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
| Autor: | Michael Heike, E Gracien, Axel Wein, Jürgen Siebler, M Menges, Thomas Höhler, Markus Moehler, A Eimermacher, T Geer, Theodor Junginger, D Flieger, Peter R. Galle |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2005 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty medicine.drug_class Leucovorin Phases of clinical research Neutropenia Adenocarcinoma Irinotecan Antimetabolite Gastroenterology gastric Stomach Neoplasms Internal medicine Clinical Studies Antineoplastic Combined Chemotherapy Protocols Medicine Humans 5-fluorouracil Stomach cancer Etoposide Peritoneal Neoplasms Aged Neoplasm Staging Levoleucovorin business.industry Middle Aged medicine.disease Survival Analysis Surgery metastatic ELF Treatment Outcome Oncology Tolerability Fluorouracil Camptothecin Female Esophagogastric Junction business ILF medicine.drug |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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