Paclitaxel, 5-fluorouracil, and cisplatin combination chemotherapy for thetreatment of advanced gastric carcinoma

BACKGROUND. Although the clinical efficacy of paclitaxel in the treatment o f gastric carcinoma has not been clearly defined, recent reports have sugge sted a possible role in the treatment of upper gastrointestinal carcinomas in vitro and in vivo. METHODS, Forty-one gastric carcinoma patients with metastatic disease, unre sectable advanced disease, or relapsed disease were treated with the follow ing regimen, administered every 28 days: paclitaxel 175 mg/m(2) by 3-hour i ntravenous (i.v.) infusion on Day 1, 5-FU 750 mg/m(2) by 24-hour continuous i.v. infusion on Days 1-5, and cisplatin 20 mg/m(2) by 2-hour i.v. infusio n on Days 1-5. Twenty-six this study, the authors evaluated the efficacy an d toxicity of a combination chemotherapy that included paclitaxel, 5-fluoro uracil (5-FU), and cisplatin in the treatment of patients with advanced gas tric carcinoma. RESULTS. Twenty-one of the 41 patients (51%; 95% confidence interval [CI], 36.5-65.7%) demonstrated an objective response, including 4 complete respon ses (10%; 95% CI, 3.9-22.5%). Sixty-five percent of the patients with measu rable disease (17of 26; 95% CI, 58-92.5%) and 27% of the patients with eval uable 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 (ra nge, 8 to 118+ weeks). The major toxicity of this treatment was myelosuppre ssion with neutropenia of World Health Organization Grade 3 and 4 in 2$% an d 10% of the patients, respectively. Nonhematologic toxicity included mucos itis, nausea/vomiting, diarrhea, neurotoxicity, and alopecia. Fluid retenti on occurred in two patients, and one patient had an anaphylatic reaction. D ose reduction was necessary for one patient, because Grade 4 neutropenia an d mucositis occurred. CONCLUSIONS. Paclitaxel, 5-FU, and cisplatin was an active combination regi men in the treatment of advanced gastric carcinoma. The toxicity of this re gimen was tolerable. Based on these findings, this combination regimen coul d be an attractive treatment in the preoperative setting. (C) 1999 American Cancer Society.