Multicentre study of allergic contact cheilitis from toothpastes.

PubMed

Francalanci, S; Sertoli, A; Giorgini, S; Pigatto, P; Santucci, B; Valsecchi, R

2000-10-01

The present work reports the results of a multicentre study of toothpaste allergic contact cheilitis (TACC) conducted by GIRDCA (Gruppo Italiano Ricerca Dermatiti da Contatto e Ambientali). The study examined 54 patients with eczematous lesions on the lips, the possible cause of which was suspected to be the use of toothpastes. Patch tests were conducted with a standard series, a specially-targeted series (toothpaste cheilitis series, TCS), and with suspected toothpaste(s). A stop-restart test (SRT) was carried out with these, together with a use test to identify possible alternative products. The TCS produced 17 positive reactions in 13 patients, the most frequent being to spearmint oil. Of the 54 patients, 5 displayed positive reactions only to the TCS. The patch tests with toothpaste produced positive reactions in 11/32 patients, the SRT a positive response in 10/12 cases. The diagnosis of TACC was confirmed in 15/54 patients. Alternative products were identified for 5 patients. In conclusion, the allergens most frequently responsible for TACC were the flavourings, and the additional series proved to be useful in many cases (together with patch tests with toothpastes and the SRT) for correct diagnosis and to initiate effective prevention.

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. Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

[Analysis of factors predicting early unplanned readmissions].

PubMed

Di Domenico, Gabriella; Tersigni, Ivan; Federico, Bruno; Leuter, Cinzia

2016-01-01

OBIETTIVI: determinare i fattori associati ai ricoveri ripetuti per identificare i pazienti a rischio di riospedalizzazione entro i 30 giorni dalla dimissione. DISEGNO: analisi retrospettiva delle dimissioni nell'anno 2013 attraverso le schede di dimissione ospedaliera (SDO). 3.900 pazienti ricoverati presso il presidio ospedaliero "Fabrizio Spaziani" di Frosinone. PRINCIPALI MISURE DI OUTCOME: analisi bivariata per l'analisi dell'associazione tra variabili. La regressione logistica è stata utilizzata per identificare i fattori di rischio associati al ricovero ripetuto. RISULTATI: tra i 3.900 pazienti considerati, il 12,8% ha avuto una riammissione non programmata entro un mese dalla dimissione precedente per le stesse categorie diagnostiche principali (MCD). Sono state rilevate differenze statisticamente significative tra i pazienti con e senza ricovero ripetuto per età, durata della degenza, titolo di studio, condizione occupazionale e diagnosi. I fattori che aumentano la probabilità di una riospedalizzazione sono il vivere da solo, la condizione di pensionato o casalinga, una degenza più lunga e alcune diagnosi, fra cui malattie dell'apparato respiratorio, del sistema nervoso e dell'apparato urinario. CONCLUSIONE: alcune caratteristiche sociodemografiche e la diagnosi dei pazienti ospedalizzati sono associate al rischio di riospedalizzazione entro 30 giorni dalla dimissione. I dati disponibili nell'archivio delle SDO possono essere utilizzati per un'identificazione dei pazienti a rischio sui quali definire specifici piani di dimissione.

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.

Follow-up of colorectal cancer patients after resection with curative intent-the GILDA trial.

PubMed

Grossmann, Erik M; Johnson, Frank E; Virgo, Katherine S; Longo, Walter E; Fossati, Rolando

2004-01-01

Surgery remains the primary treatment of colorectal cancer. Data are lacking to delineate the optimal surveillance strategy following resection. A large-scale multi-center European study is underway to address this issue (Gruppo Italiano di Lavoro per la Diagnosi Anticipata-GILDA). Following primary surgery with curative intent, stratification, and randomization at GILDA headquarters, colon cancer patients are then assigned to a more intensive or less intensive surveillance regimen. Rectal cancer patients undergoing curative resection are similarly randomized, with their follow-up regimens placing more emphasis on detection of local recurrence. Target recruitment for the study will be 1500 patients to achieve a statistical power of 80% (assuming an alpha of 0.05 and a hazard-rate reduction of >24%). Since the trial opened in 1998, 985 patients have been randomized from 41 centers as of February 2004. There were 496 patients randomized to the less intensive regimens, and 489 randomized to the more intensive regimens. The mean duration of follow-up is 14 months. 75 relapses (15%) and 32 deaths (7%) had been observed in the two more intensive follow-up arms, while 64 relapses (13%) and 24 deaths (5%) had been observed in the two less intensive arms as of February 2004. This trial should provide the first evidence based on an adequately powered randomized trial to determine the optimal follow-up strategy for colorectal cancer patients. This trial is open to US centers, and recruitment continues.

[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.

Body mass index and circulating oestrone sulphate in women treated with adjuvant letrozole★

PubMed Central

Sini, V; Lunardi, G; Cirillo, M; Turazza, M; Bighin, C; Giraudi, S; Levaggi, A; Piccioli, P; Bisagni, G; Gnoni, R; Stridi, G; Porpiglia, M; Picardo, E; Ponzone, R; Marenco, D; Mansutti, M; Puglisi, F; Del Mastro, L

2014-01-01

Background: Obesity is an independent adverse prognostic factor in early breast cancer patients, but it is still controversial whether obesity may affect adjuvant endocrine therapy efficacy. The aim of our study (ancillary to the two clinical trials Gruppo Italiano Mammella (GIM)4 and GIM5) was to investigate whether the circulating oestrogen levels during treatment with the aromatase inhibitor letrozole are related to body mass index (BMI) in postmenopausal women with breast cancer. Methods: Plasma concentration of oestrone sulphate (ES) was evaluated by radioimmunoassay in 370 patients. Plasma samples were obtained after at least 6 weeks of letrozole therapy (steady-state time). Patients were divided into four groups according to BMI. Differences among the geometric means (by ANOVA and ANCOVA) and correlation (by Spearman's rho) between the ES levels and BMI were assessed. Results: Picomolar geometric mean values (95% confidence interval, n=patients) of circulating ES during letrozole were 58.6 (51.0–67.2, n=150) when BMI was <25.0 kg m−2; 65.6 (57.8–74.6, n=154) when 25.0–29.9 kg m−2; 59.3 (47.1–74.6, n=50) when 30.0–34.9 kg m−2; and 43.3 (23.0–81.7, n=16) when ⩾35.0 kg m−2. No statistically significant difference in terms of ES levels among groups and no correlation with BMI were observed. Conclusions: Body mass index does not seem to affect circulating oestrogen levels in letrozole-treated patients. PMID:24448359

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.

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).

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.

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.

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. Copyright © 2012 John Wiley & Sons, Ltd.

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.

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.

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.

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.

Concealed renal failure and adverse drug reactions in older patients with type 2 diabetes mellitus.

PubMed

Corsonello, Andrea; Pedone, Claudio; Corica, Francesco; Mazzei, Bruno; Di Iorio, Angelo; Carbonin, Pierugo; Incalzi, Raffaele Antonelli

2005-09-01

In elderly patients serum creatinine may be normal despite decreased glomerular filtration rate (GFR). The aim of this study was to evaluate the prevalence of this "concealed" renal failure, i.e., renal failure with normal serum creatinine levels, in elderly diabetic patients, and to verify whether it is a risk factor for adverse drug reactions (ADR) to hydrosoluble drugs. We used data on 2257 hospitalized patients with type 2 diabetes mellitus enrolled in the Gruppo Italiano di Farmacovigilanza nell'Anziano study. On the basis of serum creatinine and calculated GFR, patients were grouped as follows: normal renal function (normal serum creatinine levels and normal GFR), concealed (normal serum creatinine levels and reduced GFR), or overt (increased creatinine levels and reduced GFR) renal failure. GFR was calculated using the Modification of Diet in Renal Disease (MDRD) equation. The outcome of the study was the incidence of ADR to hydrosoluble drugs during the hospital stay. The relationship between renal function and ADR was evaluated using Cox regression analysis including potential confounders. Concealed renal failure was observed in 363 (16.1%) of patients studied. Patients with concealed or overt renal failure were older, had more frequently cognitive impairment and polypharmacy, and had lower serum albumin levels than did those with normal renal function. Both concealed (hazard ratio = 1.90; 95% confidence interval, 1.04-3.48; p =.036) and overt (hazard ratio = 2.23; 95% confidence interval, 1.40-3.55; p =.001) renal failure were significantly associated with ADR to hydrosoluble drugs. The use of more than four drugs also qualified as an independent risk factor for ADRs to hydrosoluble drugs during hospital stay. Older diabetic patients should be systematically screened to ascertain the presence of concealed renal failure in an attempt to optimize the pharmacological treatment and reduce the risk of ADRs.

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.

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

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.

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

Performance of Prognostic Risk Scores in Chronic Heart Failure Patients Enrolled in the European Society of Cardiology Heart Failure Long-Term Registry.

PubMed

Canepa, Marco; Fonseca, Candida; Chioncel, Ovidiu; Laroche, Cécile; Crespo-Leiro, Maria G; Coats, Andrew J S; Mebazaa, Alexandre; Piepoli, Massimo F; Tavazzi, Luigi; Maggioni, Aldo P

2018-06-01

This study compared the performance of major heart failure (HF) risk models in predicting mortality and examined their utilization using data from a contemporary multinational registry. Several prognostic risk scores have been developed for ambulatory HF patients, but their precision is still inadequate and their use limited. This registry enrolled patients with HF seen in participating European centers between May 2011 and April 2013. The following scores designed to estimate 1- to 2-year all-cause mortality were calculated in each participant: CHARM (Candesartan in Heart Failure-Assessment of Reduction in Mortality), GISSI-HF (Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico-Heart Failure), MAGGIC (Meta-analysis Global Group in Chronic Heart Failure), and SHFM (Seattle Heart Failure Model). Patients with hospitalized HF (n = 6,920) and ambulatory HF patients missing any variable needed to estimate each score (n = 3,267) were excluded, leaving a final sample of 6,161 patients. At 1-year follow-up, 5,653 of 6,161 patients (91.8%) were alive. The observed-to-predicted survival ratios (CHARM: 1.10, GISSI-HF: 1.08, MAGGIC: 1.03, and SHFM: 0.98) suggested some overestimation of mortality by all scores except the SHFM. Overprediction occurred steadily across levels of risk using both the CHARM and the GISSI-HF, whereas the SHFM underpredicted mortality in all risk groups except the highest. The MAGGIC showed the best overall accuracy (area under the curve [AUC] = 0.743), similar to the GISSI-HF (AUC = 0.739; p = 0.419) but better than the CHARM (AUC = 0.729; p = 0.068) and particularly better than the SHFM (AUC = 0.714; p = 0.018). Less than 1% of patients received a prognostic estimate from their enrolling physician. Performance of prognostic risk scores is still limited and physicians are reluctant to use them in daily practice. The need for contemporary, more precise prognostic tools should be considered. Copyright �

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

PubMed

Cacaci, Margherita; Lelli, Rossella Colomba

2018-01-01

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

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

PubMed Central

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; Landi, Francesco

2017-01-01

Abstract Background 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. Methods 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/m2) 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). Results 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/m2 vs. 27.6 ± 4.9 kg/m2, respectively; P < 0.001). Similarly, the skeletal mass

Serum magnesium levels and cognitive impairment in hospitalized hypertensive patients.

PubMed

Corsonello, A; Pedone, C; Pahor, M; Malara, A; Carosella, L; Mazzei, B; Onder, G; Corsonello, F; Carbonin, P; Corica, F

2001-12-01

We performed this cross-sectional case control study to investigate the association between low serum magnesium levels and cognitive impairment in hypertensive hospitalized patients. The study was carried out in general medical care units at 81 hospitals participating in the Gruppo Italiano di Farmacovigilanza nell'Anziano (GIFA) study throughout Italy, and a total of 1058 patients with diagnoses of hypertension at the discharge were studied. The occurrence of cognitive impairment at discharge was the primary outcome of our study. Cognitive impairment was ascertained using the Hodkinson Abbreviated Mental Test (HAMT). Sociodemographic variables, body mass index, laboratory parameters, comorbidity, use of antihypertensive drugs and number of drugs were considered as potential confounders. Twenty-nine percent of the selected hypertensive patients were classified as having cognitive impairment. In univariate analysis, older age, female sex, and low educational level showed a significant trend for association to cognitive impairment. Moreover the proportion of subjects with cognitive impairment decreased with increasing alcohol consumption, and the prevalence of ex smokers and smokers was significantly lower in patients with cognitive impairment. The lower tertiles for serum albumin and creatinine clearance were more frequent among patients with cognitive impairment, and the lower tertile for serum magnesium levels was significantly more frequent in these patients. Number of drugs was slightly lower in cognitively impaired patients, while number of diagnoses and length of hospital stay were higher in these subjects. In the multivariate logistic regression analysis cognitive impairment decreased with increasing education level (highest education: OR 0.11; 95 per cent CI 0.05-0.25). The lower tertile for serum albumin (< 3.5 g/dl) was significantly associated to cognitive impairment (OR 2.14; 95 per cent CI 1.31-3.49), as well as the lower tertiles for serum magnesium (0

The search for a melanoma-tailored chemotherapy in the new era of personalized therapy: a phase II study of chemo-modulating temozolomide followed by fotemustine and a cooperative study of GOIM (Gruppo Oncologico Italia Meridionale).

PubMed

Guida, Michele; Tommasi, Stefania; Strippoli, Sabino; Natalicchio, Maria Iole; De Summa, Simona; Pinto, Rosamaria; Cramarossa, Antonio; Albano, Anna; Pisconti, Salvatore; Aieta, Michele; Ridolfi, Ruggiero; Azzariti, Amalia; Guida, Gabriella; Lorusso, Vito; Colucci, Giusepe

2018-05-10

It is frequently asked whether chemotherapy can still play a role in metastatic melanoma considering the effectiveness of the available drugs today, including antiCTLA4/antiPD1 immunotherapy and antiBRAF/antiMEK inhibitors. However, only approximately half of patients respond to these drugs, and the majority progress after 6-11 months. Therefore, a need for other therapeutic options is still very much apparent. We report the first large trial of a sequential full dose of fotemustine (FM) preceded by a low dose of temozolomide (TMZ) as a chemo-modulator in order to inactivate the DNA repair action of O(6)-methylguanine DNA-methyltransferase (MGMT). Primary endpoints were overall response and safety. We also evaluated specific biological parameters aiming to tailor these chemotherapies to selected patients. A total of 69 consecutive patients were enrolled. The main features included a median age of 60 years (21-81) and M1c stage, observed in 74% of the patients, with brain metastases in 15% and high LDH levels in 42% of the patients. The following schedule was used: oral TMZ 100 mg/m 2 on days 1 and 2 and FM iv 100 mg/m 2 on day 2, 4 h after TMZ; A translational study aiming to analyse MGMT methylation status and base-excision repair (BER) gene expression was performed in a subset of 14 patients. We reported an overall response rate of 30.3% with 3 complete responses and a disease control rate of 50.5%. The related toxicity rate was low and mainly of haematological types. Although our population had a very poor prognosis, we observed a PFS of 6 months and an OS of 10 months. A non-significant correlation with response was found with the mean expression level of the three genes involved in the BER pathway (APE1, XRCC1 and PARP1), whereas no association was found with MGMT methylation status. This schedule could represent a good alternative for patients who are not eligible for immune or targeted therapy or whose previous therapies have failed. EUDRACT 2009-016487-36l ; date of registration 23 June 2010.

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

Mitomycin C plus vindesine plus etoposide (MEV) versus mitomycin C plus vindesine plus cisplatin (MVP) in stage IV non-small-cell lung cancer: A phase III multicentre randomised trial. The "Gruppo Oncologico Centro-Sud-Isole' (G.O.C.S.I.).

PubMed

Gridelli, C; Perrone, F; Palmeri, S; D'Aprile, M; Cognetti, F; Rossi, A; Gebbia, V; Pepe, R; Veltri, E; Airoma, G; Russo, A; Incoronato, P; Scinto, A F; Palazzolo, G; Natali, M; Leonardi, V; Gallo, C; De Placido, S; Bianco, A R

1996-10-01

To compare mitomycin C plus vindesine plus etoposide (MEV) vs. mitomycin C plus vindesine plus cisplatin (MVP) in the treatment of stage IV non-small-cell lung cancer. 204 patients were entered in a phase III multicentre randomised trial from June 1990 to December 1994 and stratified according to the ECOG performance status (0-1 vs. 2). MVP was given in the following dosages: mitomycin C 8 mg/m2+vindesine 3 mg/m2+cisplatin 100 mg/m2 i.v. day 1 and vindesine 3 mg/m2 i.v. day 8 with cycles repeated every 4 weeks. MEV was given in the following dosages: mitomycin C 8 mg/m2+vindesine 3 mg/ m2 i.v. day 1 and etoposide 100 mg/m2 i.v. days 1 to 3 with cycles repeated every 3 weeks. For both treatments a maximum of 6 cycles was planned. Response and toxicity were evaluated according to WHO. Subjective responses were assessed by numerical scales. Analyses were made on the basis of intent to treat. The objective response rate was 21.4% (1 CR + 21 PR among 103 patients) in the MEV and 28.7% (1 CR + 28 PR among 101 patients) in the MVP arm (P = 0.48). Symptoms were similar in the two arms. 196 patients progressed and 182 died. The median times to progression were 10 weeks (95% CI 9-12) and 12 weeks (95% CI 10-15) and median survivals were 29 weeks (95% CI 25-36) and 28 weeks (95% CI 25-35) in the MEV and MVP arms, respectively. The relative risks of progressing and of dying were 0.89 (95% CL 0.66-1.20) and 0.96 (95% CL 0.71-1.30), respectively, for patients receiving MVP as compared with those receiving MEV at multivariate analysis adjusted by sex, age, histologic type, number of metastatic sites, performance status at entry, and centre. In the present study, no significant differences were observed in response rate, survival or palliation of symptoms between the MEV and MVP regimens, while toxicity was significantly more frequent and severe with MVP. Thus, MEV should be considered a reasonable alternative to the MVP regimen in the treatment of stage IV NSCLC.

Single-dose palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with aggressive non-Hodgkin's lymphoma receiving moderately emetogenic chemotherapy containing steroids: results of a phase II study from the Gruppo Italiano per lo Studio dei Linfomi (GISL).

PubMed

Di Renzo, Nicola; Montanini, Antonella; Mannina, Donato; Dondi, Alessandra; Muci, Stefania; Mancuso, Salvatrice; De Paolis, M Rosaria; Plati, Caterina; Stelitano, Caterina; Patti, Catia; Olivieri, Attilio; Liardo, Eliana; Buda, Gabriele; Cantaffa, Renato; Federico, Massimo

2011-10-01

The control of nausea and vomiting induced by chemotherapy is paramount for overall treatment success in cancer patients. Antiemetic therapy during chemotherapy in lymphoma patients generally consists of anti-serotoninergic drugs and dexamethasone. The aim of this trial was to evaluate the efficacy of a single dose of palonosetron, a second-generation serotonin type 3 (5-HT(3)) receptor antagonist, in patients with aggressive non-Hodgkin's lymphoma receiving moderately emetogenic chemotherapy (MEC) containing steroids. Patients received a single intravenous bolus of palonosetron (0.25 mg) before administration of chemotherapy. Complete response (CR) defined as no vomiting and no rescue therapy during overall phase (0-120 h) was the primary endpoint. Complete control (CC) defined as CR and only mild nausea was a secondary endpoint. Eighty-six evaluable patients entered in the study. A CR was observed in 74 patients (86.0%) during the overall phase; the CR during the acute (0-24 h) and delayed (24-120 h) phases was 90.7% and 88.4%, respectively. CC was 89.5% during the acute and 84.9% during the delayed phase; the overall CC was 82.6%. This was the first trial, which demonstrated the efficacy of a single dose of palonosetron in control CINV in patients with aggressive non-Hodgkin's lymphoma receiving MEC regimen containing steroids.

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

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

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.

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

[Guidelines on psychological intervention in cardiac rehabilitation- methodological process].

PubMed

Sommaruga, Marinella; Tramarin, Roberto; Angelino, Elisabetta; Bettinardi, Ornella; Cauteruccio, Maria Antonella; Miglioretti, Massimo; Monti, Marco; Pierobon, Antonia; Sguazzin, Cinzia

2003-03-01

The development and the role of cardiac rehabilitation in healthcare programs related to cardiovascular diseases has led to the growth of knowledge, experience and specific technical, scientific, organizational and cultural skills on the part of the different health professionals engaged with the cardiologist in the management of rehabilitation programs. The need to define the characteristics of the psychological intervention in cardiac rehabilitation programs on the basis of scientific evidence encouraged the Board of the Italian Group of Cardiac Rehabilitation and Prevention [Gruppo Italiano di Cardiologia Riabilitativa e Preventiva (GICR)] to set up a working group (WG), composed of psychologists chosen on the basis of their proven specific experience in clinical research, with the task of defining the state-of-the-art of the psychological intervention in cardiac rehabilitation on the basis of documented efficacy, as a first step to formulating Guidelines on Psychological Intervention in Cardiac Rehabilitation. The methodology adopted by the WG was in line with the recommendations of the National Guidelines Program of the Italian Ministry of Health; the WG chose, in addition, to exploit a detailed critical review of clinical psychology practice in order to provide systematic evidence for recommendations and clinical approaches at present supported only by expert opinion. The document, which represents the basis upon which the Guidelines on the psychological activity in cardiac rehabilitation will be drawn up, is subdivided into three parts: an introduction, the main body of the text, and some appendices. In the introduction, the theme and context of the Guidelines are defined, preceded by a series of notes and user instructions; also defined in this section are the intended audience. The main body of the document is structured on the basis of the steps that characterize the interactions between the patient suffering from heart disease and the psychologist

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