Cisplatin, gemcitabine, and vinorelbine (PGV) compared with cisplatin and etoposide (PE) in the first-line treatment of extensive-stage small-cell lung cancer: Two Brazilian institution experience

e18548 Background: The standard first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC) has been cisplatin plus etoposide (PE). Phase II studies showed comparable outcomes and less toxicity with platinum-doublets containing gemcitabine or vinorelbine. Aiming to improve response rates without increasing toxicity, we evaluated the combination of cisplatin, gemcitabine plus vinorelbine (PGV) in comparison to PE. Methods: Patients with ES-SCLC, ECOG 0-1, admitted from January 2002 to January 2011 in two brazilian institutions were analyzed. We compared patients treated with PE (cisplatin 80 mg/m2 D1 and etoposide 100 mg/m2 D1-D3 every 3 weeks for up to 6 cycles) versus modified PGV (cisplatin 80 mg/m2 D1, gemcitabine 1500 mg/m2 D1 and vinorelbine 30 mg/m2 D1 every 3 weeks for up to 6 cycles). Results: Of 69 patients analyzed, 29 were treated with PGV and 40 with PE. Clinical characteristics were comparable in both groups, except for adrenal metastases that were more frequent in PE group (20% vs. 0%; p=0,02). Overall response and complete response rates with PGV and PE were 75.9% vs. 65.0% (p=0.33) and 6 (20.7%) vs. 3(7.5%) (p=0.15), respectively. Median progression-free survival for PGV and PE was 6.47 and 5.06 months (p=0.37). Median overall survival for PGV and PE was 10.94 months versus 9.65 months (p=0.76). Severe neutropenia was higher with PE versus PGV (57.1% vs. 23.1%; p=0.01). Severe vomiting (38.5% vs. 17.2%; p=0.07) and peripheral neuropathy (15.4% vs. 5.3%; p=0.37) were more common with PGV than PE, although without statistical significance. Conclusions: Modified PGV presented comparable efficacy to standard PE in the first-line treatment of ES-SCLC. Response rates were higher with PGV, but without statistical significance. PGV showed less severe neutropenia than PE, but higher non-significant severe vomiting and neuropathy. Prospective studies with a large number of patients should be provided to confirm these results.