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Bruno E.,Fondazione Istituto Nazionale Dei Tumori | Gargano G.,Fondazione Istituto Nazionale Dei Tumori | Villarini A.,Fondazione Istituto Nazionale Dei Tumori | Traina A.,A.R.N.A.S Ospedali Civico e Benfratelli G. di Cristina e M. Ascoli | And 15 more authors.
International Journal of Cancer | Year: 2016

Metabolic syndrome (MetS), conventionally defined by the presence of at least three out of five dismetabolic traits (abdominal obesity, hypertension, low plasma HDL-cholesterol and high plasma glucose and triglycerides), has been associated with both breast cancer (BC) incidence and prognosis. We investigated the association between the prevalence of MetS and a score of adherence to the World Cancer Research Fund (WCRF) and American Institute for Cancer Research (AICR) recommendations for the prevention of cancer in a cross-sectional study of BC patients. The DIet and ANdrogen-5study (DIANA-5) for the prevention of BC recurrences recruited 2092 early stage BC survivors aged 35-70. At recruitment, all women completed a 24-hour food frequency and physical activity diary on their consumption and activity of the previous day. Using these diaries we created a score of adherence to five relevant WCRF/AICR recommendations. The prevalence ratios (PRs) and 95% confidence intervals (CIs) of MetS associated with the number of recommendations met were estimated using a binomial regression model. The adjusted PRs of MetS decreased with increasing number of recommendations met (p<0.001). Meeting all the five recommendations versus meeting none or only one was significantly associated with a 57% lower MetS prevalence (95% CI 0.35-0.73). Our results suggest that adherence to WCRF/AICR recommendations is a major determinant of MetS and may have a clinical impact. What's new? Postmenopausal women with metabolic syndrome (MetS) are at increased risk of breast cancer (BC), as well as poorer prognosis and possibly recurrence. In this study, the authors found that women who adhered to more dietary recommendations for preventing cancer were also less likely to develop MetS. These results warrant further study, as they suggest that following dietary guidelines that reduce MetS might, in turn, reduce the risk of BC and BC recurrence. © 2015 UICC. Source

Berrino F.,Epidemiology and Prevention Unit | Villarini A.,Epidemiology and Prevention Unit | Traina A.,A.R.N.A.S Ospedali Civico e Benfratelli G. di Cristina e M. Ascoli | Bonanni B.,Italian National Cancer Institute | And 14 more authors.
Breast Cancer Research and Treatment | Year: 2014

Metabolic syndrome (MS), conventionally defined by the presence of at least three out of five dysmetabolic traits (abdominal obesity, hypertension, low plasma HDL-cholesterol, high plasma glucose and high triglycerides), has been associated with an increased risk of several age-related chronic diseases, including breast cancer (BC). This may have prognostic implications for BC survivors. 2,092 early stage BC survivors aged 35-70, recruited in eleven Italian centres 0-5 years after surgical treatment (1.74 years on average), were followed-up over 2.8 years on average for additional BC-related events, including BC-specific mortality, distant metastasis, local recurrences and contralateral BC. At recruitment, 20 % of the patients had MS. Logistic regression models were carried out to generate OR and 95 % confidence intervals (CI) for new BC events associated with MS, adjusting for baseline pathological prognostic factors. New BC events occurred in 164 patients, including 89 distant metastases. The adjusted ORs for women with MS versus women without any MS traits were 2.17 (CI 1.31-3.60) overall, and 2.45 (CI 1.24-4.82) for distant metastasis. The OR of new BC events for women with only one or two MS traits was 1.40 (CI 0.91-2.16). All MS traits were positively associated with new BC events, and significantly so for low HDL and high triglycerides. MS is an important prognostic factor in BC. As MS is reversible through lifestyle changes, interventions to decrease MS traits in BC patients should be implemented in BC clinics. © 2014 Springer Science+Business Media. Source

Cortelezzi A.,Haematology BMT Unit | Cortelezzi A.,University of Milan | Gritti G.,University of Milan | Laurenti L.,Cattolica University | And 14 more authors.
British Journal of Haematology | Year: 2012

Low-dose alemtuzumab has shown a favourable toxicity profile coupled with good results in terms of efficacy in relapsed/refractory chronic lymphocytic leukaemia (CLL). We conducted a multicentre retrospective study on the routine clinical use of low-dose alemtuzumab in this patient setting. One hundred and eight relapsed/refractory CLL patients from 11 Italian centres were included in the analysis. All patients had an Eastern Cooperative Oncology Group performance status ≤2 and the majority (84%) had adenopathies <5cm. Low-dose alemtuzumab was defined as a total weekly dose ≤45mg and a cumulative dose ≤600mg given for up to 18weeks. The overall response rate was 56% (22% complete remissions). After a median follow-up of 42·2months, the median overall survival and progression-free survival were 39·0 and 19·4months, respectively. In univariate analysis, response was inversely associated with lymph node (P=0·01) and spleen (P=0·02) size, fludarabine-refractoriness (P=0·01) and del(11q) (P=0·009). Advanced age and del(17p) were not associated with a worse outcome. Cumulative dose of alemtuzumab was not associated to response. Toxicities were usually mild and manageable; severe infections occurred in seven patients (7%) during therapy. This retrospective analysis confirms that low-dose alemtuzumab is a valid and currently used therapeutic option for the treatment of relapsed/refractory CLL. © 2011 Blackwell Publishing Ltd. Source

Obon-Santacana M.,Catalan Institute of Oncology ICO IDIBELL | Freisling H.,International Agency for Research on Cancer | Peeters P.H.,University Utrecht | Peeters P.H.,Imperial College London | And 50 more authors.
International Journal of Cancer | Year: 2016

Acrylamide, classified in 1994 by IARC as "probably carcinogenic to humans," was discovered in 2002 in some heat-treated, carbohydrate-rich foods. Four prospective studies have evaluated the association between dietary acrylamide intake and endometrial cancer (EC) risk with inconsistent results. The purpose of this nested case-control study, based on the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort, was to evaluate, for the first time, the association between hemoglobin adducts of acrylamide (HbAA) and glycidamide (HbGA) and the risk of developing EC in non-smoking postmenopausal women. Hemoglobin adducts were measured in red blood cells by HPLC/MS/MS. Four exposure variables were evaluated: HbAA, HbGA, their sum (HbAA+HbGA), and their ratio (HbGA/HbAA). The association between hemoglobin adducts and EC was evaluated using unconditional multivariable logistic regression models, and included 383 EC cases (171 were type-I EC), and 385 controls. Exposure variables were analyzed in quintiles based on control distributions. None of the biomarker variables had an effect on overall EC (HRHbAA;Q5vsQ1: 0.84, 95%CI: 0.49-1.48; HRHbGA;Q5vsQ1: 0.94, 95%CI: 0.54-1.63) or type-I EC risk. Additionally, none of the subgroups investigated (BMI < 25 vs. ≥25 kg m-2, alcohol drinkers vs. never drinkers, oral contraceptive users vs. non-users) demonstrated effect measure modification. Hemoglobin adducts of acrylamide or glycidamide were not associated with EC or type-I EC risk in 768 nonsmoking postmenopausal women from the EPIC cohort. What's new? Acrylamide in food may not lead to endometrial cancer, according to a new report. The carcinogen has provoked public concerns because it can be detected in certain foods. Prospective studies on the relationship between endometrial cancer and dietary acrylamide, however, have produced conflicting results. Taking a different tack, these authors conducted a case-control study, drawing on data from the European Prospective Investigation into Cancer and Nutrition (EPIC). They measured the amounts of certain compounds formed by hemoglobin with acrylamide or glycidamide in nonsmoking, postmenopausal women. Neither of these levels, they report, had any impact on endometrial cancer risk. © 2015 UICC. Source

Lerose R.,Irccs Centro Of Riferimento Oncologico Of Basilicata | Musto P.,Irccs Centro Of Riferimento Oncologico Of Basilicata | Aieta M.,Irccs Centro Of Riferimento Oncologico Of Basilicata | Papa C.,Irccs Centro Of Riferimento Oncologico Of Basilicata | Tartarone A.,Irccs Centro Of Riferimento Oncologico Of Basilicata
European Journal of Clinical Pharmacology | Year: 2012

Background: Off-label use is the practice of prescribing a drug outside the terms of its official labeling. Worldwide, about 20% of the commonly prescribed medications are off-label, and the percentage increases in specific patient populations, such as children, pregnant women, and cancer patients. Off-label use is particularly widespread in oncology for many reasons, including the wide variety of cancer subtypes, the difficulties involved in performing clinical trials, the rapid diffusion of preliminary results, and delays in the approval of new drugs by regulatory organizations/agencies. Objective: The aim of this article is to describe the use of offlabel drugs in oncology, with an emphasis on the role of the world's leading regulatory agencies and an assessment of current Italian legislation. Conclusion: Off-label drug utilization is essential in oncology when based on evidence. However, off-label drugs must be prescribed in accordance with existing national laws and only when the potential benefit outweighs the potential toxic effects. © Springer-Verlag 2011. Source

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