Collova E.,Ospedale Civile di Legnano |
Ferzi A.,Ospedale Civile di Legnano |
Scandurra G.,Azienda Ospedaliera Cannizzaro |
Aurilio G.,Italian National Cancer Institute |
And 18 more authors.
Tumori | Year: 2014
Aims and background: The addition of trastuzumab to chemotherapy for HER2-positive metastatic breast cancer has significantly improved progression-free survival and overall survival, although most patients develop resistance or have a primarily resistant disease. The aim of the study was to describe the efficacy and safety of a firstline treatment in unselected metastatic HER2-positive breast cancer patients, treated according to clinical practice.Methods: From 2000 to 2009, we conducted a retrospective multi-institutional analysis of 182 consecutive patients with HER2-positive metastatic breast cancer who underwent first-line treatment with trastuzumab. The primary end points were progressionfree survival and overall survival; the secondary end points were survival after progression in patients treated with second-line chemotherapy with or without trastuzumab and safety. A total of 172 patients were analyzed.Results: Median progression-free survival and overall survival were 1.2 (95% CI, 1.1-1.4) and 4.4 years (95% CI, 3.6-5.4), respectively. For 100 patients who received secondline chemotherapy, median survival after progression was significantly longer in those who also received trastuzumab: 2.8 (95% CI, 2.1-4.0) versus 1.2 years (95% CI, 0.6-1.9).Conclusions: Although based on retrospective data, the study confirms the role of trastuzumab as first-line treatment in metastatic breast cancer outside of a controlled trial. Moreover, information obtained on the use of trastuzumab beyond disease progression supports its use in this setting.
Marraro G.A.,A.O. Fatebenefratelli and Ophthalmiatric Hospital |
Denaro C.,Azienda Ospedaliera Cannizzaro |
Spada C.,A.O. Fatebenefratelli and Ophthalmiatric Hospital |
Luchetti M.,A.O. Fatebenefratelli and Ophthalmiatric Hospital |
Giansiracusa C.,A.O. Fatebenefratelli and Ophthalmiatric Hospital
Journal of Clinical Monitoring and Computing | Year: 2010
Objective: Open lung and low tidal volume ventilation appear to be a promising ventilation for chest trauma as it can reduce ARDS and improve outcome. Local therapy (e.g. BAL) can be synergic to remove from the lung the debris, mitigate inflammatory cascade and avoid damage spreading to not compromised lung areas. Materials and methods: 44 pulmonary contused patients were randomized to receive broncho-suction and volume controlled low tidal volume ventilation-VCLTVV (Control Group) or the same ventilation plus medicated (saline + surfactant) BAL (Treatment Group). Tidal volume <10 ml/kg, PEEP of 10-12 cm H2O and PaO2 60-100 mm Hg and PaCO2 35-45 mm Hg were used in both groups. BAL was performed using a fiberscope. 4 boluses of 25 ml saline with 2.4 mg/ml of surfactant were introduced into each contused lobe in which, subsequently, 240 mg of surfactant was instilled. Results: All patients survived. In the Control Group 18 patients developed pneumonia, 5 ARDS and days of intubation were 11.50 (3.83) compared to 5.05 (1.21) of Treatment Group in which OI and PaO2/FiO2 significantly improved from 36 h. Conclusions: VCLTVV alone was not able to prevent ARDS and infection in the Control Group as the reduction of intubation. In the Treatment Group, VCLTVV and medicated BAL facilitated the removal of degradated lung material and recruited the contused lung regions, enabling the healing of the lung pathology. © 2009 Springer Science+Business Media, LLC.
A clinical and angiographic study of the XIENCE v everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease. Study design and rationale of the EXECUTIVE trial
Ribichini F.,University of Verona |
Ansalone G.,Ospedale Generale Madre Vannini |
Bartorelli A.,IRCCS Centro Cardiologico Monzino |
Beqaraj F.,Ospedale Maria Vittoria |
And 18 more authors.
Journal of Cardiovascular Medicine | Year: 2010
Background: Myocardial revascularization with drug-eluting stents (DESs) is emerging as an alternative to conventional coronary artery bypass surgery in patients with multivessel coronary artery disease (MV-CAD). First-generation DESs have yielded equivalent safety results at mid-term compared with surgery, but inferior efficacy in preventing the recurrence of ischemic symptoms. The outcome of percutaneous coronary intervention with a second-generation everolimus DES as compared with a paclitaxel DES in patients with MV-CAD has not been established. AIM OF THE STUDY: The aim of the study is the assessment of the efficacy and performance of the XIENCE V everolimus-eluting stent in the treatment of de-novo coronary artery lesions in patients with MV-CAD. STUDY DESIGN: The study is composed of two parts: a prospective, double arm, randomized multicenter trial to assess the angiographic efficacy of the XIENCE V everolimus-eluting coronary stent system (EECSS) compared with the Taxus Liberté Paclitaxel Eluting Coronary Stent System (Taxus Liberté Stent) and a prospective, open-label, single arm, controlled registry to analyze the clinical efficacy and safety of XIENCE V EECSS at mid-term and long-term follow-up in patients treated for MV-CAD. ENDPOINTS: For the EXECUTIVE randomized trial, the primary endpoint is in-stent late lumen loss at 9 months. For the EXECUTIVE registry, the primary endpoint is a composite of all death, myocardial infarction (Q-wave and non-Q-wave), and ischemia-driven target vessel revascularization at 12 months. The study will be conducted at 30 study centers in Italy and 600 patients will be enrolled in total: 200 patients will be enrolled (1: 1) in the randomized trial and 400 patients will enter the registry. SAMPLE SIZE: It was calculated that, assuming a mean in-stent late lumen loss of 0.20 ± 0.41 mm in the XIENCE V EECSS arm and 0.30 ± 0.53 mm in the Taxus Liberté stent arm, and a noninferiority margin delta of 0.12 (according to the SPIRIT III results), the analysis of 81 lesions per arm would provide over 90% power. Therefore, 200 patients will be enrolled to account for dropouts. Conclusion: The present study is expected to provide as yet unavailable information about the performance of second-generation stents in the specific setting of patients with MV-CAD. © 2010 Italian Federation of Cardiology.
Schuchert A.,Friedrich Ebert Hospital |
Schuchert A.,Universitatsklinikum Hamburg Eppendorf |
Muto C.,Ospedale Loreto Mare |
Maounis T.,Onassis Cardiac Center |
And 33 more authors.
Acta Cardiologica | Year: 2014
Background: Left-ventricular ejection fraction (LVEF) is regarded as a strong predictor for morbidity and mortality in heart failure patients. The aim of the analysis was to assess the relationship between pre-implant LVEF and outcome of patients with advanced heart failure who received cardiac resynchronization therapy (CRT). Methods: We analysed the two-year follow-up of 366 patients who had been enrolled in the MASCOT study which included NYHA class III/IV patients with a class I CRT indication. Pre-implant LVEF was stratified by tertile. Results: The boundaries for pre-implant LVEF were < 22% (n = 128; 18.2 ± 3.1%; Tlow), 22% to 28% (n = 121; 25.4 ± 1.4%; Tmiddle) and > 28% (n = 117; 32.6 ± 3.9%; Thigh) for each tertile. Two-year post-implant LVEF was 32.0 ± 11.5% (Tlow), 33.7 ± 10.8% (Tmiddle) and 36.4 ± 9.9% (Thigh). Tlow had a greater increase between pre- and post-implant LVEF compared to Tmiddle (P = 0.03) and Thigh (P = 0.0001). NYHA class improved similarly among the three groups as well as the quality of life score. No significant differences were detected between the three groups for all-cause mortality, cardiac death, all-cause hospitalization, and hospitalization due to worsening heart failure. Conclusions: Symptomatic heart failure patients with a wide QRS complex and a severe impaired LV function had a better improvement of their pre-implant LVEF than patients with a more preserved LVEF. This may be one reason that in these patient groups long-term morbidity and mortality were not related to their pre-implant LVEF. Pre-implant LVEF was in symptomatic CRT patients not predictive for their long-term cardiovascular morbidity and mortality.
Agodi A.,University of Catania |
Voulgari E.,National and Kapodistrian University of Athens |
Barchitta M.,University of Catania |
Quattrocchi A.,University of Catania |
And 8 more authors.
Journal of Hospital Infection | Year: 2014
Background: Infections caused by multidrug-resistant (MDR) Acinetobacter baumannii have become an important healthcare-associated problem, particularly in intensive care units (ICUs). Aim: To investigate the emergence of carbapenem- and colistin-resistant A.baumannii infections in two Sicilian hospitals. Methods: From October 2008 to May 2011, a period which included two Italian Nosocomial Infections Surveillance in ICUs network (SPIN-UTI) project surveys, all carbapenem-resistant A.baumannii isolates from the ICUs of two hospitals in Catania, Italy, were prospectively collected. Minimum inhibitory concentrations (MICs) were measured by agar dilution, and phenotypic testing for metallo-β-lactamase (MBL) production was performed. Carbapenem resistance genes and their genetic elements were identified by polymerase chain reaction and sequencing. Genotypic relatedness was assessed by pulsed-field gel electrophoresis (PFGE) and multi-locus sequence typing. Patient-based surveillance was conducted using the SPIN-UTI protocol and previous antibiotic consumption was recorded. Findings: Twenty-six carbapenem-resistant A.baumannii were identified. Imipenem and meropenem MICs ranged from 4 to >32mg/L, and 15 isolates exhibited high-level colistin resistance (MICs >32mg/L). PFGE demonstrated that all isolates belonged to a unique clonal type and were assigned to ST2 of the international clone II. They harboured an intrinsic blaOxA-51-like carbapenemase gene, blaOxA-82, which was flanked upstream by ISAba1. Conclusions: The dissemination of clonally related isolates of carbapenem-resistant A.baumannii in two hospitals is described. Simultaneous resistance to colistin in more than half of the isolates is a problem for effective antibiotic treatment. Prior carbapenem and colistin consumption may have acted as triggering factors. © 2014 The Healthcare Infection Society.