Wang Yunchao, Xun Ziyu, Yang Xu, Wang Yanyu, Wang Shanshan, Xue Jingnan, Zhang Nan, Yang Xiaobo, Lu Zhenhui, Zhou Jinxue, Zhou Kang, Sang Xinting, Zhao Haitao
Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing 100730, China.
Department of Hepatobiliary and Pancreatic Surgery, Affiliated Hospital of Zunyi Medical University Zunyi, Guizhou, China.
Am J Cancer Res. 2023 Mar 15;13(3):1026-1037. eCollection 2023.
Local-regional therapy combined with PD-1 inhibitors and lenvatinib (triple combination therapy) has demonstrated potent antitumor activity in solid tumors. However, the efficacy and safety of the triple combination therapy in patients with advanced biliary tract cancer (BTC) remain unclear. This retrospective study evaluated the efficacy and safety of the triple combination therapy in advanced BTC. Tumor tissues were collected to assess the expression status of PDL1 to identify efficacy biomarkers. Forty-nine patients were included: 24 in lenvatinib plus toripalimab therapy; 25 in the triple combination therapy. The triple combination therapy group showed longer median progression-free survival (mPFS) (7.9 versus 5.6 months, P=0.015) and longer median overall survival (mOS) (13.7 versus 11.1 months, P=0.145) than the lenvatinib plus toripalimab group. The overall response rate (ORR) was 32% [95% confidence interval (CI): 12.3-51.7] with the triple combination therapy versus 25% (95% CI: 6.3-43.7) with toripalimab plus lenvatinib. Three patients received surgery after the triple combination therapy. All patients experienced any-grade adverse events (AEs) without any specific toxicities. PDL1 expression was associated with improved clinical benefits. Local-regional therapy combined with PD-1 inhibitors and lenvatinib may be an encouraging treatment choice for advanced BTC without an increase in specific toxicities.
局部区域治疗联合PD-1抑制剂和乐伐替尼（三联疗法）已在实体瘤中显示出强大的抗肿瘤活性。然而，三联疗法在晚期胆管癌（BTC）患者中的疗效和安全性仍不清楚。这项回顾性研究评估了三联疗法在晚期BTC中的疗效和安全性。收集肿瘤组织以评估PDL1的表达状态，以确定疗效生物标志物。纳入49例患者：24例接受乐伐替尼加托瑞帕利单抗治疗；25例接受三联疗法。与乐伐替尼加托瑞帕利单抗组相比，三联疗法组的中位无进展生存期（mPFS）更长（7.9个月对5.6个月，P=0.015），中位总生存期（mOS）更长（13.7个月对11.1个月，P=0.145）。三联疗法的总缓解率（ORR）为32%[95%置信区间（CI）：12.3-51.7]，而托瑞帕利单抗加乐伐替尼的ORR为25%（95%CI：6.3-43.7）。3例患者在三联疗法后接受了手术。所有患者均经历了任何级别的不良事件（AE），无任何特异性毒性。PDL1表达与临床获益改善相关。局部区域治疗联合PD-1抑制剂和乐伐替尼可能是晚期BTC的一种令人鼓舞的治疗选择，且不会增加特异性毒性。
