학술논문
Comparison of gemcitabine-based chemotherapies for advanced biliary tract cancers by renal function: an exploratory analysis of JCOG1113
Document Type
article
Author
Makoto Ueno; Chigusa Morizane; Takuji Okusaka; Junki Mizusawa; Tomoko Kataoka; Masafumi Ikeda; Masato Ozaka; Naohiro Okano; Kazuya Sugimori; Akiko Todaka; Satoshi Shimizu; Nobumasa Mizuno; Tomohisa Yamamoto; Keiji Sano; Kazutoshi Tobimatsu; Akio Katanuma; Atsushi Miyamoto; Hironori Yamaguchi; Tomohiro Nishina; Hirofumi Shirakawa; Yasushi Kojima; Takamasa Oono; Yasuyuki Kawamoto; Masayuki Furukawa; Tomohisa Iwai; Kentaro Sudo; Hiroyuki Miyakawa; Tatsuya Yamashita; Ichirou Yasuda; Hidenori Takahashi; Naoya Kato; Kazuhiko Shioji; Kyoko Shimizu; Toshio Nakagohri; Ken Kamata; Hiroshi Ishii; Junji Furuse; the members of the Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG).
Source
Scientific Reports, Vol 11, Iss 1, Pp 1-9 (2021)
Subject
Language
English
ISSN
2045-2322
Abstract
Abstract JCOG1113 is a randomized phase III trial in patients with advanced biliary tract cancers (BTCs) (UMIN000001685), and gemcitabine plus S-1 (GS) was not inferior to gemcitabine plus cisplatin (GC). However, poor renal function often results in high toxicity of S-1. Therefore, we examined whether GS can be recommended for patients with low creatinine clearance (CCr). Renal function was classified by CCr as calculated by the Cockcroft-Gault formula: high CCr (CCr ≥ 80 ml/min) and low CCr (80 > CCr ≥ 50 ml/min). Of 354 patients, 87 patients on GC and 91 on GS were included in the low CCr group, while there were 88 patients on GC and 88 patients on GS in the high CCr group. The HR of overall survival for GS compared with GC was 0.687 (95% CI 0.504–0.937) in the low CCr group. Although the total number of incidences of all Grade 3–4 non-haematological adverse reactions was higher (36.0% vs. 11.8%, p = 0.0002), the number of patients who discontinued treatment was not different (14.1% vs. 16.9%, p = 0.679) for GS compared with GC in the low CCr group. This study suggests that GS should be selected for the treatment of advanced BTC patients with reduced renal function.