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Capecitabine plus oxaliplatin (XELOX) versus 5‐fluorouracil/leucovorin plus oxaliplatin (FOLFOX‐6) as first‐line treatment for metastatic colorectal cancer
Author(s) -
Ducreux Michel,
Bennouna Jaafar,
Hebbar Mohamed,
Ychou Marc,
Lledo Gérard,
Conroy Thierry,
Adenis Antoine,
Faroux Roger,
Rebischung Christine,
Bergougnoux Loic,
Kockler Leila,
Douillard JeanYves
Publication year - 2010
Publication title -
international journal of cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.475
H-Index - 234
eISSN - 1097-0215
pISSN - 0020-7136
DOI - 10.1002/ijc.25369
Subject(s) - folfox , oxaliplatin , medicine , capecitabine , neutropenia , fluorouracil , colorectal cancer , population , regimen , oncology , gastroenterology , clinical endpoint , chemotherapy , surgery , cancer , randomized controlled trial , environmental health
A regimen consisting of 5‐fluorouracil/leucovorin plus oxaliplatin (FOLFOX‐6) is widely used in France in the first‐line treatment of metastatic colorectal cancer (MCRC). The aim of our study was to demonstrate the non‐inferiority of capecitabine plus oxaliplatin (XELOX) versus FOLFOX‐6 for this indication. Patients were randomly assigned to receive XELOX or FOLFOX‐6 for 6 months. The primary endpoint was overall response rate (ORR) in the per‐protocol (PP) population; however, progression‐free and overall survival (OS), time to response and response duration were also assessed. A total of 306 patients were enrolled (XELOX n = 156; FOLFOX‐6 n = 150). ORR was 42 and 46% with XELOX and FOLFOX‐6, respectively, in the PP population. The difference between groups was 4.7%; the upper limit of the unilateral 95% confidence interval (14.4%) was below the non‐inferiority margin of 15%. In the intent‐to‐treat population, median progression‐free survival was 8.8 months with XELOX and 9.3 months with FOLFOX‐6, and median OS was 19.9 and 20.5 months, respectively. XELOX patients had significantly more grade 3/4 thrombocytopenia (12% vs . 5%) and diarrhoea (14% vs . 7%), but significantly less grade 3/4 neutropenia (5% vs . 47%), febrile neutropenia (0% vs . 6%) and neuropathy (11% vs . 26%) than FOLFOX‐6 patients. We conclude that XELOX is non‐inferior in terms of efficacy to FOLFOX‐6 in the first‐line treatment of MCRC, but has a different toxicity profile.