Phase II study of irinotecan as first-line chemotherapy for patients with advanced colorectal carcinoma

BACKGROUND, The objective of this multicenter, open-labeled, Phase LI study performed in Spain was to assess the efficacy and safety of irinotecan (CP T-11) as first-line chemotherapy for patients suffering from advanced color ectal carcinoma (CRC). METHODS. Patients with histologically proven CRC and at least one bidimensi onally measurable lesion, ages 18-70 years, with a performance status less than or equal to 2, normal analytical values, and no prior chemotherapy or only adjuvant chemotherapy completed before study entry were selected. The treatment schedule was CPT-11 350 mg/m(2) intravenously administered once e very 3 weeks. Both tumor response and toxicity were assessed using the Worl d Health Organization and National Cancer institute common toxicity criteri a. Changes in performance status, weight, and symptoms also were measured. RESULTS, Sixty-five patients (44 chemotherapy-naive patients and 21 patient s who completed prior adjuvant treatment) were enrolled. Of these, 24.7% of patients responded to the treatment, and 41.5% of patients had stable dise ase. Patients who had not received prior adjuvant chemotherapy had a lower rate of progression on therapy (27.3%) compared with those who had received prior adjuvant chemotherapy (42.9%). The median survival was 19.9 months ( range, 0.3-29.3 months). No significant differences were found in the media n survival between chemotherapy-naive patients and patients who had receive d previous chemotherapy. Grade 3-4 diarrhea and neutropenia were the most f requent severe toxic events, which were observed in 23.1% and 30.8% of pati ents and in 5.4% and 10.9% of the cycles, respectively. CONCLUSIONS. The current antitumor efficacy results show that 350 mg/m(2) o f CPT-11 administered every 3 weeks is an active and feasible first-line ch emotherapy regimen for patients with CRC. Finally, the overall safety data confirmed that CPT-11 is a well tolerated treatment. (C) 2001 American Canc er Society.