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Capecitabine, Oxaliplatin Combination Approved in Japan for Colorectal Cancer NEW YORK -- September 24, 2009 -- The Ministry of Health, Labour and Welfare has approved capecitabine in combination with oxaliplatin, for the treatment of patients with advanced or refractory colorectal cancer who are not candidates for curative surgery. The approval was based on 2 overseas studies, NO16966 and NO16967, which showed that capecitabine/oxaliplatin (Xelox) was comparable to folinic acid, fluorouracil (5-FU), and oxaliplatin (FOLFOX) in terms of progression-free survival (PFS), overall survival, and adverse event profile. The NO16966 study also showed that capecitabine/oxaliplatin in combination with bevacizumab (Avastin) significantly improved PFS compared with capecitabine/oxaliplatin alone. In addition, a domestic phase 1/2 study showed that capecitabine/oxaliplatin in combination with bevacizumab was equally tolerated by Japanese patients compared with non-Japanese patients, with a response rate of 71.9% based on the Response Evaluation Criteria in Solid Tumours (RECIST). SOURCE: Chugai Pharma E-mail this page to a friend or colleague! To print, use this version