Randomized phase 3 trial of irinotecan (CPT-11) + 5FU/folinic acid (FA) vs CDDP + 5FU in 1st-line advanced gastric cancer patients

4003 Background: An open-label, multicenter study of 1st-line advanced gastric cancer patients (pts) was designed to compare the effects of CPT-11 + 5FU/FA with CDDP + 5FU. Primary efficacy variable: time to progression (TTP); secondary endpoints: time to treatment failure (TTF), overall survival (OS), and safety. Methods: Male and female pts aged 28–77 years were randomized to receive: CPT-11 80 mg/m2 iv as 30-min infusion, followed by FA 500 mg/m2 iv over 2 h, followed by 5FU 2000 mg/m2 iv over 22 h weekly for 6 wk (IF); or CDDP 100 mg/m2 iv as 1–3 h infusion on Day 1, followed by 5FU 1000 mg/m2/d continuous infusion over 5 d every 4 wk (CF). Treatment was administered up to progression, unacceptable toxicities, or consent withdrawal. Results: Of 337 randomized pts, 333 (170 with IF; 163 with CF) were treated. In the full-analysis population, a trend toward superiority was noted for TTP with IF vs CF (hazard ratio [HR] 1.23; 95% confidence interval [CI] 0.97–1.57; P = .088), corresponding to a 19% progr...