1327 - A Phase II Trial of Cisplatin-Docetaxel-Bevacizmab Induction Chemotherapy Followed by Bevacizmab and Pemetrexed Maintenance Therapy in Patients with Nonsquamous Cell Lung Carcinoma: Okayama Lung Cancer Study Group Trial 0903

Abstract

ABSTRACT Background Addition of bevacizmab (BEV) to platinum-based doublet yields a significant but only modest survival advantage. Recently, in the PARAMOUNT trial pemetrexed (PEM) maintenance therapy produced a high magnitude of PFS improvement. The OLCSG 0903 phase 2 trial investigated efficacy and safety of cisplatin (CDDP)-docetaxel (DOC)-BEV induction therapy followed by BEV-PEM maintenance therapy in patients with advanced nonsquamous non-small cell lung carcinoma. Methods In this trial, 40 patients with good PS (0 or 1) participated in the induction phase, specified as four cycles of induction CDDP (80 mg/m2), DOC (60 mg/m2) and BEV (15 mg/kg) on day 1 of a 21-day cycle. Patients who had not progressed during CDDP-DOC-BEV induction received maintenance BEV (15 mg/kg) and PEM (500 mg/m2) on day 1 of a 21-day cycle until disease progression. The primary endpoint was PFS, and the secondary endpoints included toxicity, OS and response rate. Results Patient characteristics were as follows: median age: 62 years; 78% male; 100% Japanese; 30% PS 0; 73% stage IV; and 70% adenocarcinoma. At the time of this analysis, 23pts (58%) discontinued the treatment, and the proportion of discontinuations to AEs was 35% (8/23). The principal toxicity was myelosuppression (grade 4 hematological: 20 patients [50%]), and grade 3/4 febrile neutropenia was observed in 10 (25%) despite no treatment-related deaths. The objective response rate and disease control rate (% patients with CR/PR/SD) was 82.5% and 97.5%, respectively. The median PFS time was 10.2 months, and the 6-month PFS rate was 63.2% (95% confidence interval: 44.9-76.9 %). Conclusions CDDP-DOC-BEV followed by BEV-PEM maintenance seems an effective and moderately tolerated treatment for patients with advanced nonsquamous non-small cell lung carcinoma. Disclosure K. Hotta: Eli Lilly Japan sanofi-aventis Chugai Pharmaceutical Co. Ltd Nippon Kayaku. N. Takigawa: Eli Lilly Japan sanofi-aventis Chugai Pharmaceutical Co. Ltd. K. Kiura: Eli Lilly Japan sanofi-aventis Chugai Pharmaceutical Co. Ltd Nippon Kayaku. All other authors have declared no conflicts of interest.