Phase II study of low-dose docetaxel/fluorouracil/cisplatin in metastatic gastric carcinoma

Sook Ryun Park, Jong Ho Chun, Young Woo Kim, Jun Ho Lee, Il Ju Choi, Chan Gyoo Kim, Jong-Seok Lee, Jae Moon Bae, Hark Kyun Kim

Research output: Contribution to journalArticle

31 Scopus citations

Abstract

Objectives: 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.

Original languageEnglish
Pages (from-to)433-438
Number of pages6
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume28
Issue number5
DOIs
StatePublished - 1 Oct 2005

Keywords

  • Cisplatin
  • Docetaxel
  • Fluorouracil
  • Gastric cancer

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