as a possible antithombotic strategy in these subjects. The safety of this treatment in PV patients has been recently reassessed by the Gruppo Italiano per lo Studio della Policitemia Vera (GISP) which has followed for over one year 112 patients randomized to receive 40 mg/day aspirin or placebo. In the same study, serum TXB2 measurements provided evidence that the low-dose aspirin regimen tested was fully effective in inhibiting platelet cyclooxygenase activity. On this basis, a large scale trial aimed at assessing the antithrombotic efficacy of this approach is currently being organized. In patients with ET both the minimal aspirin dose required for complete inhibition of platelet cyclooxygenase and the safety of long-term aspirin administration need to be established prior to extensive clinical evaluation of this strategy.

  17. Stability analysis of the Ischia Mt. Nuovo block, Italy, under extreme seismic shaking

    NASA Astrophysics Data System (ADS)

    Ausilia Paparo, Maria; Tinti, Stefano

    2016-04-01

    In this work we investigate the equilibrium conditions of the Mt. Nuovo block, a unit that is found on the northwestern flank of Mt. Epomeo in the Ischia Island, Italy, using the Minimum Lithostatic Deviation Method (Tinti and Manucci 2006, 2008; Paparo et al. 2013). The block, involved in a deep-seated gravitational slope deformation (DSGSD, Della Seta et al., 2012) process, forms an interesting scenario to study earthquake-induced instability because i) Ischia is a seismically active volcanic island; ii) the slopes of Mt. Epomeo are susceptible to mass movements; iii) there exist an abundant literature on historical local seismicity and on slope geology. In our slope stability analysis, we account for seismic load by means of peak ground acceleration (PGA) values taken from Italian seismic hazard maps (Gruppo di Lavoro MPS, 2004), and integrated with estimates based on local seismicity and suitable (MCS) I - PGA regression laws. We find that the Mt Nuovo block could not be destabilised by the 1883 Casamicciola earthquake (that is the largest known historical earthquake in the island taking place on a fault to the north of the block), but we find also that if an earthquake of the same size occurred in the Mt. Nuovo zone, the block would be mobilised and therefore generate a tsunami (Zaniboni et al, 2013), with disastrous consequences not only for Ischia, but also for the surrounding region. This work was carried out in the frame of the EU Project called ASTARTE - Assessment, STrategy And Risk Reduction for Tsunamis in Europe (Grant 603839, 7th FP, ENV.2013.6.4-3)

  18. SN-1 and NEMO: the Italian cabled observatories

    NASA Astrophysics Data System (ADS)

    Favali, P.; Beranzoli, L.; Calore, D.; D'Anna, G.; Gasparoni, F.; NEMO Collaboration Team

    2003-04-01

    A fruitful synergy between Geophysics, Environmental Sciences, Nuclear Physics and Marine Technology has started through ongoing projects within different Italian research frameworks. The Neutrino Mediterranean Observatory (NEMO) project, funded by INFN, aims at the realization of a deep-sea experiment for the detection of cosmic neutrinos using an array of towers equipped by photosensors. To test the technological solutions proposed for the realization of the project, the Laboratiori Nazionali del Sud have set up an underwater Test Site off-shore Catania. A 25 km long submarine electro-optical cable was deployed in September 2001, in order to supply power from land and receive data from the underwater site located at a depth of 2000 m. A shore station has also been realize inside the Catania port area. In October 2001, Submarine Network-1 (SN-1), the first Italian deep-sea multidisciplinary observatory for geophysical and environmental monitoring was deployed at a depth of 2105 m, in the area of the Ibleo-maltese escarpment, in proximity of the marine tail of the NEMO cable. SN-1, funded by the Italian Gruppo Nazionale di Difesa dai Terremoti and coordinated by INGV, is presently operating in local mode storing measurements on hard disks and is powered by lithium batteries with an autonomy of approximately 200 days. In the view of mutual assistance, the coordinator institutions of NEMO and SN-1 have agreed that part of the optic fibres and power lines of the NEMO-1 underwater cable be made available to power SN-1 from land and to transfer in real time the signals acquired by the geophysical and environmental sensor packages of SN-1. On this latter's side, time series of environmental parameters useful for the analysis and interpretation of NEMO-1 detections will be available. A description of the two projects and of the 'state of the art' will be given and the benefits of the development of a submarine Italian prone site will be pointed out.

  19. From Inuit to implementation: omega-3 fatty acids come of age.

    PubMed

    O'Keefe, J H; Harris, W S

    2000-06-01

    During the past 25 years, the cardiovascular effects of marine omega-3 (omega-3) fatty acids have been the subject of increasing investigation. In the late 1970s, epidemiological studies revealed that Greenland Inuits had substantially reduced rates of acute myocardial infarction compared with Western control subjects. These observations generated more than 4,500 studies to explore this and other effects of omega-3 fatty acids on human metabolism and health. From epidemiology to cell culture and animal studies to randomized controlled trials, the cardioprotective effects of omega-3 fatty acids are becoming recognized. These fatty acids, when incorporated into the diet at levels of about 1 g/d, seem to be able to stabilize myocardial membranes electrically, resulting in reduced susceptibility to ventricular dysrhythmias, thereby reducing the risk of sudden death. The recent GISSI (Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico)-Prevention study of 11,324 patients showed a 45% decrease in risk of sudden cardiac death and a 20% reduction in all-cause mortality in the group taking 850 mg/d of omega-3 fatty acids. These fatty acids have potent anti-inflammatory effects and may also be antiatherogenic. Higher doses of omega-3 fatty acids can lower elevated serum triglyceride levels; 3 to 5 g/ d can reduce triglyceride levels by 30% to 50%, minimizing the risk of both coronary heart disease and acute pancreatitis. This review summarizes the emerging evidence of the use of omega-3 fatty acids in the prevention of coronary heart disease.

  20. Efficacy of adjuvant fluorouracil and folinic acid in colon cancer. International Multicentre Pooled Analysis of Colon Cancer Trials (IMPACT) investigators.

    PubMed

    1995-04-15

    The role of fluorouracil and folinic acid and adjuvant therapy for colon cancer is not clear. We undertook independently three randomised trials to find out the efficacy of fluorouracil and high-dose folinic acid after surgery for Dukes' B and C stage colon cancer. The three studies by the Gruppo Interdisciplinare Valutazione Interventi Oncologia (GIVIO), the National Cancer Institute Canada Clinical Trials Group (NCIC-CTG), and the Fondation Française de Cancerologie Digestive (FFCD) were pooled for combined analysis. Each trial was multicentre and used the same treatment regimen (fluorouracil 370-400 mg/m2 plus folinic acid 200 mg/m2 daily for 5 days, every 28 days for 6 cycles). A pooled analysis of the results was done on the basis of a previously agreed protocol when there were sufficient events to detect at least a 10% reduction in mortality with 80% power. 1526 patients with resected B (56%) and C (44%) carcinoma of the colon were enrolled and 1493 were confirmed as eligible. 736 were assigned to the treatment group and 757 to the control group. Fluorouracil/folinic acid significantly reduced mortality by 22% (95% CI 3-38; p = 0.029) and events by 35% (22-46; p < 0.0001), increasing 3-year event-free survival from 62% to 71% and overall survival from 78% to 83%. Compliance with treatment was good; more than 80% of patients completed the planned treatment. Side-effects were clinically acceptable with only 1 treatment-related death. The commonest side-effects were gastrointestinal, but severe toxic effects (WHO grade 4) occurred in fewer than 3% of cases. We conclude that fluorouracil plus high-dose folinic acid is a well-tolerated and effective 6-month adjuvant regimen for colon cancer.

  1. Continuous quality improvement in intensive care medicine. The GiViTI Margherita Project - Report 2005.

    PubMed

    Boffelli, S; Rossi, C; Anghileri, A; Giardino, M; Carnevale, L; Messina, M; Neri, M; Langer, M; Bertolini, G

    2006-06-01

    The assessment of the quality of intensive care medicine is mandatory in the modern healthcare system. In Italy, the GiViTI (Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva) network is working in this field since 1991 and it now involves 295 out of the about 450 Italian intensive care units (ICU). In 2002 GiViTI launched a project for the continuous quality assessment and improvement that is now joined by 180 ICUs. Data collected in 2005 are analyzed and presented. All admitted patients were entered in a validated software, which performs a multitude of validity checks during the data entry. Data were further reviewed by the co-ordinating center; patients admitted in months with more than 10% of incomplete or inconsistent records in each ICU were excluded from the analysis. Each year, a multivariate logistic regression model is fitted to identify predictors of hospital mortality. Starting from the SAPS 2 and the 2004 GiViTI model predictions of hospital mortality, two calibration tables and curves are presented. In 2005, 180 Italian ICUs collected data on 55 246 patients. After excluding those admitted in months with an unjustified lower recruitment rate or with less than 90% of complete and consistent data, we had 52 816 (95.6%) valid cases. Although the rough hospital mortality in 2005 was 1% higher than in 2004 (22.6% vs 21.5%), the adjusted mortality shows a statistically significant 4% reduction (obser-ved-to-expected ratio: 0.96; 95% CI: 0.94-0.97). Italian ICUs in 2005 performed better than in 2004, at a parity of patient severity.

  2. Prognostic factors associated with progression of smoldering multiple myeloma to symptomatic form.

    PubMed

    Rago, Angela; Grammatico, Sara; Za, Tommaso; Levi, Anna; Mecarocci, Sergio; Siniscalchi, Agostina; De Rosa, Luca; Felici, Stefano; Bongarzoni, Velia; Piccioni, Anna Lina; La Verde, Giacinto; Pisani, Francesco; Franceschini, Luca; Paviglianiti, Anna Lisa; Caravita, Tommaso; Petrucci, Maria Teresa; De Stefano, Valerio; Cimino, Giuseppe

    2012-11-15

    Smoldering multiple myeloma (SMM) presents a high risk of progression to symptomatic MM (sy-MM). Herein, we analyzed some predictors of development of sy-MM. In 144 patients with SMM, we also compared the risk of progression predicted by bone marrow plasma cell (BMPC) involvement on the bone marrow biopsy (BMB) versus bone marrow aspirates (BMA). From January 1980 to July 2010, 397 patients with SMM observed in 12 centers of the Multiple Myeloma GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) Latium Working Group have been analyzed. At progression to sy-MM, the severity of clinical presentation was graded according to the need of intensive supportive care. After a median follow-up of 135 months, the cumulative incidence of progression rates to sy-MM were 45%, 55%, and 75% at 10, 15, and 20 years, respectively. Hemoglobin ≤12.5 g/dL, monoclonal component ≥2.5 g/dL, and BMPC ≥60% were the only parameters negatively affecting the cumulative incidence of progression. In particular, 10 of 397 (2.5%) patients with BMPC ≥60% had a 5.6-fold increased risk of fast progression (within 2 years), which occurred with severe clinical manifestations in 62% of cases. BMB was more sensitive for the detection of BMPC involvement, even though BMA was a more reliable indicator of a rapid progression to sy-MM. The highest risk of rapid evolution to sy-MM and the severity of clinical manifestation at the progression suggest that SMM patients with a BMPC ≥60% should be treated soon after diagnosis. Moreover, BMPC is a more reliable index for progression to sy-MM if assessed by BMA. Copyright © 2012 American Cancer Society.

  3. Surface denudation rate of gypsum in Sicily

    NASA Astrophysics Data System (ADS)

    Madonia, Giuliana; Vattano, Marco; Di Maggio, Cipriano; De Waele, Jo

    2016-04-01

    Studies on surface denudation rate of karst rocks were carried out for many years with different methods, although researches on limestones are much more numerous than those on gypsum. In Sicily the most large and complete Messinian evaporite succession of Gruppo Gessoso - Solfifero outcrops and since 1993-1994 surface denudation measurements were performed on different types of gypsum by the Micro-Erosion Meter (M.E.M.) method. MEM stations were placed on natural sites representing different lithological features of gypsum outcrops of the Island: 1) selenite gypsum with centimetre-sized crystals; 2) selenite gypsum with sub-centimetre crystals; 3) gypsum arenite; 4) microcrystalline gypsum; and 5) gypsum laminite (balatino type). The measuring stations are positioned in three localities in western and central Sicily: Santa Ninfa (Trapani), Ciminna (Palermo) and Campofranco (Caltanissetta). The average lowering rates vary in the different lithofacies: from 0.25 mm yr-1 in microcrystalline gypsum to 0.74 mm yr-1 in selenite gypsum with centimetre-sized crystals. The average surface denudation rates are 0.40 mm yr-1 in balatino gypsum and gypsum arenite, and 0.37 mm yr-1 in selenite gypsum with sub-centimetre crystals. These different values are connected to several factors such as: rock texture, dip of gypsum surfaces, climatic conditions, troubles on the measurement sites (e.g.: presence of lichens, soil, remains of vegetation, etc.). The aim of this paper is to show the results of roughly twenty years of experimental measurements, and to compare the surface denudation rate of gypsum in Sicily with those of other evaporite areas characterised by different climatic settings.

  4. Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study.

    PubMed

    Colucci, Giuseppe; Labianca, Roberto; Di Costanzo, Francesco; Gebbia, Vittorio; Cartenì, Giacomo; Massidda, Bruno; Dapretto, Elisa; Manzione, Luigi; Piazza, Elena; Sannicolò, Mirella; Ciaparrone, Marco; Cavanna, Luigi; Giuliani, Francesco; Maiello, Evaristo; Testa, Antonio; Pederzoli, Paolo; Falconi, Massimo; Gallo, Ciro; Di Maio, Massimo; Perrone, Francesco

    2010-04-01

    Single-agent gemcitabine became standard first-line treatment for advanced pancreatic cancer after demonstration of superiority compared with fluorouracil. The Gruppo Italiano Pancreas 1 randomized phase III trial aimed to compare gemcitabine plus cisplatin versus gemcitabine alone (ClinicalTrials.gov ID NCT00813696). Patients with locally advanced or metastatic pancreatic cancer, age 18 to 75 years, and Karnofsky performance status (KPS) > or = 50, were randomly assigned to receive gemcitabine (arm A) or gemcitabine plus cisplatin (arm B). Arm A: gemcitabine 1,000 mg/m(2) weekly for 7 weeks, and, after a 1-week rest, on days 1, 8, and 15 every 4 weeks. Arm B: cisplatin 25 mg/m(2) added weekly to gemcitabine, except cycle 1 day 22. Primary end point was overall survival. To have 8% power of detecting a 0.74 hazard ratio (HR) of death, with bilateral alpha .05, 355 events were needed and 400 patients planned. Four hundred patients were enrolled (arm A: 199; arm B: 201). Median age was 63, 59% were male, 84% had stage IV, and 83% had KPS > or = 80. Median overall survival was 8.3 months versus 7.2 months in arm A and B, respectively (HR, 1.10; 95% CI, 0.89 to 1.35; P = .38). Median progression-free survival was 3.9 months versus 3.8 months in arm A and B, respectively (HR, 0.97; 95% CI, 0.80 to 1.19; P = .80). The objective response rate was 10.1% in A and 12.9% in B (P = .37). Clinical benefit was experienced by 23.0% in A and 15.1% in B (P = .057). Combination therapy produced more hematologic toxicity, without relevant differences in nonhematologic toxicity. The addition of weekly cisplatin to gemcitabine failed to demonstrate any improvement as first-line treatment of advanced pancreatic cancer.

  5. Regular wine consumption in chronic heart failure: impact on outcomes, quality of life, and circulating biomarkers.

    PubMed

    Cosmi, Franco; Di Giulio, Paola; Masson, Serge; Finzi, Andrea; Marfisi, Rosa Maria; Cosmi, Deborah; Scarano, Marco; Tognoni, Gianni; Maggioni, Aldo P; Porcu, Maurizio; Boni, Silvana; Cutrupi, Giovanni; Tavazzi, Luigi; Latini, Roberto

    2015-05-01

    Moderate, regular alcohol consumption is generally associated with a lower risk of cardiovascular events but data in patients with chronic heart failure are scarce. We evaluated the relations between wine consumption, health status, circulating biomarkers, and clinical outcomes in a large Italian population of patients with chronic heart failure enrolled in a multicenter clinical trial. A brief questionnaire on dietary habits was administered at baseline to 6973 patients enrolled in the Gruppo Italiano per lo Studio della Sopravvivenza nell'Insufficienza Cardiaca-Heart Failure (GISSI-HF) trial. The relations between wine consumption, fatal and nonfatal clinical end points, quality of life, symptoms of depression, and circulating biomarkers of cardiac function and inflammation (in subsets of patients) were evaluated with simple and multivariable-adjusted statistical models. Almost 56% of the patients reported drinking at least 1 glass of wine per day. After adjustment, clinical outcomes were not significantly different in the predefined 4 groups of wine consumption. However, patients with more frequent wine consumption had a significantly better perception of health status (Kansas City Cardiomyopathy Questionnaire score, adjusted P<0.0001), less frequent symptoms of depression (Geriatric Depression Scale, adjusted P=0.01), and lower plasma levels of biomarkers of vascular inflammation (osteoprotegerin and C-terminal proendothelin-1, adjusted P<0.0001, and pentraxin-3, P=0.01) after adjusting for possible confounders. We show for the first time in a large cohort of patients with chronic heart failure that moderate wine consumption is associated with a better perceived and objective health status, lower prevalence of depression, and less vascular inflammation, but does not translate into more favorable clinical 4-year outcomes. URL: http://www.clinicaltrials.gov. Unique identifier: NCT0033633. © 2015 American Heart Association, Inc.

  6. Melena as presentation of primary small intestine inflammatory myofibroblastic tumor in an adult woman. A case report.

    PubMed

    Alloni, Rossana; Ancona, Gianluca; Gallo, Ida; Crescenzi, Anna; Coppola, Roberto

    2015-07-29

    È il caso di una paziente di 32 anni affetta da Miofibroblastoma non noto, trasferita da altra struttura sanitaria presso il nostro reparto perché affetta da melena da fonte non determinata. All’anamnesi risultava un precedente ricovero in altro Pronto Soccorso per un quadro clinico caratterizzato da dispnea, cefalea, tachicardia e astenia profonda., oltre a profonda anemia (Hg 5.8 g/dl). La gastroscopia non aveva evidenziato alcun motivo di sanguinamento e l’ecografia addomino-pelvica era risultata negativa. Dopo ripetute emotrasfusioni la tentata rettosigmoidoscopia era stata interrotto per intolleranza della paziente. Una volta stabilizzata si era proceduto al trasferimento presso la nostra struttura, e qui alla Risonanza Magnetica dell’addome veniva evidenziato, un ispessimento parietale esteso per 8 cm a del digiuno medio distale, in corrispondenza del fianco destro, antero – lateralmente al duodeno, ed adiacente ad esso una formazione ipervascolare solida di 20 mm. In prima ipotesi poteva trattarsi di un tratto invaginato del piccolo intestino con all’apice una lesione parietale solida, verosimile causa del sanguinamento. Persistendo il quadro anemico e avendo localizzato una lesione sospetta, la paziente è stata sottoposta ad intervento chirurgico, che portava alla conferma dell’esistenza di una lesione nodulare parietale del piccolo intestino, per cui si procedeva ad una sua resezione segmentaria comprendente la suddetta massa, sottoponendo il pezzo operatorio ad esame istologico definitivo. L’anatomo-patologo formulava la diagnosi isto-immunologica di pseudotumore infiammatorio (c.d. Tumore miofibroblastico infiammatorio) responsabile di invaginazione digiuno-digiunale. I margini di resezione risultavano indenni. Dimessa dopo un decorso postoperatorio senza complicanze, al follow-up di 6 mesi non si è ripresentato alcun sintomo di nuovo sanguinamento. Il sanguinamento della neoformazione responsabile della melena da fonte ignota era

  7. Multimodality imaging of bilateral pheochromocytoma. A case report.

    PubMed

    Paladino, Nunzia Cinzia; Lowery, Aoife; Guérin, Carole; Taïeb, David; Sebag, Frédéric

    2015-06-22

    . La TEP alla 18 FDG, grazie all’uso della metodica qualitativa e quantitativa nell’analisi della lesione, è stata molto utile nello svelarne la natura. Veniva pertanto eseguita una surrenalectomia sinistra per via laparoscopica. L’esame istologico per entrambe le lesioni era in favore di feocromocitoma, Pass score 0. Nella fase post-operatoria la paziente veniva trattata con idrocortisone a dosi decrescenti fino ad un dosaggio giornaliero di 30 mg in associazione a 50 mg di fludrocortisone. Questo caso clinico dimostra ancora una volta la possibilità di falsi negativi da parte di tecniche di imaging funzionale specifiche. In questa esperienza, la TEP alla 18 FDG è stata molto utile. La RMN ha senza dubbio mostrato un valore incontestabile. In questa paziente non è stata trovata nessuna mutazione germinale a carico dei geni RET, VHL, SDHx.

  8. An approach to complicated diverticular disease. A retrospective study in an Acute Care Surgery service recently established.

    PubMed

    Occhionorelli, Savino; Zese, Monica; Tartarini, Daniela; Lacavalla, Domenica; Maccatrozzo, Stefano; Groppo, Giacomo; Sibilla, Maria Grazia; Stano, Rocco; Cappellari, Lorenzo; Vasquez, Giorgio

    2016-01-01

    Obiettivo: La patologia diverticolare acuta è attualmente molto frequente nei paesi occidentalizzati. L’aumento costante del numero dei pazienti ricoverati nelle Unità operative di Chirurgia per il trattamento d’Urgenza sta portando alla necessità di individuare nuove Classificazioni e Scores per il corretto e razionale trattamento medico e chirurgico, anche in relazione all’assenza di linee guida ufficiali. Metodi: Si tratta di uno studio retrospettivo che prende in considerazione tutti i pazienti ricoverati presso il nostro Dipartimento, con diagnosi di diverticolite acuta perforata, nel periodo di tempo compreso tra giugno 2010 e marzo 2015. Risultati: Nel nostro studio 41 pazienti sono stati trattati conservativamente. I restanti 58 pazienti sono stati sottoposti ad intervento chirurgico: 25 con procedura di Hartmann, 29 con intervento di resezione e consensuale confezionamento di anastomosi senza ileostomia di protezione, 3 pazienti sono stati sottoposti a riparazione diretta della lesione diverticolare (rafia) e 2 a lavaggio peritoneale laparoscopico con posizionamento di drenaggio. Di questi ultimi due pazienti, uno è stato dimesso dopo 7 giorni in buone condizioni cliniche generali ed uno è stato poi sottoposto a resezione e confezionamento di anastomosi. Abbiamo correlato i pazienti suddividendoli nei vari gruppi Hinchey modificati e sovragruppi, associandoli ai diversi trattamenti, identificandone i fattori di rischio, l’ASA score e le complicanze. Discussione: L’utilizzo di nuove tecnologie, come la TC, si sta rivelando molto utile per la diagnosi delle diverticoliti perforate. Il loro trattamento è invece ancora piuttosto dibattuto: per i pazienti Hinchey I e II è, tendenzialmente conservativo, a meno di fattori concomitanti che ne pregiudichino l’andamento clinico. I pazienti Hinchey III e IV sono di competenza chirurgica. Il trattamento preferenziale è la procedura di Hartmann ma negli ultimi anni la resezione con consensuale

  9. Ultrasound in the evaluation of interstitial pneumonia.

    PubMed

    Lo Giudice, V; Bruni, A; Corcioni, E; Corcioni, B

    2008-03-01

    ecografico associate a ring down). In 34 (61,82%) casi sono stati descritti associati aspetti di patologia pleurica. CONCLUSIONI: Attraverso l'osservazione di segni ultrasonografici e la correlazione di questi con quelli clinico-laboratoristico-strumentali di routine, gli autori valutano la possibilità di attribuire rilievo anche alla indagine US nella diagnosi di polmonite interstiziale ad eziologia infettiva e, senza voler sostituire gli US alle tradizionali e opportune tecniche di approccio e diagnosi, la propongono quale complementare tecnica metodologica di indagine.

  10. The PREgnancy and FERtility (PREFER) study: an Italian multicenter prospective cohort study on fertility preservation and pregnancy issues in young breast cancer patients.

    PubMed

    Lambertini, Matteo; Anserini, Paola; Fontana, Valeria; Poggio, Francesca; Iacono, Giuseppina; Abate, Annalisa; Levaggi, Alessia; Miglietta, Loredana; Bighin, Claudia; Giraudi, Sara; D'Alonzo, Alessia; Blondeaux, Eva; Buffi, Davide; Campone, Francesco; Merlo, Domenico F; Del Mastro, Lucia

    2017-05-19

    Fertility and pregnancy issues are of key importance for young breast cancer patients. Despite several advances in the field, there are still multiple unmet needs and barriers in discussing and dealing with these concerns. To address the significant challenges related to fertility and pregnancy issues, the PREgnancy and FERtility (PREFER) study was developed as a national comprehensive program aiming to optimize care and improve knowledge around these topics. The PREFER study is a prospective cohort study conducted across several Italian institution affiliated with the Gruppo Italiano Mammella (GIM) group evaluating patterns of care and clinical outcomes of young breast cancer patients dealing with fertility and pregnancy issues. It is composed of two distinctive studies: PREFER-FERTILITY and PREFER-PREGNANCY. The PREFER-FERTILITY study is enrolling premenopausal patients aged 18-45 years, diagnosed with non-metastatic breast cancer, who are candidates to (neo)adjuvant chemotherapy and not previously exposed to anticancer therapies. The primary objective is to obtain and centralize data about patients' preferences and choices towards the available fertility preserving procedures. The success and safety of these strategies and the hormonal changes during chemotherapy and study follow-up are secondary objectives. The PREFER-PREGNANCY study is enrolling survivors achieving a pregnancy after prior history of breast cancer and patients diagnosed with pregnancy-associated breast cancer (PABC). The primary objectives are to obtain and centralize data about the management and clinical outcomes of these women. Patients' survival outcomes, and the fetal, obstetrical and paediatric care of their children are secondary objectives. For both studies, the initial planned recruitment period is 5 years and patients will remain in active follow-up for up to 15 years. The PREFER-FERTILITY study was first activated in November 2012, and the PREFER-PREGNANCY study in May 2013

  11. High-dose cytarabine in induction treatment improves the outcome of adult patients younger than age 46 years with acute myeloid leukemia: results of the EORTC-GIMEMA AML-12 trial.

    PubMed

    Willemze, Roelof; Suciu, Stefan; Meloni, Giovanna; Labar, Boris; Marie, Jean-Pierre; Halkes, Constantijn J M; Muus, Petra; Mistrik, Martin; Amadori, Sergio; Specchia, Giorgina; Fabbiano, Francesco; Nobile, Francesco; Sborgia, Marco; Camera, Andrea; Selleslag, Dominik L D; Lefrère, Francois; Magro, Domenico; Sica, Simona; Cantore, Nicola; Beksac, Meral; Berneman, Zwi; Thomas, Xavier; Melillo, Lorella; Guimaraes, Jose E; Leoni, Pietro; Luppi, Mario; Mitra, Maria E; Bron, Dominique; Fillet, Georges; Marijt, Erik W A; Venditti, Adriano; Hagemeijer, Anne; Mancini, Marco; Jansen, Joop; Cilloni, Daniela; Meert, Liv; Fazi, Paola; Vignetti, Marco; Trisolini, Silvia M; Mandelli, Franco; de Witte, Theo

    2014-01-20

    Cytarabine plays a pivotal role in the treatment of patients with acute myeloid leukemia (AML). Most centers use 7 to 10 days of cytarabine at a daily dose of 100 to 200 mg/m(2) for remission induction. Consensus has not been reached on the benefit of higher dosages of cytarabine. The European Organisation for Research and Treatment of Cancer (EORTC) and Gruppo Italiano Malattie Ematologiche dell' Adulto (GIMEMA) Leukemia Groups conducted a randomized trial (AML-12; Combination Chemotherapy, Stem Cell Transplant and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia) in 1,942 newly diagnosed patients with AML, age 15 to 60 years, comparing remission induction treatment containing daunorubicin, etoposide, and either standard-dose (SD) cytarabine (100 mg/m(2) per day by continuous infusion for 10 days) or high-dose (HD) cytarabine (3,000 mg/m(2) every 12 hours by 3-hour infusion on days 1, 3, 5, and 7). Patients in complete remission (CR) received a single consolidation cycle containing daunorubicin and intermediate-dose cytarabine (500 mg/m(2) every 12 hours for 6 days). Subsequently, a stem-cell transplantation was planned. The primary end point was survival. At a median follow-up of 6 years, overall survival was 38.7% for patients randomly assigned to SD cytarabine and 42.5% for those randomly assigned to HD cytarabine (log-rank test P = .06; multivariable analysis P = .009). For patients younger than age 46 years, survival was 43.3% and 51.9%, respectively (P = .009; multivariable analysis P = .003), and for patients age 46 to 60 years, survival was 33.9% and 32.9%, respectively (P = .91). CR rates were 72.0% and 78.7%, respectively (P < .001) and were 75.6% and 82.4% for patients younger than age 46 years (P = .01) and 68.3% and 74.8% for patients age 46 years and older (P = .03). Patients of all ages with very-bad-risk cytogenetic abnormalities and/or FLT3-ITD (internal tandem duplication) mutation, or with secondary AML benefitted from HD

  12. The length of treatment of aggressive non-Hodgkin's lymphomas established according to the international prognostic index score: long-term results of the GISL LA03 study.

    PubMed

    Federico, Massimo; Luminari, Stefano; Gobbi, Paolo G; Sacchi, Stefano; Di Renzo, Nicola; Lombardo, Marco; Merli, Francesco; Baldini, Luca; Stelitano, Caterina; Partesotti, Giovanni; Polimeno, Giuseppe; Montanini, Antonella; Mammi, Caterina; Brugiatelli, Maura

    2006-03-01

    To compare two different schedules of two different anthracycline-containing regimens, where length of treatment is modulated according to the international prognostic index (IPI) in patients with aggressive non-Hodgkin's Lymphoma (NHL). In 1993 the Gruppo Italiano per lo Studio dei Linfomi (GISL) started a randomized 2 x 2 factorial phase III clinical trial for patients with newly diagnosed aggressive NHL comparing ProME(Epidoxorubicin)CE-CytaBOM (PE-C) to ProMI(Idarubicin)CE-CytaBOM (PI-C) and a fixed to a flexible treatment schedule where anthracycline dose was to be modulated according to observed hematological toxicity. Patients with low or low-intermediate IPI (IPI 0-2) and those with intermediate-high or high IPI (IPI 3-5) should receive six or eight courses, respectively. Involved-field radiotherapy was allowed for patients with initial bulky disease or with residual masses. Three hundred and fifty-six patients were registered into the study and randomized. Patients were well balanced among the four study arms in terms of clinical characteristics and prognostic factors. Three hundred and forty-five patients were available for evaluation of study endpoints. At the end of induction therapy complete remission rate was 61%, 5-year failure-free survival (FFS) rate was 40% and 5-year overall survival (OS) rate was 59%; no differences were observed according to treatment arms. Patients in the flexible arm received higher dose intensity of anthracycline (P < 0.001) with no apparent increase in toxicity. However, the flexible schedule was not superior to the fixed one. Patients with IPI 3-5 showed lower response rates (45% vs. 67%: P < 0.0001) and lower 5-year FFS (29% vs. 45%: P < 0.0001) compared to those with IPI 0-2. six courses of fixed or flexible PE-C or PI-C can determine a promising success rate in patients with advanced aggressive NHL with IPI 0-2, whereas the same regimens are less effective in patients with IPI 3-5, even if two additional courses are

  13. Obesity and reduction of the response rate to anti-tumor necrosis factor α in rheumatoid arthritis: an approach to a personalized medicine.

    PubMed

    Gremese, Elisa; Carletto, Antonio; Padovan, Melissa; Atzeni, Fabiola; Raffeiner, Bernd; Giardina, Anna Rita; Favalli, Ennio Giulio; Erre, Gian Luca; Gorla, Roberto; Galeazzi, Mauro; Foti, Rosario; Cantini, Fabrizio; Salvarani, Carlo; Olivieri, Ignazio; Lapadula, Giovanni; Ferraccioli, Gianfranco

    2013-01-01

    Obesity is a mild, long-lasting inflammatory disease and, as such, could increase the inflammatory burden of rheumatoid arthritis (RA). The study aim was to determine whether obesity represents a risk factor for a poor remission rate in RA patients requiring anti-tumor necrosis factor α (anti-TNFα) therapy for progressive and active disease despite treatment with methotrexate or other disease-modifying antirheumatic drugs. Patients were identified from 15 outpatient clinics of university hospitals and hospitals in Italy taking part in the Gruppo Italiano di Studio sulle Early Arthritis network. Disease Activity Score in 28 joints (DAS28), body mass index (BMI; categorized as <25, 25-30, and >30 kg/m(2) ), acute-phase reactants, IgM rheumatoid factor, and anti-cyclic citrullinated peptide antibody values were collected. DAS28 remission was defined as a score of <2.6 lasting for at least 3 months. Six hundred forty-one outpatients with longstanding RA receiving anti-TNFα blockers (adalimumab, n = 260; etanercept, n = 227; infliximab, n = 154), recruited from 2006-2009 and monitored for at least 12 months, were analyzed. The mean ± SD DAS28 at baseline was 5.6 ± 1.4. A BMI of >30 kg/m(2) was recorded in 66 (10.3%) of 641 RA patients. After 12 months of anti-TNFα treatment, a DAS28 of <2.6 was noted in 15.2% of the obese subjects, in 30.4% of the patients with a BMI of 25-30 kg/m(2) , and in 32.9% of the patients with a BMI of <25 kg/m(2) (P = 0.01). The lowest percentage of remission, which was statistically significant versus adalimumab and etanercept (P = 0.003), was observed with infliximab. Obesity represents a risk factor for a poor remission rate in patients with longstanding RA treated with anti-TNFα agents. A personalized treatment plan might be a possible solution. Copyright © 2013 by the American College of Rheumatology.

  14. Effect of the gonadotropin-releasing hormone analogue triptorelin on the occurrence of chemotherapy-induced early menopause in premenopausal women with breast cancer: a randomized trial.

    PubMed

    Del Mastro, Lucia; Boni, Luca; Michelotti, Andrea; Gamucci, Teresa; Olmeo, Nina; Gori, Stefania; Giordano, Monica; Garrone, Ornella; Pronzato, Paolo; Bighin, Claudia; Levaggi, Alessia; Giraudi, Sara; Cresti, Nicola; Magnolfi, Emanuela; Scotto, Tiziana; Vecchio, Carlo; Venturini, Marco

    2011-07-20

    Premenopausal patients with breast cancer are at high risk of premature ovarian failure induced by systemic treatments, but no standard strategies for preventing this adverse effect are yet available. To determine the effect of the temporary ovarian suppression obtained by administering the gonadotropin-releasing hormone analogue triptorelin during chemotherapy on the incidence of early menopause in young patients with breast cancer undergoing adjuvant or neoadjuvant chemotherapy. The PROMISE-GIM6 (Prevention of Menopause Induced by Chemotherapy: A Study in Early Breast Cancer Patients-Gruppo Italiano Mammella 6) study, a parallel, randomized, open-label, phase 3 superiority trial, was conducted at 16 sites in Italy and enrolled 281 patients between October 2003 and January 2008. The patients were premenopausal women with stage I through III breast cancer who were candidates for adjuvant or neoadjuvant chemotherapy. Assuming a 60% rate of early menopause in the group treated with chemotherapy alone, it was estimated that 280 patients had to be enrolled to detect a 20% absolute reduction in early menopause in the group treated with chemotherapy plus triptorelin. The intention-to-treat analysis was performed by including all randomized patients and using imputed values for missing data. Before beginning chemotherapy, patients were randomly allocated to receive chemotherapy alone or combined with triptorelin. Triptorelin was administered intramuscularly at a dose of 3.75 mg at least 1 week before the start of chemotherapy and then every 4 weeks for the duration of chemotherapy. Incidence of early menopause (defined as no resumption of menstrual activity and postmenopausal levels of follicle-stimulating hormone and estradiol 1 year after the last cycle of chemotherapy). The clinical and tumor characteristics of the 133 patients randomized to chemotherapy alone and the 148 patients randomized to chemotherapy plus triptorelin were similar. Twelve months after the last

  15. Review on colonization of residents and staff in Italian long-term care facilities by multidrug-resistant bacteria compared with other European countries.

    PubMed

    Aschbacher, Richard; Pagani, Elisabetta; Confalonieri, Massimo; Farina, Claudio; Fazii, Paolo; Luzzaro, Francesco; Montanera, Pier Giorgio; Piazza, Aurora; Pagani, Laura

    2016-01-01

    Study of Infections in LTCFs (Gruppo di Lavoro per lo Studio delle Infezioni nelle Residenze Sanitarie Assistite e Strutture Territoriali assimilabili; GLISTer), consisting of Clinical Microbiologists represented by the authors of this review article.

  16. Veterinary Public Health in Italy: From Healthy Animals to Healthy Food, Contribution to Improve Economy in Developing Countries.

    PubMed

    Cacaci, Margherita; Lelli, Rossella Colomba

    2017-06-22

    The role of the veterinarian as a public health officer is intrinsic to the history and the culture of veterinary organization in Italy. The Veterinary service being part of the Health administration since the birth of the Italian State in the XIX Century. In the second half of the last century the birth of the Italian National Health Service confirmed that the function of the Italian veterinary service was to analyze and reduce the risks for the human population connected to the relationship man-animal-environment, animal health, food safety and security. The Italian Veterinary Medicine School curricula, reflected this "model" of veterinarian as well. In the majority of countries in the world, Veterinary Services are organized within the Agriculture Administration with the main function to assure animal health and wellbeing. After the so-called "Mad-cow crisis" the awareness of the direct and essential role of veterinary services in the prevention of human illness has been officially recognized and in the third millennium the old concept of "one health" and "human-animal interface" has gained popularity worldwide.The concept of Veterinary Public Health, has evolved at International level and has incorporated the more than a century old vision of the Italian Veterinary medicine and it is defined as "the sum of the contributions to the physical, mental and social development of people through the knowledge and application of veterinary science" (WHO, Future trends in veterinary public health. Gruppo di lavoro OMS: TE, Italy, 1999, Available from: http://www.who.int/zoonoses/vph/en/ . Last visited 16 Feb 2016, 1999).On the subject of Cooperation, Sustainability and Public Health, the EXPO 2015 event and the activities of international organizations WHO, FAO and World Organization for Animal Health are refocusing at present their worldwide mandate to protect human health and the economy of both the poorest Countries and the developed countries, according to the "new

  17. Poor mobilizer: a retrospective study on proven and predicted incidence according to GITMO criteria.

    PubMed

    Piccirillo, Nicola; Vacca, Michele; Lanti, Alessandro; Ipsevich, Francesco; Maresca, Maddalena; Fiorelli, Elena; Bianchi, Maria; Adorno, Gaspare; Pierelli, Luca; Majolino, Ignazio; Leone, Giuseppe; Zini, Gina

    2012-10-01

    The Italian Group for Bone Marrow Transplantation (Gruppo Italiano Trapianto di Midollo Osseo, GITMO) recently formalized criteria for a shared definition of poor mobilizer in order to facilitate randomized clinical trials and study comparison focusing on the efficacy of current mobilizing regimens. The availability of a standardized tool for poor mobilizer definition suggested us to retrospectively test GITMO criteria feasibility and applicability. Therefore we analyzed medical and laboratory records of adult patients affected by myeloma (MM) or lymphoma undergoing mobilization for autologous peripheral blood HSC collection from January 2010 to June 2011, at Servizio di Emotrasfusione, Istituto di Ematologia, Università Cattolica Del Sacro Cuore, Roma, UOC SIMT AO S. Camillo Forlanini Roma and SIMT Fondazione Policlinico Tor Vergata Roma. We collected data about 227 patients (134 male, 93 female) affected by MM (31.3%) NHL (58.6%) e HD (10.1%). Thirty-nine patients, 21 male and 18 female met proven poor mobilizer criteria definition resulting in a incidence of 17.2% (12.7% in MM, 21.8% in NHL and 4.3% in HD). Eleven patients, seven affected by lymphoma and four affected by myeloma, were defined predicted PM according to major criteria. Eight patients, seven affected by lymphoma and one affected by myeloma, were define predicted PM according to minor criteria. Sixteen out of 39 patients defined as poor mobilizer either according to major or minor criteria underwent collection procedures and eight (20.5%) achieved a cell dose ⩾2×10(6)/kg CD34(+) cells. GITMO criteria application was easy and resulted in poor mobilizer incidence comparable to current literature. Definitions of proven poor mobilizer and predicted poor mobilizer according to major criteria were very effective while minor criteria were less predictive. These results came from a retrospective analysis and therefore should be validated in future prospective trial. On the other hand these data could be

  18. Early and six-month outcome in patients with angina pectoris early after acute myocardial infarction (the GISSI-3 APPI [angina precoce post-infarto] study).

    PubMed

    1996-12-01

    There is conflicting evidence whether or not early postinfarction angina implies an unfavorable prognosis. This prospective study assessed the significance and natural history of early angina in a broad population of patients conservatively managed after acute myocardial infarction (AMI) and enrolled in the third Gruppo Italiano per lo Studio della Sopravvivenza nel Infarto Miocardico (GISSI-3) trial. Out of 2,363 consecutive patients (age 63 +/- 11; first AMI in 86%; thrombolysis in 74%) admitted in 31 centers lacking on-site revascularization facilities, early angina associated with transient electrocardiographic (ECG) changes was documented in 332 (14%). At multivariate analysis, preinfarction angina, age > or = 70 years, female gender, and history of infarct were significant predictors of early angina. Though the in-hospital course was free from major cardiac events in 78% of patients after the first anginal episode, reinfarction was more common after early angina (7% vs 2% in patients without, RR 3.1, 95% confidence interval [CI] 1.9 to 5.6; p <0.001), and death occurred in 7% of patients with early angina (vs 5% of patients without, RR 1.4, CI 0.9 to 2.4, p = NS). No demographic or clinical characteristics identified patients who suffered nonfatal reinfarction after angina, and neither the ECG location (infarct zone or remote) nor patterns of ECG changes during angina proved significant predictors of in-hospital reinfarction or death. Early angina emerged as the sole independent predictor of 6-month cumulative reinfarction (12% vs 5% of patients without, RR 2.9, CI 2.0 to 4.4; p <0.0001) and an independent predictor of death (13% vs 7% of patients without early angina, RR 2.3, CI 1.6 to 3.3; p <0.0001). Early postinfarction angina is a powerful prognostic marker. Patients with early postinfarction angina had an unfavourable in-hospital outcome, but the prospective identification of patients at greater risk of major events after angina remains elusive

  19. The incidence of sarcopenia among hospitalized older patients: results from the Glisten study.

    PubMed

    Martone, Anna Maria; Bianchi, Lara; Abete, Pasquale; Bellelli, Giuseppe; Bo, Mario; Cherubini, Antonio; Corica, Francesco; Di Bari, Mauro; Maggio, Marcello; Manca, Giovanna Maria; Marzetti, Emanuele; Rizzo, Maria Rosaria; Rossi, Andrea; Volpato, Stefano; Landi, Francesco

    2017-09-14

    New evidence is emerging on the importance of lean body mass during periods of illness and recovery. The preservation of lean body mass during such periods of intense stress impacts both patient and treatment outcomes. However, data concerning the incidence of sarcopenia among older people during hospitalization are scarce. The objective of this study was to evaluate the development of sarcopenia in a sample of hospitalized older subjects. We used data of 394 participants from the multicentre Italian Study conducted by the Gruppo Lavoro Italiano Sarcopenia-Trattamento e Nutrizione (GLISTEN) in 12 Acute Care Wards (Internal Medicine and Geriatrics) of University Hospitals across Italy. This study was designed to determine the prevalence of sarcopenia at hospital admission and the change in muscle mass and strength during hospitalization. Sarcopenia was defined as low skeletal mass index (kg/m(2) ) along with either low handgrip strength or slow walking speed [European Working Groups on Sarcopenia in Older People (EWGSOP) criteria]. Estimation of skeletal muscle mass was performed by bioelectrical impedance analysis (BIA). The mean age of the 394 enrolled patients (including 211 females who accounted for 53% of the sample) was 79.6 ± 6.4 years. Among those without sarcopenia at hospital admission, 14.7% of the study sample met the EWGSOP sarcopenia diagnostic criteria at discharge. The incidence of sarcopenia during hospitalization was significantly associated with the number of days spent in bed but was not correlated with the total length of hospital stay. In particular, patients who developed sarcopenia spent an average of 5.1 days in bed compared with 3.2 days for those with no sarcopenia at discharge (P = 0.02). Patients with sarcopenia showed a significantly lower body mass index compared with non-sarcopenic peers (25.0 ± 3.8 kg/m(2) vs. 27.6 ± 4.9 kg/m(2) , respectively; P < 0.001). Similarly, the skeletal mass index at admission was

  20. Italy versus the United Kingdom: differing styles for treating bacteremia in the critically ill patient, but who's right?

    PubMed

    Corona, A; Cislaghi, F; Raimondi, F; Singer, M

    2008-05-01

    As no prospective, randomized, clinical trials (PRCTs) exist to inform decisions about antibiotic therapy for bacteraemia, ICUs have likely developed their own strategies. A multi-centre, multi-national questionnaire survey was used to assess variations in antibiotic strategy between ICUs in the United Kingdom (UK) and Italy. In January 2001, a detailed questionnaire regarding antibiotic policy was sent to international (e.g., European Society of Intensive Care Medicine, ESICM) and national societies (Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva, GIVITI; Australia and New Zealand Intensive Care-Critical Trial Group, ANZIC-CTG; United Kingdom-Intensive Care Society, UK-ICS). Out of the 254 participating ICUs, 81 were from Italy and 32 were from the UK. In the UK, ICUs preferred to use a shorter course of mono-therapy compared to Italian ICUs when treating, a) primary bacteremia [7 (5-7) vs 10 (7-14), P<0.001]; b) UTI [5 (4-7) vs 8 (7-10), P<0.001]; c) Staphylococcus aureus [7 (5-12) vs 10 (7-15), P<0.001]; and d) Gram-negative bacteraemia associated with lines [6 (5-7) vs 10 (7-15), P<0.001], pneumonia [7 (5-7) vs 14 (10-15), P<0.001] and peritonitis [7 (5-9) vs 15 (10-15), P<0.000]. These differences in treatment strategy were likely correlated with the median inter-quartile range (IQR) of weekly input from a microbiologist or infectious disease specialist, which was more frequent in the UK compared to Italy [5 (2-6) vs 0 (0-1), P<0.001]. Possible influences accounting for the variations found between Italy and the UK are: 1) differences in interactions with microbiologists or infectious disease specialists, 2) historical/educational dogma, and 3) antibiotic resistance patterns. Further studies are necessary to determine the optimal approach to treating bacteremia.

  1. Proposal of a flexible structural-organizing model for the Intensive Care Units.

    PubMed

    Iapichino, G; Radrizzani, D; Rossi, C; Pezzi, A; Anghileri, A; Boffelli, S; Giardino, M; Mistraletti, G; Bertolini, G

    2007-10-01

    The aim of this study was to verify the capability of the Italian Group for the Evaluation of Intervention in Intensive Care Medicine (Gruppo Italiano Valutazione Interventi in Terapia Intensiva, GiViTI) Intensive Care Units (ICUs) in providing high level care (HLC) and to develop a flexible organiziational model, allowing for different levels of care in each ICU. Once the number of active beds, personnel and technology of each ICU were determined, we computed whether the available bed number and all available resources could provide HLC according to international standards. For ICUs lacking staff or equipment for safe HLC in all declared beds, we calculated the best combination between HLC and observation/monitoring beds with less need for nurses and technology (low level of care, LLC) in order to optimise the utilization of each bed. We also investigated the work organisation of physicians and nurses in these units. There are 2 070 available beds in the 293 GiViTI ICUs. To provide HLC according to international criteria, the beds would decrease to 80.9%, because 144 ICUs do not have nurses or equipment to provide HLC in each bed. In order to maximize the suitable use of available resources, these ICUs would have to reduce the HLC bed number using the regained nurse workload for LLC. Because of this, the total number of HLC beds would further decrease to 65.9% of all declared beds. During Sundays and holidays, the bed/doctor and the bed/nurse ratios increase in most ICUs. To maximize the staff and equipment resources available, the bed numbers of a general ICU providing HLC must vary, even daily, according to the level of care provided. This level is not always high for all patients present. Applying this organizing model to each ICU, we could have enough flexibility to face the different demands for assistance if the ICU is built as a large open space to achieve the best clinical model and use of resources.

  2. Adjuvant chemotherapy after potentially curative resection of metastases from colorectal cancer: a pooled analysis of two randomized trials.

    PubMed

    Mitry, Emmanuel; Fields, Anthony L A; Bleiberg, Harry; Labianca, Roberto; Portier, Guillaume; Tu, Dongsheng; Nitti, Donato; Torri, Valter; Elias, Dominique; O'Callaghan, Chris; Langer, Bernard; Martignoni, Giancarlo; Bouché, Olivier; Lazorthes, Franck; Van Cutsem, Eric; Bedenne, Laurent; Moore, Malcolm J; Rougier, Philippe

    2008-10-20

    Adjuvant systemic chemotherapy administered after surgical resection of colorectal cancer metastases may reduce the risk of recurrence and improve survival, but its benefit has never been demonstrated. Two phase III trials (Fédération Francophone de Cancérologie Digestive [FFCD] Trial 9002 and the European Organisation for Research and Treatment of Cancer/National Cancer Institute of Canada Clinical Trials Group/Gruppo Italiano di Valutazione Interventi in Oncologia [ENG] trial) used a similar design and showed a trend favoring adjuvant chemotherapy, but both had to close prematurely because of slow accrual, thus lacking the statistical power to demonstrate the predefined difference in survival. We report here a pooled analysis based on individual data from these two trials. After complete resection of colorectal liver or lung metastases, patients were randomly assigned to chemotherapy (CT arm; fluorouracil [FU] 400 mg/m(2) administered intravenously [IV] once daily plus dl-leucovorin 200 mg/m(2) [FFCD] x 5 days or FU 370 mg/m(2) plus l-leucovorin 100 mg/m(2) IV x 5 days [ENG] for six cycles at 28-day intervals) or to surgery alone (S arm). A total of 278 patients (CT, n = 138; S, n = 140) were included in the pooled analysis. Median progression-free survival was 27.9 months in the CT arm as compared with 18.8 months in the S arm (hazard ratio = 1.32; 95% CI, 1.00 to 1.76; P = .058). Median overall survival was 62.2 months in the CT arm compared with 47.3 months in the S arm (hazard ratio = 1.32; 95% CI, 0.95 to 1.82; P = .095). Adjuvant chemotherapy was independently associated with both progression-free survival and overall survival in multivariable analysis. This pooled analysis shows a marginal statistical significance in favor of adjuvant chemotherapy with an FU bolus-based regimen after complete resection of colorectal cancer metastases.

  3. A consensus protocol: Image-improved therapeutic guidelines for limited adult Hodgkin's disease.

    PubMed

    Busetto, Mario; Sotti, Guido; Zorat, Pierluigi; Salvagno, Luigi; Dal Fior, Sandro; Gaion, Fernando; Soraru, Mariella

    2004-01-01

    Hodgkin's disease (HD) has greatly benefited from new technologies in terms of less invasive and more accurate staging as well as improved overall and relapse-free survival. However, the likelihood of late adverse effects of treatment, including second tumors, has increased due to the longer survival of patients with HD. Today's trend is to aim at minimal therapeutic exposure while guaranteeing lower therapy-related morbidity. This encourages new research efforts but also leads to less uniformity in treatments, as observed in the Veneto Region in Italy. The Gruppo Veneto Linfomi, composed of representatives of Radiotherapy and Oncology Departments of the Veneto Region, has been analyzing this problem and proposing therapy guidelines since 1995. A set of 10 prognostic factors has been developed to identify three prognostic groups: highly favorable (HF) are patients up to 40 years of age presenting with stage I disease involving only one site of disease with a maximum tumor diameter (TD) of 5 cm and no adverse factors. In this group only mantle field irradiation is recommended if the disease is located in the neck or above, inverted-Y irradiation is recommended for distal subdiaphragmatic lesions, and subtotal nodal irradiation in all other cases. HF cases may also be treated like favorable cases with limited chemoradiation. Favorable (F) cases are patients in stage I with a TD greater than 5 cm and smaller than 10 cm or stage II, up to three sites of disease and negative prognostic factors for systemic disease. All other patients are included in the "not favorable" (NF) group at Ann Arbor stage I or II with any adverse prognostic factor. For the latter two groups, chemotherapy with the ABVD or Stanford V regimen precedes involved-field radiotherapy to sites with a TD of at least 5 cm. The total irradiation dose is determined by local disease extent and level of response to chemotherapy. Images on which the radiation fields are drawn serve as an important reference

  4. Lenalidomide Maintenance After Autologous Stem-Cell Transplantation in Newly Diagnosed Multiple Myeloma: A Meta-Analysis.

    PubMed

    McCarthy, Philip L; Holstein, Sarah A; Petrucci, Maria Teresa; Richardson, Paul G; Hulin, Cyrille; Tosi, Patrizia; Bringhen, Sara; Musto, Pellegrino; Anderson, Kenneth C; Caillot, Denis; Gay, Francesca; Moreau, Philippe; Marit, Gerald; Jung, Sin-Ho; Yu, Zhinuan; Winograd, Benjamin; Knight, Robert D; Palumbo, Antonio; Attal, Michel

    2017-10-10

    Purpose Lenalidomide maintenance therapy after autologous stem-cell transplantation (ASCT) demonstrated prolonged progression-free survival (PFS) versus placebo or observation in several randomized controlled trials (RCTs) of patients with newly diagnosed multiple myeloma (NDMM). All studies had PFS as the primary end point, and none were powered for overall survival (OS) as a primary end point. Thus, a meta-analysis was conducted to better understand the impact of lenalidomide maintenance in this setting. Patients and Methods The meta-analysis was conducted using primary-source patient-level data and documentation from three RCTs (Cancer and Leukemia Group B 100104, Gruppo Italiano Malattie Ematologiche dell'Adulto RV-MM-PI-209, and Intergroupe Francophone du Myélome 2005-02) that met the following prespecified inclusion criteria: an RCT in patients with NDMM receiving ASCT followed by lenalidomide maintenance versus placebo or observation with patient-level data available and achieved database lock for primary efficacy analysis. Results Overall, 1,208 patients were included in the meta-analysis (605 patients in the lenalidomide maintenance group and 603 in the placebo or observation group). The median PFS was 52.8 months for the lenalidomide group and 23.5 months for the placebo or observation group (hazard ratio, 0.48; 95% CI, 0.41 to 0.55). At a median follow-up time of 79.5 months for all surviving patients, the median OS had not been reached for the lenalidomide maintenance group, whereas it was 86.0 months for the placebo or observation group (hazard ratio, 0.75; 95% CI, 0.63 to 0.90; P = .001). The cumulative incidence rate of a second primary malignancy before disease progression was higher with lenalidomide maintenance versus placebo or observation, whereas the cumulative incidence rates of progression, death, or death as a result of myeloma were all higher with placebo or observation versus lenalidomide maintenance. Conclusion This meta

  5. Prognostic impact of pre-transplantation transfusion history and secondary iron overload in patients with myelodysplastic syndrome undergoing allogeneic stem cell transplantation: a GITMO study

    PubMed Central

    Alessandrino, Emilio Paolo; Porta, Matteo Giovanni Della; Bacigalupo, Andrea; Malcovati, Luca; Angelucci, Emanuele; Van Lint, Maria Teresa; Falda, Michele; Onida, Francesco; Bernardi, Massimo; Guidi, Stefano; Lucarelli, Barbarella; Rambaldi, Alessandro; Cerretti, Raffaella; Marenco, Paola; Pioltelli, Pietro; Pascutto, Cristiana; Oneto, Rosi; Pirolini, Laura; Fanin, Renato; Bosi, Alberto

    2010-01-01

    Background Transfusion-dependency affects the natural history of myelodysplastic syndromes. Secondary iron overload may concur to this effect. The relative impact of these factors on the outcome of patients with myelodysplastic syndrome receiving allogeneic stem-cell transplantation remains to be clarified. Design and Methods We retrospectively evaluated the prognostic effect of transfusion history and iron overload on the post-transplantation outcome of 357 patients with myelodysplastic syndrome reported to the Gruppo Italiano Trapianto di Midollo Osseo (GITMO) registry between 1997 and 2007. Results Transfusion-dependency was independently associated with reduced overall survival (hazard ratio=1.48, P=0.017) and increased non-relapse mortality (hazard ratio=1.68, P=0.024). The impact of transfusion-dependency was noted only in patients receiving myeloablative conditioning (overall survival: hazard ratio=1.76, P=0.003; non-relapse mortality: hazard ratio=1.70, P=0.02). There was an inverse relationship between transfusion burden and overall survival after transplantation (P=0.022); the outcome was significantly worse in subjects receiving more than 20 red cell units. In multivariate analysis, transfusion-dependency was found to be a risk factor for acute graft-versus-host disease (P=0.04). Among transfusion-dependent patients undergoing myeloablative allogeneic stem cell transplantation, pre-transplantation serum ferritin level had a significant effect on overall survival (P=0.01) and non-relapse mortality (P=0.03). This effect was maintained after adjusting for transfusion burden and duration, suggesting that the negative effect of transfusion history on outcome might be determined at least in part by iron overload. Conclusions Pre-transplantation transfusion history and serum ferritin have significant prognostic value in patients with myelodysplastic syndrome undergoing myeloablative allogeneic stem cell transplantation, inducing a significant increase of non

  6. Combination of international scoring system 3, high lactate dehydrogenase, and t(4;14) and/or del(17p) identifies patients with multiple myeloma (MM) treated with front-line autologous stem-cell transplantation at high risk of early MM progression-related death.

    PubMed

    Moreau, Philippe; Cavo, Michele; Sonneveld, Pieter; Rosinol, Laura; Attal, Michel; Pezzi, Annalisa; Goldschmidt, Hartmut; Lahuerta, Juan Jose; Marit, Gerald; Palumbo, Antonio; van der Holt, Bronno; Bladé, Joan; Petrucci, Maria Teresa; Neben, Kai; san Miguel, Jesus; Patriarca, Francesca; Lokhorst, Henk; Zamagni, Elena; Hulin, Cyrille; Gutierrez, Norma; Facon, Thierry; Caillot, Denis; Benboubker, Lotfi; Harousseau, Jean-Luc; Leleu, Xavier; Avet-Loiseau, Hervé; Mary, Jean-Yves

    2014-07-10

    To construct and validate among patients with multiple myeloma (MM) who were treated with intensive therapy a prognostic index of early MM progression-related death. Patient-level data from the Intergroupe Francophone du Myélome (IFM) 2005-01 trial (N = 482) were used to construct the prognostic index. The event was MM progression-related death within 2 years from treatment initiation. The index was validated using data from three other trials: the Gruppo Italiano Malattie Ematologiche dell' Adulto (GIMEMA) 26866138-MMY-3006 trial (N = 480), the Programa para el Estudio de la Terapéutica en Hemopatía Maligna (PETHEMA)-GEMMENOS65 trial (N = 390), and the Hemato-Oncologie voor Volwassenen Nederland (HOVON) -65/German-Speaking Myeloma Multicenter Group (GMMG) -HD4 trial (N = 827). The risk of early MM progression-related death was related to three independent prognostic variables: lactate dehydrogenase (LDH) higher than than normal, International Staging System 3 (ISS3), and adverse cytogenetics [t(4;14) and/or del(17p)]. These three variables enabled the definition of an ordinal prognostic classification composed of four scores (0 to 3). Patients with a score of 3, defined by the presence of t(4;14) and/or del(17p) in addition to ISS3 and/or high LDH, comprised 5% (20 of 387 patients) to 8% (94 of 1,139 patients) of the patients in the learning and validation samples, respectively, and they had a very poor prognosis. When applied to the population of 855 patients who had received bortezomib-based induction therapy in the four trials, the prognostic classification was also able to segregate patients into four categories, with a very poor prognosis attributed to patients with a score of 3. Our model allows the simple definition of a subgroup of MM patients at high risk of early MM progression-related death despite the use of the most modern and effective strategies. © 2014 by American Society of Clinical Oncology.

  7. A project for a solar sail propelled spaceship

    NASA Astrophysics Data System (ADS)

    Bevilacqua, Franco; Cesare, Stefano

    1994-02-01

    The idea of using the solar radiation pressure for propelling a space vehicle dates back to the 1920s and was suggested by the Russian space pioneer Konstantin Tsiolkovsky and the Russian engineer Fridrickh Arturovich Tsander. NASA began technology studies in the mid-1960s in which various design and technology requirements were examined for solar sailing vehicles without reference to specific missions. In 1977 a Jet Propulsion laboratory team undertook a 1-year study under a NASA contract to assess the practical possibilities of carrying out a rendezvous mission to Halley's Comet using a solar sail. Despite the confidence of the technical team and the completion of a valid preliminary design, NASA thought the technology of solar sailing was not sufficiently 'mature' to be implemented in time for a 1981 launch to the comet and the project was abandoned. Efforts to design and develop the solar sailing concept have been continued since then by private organizations i.e. the Union pour la Promotion de la Propulsion Photonique (U3P) in France, and the World Space Foundation in the United States. The latter has already fabricated a prototype square sail of about 700 sq m, and is seeking NASA support for flying a test vehicle. U3P is also seeking sponsorship for its design and development of solar sailing spacecraft and has proposed a race to the Moon between solar sails. In December 1988 the Christopher Columbus Quincentenary Jubilee Commission, a Presidential commission created by the Congress of the United States, approved the establishment of a Columbus 500 Space Sail Cup competition to commemorate his voyage to the Americas. The intent of the Space Sail Cup was to bring about the launch of at least three solar sail vehicles representing the Americas, Europe and Asia, selected among all the presented projects, that would have travelled from a High Earth Orbit (HEO) toward the Moon and then toward Mars. The space company then called Aeritalia Gruppo Sistemi Spaziali

  8. Combination of International Scoring System 3, High Lactate Dehydrogenase, and t(4;14) and/or del(17p) Identifies Patients With Multiple Myeloma (MM) Treated With Front-Line Autologous Stem-Cell Transplantation at High Risk of Early MM Progression–Related Death

    PubMed Central

    Moreau, Philippe; Cavo, Michele; Sonneveld, Pieter; Rosinol, Laura; Attal, Michel; Pezzi, Annalisa; Goldschmidt, Hartmut; Lahuerta, Juan Jose; Marit, Gerald; Palumbo, Antonio; van der Holt, Bronno; Bladé, Joan; Petrucci, Maria Teresa; Neben, Kai; san Miguel, Jesus; Patriarca, Francesca; Lokhorst, Henk; Zamagni, Elena; Hulin, Cyrille; Gutierrez, Norma; Facon, Thierry; Caillot, Denis; Benboubker, Lotfi; Harousseau, Jean-Luc; Leleu, Xavier; Avet-Loiseau, Hervé; Mary, Jean-Yves

    2014-01-01

    Purpose To construct and validate among patients with multiple myeloma (MM) who were treated with intensive therapy a prognostic index of early MM progression–related death. Patients and Methods Patient-level data from the Intergroupe Francophone du Myélome (IFM) 2005-01 trial (N = 482) were used to construct the prognostic index. The event was MM progression–related death within 2 years from treatment initiation. The index was validated using data from three other trials: the Gruppo Italiano Malattie Ematologiche dell' Adulto (GIMEMA) 26866138-MMY-3006 trial (N = 480), the Programa para el Estudio de la Terapéutica en Hemopatía Maligna (PETHEMA)–GEMMENOS65 trial (N = 390), and the Hemato-Oncologie voor Volwassenen Nederland (HOVON) –65/German-Speaking Myeloma Multicenter Group (GMMG) –HD4 trial (N = 827). Results The risk of early MM progression–related death was related to three independent prognostic variables: lactate dehydrogenase (LDH) higher than than normal, International Staging System 3 (ISS3), and adverse cytogenetics [t(4;14) and/or del(17p)]. These three variables enabled the definition of an ordinal prognostic classification composed of four scores (0 to 3). Patients with a score of 3, defined by the presence of t(4;14) and/or del(17p) in addition to ISS3 and/or high LDH, comprised 5% (20 of 387 patients) to 8% (94 of 1,139 patients) of the patients in the learning and validation samples, respectively, and they had a very poor prognosis. When applied to the population of 855 patients who had received bortezomib-based induction therapy in the four trials, the prognostic classification was also able to segregate patients into four categories, with a very poor prognosis attributed to patients with a score of 3. Conclusion Our model allows the simple definition of a subgroup of MM patients at high risk of early MM progression–related death despite the use of the most modern and effective strategies. PMID:24888806

  9. Introduzione Nuove tecnologie in urologia.

    PubMed

    Bianchi, Giampaolo

    2011-03-30

    Negli ultimi anni sono state introdotte in urologia nuove tecniche chirurgiche alcune già applicabili nella pratica clinica, altre ancora in corso di sperimentazione. Quella che ha trovato attualmente applicazione è la LESS (Laparo Endoscopic Single-site Surgery); essa riguarda tutte le metodiche che utilizzano una sola porta (multiaccesso) per eseguire interventi laparoscopici. I vantaggi apparenti di questa metodica rispetto alla laparoscopia tradizionale sono soltanto un dimostrato miglior risultato estetico. Mancano studi prospettici randomizzati. NOTES (Natural Orifices Transluminal Endoscopic Surgery) È una metodica ancor più nuova che sfrutta gli orifizi naturali (bocca, retto, vagina, vescica per accedere alla cavità addominale. Rispetto alla LESS questa tecnica utilizza prevalentemente i gastroscopi e lo strumentario dei gastoenterologi per eseguire interventi demolitivi. In urologia l'impiego di questa metodica è puramente sperimentale, comunque piccoli passi sono stati fatti nel migliorare lo strumentario. I chirurghi stanno consolidando questa metodica sull'uomo riguardo alla colecistectomia, ma i risultati sono scarsi, discordanti sulla via d'accesso e limitati a case reports. Oggi i risultati più incoraggianti li ha descritti Estevao Lima, un ingegnoso portoghese che utilizzando una tecnica NOTES di terza generazione (accesso combinato trans-vescicale e trans-gastrico) è riuscito ad eseguire una serie di nefrectomie sul maiale. Tanto si sa e si è speculato riguardo al robot da Vinci®, che oggi la prostatectomia senza di lui non è più competitiva. Moltissimi sono i centri che lo hanno, molti quelli che lo usano, tanti quelli che hanno risultati migliori rispetto alla tecnica laparoscopica classica. Ancora ad oggi però non esistono studi prospettici randomizzati che dimostrino la sua superiorità; inoltre una spina nel fianco sono i costi. Un ulteriore sviluppo futuro di da Vinci® forse potrebbe vedersi nell'assistere le nuove tecniche

  10. Recent developments in human biomonitoring: non-invasive assessment of target tissue dose and effects of pneumotoxic metals

    PubMed Central

    Mutti, A.; Corradi, M.

    2006-01-01

    di ottenere una migliore comprensione dei meccanismi attraverso i quali i tossici inalati inducono un danno polmonare, la valutazione della dose a livello dell’organo bersaglio, in questo caso il polmone, potrebbe essere molto utile. Il condensato dell’aria espirata (CAE) è un fluido ottenuto raffreddando l’aria esalata durante la respirazione a volume corrente ed è una nuova tecnica che può fornire una valutazione della patobiologia polmonare. Il CAE è formato quasi completamente da acqua, quindi rappresenta una matrice biologica ideale per la determinazione d’elementi metallici. Dati presenti in letteratura dimostrano come nel CAE si possono dosare vari metalli tossici ed elementi di transizione, permettendo quindi di proporre questa matrice per la quantificazione della dose al bersaglio di sostanze pneumotossiche. La quantificazione della dose al bersaglio consente di avere informazioni aggiuntive rispetto a quelle ottenute con i tradizionali metodi di monitoraggio biologico in lavoratori esposti, che generalmente consentono di stimare la dose sistemica, ma non l’esposizione delle vie respiratorie ad inquinanti aerodispersi né la frazione trattenuta nel polmone, verosimilmente implicata nella patologia infiammatoria e degenerativa a livello polmonare. In questa breve rassegna sono discussi i dati ottenuti in lavoratori professionalmente esposti a metalli duri ed in fumatori con o senza bronco-pneumopatica cronica ostruttiva (BPCO), per mostrare come il CAE – oltre agli indicatori di esposizione – consente di valutare indicatori di effetto campionati direttamente dal film che riveste le vie respiratorie, fornendo quindi nuovi spunti per meglio comprendere sia gli aspetti cinetici che quelli dinamici della tossicologia dei metalli. PMID:17017350

  11. Polypoid anal melanoma. A case report and review of the literature.

    PubMed

    Tutino, Roberta; Clerico, Giuseppe; Luc, Alberto Realis; Gallo, Gaetano; Trompetto, Mario

    2016-11-12

    canale anale, risultata poi all’esame istologico un melanoma pigmentato con indice mitotico di 16/10HPF e positività per S-100 e HMB45 e negatività per Melan-A/Mart-1 e KER pan e margini parzialmente coinvolti. L’analisi del BRAF ha dimostrato la presenza di un wild type senza mutazioni. Il c-KIT è risultato negativo. La TC e la PET non hanno dimostrato secondarismi. Per la presenza di margini di resezione positivi e l’impossibilità di asportazione radicale con preservazione degli sfinteri, è stata proposta alla paziente una amputazione addomino-perineale sec. Miles, seguita da una chemioterapia adiuvante, che questa ha rifiutato. Questo report dimostra la difficoltà nel corretto management di questa neoplasia che necessita della creazione di un database internazionale per ottenere una maggior conoscenza della sua storia naturale che porti ad una scelta terapeutica condivisa.

  12. Problems, solutions, and perspectives in the evaluation of interval cancers in Italian mammography screening programmes: a position paper from the Italian group for mammography screening (GISMa).

    PubMed

    Bucchi, Lauro; Frigerio, Alfonso; Zorzi, Manuel; Fedato, Chiara; Angiolucci, Giovanni; Bernardi, Daniela; Campari, Cinzia; Crocetti, Emanuele; Ferretti, Stefano; Giorgi, Daniela; Marchisio, Francesca; Morrone, Doralba; Naldoni, Carlo; Petrella, Marco; Ponti, Antonio; Ravaioli, Alessandra; Saguatti, Gianni; Santini, Dolores; Sassoli de Bianchi, Priscilla; Serafini, Monica; Vergini, Viviana; Giordano, Livia

    2015-01-01

    In this position paper, a self-convened team of experts from the Italian Group for Mammography Screening (Gruppo italiano screening mammografico, GISMa) pointed out the problems that increasingly hamper the feasibility and validity of the estimate of the proportional incidence of interval breast cancer (IBC) in Italy, suggested potential solutions and an agenda for research, and proposed that the question of the sensitivity of mammography be viewed in a larger perspective, with a greater attention to radiological review activities and breast radiology quality assurance programmes. The main problems are as follows: the coverage of cancer registration is incomplete; the robustness of using the pre-screening incidence rates as underlying rates decreases with time since the start of screening; the intermediate mammograms performed for early detection purposes may cause an overrepresentation of IBCs; the classification of many borderline screening histories is prone to subjectivity; and, finally, the composition of cohorts of women with negative screening results is uncertain, because several mammography reports are neither clearly negative nor clearly positive, and because of the limitations and instability of the electronic mammography records. Several possibilities can be considered to cope with these issues: standard methods for using the hospital discharge records in the identification of IBCs should be established; for the calculation of regional estimates of the underlying incidence, a suitable mathematical model should be identified; the definition of IBC according to the 2008 GISMa guidelines needs to be updated, especially with respect to in situ cancers and to invasive cancers with borderline screening histories; a closer adherence to standard screening protocols, with a simplified patient management, would make it easier to objectively identify IBCs; alternative methods for estimating the sensitivity of mammography should be taken into consideration; and

  13. Seismotectonics investigations in the internal Cottian Alps (Italian Western Alps)

    NASA Astrophysics Data System (ADS)

    Perrone, Gianluigi; Eva, Elena; Solarino, Stefano; Cadoppi, Paola; Balestro, Gianni; Fioraso, Gianfranco; Tallone, Sergio

    2010-05-01

    -Early Miocene) is related to transtensive/extensional movements along the LTZ and the development of minor sub-parallel N-S faults. This kinematic evolution fits in a model of dextral-transtension at regional scale. The more recent activity of the LTZ may have caused the development of Pleistocene lacustrine basin, several hundred metres thick, in the Lower Chisone and Pellice valleys, which did not hosted glacial tongues. Along the LTZ, however, Pleistocene deposits showing evidence of brittle deformation were also found. With the aim to better understand the relation between the current seismic activity and faults, an analysis was carried out by selecting the best located earthquakes (location error less than 3 km) recorded by the seismic network of the North Western Italy (RSNI). This selection is made necessary by the relatively small size of the structures under investigations in order to avoid fake attributions. In addition to get qualitative information about the seismogenic source, the focal mechanisms of four earthquakes occurring along the mapped faults were calculated sorting out the best locatable events among those occurred in the area. The good geometric and kinematic agreement between structural and seismological data indicates a possible dependence of the seismicity of the inner Cottian Alps with the current tectonic activity of the LTZ and its associated minor structures. Balestro G. et al. (2009) Ital. J. Geosci., 128(2), 331-339. Bertotti G., Mosca P. (2009) Tectonophysics, 475, 117-127. Eva C. et al. (1990) Atti del Convegno Gruppo Nazionale Difesa dai terremoti, Ed. Ambiente, Pisa, 1, 25-34. Perrone G. et al. (2009) Ital. J. Geosci., 128(2), 541-549.

  14. Short-term and long-term risk factors in gastric cancer

    PubMed Central

    Verlato, Giuseppe; Marrelli, Daniele; Accordini, Simone; Bencivenga, Maria; Di Leo, Alberto; Marchet, Alberto; Petrioli, Roberto; Zoppini, Giacomo; Muggeo, Michele; Roviello, Franco; de Manzoni, Giovanni

    2015-01-01

    While in chronic diseases, such as diabetes, mortality rates slowly increases with age, in oncological series mortality usually changes dramatically during the follow-up, often in an unpredictable pattern. For instance, in gastric cancer mortality peaks in the first two years of follow-up and declines thereafter. Also several risk factors, such as TNM stage, largely affect mortality in the first years after surgery, while afterward their effect tends to fade. Temporal trends in mortality were compared between a gastric cancer series and a cohort of type 2 diabetic patients. For this purpose, 937 patients, undergoing curative gastrectomy with D1/D2/D3 lymphadenectomy for gastric cancer in three GIRCG (Gruppo Italiano Ricerca Cancro Gastrico = Italian Research Group for Gastric Cancer) centers, were compared with 7148 type 2 diabetic patients from the Verona Diabetes Study. In the early/advanced gastric cancer series, mortality from recurrence peaked to 200 deaths per 1000 person-years 1 year after gastrectomy and then declined, becoming lower than 40 deaths per 1000 person-years after 5 years and lower than 20 deaths after 8 years. Mortality peak occurred earlier in more advanced T and N tiers. At variance, in the Verona diabetic cohort overall mortality slowly increased during a 10-year follow-up, with ageing of the type 2 diabetic patients. Seasonal oscillations were also recorded, mortality being higher during winter than during summer. Also the most important prognostic factors presented a different temporal pattern in the two diseases: while the prognostic significance of T and N stage markedly decrease over time, differences in survival among patients treated with diet, oral hypoglycemic drugs or insulin were consistent throughout the follow-up. Time variations in prognostic significance of main risk factors, their impact on survival analysis and possible solutions were evaluated in another GIRCG series of 568 patients with advanced gastric cancer, undergoing

  15. Numerical Simulation of The Coupled Conduit and Atmospheric Dispersal Dynamics of The 4400 Bp Agnano Monte Spina Trachitic Eruption, Phlegrean Fields

    NASA Astrophysics Data System (ADS)

    Papale, P.; Neri, A.; del Seppia, D.; Esposti Ongaro, T.

    The Phlegrean Fields Caldera (PFC), close to Naples, has a very high destructive po- tential in case of activity renewal. We have simulated the coupled dynamics of magma ascent and pyroclast dispersal in the atmosphere of the 4400 BP Agnano Monte Spina eruption, which represents the highest intensity event of the last cycle of activity at PFC. Two sustained magmatic phases of the eruption, corresponding to layers B1 and D1 (De Vita et al., 1999), were selected for the simulations. Boundary conditions for the simulation of the steady phases of magma ascent in the conduit, as well as relevant magma properties, are taken from the literature and from recent results of a coordi- nated project sponsored by the Italian Gruppo Nazionale per la Vulcanologia, devoted to the determination of the eruption dynamics during relevant eruptive events at PFC. Each simulated eruptive phase is assigned a range of mass flow-rate in order to account for uncertainties in the reconstructions. The mass flow-rate of phase B1 ranges from 2.5x10^7 to 10^8 kg/s, that of phase D1 from 5 to 1.8x10^8 kg/s. Water contents were parameterized and allowed to vary from 2 to 6 wt%, and volatiles other than water were neglected. The simulations of conduit flow dynamics were carried out by means of a multiphase flow model previously developed (Papale, 2001), and show a substan- tial increase of pressure distribution in the conduit from the B1 to the D1 phase of the eruption, and within each phase, with increasing assumed mass flow-rate. The depth of fragmentation also increases by 1000-1500 m from phase B1 to D1. Calculated conduit diameters range from 50 to 130 m for phase B1, and from 65 to 150 m for phase D1, depending on the assumed mass flow-rate and water content. From phase B1 to D1, at equal water content, the conduit exit gas volume fraction, gas and particle velocity tend to slightly decrease, while exit pressure and mixture density tend to in- crease. Conduit exit conditions computed by the

  16. Short-term and long-term risk factors in gastric cancer.

    PubMed

    Verlato, Giuseppe; Marrelli, Daniele; Accordini, Simone; Bencivenga, Maria; Di Leo, Alberto; Marchet, Alberto; Petrioli, Roberto; Zoppini, Giacomo; Muggeo, Michele; Roviello, Franco; de Manzoni, Giovanni

    2015-06-07

    While in chronic diseases, such as diabetes, mortality rates slowly increases with age, in oncological series mortality usually changes dramatically during the follow-up, often in an unpredictable pattern. For instance, in gastric cancer mortality peaks in the first two years of follow-up and declines thereafter. Also several risk factors, such as TNM stage, largely affect mortality in the first years after surgery, while afterward their effect tends to fade. Temporal trends in mortality were compared between a gastric cancer series and a cohort of type 2 diabetic patients. For this purpose, 937 patients, undergoing curative gastrectomy with D1/D2/D3 lymphadenectomy for gastric cancer in three GIRCG (Gruppo Italiano Ricerca Cancro Gastrico = Italian Research Group for Gastric Cancer) centers, were compared with 7148 type 2 diabetic patients from the Verona Diabetes Study. In the early/advanced gastric cancer series, mortality from recurrence peaked to 200 deaths per 1000 person-years 1 year after gastrectomy and then declined, becoming lower than 40 deaths per 1000 person-years after 5 years and lower than 20 deaths after 8 years. Mortality peak occurred earlier in more advanced T and N tiers. At variance, in the Verona diabetic cohort overall mortality slowly increased during a 10-year follow-up, with ageing of the type 2 diabetic patients. Seasonal oscillations were also recorded, mortality being higher during winter than during summer. Also the most important prognostic factors presented a different temporal pattern in the two diseases: while the prognostic significance of T and N stage markedly decrease over time, differences in survival among patients treated with diet, oral hypoglycemic drugs or insulin were consistent throughout the follow-up. Time variations in prognostic significance of main risk factors, their impact on survival analysis and possible solutions were evaluated in another GIRCG series of 568 patients with advanced gastric cancer, undergoing

  17. Physical and chemical evolution of subduction-related eclogites: Interplay of inheritance, alteration, deformation and metamorphism

    NASA Astrophysics Data System (ADS)

    Brouwer, F. M.; Sorensen, S. S.; Philippot, P.

    2012-12-01

    Chemical fluxes in subduction zone settings ultimately determine the chemistry of arc volcanism, as well as modification of the composition of the upper mantle. To constrain such fluxes, it is required that details of the physical and chemical evolution of the rocks that enter the system at the subduction zone are understood. Subduction-related eclogites are products of igneous, metamorphic, fluid-rock, and tectonic processes acting on ocean floor basalt for 10s of millions of years. These rocks preserve evidence for changes in bulk rock and mineral chemistry, mineral assemblages and microstructures resulting from these processes. We characterize and compare the textures and major and trace element chemistry of blueschist and eclogite from three subduction complexes to evaluate how these processes interact and to assess to what extent chemical and physical changes may be preserved during a complex P-T-t-D history. Coronitic and mylonitic eclogite and blueschist samples from subduction complexes in the Franciscan (CA, U.S.A.), Monviso (Western Alps) and Gruppo di Voltri (Ligurian Alps) represent different depths of subduction, and degrees of deformation and metamorphism, as well as a variable degree of retrogression. Textural observations and the trace element composition of talc inclusions in omphacite suggest that gabbroic rocks preserve some primary magmatic mineral domains through the entire subduction-exhumation cycle. Full recrystallization has obscured all primary domains in finer-grained rocks. There is great variability in the extent to which evidence of metamorphic episodes is preserved. Bulk major and trace element chemistry analysis indicates that all samples are enriched in most trace elements compared to MORB, and at each locality, deformed rocks are more enriched than undeformed samples. Enrichment of the fluid-mobile elements (LILE, and Th, U) is particularly strong in the Franciscan samples. Trace element distributions within minerals testify to

  18. New mapping of Radlandi basin and detailed analysis of its inner plains

    NASA Astrophysics Data System (ADS)

    Minelli, Francesco; Giorgetti, Carolina; Mondini, Alessandro; Pauselli, Cristina; Mancinelli, Paolo

    2013-04-01

    NEW MAPPING OF RADITLADI BASIN AND DETAILED ANALYSIS OF ITS INNER PLAINS. Francesco Minelli 1, Carolina Giorgetti 1, Alessandro C. Mondini 2, Cristina Pauselli 1, Paolo Mancinelli1. 1 Gruppo di Geologia Strutturale e Geofisica (GSG), Dipartimento di Scienze della Terra, Università degli Studi di Perugia, 06123, Perugia, Italy . Email: minelli91@yahoo.it. 2 CNR IRPI Perugia, 06123, Perugia. Introduction: The Raditladi basin is a large peak-ring impact crater discovered during the MESSENGER (MErcury Surface, Space ENvironment, GEochemistry, and Ranging) first flyby of Mercury in January 2008 [1]. The Raditladi basin is relatively young [2], and the study of the internal structures give an indication of the processes that acted recently in Mercury's geological history. Geological mapping: We first present the geological mapping of Raditladi crater. In the map we defined different sub-units on the base of previous studies [4][5] and surface morphology and reflectance. Through a GIS software we associated a polygonal layer to each sub-unit, this allowed to distinguish nine different layers. Due to the similarities with the Rachmaninoff basin, to define sub-units mapped on Raditladi, we adopted Rachmaninoff crater's units definitions made by Marchi et al. (2011) [4]. Structures analysis : We also mapped secondary structures consisting in concentric troughs arranged in a circular pattern. We defined two different kinds of troughs: (i) structures characterized by a distinct flat floor and interpretable as grabens, and (ii) structures with linear and curvilinear segments [5]. Inner plain deposit: The analysis of the topography made possible the estimation of the deposit's thickness. The measurement of the thickness is possible thanks to the presence of two small craters, crater A and crater, located in Raditladi's Inner plain. Observing the morphology of the two small craters' rim and hummocky central floor, we distinguished two different units: the shallower consists in

  19. PREFACE: A tribute to Virginio Bortolani

    NASA Astrophysics Data System (ADS)

    Brivio, Gian Paolo

    2007-08-01

    I met Virginio Bortolani at a meeting in Salerno (Italy) in summer 1977, when I was a fresh post-doc, just back to Italy after two years at the University of Liverpool (UK). At that time since 1972, Bortolani was the first Chairman of the Surface Physics Section of GNSM (Gruppo Nazionale di Struttura della Materia) of the Italian science research council (CNR), position which he held for about a decade. So I approached him with the formal respect due to a senior scientist by a younger fellow, which was customary at Italian Universities. However, his manners looked very non-conventional for those times. While smoking his daily nth cigarette, first he said to me 'Diamoci del tu' The literal translation would be: let us switch from 'you' to 'thou', and in modern English it is equivalent to being on first-name terms, and then started getting information about my work in a way which was both friendly and fatherly. Since then we crossed each other at several meeting, often discussing physics, but we only began to collaborate at a summer school at ICTP (Trieste) in 1988. There Bortolani, one of the Directors, had the excellent idea of involving T B Grimley and myself in a project in order to investigate theoretically trapping/desorption phenomena of noble gases at metal surfaces owing to phonon interaction. Eventually we understood the limits of validity of Knudsen's law for phenomena out of equilibrium such as those in chopped beam experiments. During that school, which lasted for many weeks, I was most impressed by the relaxed atmosphere that Bortolani was able to create and maintain throughout the event. Everyone from the newcomer student from Asia, Africa or Latin America, to the top scientist felt at ease. This helped students from developing countries to interact with the lecturers beneficially, and allowed other people like me to start a few very fruitful collaborations. By the way the proceedings of that school, edited by V Bortolani, N H March and M P Tosi, and