Multi-center phase II study of irinotecan + 5-FU/l-LV (RPMI) chemotherapy for patients with metastasic colorectal cancer (OGSG0201)

Abstract

3700 Background: To evaluate the toxicity and efficacy of combination chemotherapy with irinotecan plus 5-FU/l-LV (RPMI) in patients with metastatic colorectal cancer(MCC). Methods: Forty-five patients with MCC entered this multi-centered, community-based, phase II study conducted by the Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) (Proc ASCO 22; 299, 2004). All patients were treated with irinotecan (100mg/m2), 5-FU (500 mg/m2) and l-LV (250mg/m2) on day 1, 8 and 15. Cycles were repeated every 5 weeks. Patients received second line therapy based on institutional preferences. Results: With the median follow up of 16 months (1.6–27 months), the MST was 21.1 months and the one-year survival rate was 73.3%. The response rate was 26.7% (CR 1, PR 11, SD 28, PD 5). The median relative dose intensity was 83.3% for irinotecan and 5-FU respectively. Grade 3 or 4 toxities were anemia (8.9%), leukopenia (13.3%), neutropenia (33.3%), diarrhea (6.7%), nausea (4.4%), vomiting (2.2%) and anorexia (4.4%). 5-FU/CDDP and oral FU were the second line treatment, except one patient received oxaliplatin (FOLFOX4) and cetuximab (not yet authorized in Japan). Conclusions: Despite the RR was not high enough, the survival period was favorable (21.1 months). It is expected that irinotecan + 5-FU/l-LV (RPMI), followed by the treatment with oral FU, oxaliplatin and molecule-targeting drugs may achieve the prolonged survival of patients with MCC. No significant financial relationships to disclose.