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 progression-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.