A phase II study of a combined biweekly irinotecan and monthly cisplatin treatment for metastatic or recurrent gastric cancer

Background: There is no universally confirmed standard chemotherapeutic regimen for advanced gastric cancer (AGC). The aim of this study was to investigate the efficacy and safety of combined biweekly irinotecan and monthly cisplatin treatments of patients with AGC. The primary end point was progression-free survival. Material and Methods: AGC patients with or without measurable lesions received 70 mg/m² irinotecan on days 1 and 15, and 80 mg/m² cisplatin on day 1 every 4 weeks. Results: Of 40 enrolled patients, 21 patients had measurable disease. With a median follow-up duration of 35 weeks, the median progression-free survival and overall survival were 2.2 months and 8.0 months, respectively. The progression-free survival rate at 6 months was 30.0%. The most common adverse event of grade 3 to 4 was neutropenia (32.5%). Grade 3 diarrhea was observed in 2 patients (5.0%). There was no treatment-related death. Conclusion: Current combined biweekly irinotecan and monthly cisplatin treatment did not show activity comparable with other active regimens in AGC.