TY - JOUR
T1 - Comparison of gemcitabine-based chemotherapies for advanced biliary tract cancers by renal function
T2 - an exploratory analysis of JCOG1113
AU - the members of the Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG).
AU - Ueno, Makoto
AU - Morizane, Chigusa
AU - Okusaka, Takuji
AU - Mizusawa, Junki
AU - Kataoka, Tomoko
AU - Ikeda, Masafumi
AU - Ozaka, Masato
AU - Okano, Naohiro
AU - Sugimori, Kazuya
AU - Todaka, Akiko
AU - Shimizu, Satoshi
AU - Mizuno, Nobumasa
AU - Yamamoto, Tomohisa
AU - Sano, Keiji
AU - Tobimatsu, Kazutoshi
AU - Katanuma, Akio
AU - Miyamoto, Atsushi
AU - Yamaguchi, Hironori
AU - Nishina, Tomohiro
AU - Shirakawa, Hirofumi
AU - Kojima, Yasushi
AU - Oono, Takamasa
AU - Kawamoto, Yasuyuki
AU - Furukawa, Masayuki
AU - Iwai, Tomohisa
AU - Sudo, Kentaro
AU - Miyakawa, Hiroyuki
AU - Yamashita, Tatsuya
AU - Yasuda, Ichirou
AU - Takahashi, Hidenori
AU - Kato, Naoya
AU - Shioji, Kazuhiko
AU - Shimizu, Kyoko
AU - Nakagohri, Toshio
AU - Kamata, Ken
AU - Ishii, Hiroshi
AU - Furuse, Junji
N1 - Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85108318716&partnerID=8YFLogxK
U2 - 10.1038/s41598-021-92166-3
DO - 10.1038/s41598-021-92166-3
M3 - 学術論文
C2 - 34145336
AN - SCOPUS:85108318716
SN - 2045-2322
VL - 11
JO - Scientific Reports
JF - Scientific Reports
IS - 1
M1 - 12885
ER -