Background: The combination of irinotecan (CPT-11) and cisplatin (CDDP) is an active regimen for metastatic gastric cancer in the first-line setting. The objective of this retrospective study was to clarify its efficacy and safety in patients with prior chemotherapy for advanced or recurrent gastric cancer.
Methods: Patients in the study fulfilled the following selection criteria: (1) histologically proven gastric cancer with metastatic lesions; (2) performance status of 2 or less; (3) age of 75 years or younger; (4) at least one prior chemotherapy regimen without CPT-11 or CDDP; (5) adequate bone marrow, liver, and kidney function; (6) normal cardiac function; (7) no other severe medical conditions; (8) no other active malignancy; and (9) the provision of written informed consent. The treatment consisted of CPT-11 (70 mg/m2) on day 1 and day 15 and CDDP (80 mg/m2) on day 1; repeated every 4 weeks.
Results: Thirty-two patients were recruited, and 28 were assessable for clinical response. There were eight partial responses, resulting in a response rate of 28%. Median time to progression was 104 days (range, 24-863 days) and median overall survival time was 283 days from the initiation of this therapy. The incidences of grade 4 neutropenia, grade 3 or higher infection, and diarrhea were 69%, 9%, and 3%, respectively. Other adverse reactions were mild. No treatment-related deaths occurred.
Conclusion: A combination of CPT-11 and CDDP may be active and feasible for gastric cancer patients with prior chemotherapy. Further studies with larger numbers of patients are needed to clarify this regimen's significance in the second-line setting.