Phase II study of bevacizumab in combination with S-1 plus cisplatin in patients with advanced nonsquamous non-small cell lung cancer.

Abstract

e18037 Background: Cisplatin combined with S-1 is an active regimen for patients with advanced non-small cell lung cancer (NSCLC). Although the addition of bevacizumab to platinum based regimens significantly improved outcome, it remains unknown about the safety and efficacy of first-line cisplatin plus S-1 with bevacizumab. Therefore, we conducted a phase II study to evaluate the efficacy and tolerability of bevacizumab in combination with S-1 plus cisplatin regimen in patients with advanced non-squamous NSCLC. Methods: Patient with ages ranging from 20 to 74 years, non-squamous NSCLC, no prior systemic therapy, no brain metastases and ECOG PS 0-1 were enrolled. Patients received cisplatin 60mg/m2 and bevacizumab 15mg/kg on day 1 of each cycle, and S-1 80mg/m2 orally twice daily for 14 days every 21 days. After 4-6 courses, patients were continued on bevacizumab until progression disease (PD). Primary end point was response rate (RR). Secondary end points included overall survival (OS), PFS, time to treatment failure (TTF), and safety. Results: Twenty-nine patients were enrolled in this study. Median age was 67 years (range: 42 to 74); male/female=17(58%)/12(42%); ECOG PS 0/ 1 = 18 (62%) / 11(38%); stageIIIB/IV=3(10%)/26(90%); adeno / NSCLC = 26 (90%) / 3 (10%). The median courses of the induction therapy was 4 (range: 2 to 6), and that of the maintenance therapy was 3 courses (range: 1 to 15). Response rate (RR) was 65.5%, and disease control rate (DCR) was 100%. Median PFS was 5.39 months (95%CI, 125-265 days). Hematological adverse events reaching grade 3 or 4 were leukocytopenia (6.8%), neutropenia (20.9%), anemia (3.4%), thrombocytopenia (6.9%), and febrile neutropenia (3.4%). Nonhematological toxicities of grade3/4 were hypertension (17.2%), appetite loss (3.4%), mucositis oral (3.4%), alkaline phosphatase elvation (3.4%), serum amylase elevation (3.4%), and hyponatremia (3.4%). Seven patients delayed the start of next course because of adverse events. Conclusions: Bevacizumab in combination with S-1 plus cisplatin was effective in disease control and well-tolerated regimen for the treatment of patients with advanced non-squamous NSCLC.