title: Multicenter phase II study of weekly paclitaxel plus S-1 combination chemotherapy in patients with advanced gastric cancer.
abstract: BACKGROUND
  A multicenter phase II study was conducted to evaluate the efficacy and safety of a combination regimen of weekly paclitaxel plus S-1 in patients with advanced gastric cancer.
  
  
  METHODS
  Patients with previously untreated metastatic or recurrent gastric cancer received intravenous paclitaxel 50 mg/m(2) on days 1, 8, and 15, plus oral S-1 40 mg/m(2) b.i.d. on days 1 to 14 followed by 2 weeks off, in a 28-day cycle.
  
  
  RESULTS
  A total of 54 patients were registered. All of them had measurable disease and were determined to be eligible for the present study. Two complete responses and 23 partial responses were confirmed, giving an overall response rate of 46.3%. At a final follow up of 3 years, the median progression-free survival and median overall survival were 6.0 and 14.3 months, respectively. Grade 3 neutropenia occurred in 14 patients, and grade 4 in 1 patient (total, 27.8%). The most serious nonhematological toxicity was diarrhea, where grade 3 occurred in 5 patients (9.3%). There were no treatment-related deaths.
  
  
  CONCLUSIONS
  A combination of weekly paclitaxel plus S-1 was found to be well tolerated and effective in patients with advanced gastric cancer. Further investigation with comparative trials is needed for confirmation.
authors.affiliation: Department of Surgery, Division of Digestive Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Ueda
authors.forename: Hisakazu
authors.initials: H
authors.lastname: Yamagishi
authors.forename: Daisuke
authors.initials: D
authors.lastname: Ichikawa
authors.forename: Kazuma
authors.initials: K
authors.lastname: Okamoto
authors.forename: Eigo
authors.initials: E
authors.lastname: Otsuji
authors.forename: Jun
authors.initials: J
authors.lastname: Morii
authors.forename: Kinya
authors.initials: K
authors.lastname: Koizumi
authors.forename: Naoki
authors.initials: N
authors.lastname: Kakihara
authors.forename: Masataka
authors.initials: M
authors.lastname: Shimotsuma
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Yamashita
authors.forename: Fumihiro
authors.initials: F
authors.lastname: Taniguchi
authors.forename: Hideki
authors.initials: H
authors.lastname: Aragane
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nishi
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Itokawa
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016001:Confidence Intervals; D018450:Disease Progression; D004338:Drug Combinations; D005260:Female; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel
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