High-dose, single-agent irinotecan as first-line therapy in the treatment of metastatic colorectal cancer

摘要: Abstract Purpose. The efficacy and safety of single-agent, high-dose irinotecan (CPT-11, Campto) 500 mg/m2 every 3 weeks were investigated as first-line treatment for advanced colorectal cancer (CRC). Patients methods. Patients enrolled into the study to receive a first cycle therapy with at dose 350 mg/m2 3 weeks, which could be escalated second subsequent cycles depending on toxicity. Efficacy, pharmacokinetics determined in intent treat (ITT) population (i.e. patients who had received least three irinotecan, third 500 mg/m2). Results. Of 49 (ITT population), 31 (63%) 2 3 at an (the population). response rates (RR) ITT populations 24.5% 35.5%, respectively. main grade 3/4 toxicities per neutropenia 22% 17%, febrile 5% 3%, diarrhoea 12% 7%, its metabolite SN-38 1 22 2. Irinotecan clearance exposure not sufficiently correlated toxicity identify increase cycles. increased proportion from 350 500 mg/m2. Conclusion. These results suggest that can safely administered monotherapy approximately two-thirds present CRC following selective cycle.