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Piacenza d'Adige, Italy

Santoro A.,Humanitas Cancer Center | Comandone A.,Gradenigo Hospital | Basso U.,Istituto Oncologico Veneto | Soto Parra H.,Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele | And 7 more authors.
Annals of Oncology

Introduction: We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS). Patients and methods: An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Patients received sorafenib 400 mg twice daily for 28 days. The primary end point was the progression-free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A). Results: Between November 2006 and January 2010, 101 patients (36 L, 19 A, and 46 others) were enrolled; 76 patients per-protocol (PP) and 100 per intention-to-treat (ITT) were assessable for the primary end point. In the PP analysis, 11 (14.5) achieved partial response and 25 (32.9) stable disease; 6-month PFS rates were all histologies, 34.5; L, 38.4; and A, 56.3. In the ITT analysis, 6-month PFS results were 27.1, 35, and 35.5 in all histologies, L, and A, respectively. When stratified by histology, we observed a better PFS favouring leiomyosarcoma versus other histologies (P 0.033). Treatment was well tolerated. Conclusions: Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histology-driven trials. © The Author 2012. Source

Celio L.,Medical Oncology Unit 2 | Frustaci S.,Centro Of Riferimento Oncologico | Denaro A.,Medical Oncology Unit 2 | Buonadonna A.,Centro Of Riferimento Oncologico | And 9 more authors.
Supportive Care in Cancer

Purpose: A phase III trial assessed the efficacy of palonosetron plus dexamethasone given once in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following a broad range of moderately emetogenic chemotherapy (MEC) regimens. Methods: This multicentre, randomized, open-label, non-inferiority trial evaluated two different treatment groups. One group received palonosetron (0.25 mg intravenously) and dexamethasone (8 mg intravenously) before chemotherapy, while the other was administered the same regimen on day 1 followed by dexamethasone 8 mg orally on days 2 and 3. The primary endpoint was complete response (CR; defined as no emetic episodes and no rescue medication) during the overall phase (days 1-5 after chemotherapy initiation). The non-inferiority margin was predefined as a 15% difference between groups in the primary endpoint. Results: Of 332 chemotherapy-naïve patients included in the intention-to-treat analysis, 65.1% were female, and 35.2% received anthracycline plus cyclophosphamide (AC)-based regimens. Overall CR rates were 67.5% for those administered dexamethasone only on day 1 (n=166), and 71.1% for those also administered dexamethasone on days 2 and 3 (n=166; difference -3.6% (95% confidence interval, -13.5 to 6.3)). CR rates were not significantly different between groups during the acute (0-24 h post-chemotherapy; 88.6% versus 84.3%; P=0.262) and delayed phases (days 2-5; 68.7% versus 77.7%; P=0.116). Conclusions: Palonosetron plus single-dose dexamethasone administered before common MEC regimens provide protection against acute and delayed CINV which is non-inferior to that of palonosetron plus dexamethasone for 3 days. However, the major benefit of the single-day regimen occurs in patients receiving non-AC MEC regimens. © 2010 The Author(s). Source

Citro R.,University of Salerno | Citro R.,University of Insubria | Bossone E.,University of Salerno | Parodi G.,Careggi Hospital | And 14 more authors.
International Journal of Cardiology

Aim To determine the prevalence, clinical characteristics, in-hospital course and determinants of major adverse events in a cohort of Caucasian patients with Takotsubo syndrome (TTS) and right ventricular involvement (RVi), regardless of left ventricular variant forms. Methods and results The study population consisted of 424 patients (mean age 69.1 ± 11.5 years; female 92.2%) with a diagnosis of TTS divided into two groups according to the presence or absence of RVi. RVi patients (n = 57; 13.4%) showed a higher prevalence of comorbidities, especially respiratory diseases (p = 0.011), and a higher Charlson comorbidity index (CCI; p = 0.006) than non-RVi patients. In-hospital major adverse events (acute heart failure, cardiogenic shock and death) occurred more frequently in RVi patients (p < 0.001). Heart rate and CCI, along with the echocardiographic parameters of wall motion score index, E/e’ ratio, tricuspid annular plane systolic excursion (TAPSE) and systolic pulmonary artery pressure (sPAP) were associated with adverse in-hospital outcome. At multivariate analysis, CCI (HR: 1.871; 95% CI: 1.202–2.912; p = 0.006), sPAP (HR: 1.059; 95% CI: 1.016–1.104; p = 0.007) and TAPSE (HR: 0.728; 95% CI: 0.619–0.855; p < 0.001) were independent correlates of the composite outcome in patients with RVi. Conclusion Patients with RVi are characterized by distinct clinical profile and should undergo closely clinical and echocardiographic monitoring. The presence of echocardiographic signs of right ventricular failure along with substantial comorbidities burden identify a cohort at higher risk of in-hospital major adverse cardiovascular events. © 2016 Elsevier Ireland Ltd Source

Fois P.,University of Parma | Giannuzzi A.L.,Gruppo Otologico | Paties C.T.,Ospedale Guglielmo da Saliceto | Falcioni M.,Gruppo Otologico
Ear, Nose and Throat Journal

Choristoma of the middle ear is a rare condition characterized by the presence of normal salivary gland tissue in the middle ear space. Salivary gland choristomas are benign lesions that are frequently associated with ossicular chain and facial nerve anomalies. Total surgical excision is indicated when there is no risk of damaging the facial nerve. We describe a new case of salivary gland choristoma of the middle ear, and we discuss the etiology, histologic features, and management of such lesions. Our patient was a 22-year-old woman in whom we surgically removed a whitish retrotympanic mass. Intraoperatively, we also detected an ossicular chain malformation. Histologic examination of the choristoma revealed the presence of salivary gland tissue. Furthermore, the lesion contained an extensive and previously undescribed component: a well-defined pseudostratified respiratory-type epithelium, similar to that of a normal eustachian tube. Ten months after removal of the choristoma, we surgically repaired the ossicular chain anomalies. No recurrence was noted on follow-up. © 2015 Vendome Group, LLC. Source

Griffo R.,Direzione Scientifica Istituto Cardiovascolare Camogli | Ambrosetti M.,U.O. Cardiologia e Angiologia Riabilitativa | Furgi G.,Fondazione S. Maugeri | Carlon R.,Presidio | And 10 more authors.
Monaldi Archives for Chest Disease - Cardiac Series

Despite major improvements in diagnostics and interventional therapies, cardiovascular diseases remain a major health care and socio-economic problem in Italy. Costs and resources required are increasing in close correlation to both the improved quality of care and to the population ageing. There is an overwhelming evidence of the efficacy of cardiac rehabilitation (CR) in terms of reduction in morbidity and mortality after acute cardiac events. CR services are by definition multi-factorial and comprehensive. Furthermore, systematic analysis and monitoring of the process of delivery and outcomes is of paramount importance. The aim of this position paper promoted by the Italian Association for Cardiovascular Prevention and Rehabilitation (GICR-IACPR) is to provide specific recommendations to assist CR staff in the design, evaluation and development of their care delivery organization. The position paper should also assist health care providers, insurers, policy makers and consumers in the recognition of the quality of care requirements, standards and outcome measure, quality and performance indicators, and professional competence involved in such organization and programs. The position paper i) include comprehensive CR definition and indications, ii) describes priority criteria based on the clinical risk for admission to both inpatient or outpatient CR, and iii) defines components and technological, structural and organizing requirements for inpatient or outpatient CR services, with specific indicators and standards, performance measures and required professional skills. A specific chapter is dedicated to the requirements for highly specialized CR services for patients with more advanced cardiovascular diseases. Source

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