度伐利尤单抗联合曲美木单抗治疗不可切除肝细胞癌老年患者的安全性和疗效：一项多中心分析

Safety and Efficacy of Durvalumab Plus Tremelimumab in Older Individuals With Unresectable Hepatocellular Carcinoma: A Multicenter Analysis.

作者信息

Matono Tomomitsu, Tada Toshifumi, Kumada Takashi, Hiraoka Atsushi, Hirooka Masashi, Kariyama Kazuya, Tani Joji, Atsukawa Masanori, Takaguchi Koichi, Itobayashi Ei, Fukunishi Shinya, Nishikawa Hiroki, Tanaka Kazunari, Tsuji Kunihiko, Ishikawa Toru, Tajiri Kazuto, Koshiyama Yuichi, Toyoda Hidenori, Ogawa Chikara, Hatanaka Takeshi, Kakizaki Satoru, Kawata Kazuhito, Noritake Hidenao, Ohama Hideko, Tada Fujimasa, Nouso Kazuhiro, Morishita Asahiro, Tsutsui Akemi, Nagano Takuya, Itokawa Norio, Okubo Tomomi, Arai Taeang, Nishimura Takashi, Imai Michitaka, Kosaka Hisashi, Naganuma Atsushi, Aoki Tomoko, Kuroda Hidekatsu, Yata Yutaka, Tamai Hideyuki, Matsuura Takanori, Komatsu Shohei, Ueda Yoshihide, Nakamura Yoshiko, Yoshida Osamu, Matsui Kosuke, Nakamura Shinichiro, Enomoto Hirayuki, Kaibori Masaki, Fukumoto Takumi, Hiasa Yoichi, Kudo Masatoshi

机构信息

Department of Gastroenterology, Hyogo Prefectural Harima-Himeji General Medical Center, Himeji, Hyogo, Japan.

Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.

出版信息

Hepatol Res. 2025 Aug 6. doi: 10.1111/hepr.70011.

DOI:10.1111/hepr.70011

PMID:40767262

Abstract

AIM

To evaluate the safety and efficacy of durvalumab plus tremelimumab (Dur/Tre) in older adults with unresectable hepatocellular carcinoma (HCC).

METHODS

A total of 345 patients with HCC who received Dur/Tre were included in this study. Using propensity score matching, we compared outcomes between older (aged ≥ 75 years; n = 120) and younger individuals (n = 120).

RESULTS

The median progression-free survival (PFS) was 3.3 months in the older group and 4.5 months in the younger group (p = 0.271). The median overall survival (OS) was 17.0 months in older individuals and 19.2 months in younger individuals (p = 0.598). No statistically significant differences were observed in the therapeutic response between the two groups (p = 0.264). Additionally, the incidence of immune-mediated adverse events (AEs) did not differ significantly between older and younger individuals. Multivariate analyses revealed that age group (older vs. younger) was not an independent prognostic factor for PFS (p = 0.250) or OS (p = 0.489). In a subgroup analysis stratifying older individuals into three age categories (75-79, 80-84, and ≥ 85 years), no significant differences were observed in the cumulative OS or PFS across the subgroups (p = 0.308 and 0.783). Similarly, the incidence of immune-mediated AEs did not differ significantly among the age categories.

CONCLUSIONS

Dur/Tre appears to be a safe and effective treatment option for patients with HCC, regardless of age. Dur/Tre appears to be a safe and effective treatment option for patients with unresectable HCC, regardless of age.

摘要

目的

评估度伐利尤单抗联合曲美木单抗（Dur/Tre）用于不可切除肝细胞癌（HCC）老年患者的安全性和疗效。

方法

本研究纳入了总共345例接受Dur/Tre治疗的HCC患者。采用倾向评分匹配法，我们比较了老年患者（年龄≥75岁；n = 120）和年轻患者（n = 120）的预后情况。

结果

老年组的中位无进展生存期（PFS）为3.3个月，年轻组为4.5个月（p = 0.271）。老年个体的中位总生存期（OS）为17.0个月，年轻个体为19.2个月（p = 0.598）。两组之间的治疗反应未观察到统计学上的显著差异（p = 0.264）。此外，免疫介导的不良事件（AE）的发生率在老年和年轻个体之间没有显著差异。多因素分析显示，年龄组（老年与年轻）不是PFS（p = 0.250）或OS（p = 0.489）的独立预后因素。在一项将老年个体分为三个年龄类别（75 - 79岁、80 - 84岁和≥85岁）的亚组分析中，各亚组的累积OS或PFS未观察到显著差异（p = 0.308和0.783）。同样，免疫介导的AE的发生率在各年龄类别之间没有显著差异。