Scientific Reports (Jun 2021)
Comparison of gemcitabine-based chemotherapies for advanced biliary tract cancers by renal function: an exploratory analysis of JCOG1113
- 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).
Affiliations
- Makoto Ueno
- Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center
- Chigusa Morizane
- Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital
- Takuji Okusaka
- Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital
- Junki Mizusawa
- Japan Clinical Oncology Group/Operations Office, National Cancer Center Hospital
- Tomoko Kataoka
- Japan Clinical Oncology Group/Operations Office, National Cancer Center Hospital
- Masafumi Ikeda
- Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East
- Masato Ozaka
- Hepato-Biliary-Pancreatic Medicine Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research
- Naohiro Okano
- Department of Medical Oncology, Faculty of Medicine, Kyorin University
- Kazuya Sugimori
- Gastroenterological Center, Yokohama City University Medical Center
- Akiko Todaka
- Division of Gastrointestinal Oncology, Shizuoka Cancer Center
- Satoshi Shimizu
- Department of Gastroenterology, Saitama Cancer Center
- Nobumasa Mizuno
- Department of Gastroenterology, Aichi Cancer Center Hospital
- Tomohisa Yamamoto
- Department of Surgery, Kansai Medical University Hospital
- Keiji Sano
- Department of Surgery, Teikyo University School of Medicine
- Kazutoshi Tobimatsu
- Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
- Akio Katanuma
- Center for Gastroenterology, Teine Keijinkai Hospital
- Atsushi Miyamoto
- Department of Hepatobiliary and Pancreatic Surgery, Osaka National Hospital
- Hironori Yamaguchi
- Department of Surgery, Jichi Medical University
- Tomohiro Nishina
- Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center
- Hirofumi Shirakawa
- Department of Medical Oncology, Tochigi Cancer Center
- Yasushi Kojima
- Department of Gastroenterology, National Center for Global Health and Medicine
- Takamasa Oono
- Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University
- Yasuyuki Kawamoto
- Department of Gastroenterology and Hepatology, Hokkaido University Hospital
- Masayuki Furukawa
- Department of Hepato-Biliary-Pancreatology, National Hospital Organization Kyushu Cancer Center
- Tomohisa Iwai
- Department of Gastroenterology, Kitasato University Hospital
- Kentaro Sudo
- Gastrointestinal Medical Oncology, Chiba Cancer Center
- Hiroyuki Miyakawa
- Department of Bilio-Pancreatology, Sapporo-Kosei General Hospital
- Tatsuya Yamashita
- Department of Gastroenterology, Kanazawa University
- Ichirou Yasuda
- Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama
- Hidenori Takahashi
- Department of Gastroenterological Surgery, Osaka International Cancer Institute
- Naoya Kato
- Department of Gastroenterology, Graduate School of Medicine, Chiba University
- Kazuhiko Shioji
- Department of Internal Medicine, Niigata Cancer Center Hospital
- Kyoko Shimizu
- Department of Gastroenterology, Tokyo Women’s Medical University
- Toshio Nakagohri
- Gastroenterological Surgery, Tokai University School of Medicine
- Ken Kamata
- Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University
- Hiroshi Ishii
- Gastrointestinal Medical Oncology, Chiba Cancer Center
- Junji Furuse
- Department of Medical Oncology, Faculty of Medicine, Kyorin University
- the members of the Hepatobiliary and Pancreatic Oncology Group of the Japan Clinical Oncology Group (JCOG-HBPOG).
- DOI
- https://doi.org/10.1038/s41598-021-92166-3
- Journal volume & issue
-
Vol. 11,
no. 1
pp. 1 – 9
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.
