title: Addition of docetaxel to S-1 without platinum prolongs survival of patients with advanced gastric cancer: a randomized study (START).
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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).
authors.affiliation: Kitasato University School of Medicine, Sagamihara, Japan.
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
authors.forename: Yeul Hong
authors.initials: YH
authors.lastname: Kim
authors.forename: Masashi
authors.initials: M
authors.lastname: Fujii
authors.forename: Hoon Kyo
authors.initials: HK
authors.lastname: Kim
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Imamura
authors.forename: Kyung Hee
authors.initials: KH
authors.lastname: Lee
authors.forename: Takuo
authors.initials: T
authors.lastname: Hara
authors.forename: Hyun Cheol
authors.initials: HC
authors.lastname: Chung
authors.forename: Taroh
authors.initials: T
authors.lastname: Satoh
authors.forename: Jae Yong
authors.initials: JY
authors.lastname: Cho
authors.forename: Hisashi
authors.initials: H
authors.lastname: Hosaka
authors.forename: Akihito
authors.initials: A
authors.lastname: Tsuji
authors.forename: Akinori
authors.initials: A
authors.lastname: Takagane
authors.forename: Mikito
authors.initials: M
authors.lastname: Inokuchi
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Tanabe
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Okuno
authors.forename: Mariko
authors.initials: M
authors.lastname: Ogura
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yoshida
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takeuchi
authors.forename: Toshifusa
authors.initials: T
authors.lastname: Nakajima
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid; D002945:Cisplatin