Showing papers by "Sergio Ricci published in 2009"
TL;DR: Nadroparin reduces the incidence of thromboembolic events in ambulatory patients with metastatic or locally advanced cancer who are receiving chemotherapy, and future studies should focus on patients who are at a high risk for thrombolic events.
Abstract: Summary Background Clinical trials are needed to assess the clinical benefit of antithrombotic prophylaxis in patients with cancer who are receiving chemotherapy, since these patients are at an increased risk of developing a thromboembolism. We did a trial to assess the clinical benefit of the low-molecular-weight heparin nadroparin for the prophylaxis of thromboembolic events in ambulatory patients receiving chemotherapy for metastatic or locally advanced solid cancer. Methods Between October, 2003, and May, 2007, ambulatory patients with lung, gastrointestinal, pancreatic, breast, ovarian, or head and neck cancer were randomly assigned in a double-blind manner to receive subcutaneous injections of nadroparin (3800 IU anti-Xa once a day, n=779) or placebo (n=387), in a 2:1 ratio. Study treatment was given for the duration of chemotherapy up to a maximum of 4 months. The primary study outcome was the composite of symptomatic venous or arterial thromboembolic events, as assessed by an independent adjudication committee. All randomised patients who received at least one dose of study treatment were included in the efficacy and safety analyses (modified intention-to-treat population). The study is registered with ClinicalTrials.gov, NCT 00951574. Findings 1150 patients were included in the primary efficacy and safety analyses: 769 patients in the nadroparin group and 381 patients in the placebo group. 15 (2·0%) of 769 patients treated with nadroparin and 15 (3·9%) of 381 patients treated with placebo had a thromboembolic event (single-sided p=0·02). Five (0·7%) of 769 patients in the nadroparin group and no patients in the placebo group had a major bleeding event (two-sided p=0·18). The incidences of minor bleeding were 7·4% (57 of 769) with nadroparin and 7·9% (30 of 381) with placebo. There were 121 (15·7%) serious adverse events in the nadroparin goup and 67 (17·6%) serious adverse events in the placebo group. Interpretation Nadroparin reduces the incidence of thromboembolic events in ambulatory patients with metastatic or locally advanced cancer who are receiving chemotherapy. Future studies should focus on patients who are at a high risk for thromboembolic events. Funding Italfarmaco SpA, Milan, Italy.
506 citations
TL;DR: The GONO-FOLFOXIRI regimen allow an R0 surgery in approximately 1 out of 5 unselected patients with initially unresectable metastatic colorectal cancer, and the long-term survival of resected patients is considerable.
Abstract: Objective/Background: The GONO-FOLFOXIRI regimen improved the rate of R0 secondary resection of metastases in initially unresectable metastatic colorectal cancer The objective of this study was to evaluate the long-term outcome of resected patients and the impact of FOLFOXIRI on perioperative morbidities, mortality, and chemotherapy induced hepatotoxicity Patients and Methods: Overall, 196 patients with initially unresectable metastatic colorectal cancer were treated with FOLFOXIRI in 2 phase II and 1 phase III trial This regimen was associated with an elevated response rate (704%) and 37 patients (19%) could undergo a secondary R0 surgery on metastases This study was registered with the Australian New Zealand Clinical Trials Registry Database at http://wwwanzctrorgau/Statisticsaspx and has ID number ACTRN12608000615381 Results: Main characteristics of the 37 radically resected patients were: median age 64 years (45–73), Eastern Cooperative Oncology Group Performance Status (ECOG) PS 1 in 30%, synchronous metastases in 65%, multiple sites of disease in 22%, and metastases confined to the liver in 68% Preoperative FOLFOXIRI was administered for a median of 55 months There was no perioperative mortality and all morbidities (27% of patients) resolved without sequelae After a median follow up of 67 months, 5-year and 8-year survival are 42% and 33% respectively At 5 years, 29% of patients are free of disease The analysis of treatmentinduced liver injury showed neither G3 vascular toxicity nor G4 steatosis, and steato-hepatitis in only 5% of patients Conclusions: The GONO-FOLFOXIRI regimen allow an R0 surgery in approximately 1 out of 5 unselected patients with initially unresectable metastatic colorectal cancer, and the long-term survival of resected patients is considerable Neoadjuvant FOLFOXIRI for 3-6 months is safe and not associated with severe liver injury (Ann Surg 2009;249: 420 – 425)
227 citations
TL;DR: Histology was prognostic for survival, with better outcomes associated with squamous cell carcinoma, but was not predictive of PCb, GC, or VC treatment effect for either survival or TTP.
42 citations
TL;DR: The PI3K-Akt cascade is a key signaling pathway involved in cell proliferation, survival, and growth and the PIK3CA mutation seems to characterize the luminal-type BC, in both sporadic and BRCA2 mutated forms, and is absent in the basal- type BC.
Abstract: The PI3K-Akt cascade is a key signaling pathway involved in cell proliferation, survival, and growth. Activating PIK3CA mutations have been reported in breast carcinoma (BC). The aim of this study was to characterize the PIK3CA mutations at exons 9 and 20 in a series of 176 sporadic and 22 hereditar
35 citations
TL;DR: The safety and efficacy data suggest that the association So + IL-2 is safe and feasible and, compared to So alone, improves tumour shrinkage, disease control rate and PFS.
Abstract: 5099 Background: So is an orally active multikinase inhibitor with a well documented activity in advanced RCC. IL-2 is a pleiotropic cytokine with antitumoral activity depending on dose and schedule. The aim of the study is to evaluate the activity and the safety of So and IL-2 association compared to So alone. Methods: In this multicenter, randomized, open label, phase II study, 128 previously untreated metastatic RCC patients (pts) were randomized to receive 400 mg of So, orally given twice daily continuously, in combination with IL-2, 4.5 MIU administered subcutaneously, five times a week for six consecutive weeks any eight weeks (arm A), or So alone (arm B) at the same dose. Therapy continued until progression of disease or unacceptable toxicity. The primary end point was progression free survival (PFS) and the secondary endpoints were response rate, safety and overall survival. Eligible pts had histological diagnosis of RCC, ECOG 0–2, no brain metastases, measurable disease and any Motzer's score. Pt...
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