title: Phase II study of docetaxel and S-1 combination therapy for advanced or recurrent gastric cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of docetaxel in combination with a novel oral 5-fluorouracil analogue S-1 for patients with advanced or recurrent gastric cancer.
  
  
  METHODS
  Patients with advanced or recurrent adenocarcinoma of the stomach and up to one previous chemotherapy regimen were treated with i.v. docetaxel 40 mg/m2 on day 1 and oral S-1 80 mg/m2/d on days 1 to 14 every 3 weeks.
  
  
  RESULTS
  Forty-eight patients (median age, 65 years; range, 25-75 years) received a total of 272 treatment cycles (median, 4; range, 1-17). No complete responses and 27 partial responses were observed for an overall response rate of 56.3% [95% confidence interval (95% CI), 38-66%]. Eighteen patients (37.5%) had stable disease and three patients (6.3%) had progressive disease as best response. The tumor control rate (complete response + partial response + stable disease) was 93.8% (95% CI, 83-98%). Median overall survival was 14.3 months (95% CI, 10.7-20.3 months) and median time to tumor progression was 7.3 months (95% CI, 4.3-10.0 months). The most common grade 3 to 4 hematologic toxicities were neutropenia (58.3%), leukopenia (41.7%), febrile neutropenia (8.3%), and anemia (8.3%). The most common grade 3 nonhematologic toxicities included anorexia (14.6%), stomatitis (8.3%), and nausea (6.3%). No grade 4 nonhematologic toxicities were reported and all treatment-related toxicities were resolved.
  
  
  CONCLUSIONS
  Docetaxel/S-1 combination is highly active and well tolerated in advanced or recurrent gastric cancer. Further investigation in randomized studies is warranted.
authors.affiliation: Department of Surgical Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yoshida
authors.forename: Motoki
authors.initials: M
authors.lastname: Ninomiya
authors.forename: Norihisa
authors.initials: N
authors.lastname: Takakura
authors.forename: Naoki
authors.initials: N
authors.lastname: Hirabayashi
authors.forename: Wataru
authors.initials: W
authors.lastname: Takiyama
authors.forename: Yuji
authors.initials: Y
authors.lastname: Sato
authors.forename: Satoru
authors.initials: S
authors.lastname: Todo
authors.forename: Masanori
authors.initials: M
authors.lastname: Terashima
authors.forename: Mitsukazu
authors.initials: M
authors.lastname: Gotoh
authors.forename: Jyunnichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Masahiko
authors.initials: M
authors.lastname: Nishiyama
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis / Q000188:drug therapy*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007275:Injections, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000188:drug therapy*; D010094:Oxonic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000175:diagnosis / Q000188:drug therapy*; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D043823:Taxoids; C079198:S 1 (combination); D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid