Clinical activity and benefit of irinotecan (CPT-11) in patients with colorectal cancer truly resistant to 5-fluorouracil (5-FU)

摘要: The aim of this prospective study was to assess the efficacy, clinical benefit and safety CPT-11 (irinotecan) in patients with stringently-defined 5-fluorouracil-resistant metastatic colorectal cancer (CRC). 107 documented progression CRC during 5-FU were treated 350 mg/m(2) once every 3 weeks a multicentre phase II study. Tumour response toxicity assessed using WHO criteria. Changes performance status (PS), weight pain also measured. rate 13/95 (13.7%, 95% CI 7.5% 22.3%) eligible median duration 8.5 months (37 weeks, range: 18-53 +). There high disease stabilisation (44.2%) 4.8 months. probability being free at 4 50%. Median survival from first administration 10.4 or 45 (range: 3-66 + weeks). stabilisatian gain 81% (73/90) patients, favourable outcome PS 91% (82/90) (improvement 2 0-1), relief 54% (26/48). no toxic deaths. Neutropenia short-lasting non-cumulative. Diarrhoea grade greater than equal occurred 7% cycles 28/107 (26%) patients. has an encouraging degree activity progressive truly resistant relatively tumour growth control translated into benefit. profile is becoming better understood been considerably improved. (C) 1999 Elsevier Science Ltd. All rights reserved.