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

Objectives: In several recent reports, docetaxel (75-85 mg/m(2)) 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/m(2)) of docetaxel, combined with 5-FU and cisplatin, in metastatic gastric cancer (MGC). Methods: Chemonaive patients with MGC received docetaxel (50 mg/m(2) on day 1), cisplatin (80 mg/m(2) on day 1), and 5-FU (1200 mg/m(2) 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 I possible treatment-related death. Conclusions: Lower dose (50 mg/m(2)) docetaxel combined with 5-FU and cisplatin was active in MGC with a tolerable toxicity profile.