title: A multicenter phase II study of combined chemotherapy with docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer (KDOG 0601).
abstract: OBJECTIVE
  We conducted a phase II study to evaluate the efficacy and safety of a triplet regimen of docetaxel, cisplatin, and S-1 in patients with unresectable or recurrent gastric cancer.
  
  
  METHODS
  Docetaxel (40 mg/m(2)) and cisplatin (70 or 60 mg/m(2)) were given on day 1 of a 28-day cycle. S-1 (40 mg/m(2)) was given twice daily on days 1-14. Treatment with this regimen was continued for a maximum of 6 cycles. Subsequently, patients with no disease progression received a combination of docetaxel and S-1.
  
  
  RESULTS
  Fifty-nine patients were enrolled. The median number of administered cycles was 8 (range, 1-25). Because some patients had serious myelosuppression and renal dysfunction with 70 mg/m(2) of cisplatin, dose of cisplatin was reduced to 60 mg/m(2) after 19 patients had been treated. Common severe toxic effects of grade 3 or 4 were leukocytopenia (44%), neutropenia (72%), anemia (15%), and febrile neutropenia (14%). The overall response rate of this group was 81% (95% confidence interval (CI), 71-91%). The median overall survival and progression-free survival were 18.5 (95% CI, 15.6-21.5) and 8.7 (95% CI, 6.7-10.7) months, respectively.
  
  
  CONCLUSIONS
  Triplet of docetaxel, cisplatin, and S-1 is a well-tolerated and highly active regimen for advanced or recurrent gastric cancer. A 60 mg/m(2) of cisplatin is as effective as 70 mg/m(2) of cisplatin.
authors.affiliation: Department of Gastroenterology/Gastrointestinal Oncology, Kitasato University East Hospital, 2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan. koizumi@med.kitasato-u.ac.jp
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
authors.forename: Norisuke
authors.initials: N
authors.lastname: Nakayama
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanabe
authors.forename: Tohru
authors.initials: T
authors.lastname: Sasaki
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Higuchi
authors.forename: Ken
authors.initials: K
authors.lastname: Nishimura
authors.forename: Seiichi
authors.initials: S
authors.lastname: Takagi
authors.forename: Mizutomo
authors.initials: M
authors.lastname: Azuma
authors.forename: Takako
authors.initials: T
authors.lastname: Ae
authors.forename: Kenji
authors.initials: K
authors.lastname: Ishido
authors.forename: Kento
authors.initials: K
authors.lastname: Nakatani
authors.forename: Akira
authors.initials: A
authors.lastname: Naruke
authors.forename: Chikatoshi
authors.initials: C
authors.lastname: Katada
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D005641:Tegafur; D000077143:Docetaxel; D010094:Oxonic Acid; D002945:Cisplatin