title: A randomized phase-II trial comparing sequential and concurrent paclitaxel with oral or parenteral fluorinated pyrimidines for advanced or metastatic gastric cancer.
abstract: BACKGROUND
  The purpose of this study was twofold: (1) to compare S-1 with infusional 5-fluorouracil (FU) to determine which would be a better partner of paclitaxel (PTX), and (2) to compare a concurrent strategy with a sequential one, the latter strategy being the one that is widely used in Japanese general practice.
  
  
  METHODS
  The 161 eligible patients were randomized into four arms to receive the following regimens: A (sequential), intravenous 5-FU at 800 mg/m(2) for 5 days every 4 weeks followed by weekly PTX at 80 mg/m(2); B (sequential), S-1 at 80 mg/m(2) for 4 weeks and 2-week rest followed by PTX; C (concurrent), intravenous 5-FU at 600 mg/m(2) for 5 days and weekly PTX at 80 mg/m(2) every 4 weeks; and D (concurrent), S-1 for 14 days and PTX at 50 mg/m(2) on days 1 and 8 every 3 weeks. The primary endpoint was the overall survival (OS) rate at 10 months.
  
  
  RESULTS
  The ten-month OS rates in arms A, B, C, and D were 63, 65, 61, and 73%, respectively. The OS was best in the concurrent S-1/PTX arm, with a mean survival time of 15.4 months, but no significant difference was observed between the four arms. Response rates were higher in the concurrent arms than in the sequential arms.
  
  
  CONCLUSIONS
  Our study did not show sufficient prolongation of survival with the concurrent strategy to proceed to a phase-III trial; however, the sequential arms showed survival comparable to that in the concurrent arms, with less toxicity. In patients who are ineligible for cisplatin (CDDP), sequential treatment starting with S-1 and proceeding to PTX would be a good alternative strategy, considering quality of life (QOL) and the cost-benefits of an oral agent as first-line treatment.
authors.affiliation: Department of Surgery, Osaka General Medical Center, 3-1-56 Bandai-higashi, Sumiyoshi-ku, Osaka 558-8558, Japan. kazuno1@gh.opho.jp
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Nishikawa
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Takanori
authors.initials: T
authors.lastname: Matsui
authors.forename: Michiya
authors.initials: M
authors.lastname: Kobayashi
authors.forename: Yoji
authors.initials: Y
authors.lastname: Takeuchi
authors.forename: Ikuo
authors.initials: I
authors.lastname: Takahashi
authors.forename: Seiji
authors.initials: S
authors.lastname: Sato
authors.forename: Yumi
authors.initials: Y
authors.lastname: Miyashita
authors.forename: Akira
authors.initials: A
authors.lastname: Tsuburaya
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Kakeji
authors.forename: Hideo
authors.initials: H
authors.lastname: Baba
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007263:Infusions, Parenteral; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use; D010349:Patient Compliance; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel; D005472:Fluorouracil