A study of weekly paclitaxel plus 5-fluorouracil and cisplatin for patients with advanced or recurrent inoperable gastric cancer

Purpose: To investigate the efficacy and safety of weekly paclitaxel plus 5-fluorouracil and cisplatin for patients with advanced or recurrent inoperable gastric cancer. Patients and methods: The eligibility criteria included histologically confirmed advanced gastric cancer or recurrent inoperable gastric cancer. Patients were treated with weekly paclitaxel 60 mg/m(2) on the 1st, 8th and 15th days combined with 5-fluorouracil 500 mg/m(2) by a continuous intravenous infusion from the 1st to the 5th day, and a cisplatin 75 mg/m(2) intravenous infusion for 3 days. The cycles were repeated every 4 weeks. Results: Forty-six patients were assessed for response and toxicity. Three patients achieved complete responses, and 20 patients achieved partial responses; the overall response rate was 50.0% (95% confidence interval [CI], 34.9-65.1%). With a median follow-up of 20 months, the median progress ion-free and overall survivals were 24 and 46 weeks, respectively, with a 1-year survival rate of 41.3% (95% CI, 27.0-56.8%). The most common hematological toxicity was myelosuppression, which included neutropenia, anemia, thrombocytopenia; the grade 3 toxicity rate was 26.1% (12/46), and only 1 patient was observed with a grade 4 neutropenia. The nonhematological toxicities included anorexia, diarrhea, nausea/vomiting, stomatitis/mucositis, alopecia, dizziness, skin rash, neurotoxicity, and infection; the grade 3 toxicity rate was 34.8% (16/46), but no grade 4 nonhematologic toxicity was observed. Conclusions: The combination chemotherapy consisting of weekly paclitaxel plus 5-fluorouracil and cisplatin was effective and well tolerated in patients with advanced and recurrent inoperable gastric cancers. (C) 2008 Elsevier Masson SAS. All rights reserved.