Purpose: Cisplatin plus 5-fluorouracil has been globally accepted as a standard regimen for the treatment for advanced gastric cancer. However, cisplatin has several disadvantages, including renal toxicity and the need for admission. S-1 plus cisplatin has become a standard treatment for advanced gastric cancer in East Asia. This phase III study was designed to evaluate the potential benefits of adding docetaxel to S-1 without a platinum compound in patients with advanced gastric cancer. Methods: Patients were randomly assigned to receive docetaxel plus S-1 or S-1 alone. The docetaxel plus S-1 group received docetaxel on day 1 and oral S-1 on days 1-14 of a 21-day cycle. The S-1 alone group received oral S-1 on days 1-28 of a 42-day cycle. The primary end point was overall survival. Results: Of the 639 patients enrolled, 635 were eligible for analysis. The median overall survival was 12.5 months in the docetaxel plus S-1 group and 10.8 months in the S-1 alone group (p = 0.032). The median progression-free survival was 5.3 months in the docetaxel plus S-1 group and 4.2 months in the S-1 alone group (p = 0.001). As for adverse events, neutropenia was more frequent in the docetaxel plus S-1 group, but remained manageable. Conclusion: As first-line treatment for advanced gastric cancer, docetaxel plus S-1 significantly improves median overall and progression-free survival as compared with S-1 alone. (ClinicalTrials.gov number: NCT00287768).
Bibliographical noteFunding Information:
Acknowledgments This study was supported by the Japan Clinical Cancer Research Organization (JACCRO) and Korean Cancer Study Group (KCSG). We thank all of our patients and their families, as well as all of the site investigators. We are grateful to Dr. Y. Shimada of National Cancer Center Hospital and to Dr. T. Sasaki of Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital for their kind advice as members of the Independent Data Monitoring Committee. The authors are indebted to Prof. J. Patrick Barron of the Department of International Medical Communications of Tokyo Medical University for his review of this manuscript.
JACCRO and KCSG employees contributed to the study design and data collection and interpretation. This study was supported by an unconditioned grant from Sanofi K.K. Japan. Sanofi K.K. Japan had no role in the study design, data collection, analysis, or interpretation, or in writing
All Science Journal Classification (ASJC) codes
- Cancer Research