690P - A Randomized, Controlled Phase III Trial of Docetaxel, Cisplatin and Fluorouracil (DCF) versus Cisplatin Plus Fluorouracil (CF) as First-Line Therapy in Chinese advanced Gastric Cancer

Abstract

ABSTRACT Background Gastric cancer is the second prevalent cancer in China accounting for more than 200,000 deaths per year. Effective regimens are needed to improve the outcome for gastric cancer patients. TAX 325 study has demonstrated OS benefit and high toxicity of DCF regimen compared with CF in western population. Thus we investigated the effect of modified DCF (mDCF) regimen in Chinese patients with advanced gastric cancer in this prospective, multicenter, open-label, randomized and parallel-controlled phase III study. Methods Eligible no prior palliative chemotherapy, advanced gastric cancer patients were randomized to either mDCF (Docetaxel 60mg/m2 1-hour intravenous infusion (IV) and cisplatin 60mg/m2 1-3-hour IV on day 1, followed by fluorouracil 600mg/m2/d continuous IV for 5 days, every 3 weeks) or modified CF (mCF) (cisplatin 75mg/m2 1-3-hour IV on day 1, followed by fluorouracil 600mg/m2/d continuous IV for 5 days, every 3 weeks). Treatment continued until disease progression, unacceptable toxicity, death, or consent withdrawal. The primary end point was progression-free survival (PFS). Results Between Nov 2008 and Dec 2010, a total of 241 patients were randomized, 234 patients were treated and analyzed (mDCF = 119, mCF = 115) PFS was prolonged with mDCF vs mCF significantly (HR, 0.63; 95% CI, 0.48 to 0.85; P = 0.0018; median PFS, 7.2 months vs.4.9 months), the trend of OS improvement was seen (HR, 0.78; 95% CI, 0.58 to 1.05; P = 0.099; median OS 10.2 months vs. 8.5 months), Overall best response rate (ORR) was improved significantly with mDCF vs mCF (58% vs 39%, P = 0.0244). Treatment related grade 3/4 AEs occurred in 75.6% (DCF) vs 33.0% (CF), P Conclusion mDCF regimen significantly improved PFS and ORR. The safety profile was consistent with previous report. mDCF should be considered as an option for untreated Chinese advanced gastric cancer patients. This study was funded by Sanofi, ClinicalTrials.gov identifier: NCT00811447. Disclosure All authors have declared no conflicts of interest.