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 - Funding Information:
Dr. Ueno reports grants and personal fees from Yakult Honsha, grants and personal fees from Taiho Pharmaceutical, AstraZeneca, Merck Serono, MSD, Daiichi Sankyo and Ono Pharmaceutical, personal fees from Nihon Servier, grants from Astellas Pharma, Eisai, Sumitomo Dainippon Pharma and Incyte. Dr. Morizane reports grants and personal fees from Yakult Honsha, J-Pharma, AstraZeneca, MSD and Taiho Pharmaceutical, grants from Eisai, Merck Biopharma and Ono Pharmaceutical, personal fees from Teijin Pharma, Novartis and Abbvie. Dr. Okusaka reports grants and personal fees from Eli Lilly, Taiho Pharmaceutical, Pfizer Japan and Yakult Honsha, personal fees from Meiji Seika Pharma, grants and personal fees from Ono Pharmaceutical, Eisai, Sumitomo Dainippon Pharma, Bristol-Myers Squibb, Bayer Yakuhin, Chugai Pharmaceutical, Zeria Pharmaceutical, Daiichi Sankyo and MSD, grants from Kyowa Hakko Kirin, NanoCarrier and Baxter, personal fees from EA Pharma, FUJIFILM RI Pharma, Celgene, Teijin Pharma, Shire, AbbVie, Takeda Pharmaceutical, Mundipharma, Nihon Servier and Nippon Shinyaku. Mr. Mizusawa reports grants from the Ministry of Health, Labour and Welfare, Japan and Japan Agency for Medical Research and Development (AMED), personal fees from Chugai Pharmaceutical. Dr. Ikeda reports grants from Yakult Honsha, Ono Pharmaceutical, AstraZeneca, J-Pharma, Merck Serono, Bristol-Myers Squibb, Pfizer, Takeda Pharmaceutical and Chiome Bioscience, personal fees and grants from ASLAN, Nihon Servier, NanoCarrier, Novartis, Bayer Yakuhin, Eli Lilly, MSD and Chugai Pharmaceutical, personal fees from Taiho Phamaceutical, Sumitomo Dainippon Pharma, Teijin Pharma, Mylan, Astellas Pharma, EA Pharma, Shire, Gilead and Otsuka. Dr. Okano reports personal fees from Taiho Pharmaceutical, Eli Lilly Japan, Kyowa Hakko Kirin, Eisai, Bayer Yakuhin, Chugai Pharmaceutical, J-Pharma, Ono Pharmaceutical, Takeda Pharmaceutical and Merck BioPharma. Dr. Shimizu reports grants from Sumitomo Dainippon Pharma, Yakult Honsha, Incyte and AstraZeneca. Dr. Mizuno reports grants and personal fees from Taiho Pharmaceutical, grants from the Ministry of Health, Labour and Welfare, Japan, grants and personal fees from Novartis, AstraZeneca, MSD and Yakult Honsha, grants from NanoCarrier, Eisai, Sumitomo Dainippon Pharma, ASLAN Pharmaceuticals, Incyte and Ono Pharmaceutical, personal fees from Teijin Pharma. Dr. Takahashi reports grants from Taiho Pharmaceutical. Dr. Ishii reports personal fees from Ono Pharmaceutical, Yakult Honsha, Taiho Pharmaceutical, Eli Lilly Japan and Teijin Pharma. Dr. Furuse reports grants from the National Cancer Center Research and Development Fund and a Grant-in-Aid for Clinical Cancer Research from the Ministry of Health, Labour and Welfare of Japan, personal fees from Eisai, Bayer Yakuhin, Taiho Pharmaceutical, Ono Pharmaceutical, Novartis, Yakult Honsha, Teijin pharma, Shionogi, EA Pharma, Eli Lilly Japan, Takeda Pharmaceutical, Chugai Pharmaceutical, Mochida Pharmaceutical, Nihon Servier, Sanofi, Fujifilm Toyama Chemical, Nobelpharma, Pfizer, Sawai Pharmaceutical, Daiichi Sankyo, Sumitomo Dainippon Pharma, Merck Serono, Nippon Kayaku, MSD, Shire and Kyowa Hakko Kirin, grants from Ono Pharmaceutical, MSD, Sumitomo Dainippon Pharma, J-Pharma, Yakult Honsha, AstraZeneca, Daiichi Sankyo, Eisai, Bayer Yakuhin, Pfizer, NanoCarrier, Kyowa Hakko Kirin, Taiho Pharmaceutical, Chugai Pharmaceutical, Sanofi, Takeda Pharmaceutical, Mochida Pharmaceutical, Astel-las Pharma and Eli Lilly Japan. All other authors declare no conflicts of interest in relation to the present work.
Funding Information:
This work was supported by the National Cancer Center Research and Development Fund (grant numbers 23-A-22, 26-A-4, 29-A-3, 2020-J-3), the Japan Agency for Medical Research and Development (grant numbers JP16ck0106079 and JP19ck0106350), and a Grant-in-Aid for Clinical Cancer Research (H22-ganrinsho-ippan-013) from the Ministry of Health, Labour and Welfare of Japan.
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.
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U2 - 10.1038/s41598-021-92166-3
DO - 10.1038/s41598-021-92166-3
M3 - Article
C2 - 34145336
AN - SCOPUS:85108318716
VL - 11
JO - Scientific Reports
JF - Scientific Reports
SN - 2045-2322
IS - 1
M1 - 12885
ER -