放疗联合程序性死亡受体-1 抑制剂和仑伐替尼治疗晚期胆道癌患者的有效性和安全性：一项真实世界研究。

Effectiveness and safety of radiotherapy plus programmed death-1 inhibitors and lenvatinib in patients with advanced biliary tract carcinoma: a real-world study.

机构信息

Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China.

Department of Radiation Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), No. 1, Shuaifuyuan, Dongcheng District, Beijing, China.

出版信息

Cancer Immunol Immunother. 2023 Jul;72(7):2197-2204. doi: 10.1007/s00262-023-03399-2. Epub 2023 Mar 1.

DOI:10.1007/s00262-023-03399-2

PMID:36856834

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10992455/

Abstract

BACKGROUND

Radiotherapy (RT) may function synergistically with immunotherapy and targeted agents (TA). This study aimed to assess the effectiveness and safety of RT combined with programmed death-1 (PD-1) inhibitors and lenvatinib in patients with relapsed or refractory advanced biliary tract carcinoma (BTC).

METHODS

This retrospective study included patients with relapsed or refractory advanced BTC who received RT combined with PD-1 inhibitors and lenvatinib at the Peking Union Medical College Hospital (PUMCH). Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety were evaluated.

RESULTS

Thirty-one patients who received RT combined with PD-1 inhibitors and lenvatinib as a second- or later-line therapy were analyzed. RT sites were mainly distributed in the liver lesions (64.5%) and lymph nodes (58.1%). The ORR and DCR were 32.3% (10/31; 95% CI: 14.8-49.7) and 87.1% (27/31; 95% CI: 74.6-99.6), respectively. The median PFS (mPFS) and median OS (mOS) were 7.9 (95% CI: 7.1-8.7) and 11.7 (95% CI: 8.3-15.0) months, respectively. Subgroup analyses of this cohort included 12 and 19 patients who received concurrent and salvage (> 6 weeks after commencing PD-1 inhibitor therapy) RT, respectively. The salvage RT group had higher mOS (11.7 vs. 10.5; p = 0.75) and mPFS (7.9 vs. 6.9; p = 0.85) than the concurrent RT group; however, statistical significance was not reached. All patients experienced any-grade adverse events (AEs), and excessive PD-1 inhibitors or RT toxicity were not observed.

CONCLUSIONS

RT, PD-1 inhibitors, and lenvatinib may be safely combined and have antitumor effectiveness in patients with advanced BTC.

摘要

背景

放疗（RT）可能与免疫疗法和靶向药物（TA）协同作用。本研究旨在评估 RT 联合程序性死亡受体-1（PD-1）抑制剂和仑伐替尼治疗复发或难治性晚期胆道癌（BTC）患者的有效性和安全性。

方法

本回顾性研究纳入了在北京协和医院接受 RT 联合 PD-1 抑制剂和仑伐替尼二线或以上治疗的复发或难治性晚期 BTC 患者。评估总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、疾病控制率（DCR）和安全性。

结果

分析了 31 例接受 RT 联合 PD-1 抑制剂和仑伐替尼二线或以上治疗的患者。RT 部位主要分布在肝病变（64.5%）和淋巴结（58.1%）。ORR 和 DCR 分别为 32.3%（10/31；95%CI：14.8-49.7）和 87.1%（27/31；95%CI：74.6-99.6）。中位 PFS（mPFS）和中位 OS（mOS）分别为 7.9（95%CI：7.1-8.7）和 11.7（95%CI：8.3-15.0）个月。该队列的亚组分析包括 12 例和 19 例分别接受同期和挽救性（开始 PD-1 抑制剂治疗后>6 周）RT 的患者。挽救性 RT 组的 mOS（11.7 比 10.5；p=0.75）和 mPFS（7.9 比 6.9；p=0.85）均高于同期 RT 组，但未达到统计学意义。所有患者均出现任何级别的不良事件（AE），未观察到过度的 PD-1 抑制剂或 RT 毒性。