Adjuvant chemotherapy with cisplatin and gemcitabine versus chemotherapy at relapse in patients with muscle-invasive bladder cancer submitted to radical cystectomy: An italian, multicenter, randomized phase iii trial
Cognetti F.,Regina Elena Cancer Institute |
Ruggeri E.M.,Belcolle Hospital |
Felici A.,Regina Elena Cancer Institute |
Gallucci M.,Regina Elena Cancer Institute |
And 6 more authors.
Annals of Oncology | Year: 2012
Background: The purpose of the study was to evaluate the benefit of adjuvant chemotherapy (AC) versus surgery alone in patients with muscle-invasive bladder cancer (MIBC). Patients and methods: One hundred and ninety-four patients with pT2G3, pT3-4, N0-2 transitional cell bladder carcinoma were randomly allocated to control (92 patients) or to four courses of AC (102 patients). These latter patients were further randomly assigned to receive gemcitabine 1000 mg/m 2 days 1, 8 and 15 and cisplatin 70 mg/m 2 day 2 or gemcitabine as above plus cisplatin 70 mg/m 2 day 15, every 28 days. Results: At a median follow-up of 35 months, the 5-year overall survival (OS) was 48.5%, with no difference between the two arms [P = 0.24, hazard ratio (HR) 1.29, 95% confidence interval (CI) 0.84-1.99]. Mortality hazard was significantly correlated with Nodes (N) and Tumor (T) stage. The control and AC arms had comparable disease-free survival (42.3% and 37.2%, respectively; P = 0.70, HR 1.08, 95% CI 0.73-1.59). Only 62% of patients received the planned cycles. A significant higher incidence of thrombocytopenia was observed in patients receiving cisplatin on day 2 (P = 0.006). A similar global quality of life was observed in the two arms. Conclusion: The study was underpowered to demonstrate that AC with cisplatin and gemcitabine improves OS and disease-free survival in patients with MIBC. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
La Franca E.,Policlinico Universitario
Global journal of health science | Year: 2013
The determination of inflammation markers in circulation has enabled an important improvement in the study of cardiovascular diseases. It was tested the hypothesis that non-specific markers such as erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and fibrinogen may provide prognostic information in patients with acute myocardial infarction with persistent ST-segment elevation (STEMI) undergoing primary angioplasty (PCI). Patients: A cohort of 197 consecutive patients with STEMI undergoing primary PCI was enrolled, evaluating during hospitalization, the peak values of the following markers of inflammation: ESR, CRP and fibrinogen. A telephone follow-up has been made in order to investigate any possible new cardiovascular events after hospital discharge and the procedure performed. Higher values of CRP were statistically associated with adverse future events as composite endpoint and with the single endpoint of death. Furthermore, higher age, presence of hypertension, history of previous cardiovascular events, were statistically significantly associated with cardiac events at follow up. In this group were also overrepresented subjects with anterior myocardial infarction in the anterior localization and with an EF ? 35% at discharge. CRP appears to be a predictor of future cardiovascular events, confirming that a pro-inflammatory state promotes the progression of atherosclerotic disease and its complications.
Webb J.,University of British Columbia |
Gerosa G.,Policlinico Universitario |
Lefevre T.,Institute Jacques Cartier |
Leipsic J.,University of British Columbia |
And 6 more authors.
Journal of the American College of Cardiology | Year: 2014
Background The SAPIEN 3 (Edwards Lifesciences Inc., Irvine, California) transcatheter valve incorporates features designed to address the well-known deficiencies of transcatheter aortic valve replacement (TAVR). An ultra-low-profile delivery system facilitates safe, controlled, and accurate implantation and an external seal minimizes paravalvular regurgitation. Objectives The study evaluated whether TAVR with this third-generation valve would be a viable alternative to high- or intermediate-risk surgery for severe aortic stenosis. Methods The prospective study enrolled 150 patients at 16 sites in Europe and Canada. Clinical and echocardiographic outcomes were assessed at baseline, post-procedure, and 30 days. New sizing recommendations were developed during the course of the study. Results Patients were 83.6 ± 5.0 years of age, with multiple comorbidities reflected by a Society of Thoracic Surgeons score of 7.4 ± 4.5% and logistic EuroSCORE of 21.6 ± 12.3%. A transfemoral approach was chosen in 64.0% and alternative access (transapical/direct aortic) in the remainder. At 30 days, paravalvular regurgitation was none to mild in 96.4% and moderate in 3.5%. No patient had severe regurgitation. Transfemoral implantation was associated with low mortality (2.1%), no disabling stroke (0.0%), and fully percutaneous access and closure in 95.8%. Nontransfemoral alternative access was associated with higher rates of mortality (11.6%) and stroke (5.6%). Conclusions This third-generation device addresses major deficiencies of earlier valves in terms of ease of use, accuracy of positioning, and paravalvular sealing. The rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients. (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve [SAPIEN3]; NCT01808287) © 2014 American College of Cardiology Foundation.
Busetto L.,Policlinico Universitario
Surgery for Obesity and Related Diseases | Year: 2015
Background Improvements in health-related quality of life (HR-QoL) occur after bariatric surgery. However, sustainability of these changes over time remains debated. Methods Data collected in a prospective 3-year multicenter Italian study on changes of HR-QoL after laparoscopic adjustable gastric banding were used. HR-QoL has investigated with the SF-36 questionnaire. Hunger, satiety, and the self-perceived effects of LAGB were recorded. Results A total of 230 patients (53 male and 177 female) were analyzed. Body mass index was 41.4±5.4 kg/m2 at baseline, declined to 33.8±5.8 kg/m2 12 months after surgery (P<.001), and further reduced to 31.9±5.1 kg/m2 36 months after surgery (P<.001 versus 12 months). Scores in the SF-36 subscales were lower than in the general Italian population at baseline. The physical component summary score was 51.9±11.6 at baseline, improved to 79.2±15.4 at 12 months (P<.001), and stabilized to 79.8±15.6 at 36 months. The mental summary score was 52.3±11.8 at baseline, improved to 75.2±17.3 at 12 months (P<.001), and stabilized to 74.2±17.5 at 36 months. A decline>10 points between 12 and 36 months in the summary scores was observed in 22.0% of the patients for PCS and in 26.8% for MCS. In a multiple linear regression analysis, deterioration in HR-QoL in the 12-36 months period was associated to the presence of better HR-QoL values at 12 months and to a more pronounced reduction of the self-perceived effect of the banding at 36 months. Conclusion Improvements in HR-QoL observed in the first year after surgery maintained up to the third year after gastric banding. © 2015 American Society for Bariatric Surgery.
Tomasello F.,Messina University |
Conti A.,Messina University |
Conti A.,Policlinico Universitario |
Cardali S.,Messina University |
Angileri F.F.,Messina University
Journal of Neurosurgery | Year: 2013
Object. Surgical treatment of parasagittal meningiomas is challenging. Preserving the venous outflow is the key point, but this may preclude radical resection. Different surgical strategies have been proposed. To contribute to the debate on the optimal strategy for treating these tumors, a single-institutional, single-surgeon series of patients with parasagittal meningiomas was analyzed and the available literature reviewed. Methods. Clinical charts of patients with parasagittal meningioma, managed at the University of Messina between 1988 and 2008, were retrospectively reviewed. A microsurgical resection, the goal of which was to preserve the venous outflow, was performed. Only if the superior sagittal sinus (SSS) was angiographically occluded, but if alternative venous outflow was clearly recognized, was the tumor resected, together with the sinus without further flow restoration. A MEDLINE review of the literature published between 1955 and 2011 was performed. Results. Long-term follow-up (mean 80 months) data obtained in 67 patients with meningiomas involving the SSS were analyzed. The recurrence rate was 10.4%; the morbidity and mortality rates were 10.4% and 4.5%, respectively. The authors identified in the literature 19 relevant studies on this issue, and based on their review of the literature, there is no evidence that aggressive management offers an advantage in terms of recurrence rate. Conclusions. Analysis of the data obtained in the 67 patients confirmed good outcome and long-term tumor control following a surgical strategy aimed to preserve venous outflow. These findings and the results of the authors' analysis of the literature emphasize that the goal of radical tumor resection should be balanced by an awareness of the increased surgical risk attendant on aggressive management of the SSS and bridging veins. © AANS, 2013.