A combination of oxaliplatin and UFT-l,-leucovorin as first line treatment in advanced colorectal cancer. An ONCOPAZ phase II study

Autor:	Joaquín Montalar, Manuel González-Barón, J. de Castro, M. Lomas, C. García-Girón, M. Constela, L. Antón-Aparicio, E. Fonseca, J. M. Vicent, F J Dorta
Rok vydání:	2004
Předmět:	Cancer Research Chemotherapy medicine.medical_specialty business.industry medicine.medical_treatment Phases of clinical research Gastroenterology Oxaliplatin Surgery Advanced colorectal cancer First line treatment Regimen Oncology Pill Internal medicine Toxicity medicine business medicine.drug
Zdroj:	Journal of Clinical Oncology. 22:3726-3726
ISSN:	1527-7755 0732-183X
DOI:	10.1200/jco.2004.22.90140.3726
Popis:	3726 Background: To assess the efficacy and safety of the oxaliplatin-UFT-l,LV combination as first-line treatment in patients with advanced CRC. Methods:Between 04/99 and 01/00, 81 patients with recurrent or metastatic CRC were included. Mean age was 63 years (40–77), male/female ratio 46/35, ECOG 0/1/2 39/36/6. The study regimen consisted of Oxaliplatin 85 mg/m2 in 120-minute intravenous infusion on days 1 and 15; intravenous l,LV 250 mg/m2 given in two hours on day 1, followed by oral UFT 390 mg/m2 on days 1 to 14, and oral l,LV 7.5 mg/12 hours on days 2 to 14. Pills were taken before meals to favour absorption (for instance, at 8 a.m. and 8 p.m.). Cycles were repeated every 28 days. Results:A total of 470 cycles of chemotherapy were delivered with a median of six cycles per patient (range 1–12). A pre-scheduled preliminary analysis was performed after inclusion of 16 patients. High gastro-intestinal toxicity was observed: G 3–4 diarrhoea 9/16 (56%), G 3–4 nausea-vomiting 3/16 (18%). This lead to reduc...
Databáze:	OpenAIRE
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