Multicenter phase II study of irinotecan plus weekly bolus 5-FU and high dose l-leucovorin for patients with metastatic colorectal cancer (OGSG 0201)

Abstract

3718 Background: This phase II study was undertaken to determine the efficacy of irinotecan plus weekly bolus 5-FU and high dose l-leucovorin for patients with metastasic colorectal cancer. Methods:On the basis of the results of our phase I study (Proc ASCO 22: 338, 2003), irinotecan (100 mg/m2), 5-FU (500 mg/m2), and l-LV (250 mg/m2) (Rosewell park regimen) were administered on days 1, 8, and 15, respectively, Cycles were repeated every 5 weeks. Results: Forty-five patients (median age, 64 years: males, 60%) were enrolled onto this multicenter, phase II study (Osaka Gastrointestinal Cancer Chemotherapy Study Group: OGSG protocol 0201). Objective complete response, partial response or stable disease was observed in 2.2%, 22.2% and 62.2% of patients respectively. The common grade 3 to 4 toxicities were neutropenia (31.1%), leukopenia (15.6%), anemia (6.7%), diarrhea (6.7%), anorexia (4.4%), nausea (2.2%) and vomiting (2.2%). The median relative dose intensity of irinotecan and 5-FU was 83.3% (33.3–100%) respectively. The median cycles were four. There were no deaths related to this combination therapy. Conclusions: The combination therapy of irinotecan plus weekly bolus 5-FU and high dose l-leucovorin for patients with metastatic colorectal cancer seems to be effective and well tolerated in Japan. The survival period is being assessed and updated data will be present at the meeting. No significant financial relationships to disclose.