TY - JOUR
T1 - The clinical outcomes of combination chemotherapy in elderly patients with advanced biliary tract cancer
T2 - an exploratory analysis of JCOG1113
AU - JCOG-HBPOG
AU - Yamada, Ikuhiro
AU - Morizane, Chigusa
AU - Okusaka, Takuji
AU - Mizusawa, Junki
AU - Kataoka, Tomoko
AU - Ueno, Makoto
AU - Ikeda, Masafumi
AU - Okano, Naohiro
AU - Todaka, Akiko
AU - Shimizu, Satoshi
AU - Mizuno, Nobumasa
AU - Sekimoto, Mitsugu
AU - Tobimatsu, Kazutoshi
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 - Okamura, Keiya
AU - Yamashita, Tatsuya
AU - Kato, Naoya
AU - Shioji, Kazuhiko
AU - Shimizu, Kyouko
AU - Nakagohri, Toshio
AU - Kamata, Ken
AU - Ishii, Hiroshi
AU - Furuse, Junji
AU - Yamada, Ikuhiro
AU - Morizane, Chigusa
AU - Okusaka, Takuji
AU - Mizusawa, Junki
AU - Kataoka, Tomoko
AU - Ueno, Makoto
AU - Ikeda, Masafumi
AU - Ozaka, Masato
AU - Okano, Naohiro
AU - Sugimori, Kazuya
AU - Todaka, Akiko
AU - Shimizu, Satoshi
AU - Mizuno, Nobumasa
AU - Sekimoto, Mitsugu
AU - Sano, Keiji
AU - Tobimatsu, Kazutoshi
AU - Katanuma, Akio
AU - Sakai, Kenji
AU - Oono, Takamasa
N1 - Funding Information:
CM reports grants and personal fees from Yakult, MSD, J-Pharma, AstraZeneca and Taiho, grants from ONO, Eisai, Merck biopharma and Daiichi Sankyo, personal fees from Teijin, Novartis and Abbvie, outside the submitted work. TO reports grants and personal fees from Taiho and Bristol-Myers Squibb, personal fees from Yakult, Pfizer, Takeda and Eli Lilly, during the conduct of the study; grants and personal fees from AstraZeneca, Eisai, MSD and Dainippon Sumitomo, grants from Baxter, personal fees from Nippon Servier, Meiji Seika, Shire, AbbVie, Incyte, ONO, Daiichi Sankyo, Takara Bio, Chugai, Teijin, Nippon Shinyaku, Novartis, Bayer and Mundipharma, outside the submitted work. JM reports grants from Ministry of Health, Labour and Welfare (MHLW), Japan and Japan AMED, during the conduct of the study; personal fees from Chugai and Taiho, outside the submitted work. MU reports grants and personal fees from Taiho, AstraZeneca, Merck Serono, MSD, Daiichi Sankyo, Ono and Chugai, grants from Astellas, Eisai, Dainippon Sumitomo and Incyte, personal fees from Nihon Servier, outside the submitted work. MI reports personal fees and other from Eisai, MSD, Eli Lilly, Yakult and ASLAN, personal fees from GSK, other from Merck Serono, Ono, J-Pharma and AstraZeneca, during the conduct of the study; personal fees and other from EA Pharma, Yakult, Nihon Servier, Chugai, Bristol-Myers Squibb, Novartis, Bayer and Takeda, personal fees from Teijin, Astellas, Sumitomo Dainippon, Otsuka and Taiho, other from Pfizer, Merus N.V., Ono, Delta-Fly Pharma and Chiome Bioscience, outside the submitted work. NO reports personal fees from Taiho, Eli Lilly, Kyowa Hakko Kirin, Eisai, Bayer, Chugai, J-Pharma, Takeda and GSK, outside the submitted work. SS reports grants from Yakult, Incyte, AstraZeneca and Delta-Fly Pharma, outside the submitted work. NM reports grants from MHLW, Japan and Taiho, during the conduct of the study; grants and personal fees from Novartis, MSD and Yakult, grants from NanoCarrier, Dainippon Sumitomo, ASLAN, Incyte and Ono, personal fees from AstraZeneca and Teijin, outside the submitted work. TN reports grants and personal fees from Taiho, Chugai, Ono, Bristol Myers Squibb, Eli Lilly, grants from MSD, Dainippon sumitomo and AstraZeneca, outside the submitted work. YK reports grants from Beigene, Incyte, Ono, Takeda, Daiichi Sankyo and Eisai, personal fees from Chugai, Sanofi, Bristol-Myers Squibb, Taiho, Eli Lilly and Yakult, personal fees and non-financial support from AstraZeneca, outside the submitted work. YK reports personal fees from Takeda, Merck Biopharma, Eli Lilly, Taiho and Yakult, outside the submitted work. TY reports personal fees from Eli Lilly, outside the submitted work. HI reports personal fees from Taiho, Eli Lilly, Yakult, Daiichi Sankyo, Kyowa Hakko Kirin, Mochida and Hospira Japan, during the conduct of the study; personal fees from Yakult and Taiho, outside the submitted work. JF reports grants from the National Cancer Center and the MHLW, Japan, during the conduct of the study; grants from Ono, MSD, Merck Bio, J-Pharma, Taiho, Takeda, Chugai, Astra Zeneca, Yakult, Eisai, Daiichi Sankyo, Mochida, Sanofi, Sumitomo Dainippon, Bayer, Astellas and Incyte, personal fees from Ono, Bayer, Eisai, Eli Lilly, MSD, Yakult, Chugai, Novartis, Astra Zeneca, Pfizer, Takeda, Taiho, Sanofi, Mylan EPD, EA Pharma, Kyowa Hakko Kirin, Daiichi Sankyo, Teijin, Servier Japan and Incyte, outside the submitted work. All other authors declare no competing interests.
Funding Information:
The study was supported in part by the National Cancer Center Research and Development Funds (23-A-22, 26-A-4, 29-A-3, 2020-J-3), AMED under Grant Number JP 16ck0106350, and the Grant-in-Aid for Clinical Cancer Research (H22-ganrinsho-ippan-013) from the Ministry of Health, Labour and Welfare of Japan.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12
Y1 - 2022/12
N2 - In the FUGA-BT trial (JCOG1113), gemcitabine plus S-1 (GS) showed non-inferiority to gemcitabine plus cisplatin (GC) in overall survival (OS) with good tolerance for patients with advanced biliary tract cancer (BTC). We performed a subgroup analysis focused on the elderly cohort of this trial. All 354 enrolled patients in JCOG1113 were classify into two groups; < 75 (non-elderly) and ≥ 75 years (elderly) group. We investigated the influence of age on the safety analysis, including the incidence of chemotherapeutic adverse events and the efficacy analysis, including OS. There were no remarkable differences in OS between the elderly (n = 60) and the non-elderly groups (n = 294). In the elderly group, median OS was 12.7 and 17.7 months for those who received GC (n = 20) and GS (n = 40), respectively. The prevalence of all-grade adverse events was similar between the elderly and the non-elderly groups. However, among the elderly group, Grade ≥ 3 hematological adverse events were more frequently observed in the GC arm than in the GS arm. The clinical outcomes of combination chemotherapy in elderly patients with advanced BTC were comparable to non-elderly patients. GS may be the more favorable treatment for elderly patients with advanced BTC.
AB - In the FUGA-BT trial (JCOG1113), gemcitabine plus S-1 (GS) showed non-inferiority to gemcitabine plus cisplatin (GC) in overall survival (OS) with good tolerance for patients with advanced biliary tract cancer (BTC). We performed a subgroup analysis focused on the elderly cohort of this trial. All 354 enrolled patients in JCOG1113 were classify into two groups; < 75 (non-elderly) and ≥ 75 years (elderly) group. We investigated the influence of age on the safety analysis, including the incidence of chemotherapeutic adverse events and the efficacy analysis, including OS. There were no remarkable differences in OS between the elderly (n = 60) and the non-elderly groups (n = 294). In the elderly group, median OS was 12.7 and 17.7 months for those who received GC (n = 20) and GS (n = 40), respectively. The prevalence of all-grade adverse events was similar between the elderly and the non-elderly groups. However, among the elderly group, Grade ≥ 3 hematological adverse events were more frequently observed in the GC arm than in the GS arm. The clinical outcomes of combination chemotherapy in elderly patients with advanced BTC were comparable to non-elderly patients. GS may be the more favorable treatment for elderly patients with advanced BTC.
UR - http://www.scopus.com/inward/record.url?scp=85123398667&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85123398667&partnerID=8YFLogxK
U2 - 10.1038/s41598-021-04550-8
DO - 10.1038/s41598-021-04550-8
M3 - Article
C2 - 35046457
AN - SCOPUS:85123398667
SN - 2045-2322
VL - 12
JO - Scientific Reports
JF - Scientific Reports
IS - 1
M1 - 987
ER -
