التفاصيل البيبلوغرافية
| العنوان: |
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. |
| المؤلفون: |
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., Höhler, T |
| المصدر: |
British Journal of Cancer; 6/20/2005, Vol. 92 Issue 12, p2122-2128, 7p |
| مصطلحات موضوعية: |
GASTRIC diseases, FLUOROURACIL, FOLINIC acid, CANCER treatment, ANTINEOPLASTIC agents, ETOPOSIDE, ADENOCARCINOMA, CAMPTOTHECIN, COMPARATIVE studies, ESOPHAGUS, RESEARCH methodology, MEDICAL cooperation, RESEARCH, STATISTICAL sampling, STOMACH tumors, SURVIVAL analysis (Biometry), TUMOR classification, PERITONEUM tumors, EVALUATION research, RANDOMIZED controlled trials, TREATMENT effectiveness |
| مستخلص: |
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. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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