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Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer: a randomized study (START)

 Wasaburo Koizumi  ;  Yeul Hong Kim  ;  Masashi Fujii  ;  Hoon Kyo Kim  ;  Hiroshi Imamura  ;  Kyung Hee Lee  ;  Takuo Hara  ;  Hyun Cheol Chung  ;  Taroh Satoh  ;  Jae Yong Cho  ;  Hisashi Hosaka  ;  Akihito Tsuji  ;  Akinori Takagane  ;  Mikito Inokuchi  ;  Kazuaki Tanabe  ;  Tatsuya Okuno  ;  Mariko Ogura  ;  Kazuhiro Yoshida  ;  Masahiro Takeuchi  ;  Toshifusa Nakajima 
 Journal of Cancer Research and Clinical Oncology, Vol.140(2) : 319-328, 2014 
Journal Title
 Journal of Cancer Research and Clinical Oncology 
Issue Date
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).
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
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Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
Cho, Jae Yong(조재용) ORCID logo https://orcid.org/0000-0002-0926-1819
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