title: Phase I/II study of a combination of S-1 and weekly paclitaxel in patients with advanced or recurrent gastric cancer.
abstract: OBJECTIVE
  A phase I/II study of a combination of S-1 and weekly paclitaxel was conducted to determine the maximum tolerated dose (MTD), recommended dose (RD), dose-limiting toxicities (DLTs) and objective response rate (RR) in patients with advanced or recurrent gastric cancer.
  
  
  METHODS
  S-1 was administered orally at a fixed dose of 80 mg/m(2) per day on days 1-14. Paclitaxel was injected intravenously on days 1, 8, and 15, starting with a dose of 50 mg/m(2). The dose was increased in a stepwise manner.
  
  
  RESULTS
  In phase I, level 2 (60 mg/m(2)) was considered the MTD, because 2 of 3 patients in level 2 developed DLTs (grade 3 neutropenia and anemia, and grade 4 diarrhea and stomatitis). Therefore, the RD was determined to be level 1 (50 mg/m(2)). In phase II, efficacy and safety were assessed in 18 patients treated with the RD. The RR was 64.7% and the median survival time was 13.5 months. The most severe toxicities were grade 3 leukopenia (5.5%) and grade 3 neutropenia (5.5%).
  
  
  CONCLUSIONS
  Our study showed that S-1 combined with 50 mg/m(2) paclitaxel is effective and safe in patients with advanced or recurrent gastric cancer.
authors.affiliation: Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Ryohei
authors.initials: R
authors.lastname: Kawabata
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Fujiwara
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
authors.forename: Junya
authors.initials: J
authors.lastname: Fujita
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Tsukahara
authors.forename: Makoto
authors.initials: M
authors.lastname: Yamasaki
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Miyata
authors.forename: Shuji
authors.initials: S
authors.lastname: Takiguchi
authors.forename: Morito
authors.initials: M
authors.lastname: Monden
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005641:Tegafur / Q000008:administration & dosage
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel