Phase II trial of the combination of paclitaxel and 5-fluorouracil in the treatment of advanced gastric cancer - A novel, safe, and effective regimen

This prospective phase II clinical trial was performed to explore the activ ity and efficacy of the combination of paulitaxel and 5-fluorouracil in the treatment of advanced gastric adenocarcinoma. Thirty-one patients ages 18 to 70 years, with Karnofsky performance status (KPS) >50, adequate cardiac, renal, and hepatic functions, measurable metastatic or locally unresectabl e disease, life expectancy greater than or equal to 3 months, signed writte n informed consent, and without any previous chemotherapy were assigned to receive on an outpatient basis: paclitaxel-175 mg/m(2), in a 3-hour infusio n on day I and 5-fluorouracil-1.5 g/m(2), also in a 3-hour infusion on day 2 every 21 days, for a maximum of seven cycles. A system to assess clinical benefit based on KPS, analgesic consumption, and weight gain was also used in this trial. Median age was 61 years (range, 31-70 years). The 29 patien ts eligible For response and toxicity evaluation underwent 147 cycles of ch emotherapy. There were 19 (65.5%) objective responses (95% confidence inter val: 48%-83%), including 7 (24.1%) complete responses and 12 (41.4%) partia l responses. Three patients had the complete response pathologically confir med. In three of six patients who went to second-look laparotomy, a potenti ally curative esophagogastrectomy was possible. The toxicity of this combin ation was considered low, predictable, and manageable and was characterized mainly by reversible alopecia, peripheral neuropathy, myalgia, and mild ne utropenia. Fifteen (51.7%) patients attained a clinical benefit response. T he median overall survival was 12 months (range, 2-30+ months) and the 30-m onth overall survival was 20%. This novel regimen appears to be very effect ive in advanced gastric cancer. The projected 2-year survival of 20% is hig her than that achieved with other first-line regimens. These encouraging re sults indicate the need for further studies to confirm the merit of this re gimen.