Combination chemotherapy for older patients with unresectable biliary tract cancer: a prospective observational study using propensity-score matched analysis (JON2104-B).

IF 5.5 2区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Satoshi Kobayashi, Kohei Nakachi, Kouji Yamamoto, Makoto Ueno, Yuta Maruki, Kenji Ikezawa, Takeshi Terashima, Satoshi Shimizu, Kotoe Oshima, Kunihiro Tsuji, Yoshiharu Masaki, Hidetaka Tsumura, Taro Shibuki, Masato Ozaka, Naohiro Okano, Yukiyasu Okamura, Kumiko Umemoto, Tatsunori Satoh, Yasushi Kojima, Kazuhiko Shioji, Hiroko Nebiki, Toshifumi Doi, Atsushi Naganuma, Shigeki Kataoka, Emiri Kita, Hiroyuki Asama, Kaoru Tsuchiya, Michiaki Unno, Reiko Ashida, Kazuyuki Matsumoto, Izumi Ohno, Takao Itoi, Yuji Negoro, Yasunari Sakamoto, Shiho Arima, Akinori Asagi, Hiroyuki Okuyama, Yoshito Komatsu, Noritoshi Kobayashi, Hiroaki Nagano, Junji Furuse
{"title":"Combination chemotherapy for older patients with unresectable biliary tract cancer: a prospective observational study using propensity-score matched analysis (JON2104-B).","authors":"Satoshi Kobayashi, Kohei Nakachi, Kouji Yamamoto, Makoto Ueno, Yuta Maruki, Kenji Ikezawa, Takeshi Terashima, Satoshi Shimizu, Kotoe Oshima, Kunihiro Tsuji, Yoshiharu Masaki, Hidetaka Tsumura, Taro Shibuki, Masato Ozaka, Naohiro Okano, Yukiyasu Okamura, Kumiko Umemoto, Tatsunori Satoh, Yasushi Kojima, Kazuhiko Shioji, Hiroko Nebiki, Toshifumi Doi, Atsushi Naganuma, Shigeki Kataoka, Emiri Kita, Hiroyuki Asama, Kaoru Tsuchiya, Michiaki Unno, Reiko Ashida, Kazuyuki Matsumoto, Izumi Ohno, Takao Itoi, Yuji Negoro, Yasunari Sakamoto, Shiho Arima, Akinori Asagi, Hiroyuki Okuyama, Yoshito Komatsu, Noritoshi Kobayashi, Hiroaki Nagano, Junji Furuse","doi":"10.1007/s00535-025-02294-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Systemic chemotherapy with gemcitabine plus S-1 (GEM + S-1), GEM + CDDP plus S-1 (GEM + CDDP + S-1), or gemcitabine plus cisplatin (GEM + CDDP) is standard treatment for advanced biliary tract cancer (aBTC). We aimed to evaluate the efficacy and safety of combination chemotherapy in older patients with aBTC.</p><p><strong>Methods: </strong>This multicenter prospective observational study (JON2104-B, UMIN000045156) included patients aged ≥ 70 years with aBTC. Inverse-probability weighting propensity-score analyses (IPW) were used to compare overall survival (OS) as the primary endpoint and progression-free survival (PFS) across treatment groups.</p><p><strong>Results: </strong>This study included 305 patients between August 2021 and January 2023. Of them, 75, 131, 26, 52, and 10 received GEM + CDDP + S-1, GEM + CDDP, GEM + S-1, gemcitabine, and S-1; their median ages were 74, 75, 77.5, 80, and 80 years, and approximately 24%, 16.8%, 23.1%, 9.6%, and 0% had G-8 scores of > 14, respectively. GEM + CDDP had a safety profile comparable to that of GEM + CDDP + S-1 but was more toxic than gemcitabine. Per IPW, the hazard ratio (HR) for GEM + CDDP + S-1 versus GEM + CDDP was 0.80 for OS (95% confidence interval [CI], 0.55-1.17) and 0.55 for PFS (95% CI 0.38-0.80). The HR for GEM + CDDP versus gemcitabine was 0.74 for OS (95% CI 0.42-1.29) and 0.79 for PFS (95% CI 0.42-1.49).</p><p><strong>Conclusions: </strong>GEM + CDDP + S-1 was associated with longer PFS without additional toxicity than GEM + CDDP for fit older patients. However, the OS for both were not statistically different. The efficacies of GEM + CDDP and gemcitabine for vulnerable older patients did not also differ significantly. These findings highlight the importance of vulnerability in patients with aBTC.</p>","PeriodicalId":16059,"journal":{"name":"Journal of Gastroenterology","volume":" ","pages":""},"PeriodicalIF":5.5000,"publicationDate":"2025-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Gastroenterology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00535-025-02294-0","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Systemic chemotherapy with gemcitabine plus S-1 (GEM + S-1), GEM + CDDP plus S-1 (GEM + CDDP + S-1), or gemcitabine plus cisplatin (GEM + CDDP) is standard treatment for advanced biliary tract cancer (aBTC). We aimed to evaluate the efficacy and safety of combination chemotherapy in older patients with aBTC.

Methods: This multicenter prospective observational study (JON2104-B, UMIN000045156) included patients aged ≥ 70 years with aBTC. Inverse-probability weighting propensity-score analyses (IPW) were used to compare overall survival (OS) as the primary endpoint and progression-free survival (PFS) across treatment groups.

Results: This study included 305 patients between August 2021 and January 2023. Of them, 75, 131, 26, 52, and 10 received GEM + CDDP + S-1, GEM + CDDP, GEM + S-1, gemcitabine, and S-1; their median ages were 74, 75, 77.5, 80, and 80 years, and approximately 24%, 16.8%, 23.1%, 9.6%, and 0% had G-8 scores of > 14, respectively. GEM + CDDP had a safety profile comparable to that of GEM + CDDP + S-1 but was more toxic than gemcitabine. Per IPW, the hazard ratio (HR) for GEM + CDDP + S-1 versus GEM + CDDP was 0.80 for OS (95% confidence interval [CI], 0.55-1.17) and 0.55 for PFS (95% CI 0.38-0.80). The HR for GEM + CDDP versus gemcitabine was 0.74 for OS (95% CI 0.42-1.29) and 0.79 for PFS (95% CI 0.42-1.49).

Conclusions: GEM + CDDP + S-1 was associated with longer PFS without additional toxicity than GEM + CDDP for fit older patients. However, the OS for both were not statistically different. The efficacies of GEM + CDDP and gemcitabine for vulnerable older patients did not also differ significantly. These findings highlight the importance of vulnerability in patients with aBTC.

老年不可切除胆道癌患者联合化疗:一项使用倾向评分匹配分析的前瞻性观察研究(JON2104-B)。
背景:吉西他滨+ S-1 (GEM + S-1)、GEM + CDDP + S-1 (GEM + CDDP + S-1)或吉西他滨+顺铂(GEM + CDDP)的全身化疗是晚期胆道癌(aBTC)的标准治疗方案。我们的目的是评估联合化疗对老年aBTC患者的疗效和安全性。方法:这项多中心前瞻性观察性研究(JON2104-B, UMIN000045156)纳入了年龄≥70岁的aBTC患者。采用反概率加权倾向评分分析(IPW)比较各治疗组的总生存期(OS)和无进展生存期(PFS)。结果:该研究包括2021年8月至2023年1月期间的305例患者。其中,接受GEM + CDDP + S-1、GEM + CDDP、GEM + S-1、吉西他滨和S-1治疗的分别为75、131、26、52和10例;中位年龄分别为74岁、75岁、77.5岁、80岁和80岁,G-8评分分别约为24%、16.8%、23.1%、9.6%和0%。GEM + CDDP的安全性与GEM + CDDP + S-1相当,但毒性高于吉西他滨。每IPW, GEM + CDDP + S-1与GEM + CDDP相比,OS的风险比(HR)为0.80(95%可信区间[CI], 0.55-1.17), PFS的风险比(HR)为0.55 (95% CI 0.38-0.80)。GEM + CDDP与吉西他滨相比,OS的HR为0.74 (95% CI 0.42-1.29), PFS的HR为0.79 (95% CI 0.42-1.49)。结论:对于适合的老年患者,GEM + CDDP + S-1与GEM + CDDP相比具有更长的PFS,且没有额外的毒性。然而,两者的操作系统并没有统计学上的差异。GEM + CDDP和吉西他滨对老年易感患者的疗效也无显著差异。这些发现强调了aBTC患者易感性的重要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Journal of Gastroenterology
Journal of Gastroenterology 医学-胃肠肝病学
CiteScore
12.20
自引率
1.60%
发文量
99
审稿时长
4-8 weeks
期刊介绍: The Journal of Gastroenterology, which is the official publication of the Japanese Society of Gastroenterology, publishes Original Articles (Alimentary Tract/Liver, Pancreas, and Biliary Tract), Review Articles, Letters to the Editors and other articles on all aspects of the field of gastroenterology. Significant contributions relating to basic research, theory, and practice are welcomed. These publications are designed to disseminate knowledge in this field to a worldwide audience, and accordingly, its editorial board has an international membership.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信