title: Three-year outcomes of a phase II study of adjuvant chemotherapy with S-1 plus docetaxel for stage III gastric cancer after curative D2 gastrectomy.
abstract: BACKGROUND
  We have previously reported the superior feasibility and safety of adjuvant S-1 plus docetaxel in patients with stage III gastric cancer during a prospective phase II study. We report 3-year follow-up data on patients enrolled in this study.
  
  
  METHODS
  Fifty-three patients with histologically confirmed stage III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were enrolled into this study. They received oral S-1 (80 mg/m(2)/day) for 2 consecutive weeks and intravenous docetaxel (40 mg/m(2)) on day 1, repeated every 3 weeks (one cycle). Treatment was initiated within 45 days after surgery and repeated for four cycles, followed by S-1 monotherapy (4 weeks on, 2 weeks off) until 1 year after surgery. Three-year overall survival (OS) and disease-free survival (DFS) were evaluated.
  
  
  RESULTS
  The OS rate at 3 years was 78.4 % [95 % confidence interval (CI), 67.9-90.6 %] and the DFS rate at 3 years was 66.2 % (95 % CI, 54.4-80.7 %). Subgroup analyses according to disease stage showed a 3-year OS and DFS rate of 85.7 % (95 % CI, 74.9-98.1 %) and 70.8 % (95 % CI, 57.1-87.8 %) for stage IIIA, and 62.5 % (95 % CI, 42.8-91.4 %) and 56.2 % (95 % CI, 36.5-86.7 %) for stage IIIB, respectively.
  
  
  CONCLUSIONS
  On the basis of 3-year follow-up data, postoperative adjuvant therapy with S-1 plus docetaxel yielded promising OS and DFS in stage IIIA gastric cancer patients who had undergone D2 gastrectomy. We believe that this regimen is a candidate for future phase III trials studying the optimal adjuvant chemotherapy regimen for stage III gastric cancer.
authors.affiliation: Department of Surgery, Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka, 540-0006, Japan, fujitani@onh.go.jp.
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Fujitani
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Tamura
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kimura
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tsuji
authors.forename: Jin
authors.initials: J
authors.lastname: Matsuyama
authors.forename: Shohei
authors.initials: S
authors.lastname: Iijima
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Imamura
authors.forename: Kentaro
authors.initials: K
authors.lastname: Inoue
authors.forename: Kenji
authors.initials: K
authors.lastname: Kobayashi
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Kurokawa
authors.forename: Toshio
authors.initials: T
authors.lastname: Shimokawa
authors.forename: Toshimasa
authors.initials: T
authors.lastname: Tsujinaka
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Furukawa
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D000077143:Docetaxel; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D016879:Salvage Therapy; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D013997:Time Factors
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid