RESUMO
To prospectively evaluate efficacy and tolerability of weekly irinotecan [CPT-11] in patients with advanced colorectal carcinoma [CRC] that had recurred or progressed following fluorouracil [5-FU]-based therapy. Forty eight patients were enrolled in this study. They were treated with irrinotecan 125 mg/m[2] intravenously [IV] every week for 4 weeks, followed by a 2- week rest. All patients were accessible for toxicity and only 44 patients completed one full course of therapy and were accessable for response. Nine patients [20.5%] attained partial response [95% CI, 10% to 27%] and no cases achieved complete response. The median duration of response was 7 months [range4to 11.5 months]. The median survival time was 10 months [95% CI 8.2 to 13.1 months] and the 1-year survival rate was 43.8% [95% CI, 33% to 53%]. Median time to progression was 4.0 months [95% CI, 2.6 to 5.1 months]. Grade 3-4 diarrhea was observed in 17 patients [35.4%], grade 3-4 nausea and vomiting in 3 patients [6.3%] and 4 patients [8.3%] respectively. Grade 3-4 neutropenia was reported in 5 patients [31.3%]. Grade 3-4 febrile neutropenia or infection affected only 2 patients [4.2%]. Weekly schedule of irinotecan has demon strated significant activity against colorectal cancer that has progressed during or shortly after treatment with 5-FU-based chemotherapy. Diarrhea is the most frequent dose limiting toxicity but can be substantially reduced through appropriate interventional management