Comparison of gemcitabine-based chemotherapies for advanced biliary tract cancers by renal function: an exploratory analysis of JCOG1113
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Published:2021-06-18
Issue:1
Volume:11
Page:
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ISSN:2045-2322
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Container-title:Scientific Reports
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language:en
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Short-container-title:Sci Rep
Author:
Ueno MakotoORCID, Morizane Chigusa, Okusaka Takuji, Mizusawa Junki, Kataoka Tomoko, Ikeda Masafumi, Ozaka Masato, Okano Naohiro, Sugimori Kazuya, Todaka Akiko, Shimizu Satoshi, Mizuno Nobumasa, Yamamoto Tomohisa, Sano Keiji, Tobimatsu Kazutoshi, Katanuma Akio, Miyamoto Atsushi, Yamaguchi Hironori, Nishina Tomohiro, Shirakawa Hirofumi, Kojima Yasushi, Oono Takamasa, Kawamoto Yasuyuki, Furukawa Masayuki, Iwai Tomohisa, Sudo Kentaro, Miyakawa Hiroyuki, Yamashita Tatsuya, Yasuda Ichirou, Takahashi Hidenori, Kato Naoya, Shioji Kazuhiko, Shimizu Kyoko, Nakagohri Toshio, Kamata Ken, Ishii Hiroshi, Furuse Junji,
Abstract
AbstractJCOG1113 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.
Funder
National Cancer Center Research and Development Fund Japan Agency for Medical Research and Development Ministry of Health, Labour and Welfare of Japan
Publisher
Springer Science and Business Media LLC
Subject
Multidisciplinary
Reference22 articles.
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