• A Antón, E Aranda, A Carrato, E Marcuello, B Massutti, A Cervantes, A Abad, J Sastre, C Fenández-Martos, M Gallén, E Díaz-Rubio, L Huarte, M Balcells, and TTD cooperative group.
• Department of Oncological Medicine, Hospital Miguel Servet, Paseo de Isabel la Católica 1-3, 50013 Zaragoza, Spain. aantont@salud.aragob.es
• Methods Find Exp Clin Pharmacol. 2003 Oct 1; 25 (8): 639-43.

AbstractThe efficacy and toxicity of irinotecan (CPT-11) 350 mg/m(2) i.v. once every 3 weeks was assessed in 60 patients with advanced colorectal cancer (CRC) showing failure to 5-fluorouracil (5-FU) treatment. The overall objective response rate was 13.6% (1 complete response and 4 partial responses) and 25 patients (42.4%) showed stable disease; the median time to disease progression was 4.4 months and the median survival was 10.5 months. The main non-hematological toxicities were alopecia (80.3% of patients), diarrhea (75.0%), and nausea/vomiting (71.7%); neutropenia was the main hematological toxicity. Grade 3 or 4 diarrhea appeared in 21 of 131 cycles (16.1%), whereas grade 3 or 4 neutropenia appeared in 78 cycles (25.0%). In conclusion, the present phase II study confirms that CPT-11 350 mg/m(2) every 3 weeks is active and well tolerated as second-line chemotherapy for CRC in 5-FU resistant patients.(c) 2003 Prous Science. All rights reserved.

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