A multicenter, phase II trial of weekly irinotecan (CPT-11) in patients with previously treated colorectal carcinoma.

摘要: BACKGROUND This multicenter, Phase II trial was performed to evaluate the antitumor activity and toxicity of irinotecan (CPT-11) in patients with metastatic colorectal carcinoma that had recurred or progressed after 5-fluorouracil (5-FU)-based chemotherapy. METHODS CPT-11 given as a 90-minute intravenous infusion repeated 6-week (42-day) courses comprising weekly treatment for 4 consecutive weeks followed by 2-week rest. Tumor measurements were obtained every second course therapy. Toxicity assessed using National Cancer Institute Common Criteria. RESULTS A total 166 entered into trial. The first 64 received starting dose 125 mg/m2. An additional 102 enrolled at 100 mg/m2 determine whether reduction would result lower without sacrificing efficacy. Objective responses CPT-11 observed 18 (1 complete response 17 partial responses) (response rate [RR] = 10.8%; 95% confidence interval [CI], 6.1-15.6%). 67 (40.4%) stable disease their best response. At dose, RR 14.1% (9 patients; CI, 5.5-22.6%). Among mg/m2, 8.8% 3.3-14.3%). overall median survival 9.9 months (range, 0.3-36.8 months). most frequently Grade 3/4 toxicities gastrointestinal events (i.e., diarrhea [27.1%], nausea [15.1%], emesis [9.6%], abdominal cramping [22.2%], neutropenia [19.9%]). There no significant differences frequencies between levels except (21.9% vs. 2%; P < 0.001). Patients age ≥ 65 years twice likely (38.6% 18.8%; 0.008) develop compared younger when all therapy evaluated. However, older did not significantly predict higher incidence first-course (25.0% 14.7%; =0.106). CONCLUSIONS CPT-11 can induce tumor regression has during shortly 5-FU-based chemotherapy. Gastrointestinal common serious toxicities. Given trend toward substantially greater toxicity, been selected preferred further studies. Careful attention appropriate modification early intervention loperamide may be especially important elderly patients. 1999;85:786–95. © 1999 American Society.