老年不可切除胆管癌患者的联合化疗：一项使用倾向评分匹配分析的前瞻性观察性研究（JON2104-B）
Combination chemotherapy for older patients with unresectable biliary tract cancer: a prospective observational study using propensity-score matched analysis (JON2104-B).
作者信息
Kobayashi Satoshi, Nakachi Kohei, Yamamoto Kouji, Ueno Makoto, Maruki Yuta, Ikezawa Kenji, Terashima Takeshi, Shimizu Satoshi, Oshima Kotoe, Tsuji Kunihiro, Masaki Yoshiharu, Tsumura Hidetaka, Shibuki Taro, Ozaka Masato, Okano Naohiro, Okamura Yukiyasu, Umemoto Kumiko, Satoh Tatsunori, Kojima Yasushi, Shioji Kazuhiko, Nebiki Hiroko, Doi Toshifumi, Naganuma Atsushi, Kataoka Shigeki, Kita Emiri, Asama Hiroyuki, Tsuchiya Kaoru, Unno Michiaki, Ashida Reiko, Matsumoto Kazuyuki, Ohno Izumi, Itoi Takao, Negoro Yuji, Sakamoto Yasunari, Arima Shiho, Asagi Akinori, Okuyama Hiroyuki, Komatsu Yoshito, Kobayashi Noritoshi, Nagano Hiroaki, Furuse Junji
机构信息
Department of Gastroenterology, Kanagawa Cancer Center, 2-3-2, Nakao, Asahi-ku, Yokohama, 241-0815, Japan.
Department of Medical Oncology, Tochigi Cancer Center, Utsunomiya, 320-0834, Japan.
出版信息
J Gastroenterol. 2025 Sep 6. doi: 10.1007/s00535-025-02294-0.
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.
背景
吉西他滨联合S-1（GEM+S-1）、吉西他滨联合顺铂（GEM+CDDP）加S-1（GEM+CDDP+S-1）或吉西他滨联合顺铂（GEM+CDDP）是晚期胆管癌（aBTC）的标准治疗方案。我们旨在评估联合化疗在老年aBTC患者中的疗效和安全性。
方法
这项多中心前瞻性观察研究（JON2104-B，UMIN000045156）纳入了年龄≥70岁的aBTC患者。采用逆概率加权倾向评分分析（IPW）比较各治疗组的总生存期（OS）作为主要终点和无进展生存期（PFS）。
结果
本研究纳入了2021年8月至2023年1月期间的305例患者。其中，75例、131例、26例、52例和10例分别接受了GEM+CDDP+S-1、GEM+CDDP、GEM+S-1、吉西他滨和S-1治疗；他们的中位年龄分别为74岁、75岁、77.5岁、80岁和80岁，G-8评分>14的患者分别约为24%、16.8%、23.1%、9.6%和0%。GEM+CDDP的安全性与GEM+CDDP+S-1相当，但毒性比吉西他滨更大。根据IPW分析结果，GEM+CDDP+S-1与GEM+CDDP相比，OS的风险比（HR）为0.80（95%置信区间[CI]，0.55-1.17），PFS的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
对于身体状况良好的老年患者，GEM+CDDP+S-1与GEM+CDDP相比，PFS更长且无额外毒性。然而，两者的OS在统计学上无差异。GEM+CDDP和吉西他滨对身体虚弱的老年患者的疗效也无显著差异。这些发现凸显了aBTC患者身体虚弱的重要性。
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