615ORANDOMIZED PHASE II STUDY OF CAPECITABINE AND CISPLATIN WITH OR WITHOUT SORAFENIB IN PATIENTS WITH METASTATIC GASTRIC CANCER: STARGATE STUDY

摘要: ABSTRACT Aim: Capecitabine and cisplatin (XP) combination chemotherapy is one of the standard 1st line regimens for treatment metastatic gastric cancer (MGC). Sorafenib a multi-kinase inhibitor with activity against angiogenesis RAF-MEK-ERK pathway. In this study, we aimed to evaluate efficacy sorafenib (S) in XP as MGC. Methods: This study was randomized (1:1), open-label, phase II study. The patients (pts) or gastroesophageal junction adenocarcinoma measurable lesion(s) were eligible. primary endpoint progression-free survival (PFS). + S consisted capecitaine 800 mg/m2 po bid on days 1-14, 60 mg/m2 iv day 1, 400 mg 1-21, every 3 weeks. capecitabine 1000 mg/m2 80 mg/m2 continued up 8 cycles until disease progression intolerance. Pts arm allowed cross over alone when their diseases progressed. Results: Between Jan 2011 Feb 2013, total 195 pts from 12 sites Korea, China Taiwan. Median age 56 years. All had ECOG performance status 0-1. 19% prior gastrectomy. Overall response rate 54% arm, 52% (p = 0.826). With median follow-up 12.6 months (range, 0.1-29.2), PFS assessed by independent review 5.6 5.3 (HR 0.92, 95% CI 0.67-1.27, p 0.609). OS not different between two arms (median 11.7 vs. 10.8 months; HR 0.93, 0.65-1.31, 0.661). Frequencies grade 3/4 toxicities similar arms, except neutropenia (21% vs 37%), febrile (2% 6%), palmar-plantar erythrodysesthesia syndrome (7% 1%). 51 who crossed there no objective 1.3 (95% CI, 1.2-1.7). Conclusions: addition safe but more effective than Biomarker analyses are now ongoing identify potential can get benefit S. Disclosure: Y. Kang: Honorarium, consultant Bayer, Roche Research grant Roche. other authors have declared conflicts interest.