title: Phase II study of weekly paclitaxel following fixed three cycles of S-1-based chemotherapy for advanced gastric cancer.
abstract: OBJECTIVE
  Awareness of the clinical importance of second-line chemotherapy for incurable gastric cancer has been increasing. To assess the clinical validity of the new concept that second-line chemotherapy following predetermined cycles of first-line chemotherapy would improve survival, we conducted a phase II study.
  
  
  METHODS
  Patients with pathologically proven incurable gastric adenocarcinoma and adequate organ functions were enrolled. S-1 or S-1 plus cisplatin was administered as first-line chemotherapy. The number of cycles of S-1-based chemotherapy was determined to be three as a maximum unless there was disease progression. The treatment was followed by weekly administration of paclitaxel. The primary endpoint was overall survival and the secondary endpoints were progression-free survival and safety.
  
  
  RESULTS
  Thirty-seven patients were eligible for enrollment. Twenty-eight patients (76%) underwent the second-line chemotherapy with paclitaxel after completion of S-1-based chemotherapy or disease progression. Treatment-related grade 3 or 4 toxicity was noted in 14 patients during S-1-based chemotherapy, and in 6 patients during paclitaxel treatment. The median survival time was 455 days and the median progression-free survival was 229 days.
  
  
  CONCLUSIONS
  Sequential set chemotherapy with three cycles of S-1-based chemotherapy followed by weekly paclitaxel is feasible. The survival results are equivalent to those of other current regimens using S-1.
authors.affiliation: Division of Digestive and General Surgery, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
authors.forename: Manabu
authors.initials: M
authors.lastname: Ohashi
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Kanda
authors.forename: Takashi
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Masaki
authors.initials: M
authors.lastname: Hirota
authors.forename: Morihito
authors.initials: M
authors.lastname: Hayami
authors.forename: Kazuhito
authors.initials: K
authors.lastname: Yajima
authors.forename: Atsushi
authors.initials: A
authors.lastname: Matsuki
authors.forename: Shin-ichi
authors.initials: S
authors.lastname: Kosugi
authors.forename: Katsuyoshi
authors.initials: K
authors.lastname: Hatakeyama
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000627:therapeutic use*; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D005641:Tegafur / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel