Background: Adding more than four cycles of the combination regimen increase toxicities. The availabilityof an intravenous (i.v.) and oral form of vinorelbine appeared as a particularly convenient way to provide aconsolidation treatment to patients who have achieved an objective response or stable disease. Patients andmethods: This study was retrospectively designed to investigate the efficacy in terms of response and safety ofi.v. vinorelbine 25 mg/m2 on day 1 and oral vinorelbine 60 mg/m2 on day 8 given with carboplatin area underthe curve (AUC) 5 once every 3 weeks (q3w) for four cycles followed by consolidation therapy with single-agentvinorelbine in non-progressive patients with advanced non-small-cell lung cancer (NSCLC).
Results: Seventytwopatients enrolled into the study from October 2006 to July 2009 received the combination regimen. Thirtysevenpatients (51.3%) also received the subsequent consolidation treatment. Partial tumor responses wereobtained in 25 patients (34.7%) of 72 evaluable patients. Stable disease was observed in 26 (36.1%) of patients.The median progression free-survival was 4 months (95% CI 3.1-4.8). The median overall survival time was 10months (95% CI 8.2-11.7) and the 1 year survival was 38.1%. The main toxicities recorded were hematological.Grade 3-4 neutropenia were observed in 17 patients (23.6%). Only two patients experienced grade three febrileneutropenia in the induction period, and there was no occurrence of febril neutropenia in the consolidationperiod. Nausea and vomiting were the major non-hematological toxicities reported. Toxicities occurred primarilyduring the initial combination phase of the chemotherapy.
Conclusions: Despite the low dose of vinorelbine(25mg/m2 i.v. on day 1 and only 60 mg/m2 oral on day 8, every 3 weeks) achieved during the study, the responserate of 34.7%, the disease control of 70.8% and the 10 months median overall survival with tolerable toxicityprofile, confirmed that this combination, offers an active and safe regimen for patients with advanced NSCLC