title: Phase II multi-institutional prospective randomized trial comparing S-1 plus paclitaxel with paclitaxel alone as second-line chemotherapy in S-1 pretreated gastric cancer (CCOG0701).
abstract: BACKGROUND
  The aim of this study was to explore whether a combination of S-1 and paclitaxel offers any benefit over paclitaxel alone to patients pretreated by S-1.
  
  
  METHODS
  Gastric cancer patients who developed progression during S-1-based first-line chemotherapy or had recurrence during postoperative adjuvant chemotherapy by S-1 were randomly assigned to receive second-line treatment either by weekly administration of paclitaxel at 80 mg/m(2) three times every 4 weeks or daily oral S-1 (80 mg/m(2)) for 2 weeks plus paclitaxel (50 mg/m(2)) given on days 1 and 8, every 3 weeks (S-1 plus paclitaxel). The primary endpoint was progression-free survival (PFS) at 4 months after the initiation of treatment.
  
  
  RESULTS
  A total of 78 patients were eligible for efficacy analyses-40 were assigned to the paclitaxel group and 38 to the S-1 plus paclitaxel group. PFS at 4 months was similar between the groups (50 % for paclitaxel vs 55 % for S-1 plus paclitaxel, P = 0.641). There were no differences between the groups either in progression-free survival (4.6 vs 4.6 months, respectively, P = 0.526), overall survival (10.0 vs 10.0 months, respectively, P = 0.464), or overall response rate (27 vs 22 %, respectively, P = 0.767). The incidences of grade 3 or 4 hematological and non-hematological toxicities were also equivalent between the two groups (25 vs 26 % and 24 vs 26 %, respectively).
  
  
  CONCLUSIONS
  No benefit of S-1 administration beyond progression was shown when paclitaxel was selected as the key drug for second-line chemotherapy.
authors.affiliation: Department of Surgery, Komaki City Hospital, Komaki, Japan.
authors.forename: Koki
authors.initials: K
authors.lastname: Nakanishi
authors.affiliation: Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan. kobadai@med.nagoya-u.ac.jp.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Kobayashi
authors.affiliation: Department of Surgery, Komaki City Hospital, Komaki, Japan.
authors.forename: Yoshinari
authors.initials: Y
authors.lastname: Mochizuki
authors.affiliation: Department of Surgery, Konan Kosei Hospital, Konan, Japan.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Ishigure
authors.affiliation: Department of Gastroenterological Surgery, Aichi Cancer Center, Nagoya, Japan.
authors.forename: Seiji
authors.initials: S
authors.lastname: Ito
authors.affiliation: Department of Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Kojima
authors.affiliation: Department of Surgery, Okazaki City Hospital, Okazaki, Japan.
authors.forename: Akiharu
authors.initials: A
authors.lastname: Ishiyama
authors.affiliation: Department of Surgery, Nishio Municipal Hospital, Nishio, Japan.
authors.forename: Shinichi
authors.initials: S
authors.lastname: Fujitake
authors.affiliation: Department of Surgery, Yokkaichi Municipal Hospital, Yokkaichi, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Shikano
authors.affiliation: Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.affiliation: Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8550, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Kodera
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D019233:Retreatment; D013274:Stomach Neoplasms / Q000188:drug therapy*; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel
keywords: Gastric cancer; Paclitaxel; S-1; Second-line chemotherapy