Author(s)

Toshikazu Moriwaki^1*, Tetsuya Eto², Akihito Tsuji³, Nobushige Kakinoki⁴, Mitsuo Shimada⁵, Takashi Maeba⁶, Hiroaki Hatano⁷, Ikuo Takahashi⁸, Hiroyasu Ishida⁹, Kazuho Ikeda¹⁰, Yoshiaki Bando¹¹, Ichinosuke Hyodo¹

¹Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
²Department of Gastroenterology, Tsuchiura Kyodo General Hospital, Tsuchiura, Japan.
³Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.
⁴Department of Gastroenterology, Hitachi General Hospital, Hitachi, Japan.
⁵Department of Surgery, Tokushima University, Tokushima, Japan.
⁶Department of Surgery, Japan Community Health Care Organization Ritsurin Hospital, Takamatsu, Japan.
⁷Department of Surgery, Matsuyama Shimin Hospital, Matsuyam, Japan.
⁸Department of Surgery, Matsuyama Red Cross Hospital, Matsuyama, Japan.
⁹Department of Gastroenterology, National Hospital Organization Mito Medical Center, Higashi Ibaraki-Gun, Japan.
¹⁰Department of Gastroenterology, Koyama Memorial Hospital, Kashima, Japan.
¹¹Department of Surgery, Tokushima Prefecture Naruto Hospital, Naruto, Japan.

Fluoropyrimidine combined with bevacizumab is commonly used in elderly patients with metastatic colorectal cancer worldwide. However, the proportion of elderly patients who discontinued treatment due to toxicities was higher than that of younger patients. The aim of this study is to develop a less toxic schedule of S-1, while maintaining the anti-tumor effect. This phase II study is aimed to evaluate an alternate-day administration of S-1 combined with bevacizumab in untreated elderly patients (aged ≥75 years) with metastatic colorectal cancer. The primary endpoint is progression-free survival, and the secondary endpoints are safety, response rate, and overall survival. The expected median progression-free survival is 8.5 months, and the minimum efficacy threshold is 5.0 months. The total required sample size is calculated as 50 patients, with a 2-sided type I error of 0.10 and a power of more than 80%. This study is ongoing, and fifty-four patients were enrolled until October 2016. We hope that S-1 on alternate days combined with bevacizumab for elderly patients with colorectal cancer is well tolerated and can maintain effectiveness. Trial registration: UMIN clinical trials UMIN000010402.

Alternate Days, Bevacizumab, Colorectal Cancer, Fluoropyrimidine, Elderly, Older, S-1

Moriwaki, T. , Eto, T. , Tsuji, A. , Kakinoki, N. , Shimada, M. , Maeba, T. , Hatano, H. , Takahashi, I. , Ishida, H. , Ikeda, K. , Bando, Y. and Hyodo, I. (2017) Rationale and Study Protocol of the J-SAVER Study: A Phase II Study of S-1 on Alternate Days Combined with Bevacizumab in Patients Aged ≥75 Years with Metastatic Colorectal Cancer. Journal of Cancer Therapy, 8, 1040-1048. doi: 10.4236/jct.2017.811088.