Phase II trial of weekly irinotecan plus cisplatin as second line chemotherapy in metastatic gastric adenocarcinoma

Background: This phase-II study was conducted to evaluate the efficacy and tolerability of weekly irinotecan and cisplatin in a three-week cycle for patients with metastatic gastric adenocarcinoma (MGC). Methods: Patients with histologically -proven adenocarcinoma of the stomach, who were previously treated with epirubicin and or taxane containing chemotherapy regimen, received cisplatin 30 mg/m2 and irinotecan 65 mg/m2 for two consecutive weeks based on a 3-week cycle. Response rate was evaluated after two cycles of chemotherapy. Results: From January 2003 to April 2006, 43 patients were registered in this study at the Medical Oncology Department of the Cancer Institute of Tehran. A total of 182 chemotherapy cycles were administered. The median patient age was 62 years. Nine patients (20%) achieved a complete or partial response. Seventeen patients (40%) had stable disease or minor response and the disease progressed under the treatment in 17 of patients (40%). With a mean follow up time of 13 months, median progression-free survival and overall survival were five and nine months, respectively. Overall, grade 3/4 toxicity was observed in 32% of cycles including fatigue (9%o) nausea/vomiting (8%), neutropenia (7%) and anorexia (3.5%) and diarrhea (2%). Conclusion: Not only is the combination of weekly irinotecan and cisplatin in three-week cycles as effective as six-week cycles but it is also less toxic. Therefore, we recommend this regimen for the treatment of MGC.