Salvage chemotherapy with irinotecan and cisplatin in patients with metastatic gastric cancer failing both 5-fluorouracil and taxanes.

We conducted a phase II study to assess the efficacy and tolerability of irinotecan and cisplatin as salvage chemotherapy in patients with advanced gastric adenocarcinoma, progressing after both 5-fluorouracil (5-FU)- and taxane-containing regimen. Patients with measurable metastatic gastric cancer, progressive after previous chemotherapy that consisted either of a 5-FU-based regimen followed by second-line chemotherapy containing taxanes or a 5-FU and taxane combination were treated with irinotecan and cisplatin. Irinotecan 70 mg/m(2) was administered on day 1 and day 15; cisplatin 70 mg/m(2) was administered on day 1. Treatment was repeated every 4 weeks. For 28 patients registered, a total of 94 chemotherapy cycles were administered. The patients' median age was 51 years and 27 (96%) had an ECOG performance status of 1 or below. In an intent-to-treat analysis, seven patients (25%) achieved a partial response, which maintained for 6.3 months (95% confidence interval 6.2-6.4 months). The median progression-free and overall survival were 3.5 and 5.6 months, respectively. Major toxic effects included nausea, diarrhea and neurotoxicity. Although there was one possible treatment-related death, toxicity profiles were generally predictable and manageable. We conclude that irinotecan and cisplatin is an active combination for patients with metastatic gastric cancer in whom previous chemotherapy with 5-FU and taxanes has failed.