Prospective multicenter phase II study of irinotecan as third-line therapy in metastatic colorectal cancer and progression after bolus and infusional 5-fluorouracil.

摘要: Irinotecan has proven anti-tumor activity as induction treatment in combination with 5-fluorouracil (5-FU) or second-line after 5-FU patients metastatic colorectal cancer. The aim of the present phase II study was to evaluate irinotecan third-line chemotherapy cancer sequential bolus followed by an infusional regimen. Patients pretreated 5-FU/folinic acid and regimen were treated 350 mg/m i.v. once every 3 weeks a multicenter study. Tumor size measured cycle continued until occurrence progressive disease unacceptable toxicity. A total 50 included. Of 45 evaluable patients, 13.3% [n=6, 95% confidence interval (CI) 5.1-26.8] attained response (complete/partial response) lasting 5.6 months (95% CI 4.2-6.3) four been confirmed (8.9%, 2.5-21.2). Disease stabilization noted 51.1% (n=23, 35.8-66.3). median duration response/disease 4.2 3.2-6.0). Median overall survival 7.9 6.1-11.1), corresponding calculated 1-year 28.3% 15.2-41.3). Severe neutropenia occurred 14% (n=7) anemia grade III 6% (n=3). most frequent non-hematological toxicity III/IV related diarrhea 24% (n=12), vomiting 8% (n=4) constipation well infection two each (4%) (evaluable n=50). We conclude single-agent is effective well-tolerable failure regimens. Elderly had same probability respond.