Cargando…

Randomised phase II evaluation of irinotecan plus high-dose 5-fluorouracil and leucovorin (ILF) vs 5-fluorouracil, leucovorin, and etoposide (ELF) in untreated metastatic gastric cancer

An open-label randomised comparison of efficacy and tolerability of irinotecan plus high-dose 5-fluorouracil (5-FU) and leucovorin (LV) (ILF) with etoposide plus 5-FU/LV (ELF) in patients with untreated metastatic or locally advanced gastric cancer. One cycle of ILF comprised six once-weekly infusio...

Descripción completa

Detalles Bibliográficos
Autores principales: Moehler, M, Eimermacher, A, Siebler, J, Höhler, T, Wein, A, Menges, M, Flieger, D, Junginger, T, Geer, T, Gracien, E, Galle, P R, Heike, M
Formato: Texto
Lenguaje:English
Publicado: Nature Publishing Group 2005
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2361806/
https://www.ncbi.nlm.nih.gov/pubmed/15942629
http://dx.doi.org/10.1038/sj.bjc.6602649
Descripción
Sumario:An open-label randomised comparison of efficacy and tolerability of irinotecan plus high-dose 5-fluorouracil (5-FU) and leucovorin (LV) (ILF) with etoposide plus 5-FU/LV (ELF) in patients with untreated metastatic or locally advanced gastric cancer. One cycle of ILF comprised six once-weekly infusions of irinotecan 80 mg m(−2), LV 500 mg m(−2), 24-h 5-FU 2000 mg m(−2), and ELF comprised three once-daily doses of etoposide 120 mg m(−2), LV 300 mg m(−2), 5-FU 500 mg m(−2). In all, 56 patients received ILF and 58 ELF. Median age was 62 years, Karnofsky performance 90%, and disease status was comparable for both arms. The objective clinical response rates after 14 weeks treatment (primary end point) were 30% for ILF and 17% for ELF (risk ratio (RR) 0.57, 95% confidence interval (CI) 0.29–1.13, P=0.0766). Overall response rates over the entire treatment period for ILF and ELF were 43 and 24%, respectively (RR 0.56, 95% CI 0.33–0.97; P=0.0467). For ILF and ELF, respectively, median progression-free survival was 4.5 vs 2.3 months, time to treatment failure was 3.6 vs 2.2 months (P=0.4542), and overall survival was 10.8 vs 8.3 months (P=0.2818). Both regimens were well tolerated, the main grade 3/4 toxicities being diarrhoea (18%, ILF) and neutropenia (57%, ELF). The data from this randomised phase II study indicate that ILF provides a better response rate than ELF, and that ILF should be investigated further for the treatment of metastatic gastric cancer.