TITLE:
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
AUTHORS:
Toshikazu Moriwaki, Tetsuya Eto, Akihito Tsuji, Nobushige Kakinoki, Mitsuo Shimada, Takashi Maeba, Hiroaki Hatano, Ikuo Takahashi, Hiroyasu Ishida, Kazuho Ikeda, Yoshiaki Bando, Ichinosuke Hyodo
KEYWORDS:
Alternate Days, Bevacizumab, Colorectal Cancer, Fluoropyrimidine, Elderly, Older, S-1
JOURNAL NAME:
Journal of Cancer Therapy,
Vol.8 No.11,
November
28,
2017
ABSTRACT: 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.