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

Verfasser / Beitragende:
[Toshihiko Matsumoto, Tomohiro Nishina, Minoru Mizuta, Akihito Tsuji, Ryouhei Watanabe, Ikuo Takahashi, Yuji Watanabe, Toshikazu Moriwaki, Takashi Maeba, Ichinosuke Hyodo]
Ort, Verlag, Jahr:
2015
Enthalten in:
International Journal of Clinical Oncology, 20/1(2015-02-01), 111-116
Format:
Artikel (online)
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245 0 0 |a 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  |h [Elektronische Daten]  |c [Toshihiko Matsumoto, Tomohiro Nishina, Minoru Mizuta, Akihito Tsuji, Ryouhei Watanabe, Ikuo Takahashi, Yuji Watanabe, Toshikazu Moriwaki, Takashi Maeba, Ichinosuke Hyodo] 
520 3 |a 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. 
540 |a Japan Society of Clinical Oncology, 2014 
690 7 |a Chemotherapy  |2 nationallicence 
690 7 |a Elderly patients  |2 nationallicence 
690 7 |a UFT  |2 nationallicence 
690 7 |a Metastatic colorectal cancer  |2 nationallicence 
700 1 |a Matsumoto  |D Toshihiko  |u Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Kou 160, Minamiumemotomachi, 791-0280, Matsuyama, Ehime, Japan  |4 aut 
700 1 |a Nishina  |D Tomohiro  |u Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Kou 160, Minamiumemotomachi, 791-0280, Matsuyama, Ehime, Japan  |4 aut 
700 1 |a Mizuta  |D Minoru  |u Mitoyo General Hospital, Himehama, Toyohama-cho, 769-1695, Kanonji, Kagawa, Japan  |4 aut 
700 1 |a Tsuji  |D Akihito  |u Kochi Health Sciences Center, Ike, 781-8555, Kochi, Kochi, Japan  |4 aut 
700 1 |a Watanabe  |D Ryouhei  |u Matsuyama-shimin Hospital, Ootemachi, 790-0067, Matsuyama, Ehime, Japan  |4 aut 
700 1 |a Takahashi  |D Ikuo  |u Matsuyama Red Cross Hospital, Bunkyo-cho, 790-8524, Matsuyama, Ehime, Japan  |4 aut 
700 1 |a Watanabe  |D Yuji  |u Ehime University School of Medicine, Shitsukawa, 791-0295, Toon, Ehime, Japan  |4 aut 
700 1 |a Moriwaki  |D Toshikazu  |u University of Tsukuba, Tennodai, 305-0006, Tsukuba, Ibaraki, Japan  |4 aut 
700 1 |a Maeba  |D Takashi  |u Social Insurance Ritsurin Hospital, Ritsurin-cho, 760-007, Takamatsu, Kagawa, Japan  |4 aut 
700 1 |a Hyodo  |D Ichinosuke  |u University of Tsukuba, Tennodai, 305-0006, Tsukuba, Ibaraki, Japan  |4 aut 
773 0 |t International Journal of Clinical Oncology  |d Springer Japan  |g 20/1(2015-02-01), 111-116  |x 1341-9625  |q 20:1<111  |1 2015  |2 20  |o 10147 
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950 |B NATIONALLICENCE  |P 700  |E 1-  |a Matsumoto  |D Toshihiko  |u Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Kou 160, Minamiumemotomachi, 791-0280, Matsuyama, Ehime, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Nishina  |D Tomohiro  |u Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Kou 160, Minamiumemotomachi, 791-0280, Matsuyama, Ehime, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Mizuta  |D Minoru  |u Mitoyo General Hospital, Himehama, Toyohama-cho, 769-1695, Kanonji, Kagawa, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Tsuji  |D Akihito  |u Kochi Health Sciences Center, Ike, 781-8555, Kochi, Kochi, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Watanabe  |D Ryouhei  |u Matsuyama-shimin Hospital, Ootemachi, 790-0067, Matsuyama, Ehime, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Takahashi  |D Ikuo  |u Matsuyama Red Cross Hospital, Bunkyo-cho, 790-8524, Matsuyama, Ehime, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Watanabe  |D Yuji  |u Ehime University School of Medicine, Shitsukawa, 791-0295, Toon, Ehime, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Moriwaki  |D Toshikazu  |u University of Tsukuba, Tennodai, 305-0006, Tsukuba, Ibaraki, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Maeba  |D Takashi  |u Social Insurance Ritsurin Hospital, Ritsurin-cho, 760-007, Takamatsu, Kagawa, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 700  |E 1-  |a Hyodo  |D Ichinosuke  |u University of Tsukuba, Tennodai, 305-0006, Tsukuba, Ibaraki, Japan  |4 aut 
950 |B NATIONALLICENCE  |P 773  |E 0-  |t International Journal of Clinical Oncology  |d Springer Japan  |g 20/1(2015-02-01), 111-116  |x 1341-9625  |q 20:1<111  |1 2015  |2 20  |o 10147