title: Phase II feasibility study of adjuvant S-1 plus docetaxel for stage III gastric cancer patients after curative D2 gastrectomy.
abstract: OBJECTIVE
  The aim of this prospective study was to evaluate the feasibility and safety of adjuvant S-1 plus docetaxel in patients with stage III gastric cancer.
  
  
  METHODS
  We enrolled 53 patients with pathological stage III gastric cancer who underwent D2 gastrectomy. They received oral S-1 (80 mg/m(2)/day) administration for 2 consecutive weeks and intravenous docetaxel (40 mg/m(2)) on day 1, repeated every 3 weeks (1 cycle). The treatment was started within 45 days after surgery and repeated for 4 cycles, followed by S-1 monotherapy (4 weeks on, 2 weeks off) until 1 year after surgery. The feasibility of the 4 cycles of chemotherapy, followed by S-1 administration, was evaluated.
  
  
  RESULTS
  A total of 42 patients (79.2%, 95% CI 65.9-82.9) tolerated the planned 4 cycles of treatment with S-1 and docetaxel, and 34 patients (64.2%, 95% CI 49.8-76.9) completed subsequent S-1 monotherapy for 1 year. Grade 4 neutropenia was observed in 28% and grade 3 febrile neutropenia in 9% of the patients, while grade 3 nonhematological toxicities were relatively low.
  
  
  CONCLUSIONS
  Adjuvant S-1 plus docetaxel therapy is feasible and has only moderate toxicity in stage III gastric cancer patients. We believe that this regimen will be a candidate for future phase III trials seeking the optimal adjuvant chemotherapy for stage III gastric cancer patients.
authors.affiliation: Department of Surgery, Kansai Rosai Hospital, Amagasaki, Japan. stamura@kanrou.net
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Tamura
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Fujitani
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: Hiroshi
authors.initials: H
authors.lastname: Furukawa
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005240:Feasibility Studies; D005260:Female; D005743:Gastrectomy / Q000379:methods; D006801:Humans; D007262:Infusions, Intravenous; D008197:Lymph Node Excision; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010094:Oxonic Acid / Q000008:administration & dosage; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D043823:Taxoids / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid