Authors: Toshihiko Matsumoto Tomohiro Nishina Minoru Mizuta Akihito Tsuji Ryouhei Watanabe Ikuo Takahashi Yuji Watanabe Toshikazu Moriwaki Takashi Maeba Ichinosuke Hyodo
Publish Date: 2014/02/20
Volume: 20, Issue: 1, Pages: 111-116
Abstract
Oral uraciltegafur and leucovorin UFT/LV therapy for elderly patients with metastatic colorectal cancer mCRC requires careful handling in Western countries because of a high incidence ≥20 of grade 3 diarrhea However its efficacy and safety for elderly Asian patients have not been investigatedIn this multicenter cooperative phase II study the eligibility criteria were age of 75 years or older no prior chemotherapy and histologically confirmed colorectal cancer with one or more measurable lesions UFT 300 mg/m2/day and LV 75 mg/day were administered orally for 28 days followed by a 7day rest periodTwentyone patients were enrolled in this study prior to study termination after approval of bevacizumab and all patients were eligible for efficacy and safety analysis The median age was 79 years range 75–83 years The majority of patients 95 had ECOG Performance Status 0 or 1 The overall response rate was 33 95 confidence interval CI 18–53 The median progressionfree and overall survivals were 53 months 95 CI 40–79 months and 18 months 95 CI 13–21 months respectively Grade 3 or greater adverse events included anorexia 10 diarrhea 10 and leukopenia 5 These results were compatible with those seen in Japanese patients in a previous bridging study between Japan and the US in which patients under 75 years old were evaluatedIchinosuke Hyodo and Toshikazu Moriwaki received a research grant from Taiho Pharmaceutical Co Ltd Tomohiro Nishina Minoru Mizuta Akihito Tsuji Ryohei Watanabe Ikuo Takahashi Yuji Watanabe Toshikazu Moriwaki Takashi Maeba and Ichinosuke Hyodo received lecture fees from Taiho Pharmaceutical Co Ltd
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