A phase II trial of weekly fractionated irinotecan and cisplatin for advanced gastric cancer

Purpose: This study was to evaluate the activity and the safety of a combination chemotherapy regimen of weekly fractionated irinotecan and cisplatin in advanced gastric cancer patients. Methods: Patients with advanced gastric adenocarcinoma with either chemotherapy-naive or only one prior chemotherapy regimen received irinotecan 50 mg/m² followed by cisplatin 30 mg/m². Both drugs were administered weekly for 3 consecutive weeks, followed by 1-week rest. Treatment was repeated until disease progression occurred. Response evaluation was performed according to the RECIST criteria. Results: Forty-seven patients (13 chemo-naive, 34 prior chemotherapy) were enrolled. Of 46 evaluable patients, overall response rate was 25.5% (95% CI, 12.9-39.3%) and disease control rate was 63.8% (95% CI, 50.9-79.5%) by intent-to-treat analysis. The time to progression and overall survival duration were 21 and 44 weeks, respectively. One-year survival rate was 41.6%. The most frequent grade 4 toxicity was neutropenia, which was the major cause of treatment delay. Non-hematological toxicities of grade 3-4 were rare with occurrence rate of 14.9% for anorexia and emesis. Conclusions: Fractionated irinotecan combined with cisplatin with 3-week-on and 1-week-off schedule produced favorable clinical results for advanced gastric cancer. Because of the feasible efficacy and low non-hematologic toxicity, this treatment could be a promising salvage regimen in patients who have failed to taxanes.