BACKGROUND Although the clinical efficacy of paclitaxel in the treatment of gastric carcinoma has not been clearly defined, recent reports have suggested a possible role in the treatment of upper gastrointestinal carcinomas in vitro and in vivo. In this study, the authors evaluated the efficacy and toxicity of a combination chemotherapy that included paclitaxel, 5‐fluorouracil (5‐FU), and cisplatin in the treatment of patients with advanced gastric carcinoma. METHODS Forty‐one gastric carcinoma patients with metastatic disease, unresectable advanced disease, or relapsed disease were treated with the following regimen, administered every 28 days: paclitaxel 175 mg/m2 by 3‐hour intravenous (i.v.) infusion on Day 1, 5‐FU 750 mg/m2 by 24‐hour continuous i.v. infusion on Days 1–5, and cisplatin 20 mg/m2 by 2‐hour i.v. infusion on Days 1–5. Twenty‐six patients had measurable disease, and 15 had evaluable disease. All patients were assessable for toxicity. RESULTS Twenty‐one of the 41 patients (51%; 95% confidence interval [CI], 36.5–65.7%) demonstrated an objective response, including 4 complete responses (10%; 95% CI, 3.9–22.5%). Sixty‐five percent of the patients with measurable disease (17of 26; 95% CI, 58–92.5%) and 27% of the patients with evaluable disease (4 of 15: 95% CI, 11.1–52.3%) achieved a complete response or a partial response. The median response duration was 17 weeks (range, 4–90 weeks), and the median survival duration for all patients was 26 weeks (range, 8 to 118+ weeks). The major toxicity of this treatment was myelosuppression with neutropenia of World Health Organization Grade 3 and 4 in 24% and 10% of the patients, respectively. Nonhematologic toxicity included mucositis, nausea/vomiting, diarrhea, neurotoxicity, and alopecia. Fluid retention occurred in two patients, and one patient had an anaphylatic reaction. Dose reduction was necessary for one patient, because Grade 4 neutropenia and mucositis occurred. CONCLUSIONS Paclitaxel, 5‐FU, and cisplatin was an active combination regimen in the treatment of advanced gastric carcinoma. The toxicity of this regimen was tolerable. Based on these findings, this combination regimen could be an attractive treatment in the preoperative setting. Cancer 1999;85:295–301. © 1999 American Cancer Society.

Paclitaxel, 5-FU, and cisplatin was an active combination regimen in the treatment of advanced gastric carcinoma. The toxicity of this regimen was tolerable. Based on these findings, this combination regimen could be an attractive treatment in the preoperative setting.