title: Phase II study of low-dose docetaxel/fluorouracil/cisplatin in metastatic gastric carcinoma.
abstract: OBJECTIVE
  In several recent reports, docetaxel (75-85 mg/m2) combined with fluorouracil (5-FU) and cisplatin has shown considerable efficacy but significant toxicities, especially neutropenia, in patients with advanced gastric cancer. The authors tested the efficacy and safety of a lower dose (50 mg/m2) of docetaxel, combined with 5-FU and cisplatin, in metastatic gastric cancer (MGC).
  
  
  METHODS
  Chemonaive patients with MGC received docetaxel (50 mg/m2 on day 1), cisplatin (80 mg/m2 on day 1), and 5-FU (1200 mg/m2 on days 1-3) every 21 days.
  
  
  RESULTS
  Forty-seven patients with a median age of 55 years (range, 30-73 years) received a median of 4 cycles (range, 1-13+ cycles). Of the 42 efficacy-"evaluable" patients, 17 showed a partial response (response rate, 40%; 95% confidence interval [CI], 26-55) according to the independent review panel. With a median follow-up of 12.6 months for all patients, the median time to progression was 4.6 months (95% CI, 3.6-5.6 months) and overall survival was 9.7 months (95% CI, 8.4-11.0 months). Grade 3/4 neutropenia developed in 68% of patients, and febrile neutropenia/neutropenic infection occurred in 26%. The most common grade 3/4 nonhematologic toxicity was stomatitis (21%), followed by syncope (6%), diarrhea (4%), peripheral neuropathy (4%), dizziness (2%), constipation (2%), and abnormal liver function tests (2%). There was 1 possible treatment-related death.
  
  
  CONCLUSIONS
  Lower dose (50 mg/m2) docetaxel combined with 5-FU and cisplatin was active in MGC with a tolerable toxicity profile.
authors.affiliation: Research Institute & Hospital, National Cancer Center, Goyang, Gyeonggi, Republic of Korea.
authors.forename: Sook Ryun
authors.initials: SR
authors.lastname: Park
authors.forename: Jong Ho
authors.initials: JH
authors.lastname: Chun
authors.forename: Young Woo
authors.initials: YW
authors.lastname: Kim
authors.forename: Jun Ho
authors.initials: JH
authors.lastname: Lee
authors.forename: Il Ju
authors.initials: IJ
authors.lastname: Choi
authors.forename: Chan Gyoo
authors.initials: CG
authors.lastname: Kim
authors.forename: Jong Seok
authors.initials: JS
authors.lastname: Lee
authors.forename: Jae-Moon
authors.initials: JM
authors.lastname: Bae
authors.forename: Hark Kyun
authors.initials: HK
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil