Pesaro, Italy
Pesaro, Italy

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Lee A.Y.Y.,University of British Columbia | Lee A.Y.Y.,British Columbia Cancer Agency | Kamphuisen P.W.,University of Groningen | Meyer G.,University of Paris Descartes | And 161 more authors.
JAMA - Journal of the American Medical Association | Year: 2015

Importance: Low-molecular-weight heparin is recommended over warfarin for the treatment of acute venous thromboembolism (VTE) in patients with active cancer largely based on results of a single, large trial. Objective: To study the efficacy and safety of tinzaparin vs warfarin for treatment of acute, symptomatic VTE in patients with active cancer. Design, Settings, and Participants: A randomized, open-label study with blinded central adjudication of study outcomes enrolled patients in 164 centers in Asia, Africa, Europe, and North, Central, and South America between August 2010and November 2013. Adult patients with active cancer (defined as histologic diagnosis of cancer and receiving anticancer therapy or diagnosed with, or received such therapy, within the previous 6 months) and objectively documented proximal deep vein thrombosis (DVT) or pulmonary embolism, with a life expectancy greater than 6 months and without contraindications for anticoagulation, were followed up for 180 days and for 30days after the last study medication dose for collection of safety data. Interventions: Tinzaparin (175 IU/kg) once daily for 6 months vs conventional therapy with tinzaparin (175 IU/kg) once daily for 5 to 10 days followed bywarfarin at a dose adjusted to maintain the international normalized ratio within the therapeutic range (2.0-3.0) for 6 months. Main Outcomes and Measures: Primary efficacy outcomewas a composite of centrally adjudicated recurrent DVT, fatal or nonfatal pulmonary embolism, and incidental VTE. Safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and overall mortality. Results: Nine hundred patients were randomized and included in intention-to-treat efficacy and safety analyses. Recurrent VTE occurred in 31 of 449 patients treated with tinzaparin and 45 of 451 patients treated with warfarin (6-month cumulative incidence, 7.2% for tinzaparin vs 10.5% for warfarin; hazard ratio [HR], 0.65 [95% CI, 0.41-1.03]; P = .07). There were no differences in major bleeding (12 patients for tinzaparin vs 11 patients for warfarin; HR, 0.89 [95% CI, 0.40-1.99]; P = .77) or overall mortality (150 patients for tinzaparin vs 138 patients for warfarin; HR, 1.08 [95% CI, 0.85-1.36]; P = .54). A significant reduction in clinically relevant nonmajor bleeding was observed with tinzaparin (49 of 449 patients for tinzaparin vs 69 of 451 patients for warfarin; HR, 0.58 [95% CI, 0.40-0.84]; P = .004). Conclusions and Relevance: Among patients with active cancer and acute symptomatic VTE, the use of full-dose tinzaparin (175 IU/kg) daily compared with warfarin for 6 months did not significantly reduce the composite measure of recurrent VTE and was not associated with reductions in overall mortality or major bleeding, but was associated with a lower rate of clinically relevant nonmajor bleeding. Further studies are needed to assess whether the efficacy outcomes would be different in patients at higher risk of recurrent VTE. Copyright © 2015 American Medical Association. All rights reserved.


Luzi M.,Azienda Ospedaliero Universitaria Ospedali Riuniti | Simone A.D.,Clinica San Michele | Leoni L.,Azienda Ospedaliera Universitaria di Padua | Amellone C.,Ospedale Civile di Cirie | And 13 more authors.
Journal of Medical Internet Research | Year: 2013

Background: Remote monitoring (RM) permits home interrogation of implantable cardioverter defibrillator (ICD) and provides an alternative option to frequent in-person visits. Objective: The Italia-RM survey aimed to investigate the current practice of ICD follow-up in Italy and to evaluate the adoption and routine use of RM. Methods: An ad hoc questionnaire on RM adoption and resource use during in-clinic and remote follow-up sessions was completed in 206 Italian implanting centers. Results: The frequency of routine in-clinic ICD visits was 2 per year in 158/206 (76.7%) centers, 3 per year in 37/206 (18.0%) centers, and 4 per year in 10/206 (4.9%) centers. Follow-up examinations were performed by a cardiologist in 203/206 (98.5%) centers, and by more than one health care worker in 184/206 (89.3%) centers. There were 137/206 (66.5%) responding centers that had already adopted an RM system, the proportion of ICD patients remotely monitored being 15% for single- and dual-chamber ICD and 20% for cardiac resynchronization therapy ICD. Remote ICD interrogations were scheduled every 3 months, and were performed by a cardiologist in 124/137 (90.5%) centers. After the adoption of RM, the mean time between in-clinic visits increased from 5 (SD 1) to 8 (SD 3) months (P<.001). Conclusions: In current clinical practice, in-clinic ICD follow-up visits consume a large amount of health care resources. The results of this survey show that RM has only partially been adopted in Italy and, although many centers have begun to implement RM in their clinical practice, the majority of their patients continue to be routinely followed-up by means of in-clinic visits.


Baronzio G.,Cancer Center | Schwartz L.,Hopital Raymond Poincare | Schwartz L.,Ecole Polytechnique - Palaiseau | Crespi E.,Cancer Center | And 4 more authors.
Biomedical Research | Year: 2012

The metabolism of tumor cells plays an important role in cancer development. Although aerobic glycolysis is inefficient from the standpoint of ATP production, it provides cancer cells with biomolecules implicated in the synthesis of lipids and nucleotides required for cellular proliferation. Thus, targeting aerobic glycolysis has clearly been recognized as a potentially fruitful approach for the treatment of cancer. The inhibition of aerobic glycolysis by a combination of alpha lipoic acid and hydroxycitrate (METABLOC) is efficient to inhibit tumor development in several mouse models. In association with chemotherapy, it seems to improve survival of patients with tumors difficult to treat when compared to a single chemotherapy regimen. We herein report our preliminary cases on both the clinical efficacy and side effects of METABLOC. Eleven patients with advanced metastatic cancer from were treated with per os 0.4 to 1.8 g of lipoic acid and 1.2 to 3 g of hydroxycitrate during 2 to 21 months inaddition to their normal chemotherapeutic regimen. Side effects occurred in half of the patients but were mild (grade 1-3) and limited to gastrointestinal disorders that disappeared on using proton pump inhibitors or decreasing the doses. Five patients were characterized by a partial regression, 3 by a stable disease, and 3 by disease progression. In conclusion the results from these preliminary treatments support that METABLOC can be used safely with various common standard chemotherapeutic regimens. It also suggests that its use may slow down tumor growth, an observation that needs to be confirmed by a randomized controlled trial.

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