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Monza, Italy

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 | Year: 2011

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


Bianda N.,Ospedale San Giovanni | Di Valentino M.,Ospedale San Giovanni | Priat D.,University of Zurich | Segatto J.M.,Ospedale San Giovanni | And 13 more authors.
European Heart Journal | Year: 2012

Aims The time course of atherosclerosis burden in distinct vascular territories remains poorly understood. We longitudinally evaluated the natural history of atherosclerotic progression in two different arterial territories using high spatial resolution magnetic resonance imaging (HR-MRI), a powerful, safe, and non-invasive tool. Methods and Results We prospectively studied a cohort of 30 patients (mean age 68.3, n= 9 females) with high Framingham general cardiovascular disease 10-year risk score (29.5) and standard medical therapy with mild-to-moderate atherosclerosis intra-individually at the level of both carotid and femoral arteries. A total of 178 HR-MRI studies of carotid and femoral arteries performed at baseline and at 1-and 2-year follow-up were evaluated in consensus reading by two experienced readers for lumen area (LA), total vessel area (TVA), vessel wall area (VWA= TVA-LA), and normalized wall area index (NWI= VWA/TVA). At the carotid level, LA decreased (-3.19/year, P 0.018), VWA increased (3.83/year, P= 0.019), and TVA remained unchanged. At the femoral level, LA remained unchanged, VWA and TVA increased (5.23/year and 3.11/year, both P < 0.01), and NWI increased for both carotid and femoral arteries (2.28/year, P= 0.01, and 1.8/year, P= 0.033). Conclusion The atherosclerotic burden increased significantly in both carotid and femoral arteries. However, carotid plaque progression was associated with negative remodelling, whereas the increase in femoral plaque burden was compensated by positive remodelling. This finding could be related to anatomic and flow differences and/or to the distinct degree of obstruction in the two arterial territories. © 2011 The Author. Source


Many studies suggests that a strong relationship exists between hypertension and the risk of major vascular events. Current hypertension management guidelines recommend target blood pressures <140/90 mm Hg in primary prevention of low risk patients and lower values in high risk populations (secondary prevention, diabetes, kidney disease etc). Unfortunately, observational studies and post hoc analysis of intervention megatrials demonstrate that more than 50-60% of treated patients are not adequately controlled in clinical practice. Many factors contribute to poor control of hypertension, including reduced compliance, physician inertia, inadequate drugs choice and lack of simplicity. A practical solution outlined in more updated guidelines to improve the percentage of patients in goal is to use a combination of two or more complementary antihypertensive drugs in a single pill. The use of two well-known blood pressure lowering drugs synergically acting on different pathways, such as amlodipine and valsartan at fixed-dose combination in a single pill, is a real opportunity to achieve the blood pressure goal in higher percentage of treated patients than the single drugs, so preventing both the exceeding vascular events and the economic burden thanks to the reduction of the hypertensive residual risk. ©2011 Pharma Project Group srl. Source


Lefebvre J.-L.,Center Oscar Lambret | Andry G.,Institute Jules Bordet | Chevalier D.,Center Hospitalier Regional Claude Huriez | Luboinski B.,Institute Gustave Roussy | And 9 more authors.
Annals of Oncology | Year: 2012

Background: We report the 10-year results of the EORTC trial 24891 comparing a larynx-preservation approach to immediate surgery in hypopharynx and lateral epilarynx squamous cell carcinoma. Material and methods: Two hundred and two patients were randomized to either the surgical approach (total laryngectomy with partial pharyngectomy and neck dissection, followed by irradiation) or to the chemotherapy arm up to three cycles of induction chemotherapy (cisplatin 100 mg/m. 2 day 1 + 5-FU 1000 mg/m. 2 day 1-5) followed for complete responders by irradiation and otherwise by conventional treatment. The end points were overall survival [OS, noninferiority: hazard ratio (preservation/surgery) ≤ 1.428, one-sided α = 0.05], progression-free survival (PFS) and survival with a functional larynx (SFL). Results: At a median follow-up of 10.5 years on 194 eligible patients, disease evolution was seen in 54 and 49 patients in the surgery and chemotherapy arm, respectively, and 81 and 83 patients had died. The 10-year OS rate was 13.8% in the surgery arm and 13.1% in the chemotherapy arm. The 10-year PFS rates were 8.5% and 10.8%, respectively. In the chemotherapy arm, the 10-year SFL rate was 8.7%. Conclusion: This strategy did not compromise disease control or survival (that remained poor) and allowed more than half of the survivors to retain their larynx. © The Author 2012. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source


Lidove O.,Hopital Bichat | West M.L.,Dalhousie University | Pintos-Morell G.,Germans Trias i Pujol University Hospital | Reisin R.,Hospital Britanico | And 7 more authors.
Genetics in Medicine | Year: 2010

Enzyme replacement therapy with α-galactosidase A has been used to treat Fabry disease since 2001. This article reviews the published evidence for clinical efficacy of the two available enzyme preparations. We focused on heart, kidney, and nervous system manifestations, which impact both quality of life and overall prognosis. A literature search was undertaken to identify prospective open or randomized controlled trials of enzyme replacement therapy in patients with Fabry disease published since 2001. To date, no definitive conclusion can be drawn from studies that have directly compared therapeutic responses between the two commercially available enzyme preparations. Significant clinical benefits of enzyme replacement therapy have been demonstrated, mainly in patients at an early phase of the disease, with beneficial effects on heart, kidneys, pain, and quality of life in treated patients. Incidence of antibodies against agalsidase alfa and agalsidase beta observed during major clinical studies suggests a greater antigenic response to agalsidase beta. Further studies are required to confirm the long-term clinical benefits of enzyme replacement therapy. More studies with female patients are needed as are investigations of early initiation of enzyme replacement therapy to determine the optimal time to start treatment to prevent irreversible organ damage. The value of adjunctive and supportive therapies should also be rigorously analyzed. © 2010 Lippincott Williams & Wilkins. Source

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