caa a22 4500 605490422 CHVBK 20210128100504.0 cr unu---uuuuu 210128e20150201xx s 000 0 eng 10.1007/s10147-014-0675-5 doi (NATIONALLICENCE)springer-10.1007/s10147-014-0675-5 Phase II study of first-line chemotherapy with uracil-tegafur plus oral leucovorin in elderly (≥75years) Japanese patients with metastatic colorectal cancer: SGOSG-CR0501 study [Elektronische Daten] [Toshihiko Matsumoto, Tomohiro Nishina, Minoru Mizuta, Akihito Tsuji, Ryouhei Watanabe, Ikuo Takahashi, Yuji Watanabe, Toshikazu Moriwaki, Takashi Maeba, Ichinosuke Hyodo] Background: Oral uracil-tegafur 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 investigated. Methods: In this multicenter cooperative phase II study, the eligibility criteria were: age of 75years or older, no prior chemotherapy, and histologically confirmed colorectal cancer with one or more measurable lesions. UFT 300mg/m2/day and LV 75mg/day were administered orally for 28days followed by a 7-day rest period. Results: Twenty-one 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 79years (range, 75-83years). 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 progression-free and overall survivals were 5.3months (95% CI 4.0-7.9months) and 18months (95% CI 13-21months), 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 75years old were evaluated. Conclusions: UFT/LV therapy was safe and feasible in elderly Japanese patients with mCRC, and further study of UFT/LV therapy in combination with bevacizumab is warranted. Japan Society of Clinical Oncology, 2014 Chemotherapy nationallicence Elderly patients nationallicence UFT nationallicence Metastatic colorectal cancer nationallicence Matsumoto Toshihiko Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Kou 160, Minamiumemotomachi, 791-0280, Matsuyama, Ehime, Japan aut Nishina Tomohiro Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Kou 160, Minamiumemotomachi, 791-0280, Matsuyama, Ehime, Japan aut Mizuta Minoru Mitoyo General Hospital, Himehama, Toyohama-cho, 769-1695, Kanonji, Kagawa, Japan aut Tsuji Akihito Kochi Health Sciences Center, Ike, 781-8555, Kochi, Kochi, Japan aut Watanabe Ryouhei Matsuyama-shimin Hospital, Ootemachi, 790-0067, Matsuyama, Ehime, Japan aut Takahashi Ikuo Matsuyama Red Cross Hospital, Bunkyo-cho, 790-8524, Matsuyama, Ehime, Japan aut Watanabe Yuji Ehime University School of Medicine, Shitsukawa, 791-0295, Toon, Ehime, Japan aut Moriwaki Toshikazu University of Tsukuba, Tennodai, 305-0006, Tsukuba, Ibaraki, Japan aut Maeba Takashi Social Insurance Ritsurin Hospital, Ritsurin-cho, 760-007, Takamatsu, Kagawa, Japan aut Hyodo Ichinosuke University of Tsukuba, Tennodai, 305-0006, Tsukuba, Ibaraki, Japan aut International Journal of Clinical Oncology Springer Japan 20/1(2015-02-01), 111-116 1341-9625 20:1<111 2015 20 10147 https://doi.org/10.1007/s10147-014-0675-5 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-014-0675-5 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Matsumoto Toshihiko Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Kou 160, Minamiumemotomachi, 791-0280, Matsuyama, Ehime, Japan aut NATIONALLICENCE 700 1- Nishina Tomohiro Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Kou 160, Minamiumemotomachi, 791-0280, Matsuyama, Ehime, Japan aut NATIONALLICENCE 700 1- Mizuta Minoru Mitoyo General Hospital, Himehama, Toyohama-cho, 769-1695, Kanonji, Kagawa, Japan aut NATIONALLICENCE 700 1- Tsuji Akihito Kochi Health Sciences Center, Ike, 781-8555, Kochi, Kochi, Japan aut NATIONALLICENCE 700 1- Watanabe Ryouhei Matsuyama-shimin Hospital, Ootemachi, 790-0067, Matsuyama, Ehime, Japan aut NATIONALLICENCE 700 1- Takahashi Ikuo Matsuyama Red Cross Hospital, Bunkyo-cho, 790-8524, Matsuyama, Ehime, Japan aut NATIONALLICENCE 700 1- Watanabe Yuji Ehime University School of Medicine, Shitsukawa, 791-0295, Toon, Ehime, Japan aut NATIONALLICENCE 700 1- Moriwaki Toshikazu University of Tsukuba, Tennodai, 305-0006, Tsukuba, Ibaraki, Japan aut NATIONALLICENCE 700 1- Maeba Takashi Social Insurance Ritsurin Hospital, Ritsurin-cho, 760-007, Takamatsu, Kagawa, Japan aut NATIONALLICENCE 700 1- Hyodo Ichinosuke University of Tsukuba, Tennodai, 305-0006, Tsukuba, Ibaraki, Japan aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/1(2015-02-01), 111-116 1341-9625 20:1<111 2015 20 10147