Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction

摘要: Abstract Background We aimed to establish the superiority (or noninferiority if was not achieved) in terms of time progression (TTP) irinotecan/5-fluorouracil (IF) over cisplatin/5-fluorouracil (CF) chemonaive patients with adenocarcinoma stomach/esophagogastric junction. Patients and methods received either IF: i.v. irinotecan 80 mg/m2 30 min, folinic acid 500 2 h, 5-fluorouracil (5-FU) 2000 22 for 6/7 weeks or CF: cisplatin 100 1–3 5-FU 1000 mg/m2/day 24 days 1–5, every 4 weeks. Results In all, 333 were randomized treated (IF 170, CF 163). Patient characteristics balanced except more IF had Karnofsky performance status 100%. TTP 5.0 months [95% confidence interval (CI) 3.8–5.8] 4.2 (95% CI 3.7–5.5) (P = 0.088). Overall survival (OS) 9.0 versus 8.7 months, response rate 31.8% 25.8%, treatment failure (TTF) 4.0 3.4 CF, respectively. The difference TTF statistically significant 0.018). better toxic deaths (0.6% 3%), discontinuation toxicity (10.0% 21.5%), severe neutropenia, thrombocytopenia stomatitis, but diarrhea. Conclusion did yield a OS results borderline. However, may provide viable, platinum-free front-line alternative metastatic gastric cancer.