Department of Liver Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (CAMS & PUMC), Beijing, China.
Front Immunol. 2023 Jan 17;14:1084843. doi: 10.3389/fimmu.2023.1084843. eCollection 2023.
Toripalimab shows antitumor efficacy in cholangiocarcinoma. Radiotherapy (RT) may enhance systemic responses of PD-1 inhibitors and lenvatinib. This study was designed to assess the safety and feasibility of toripalimab plus lenvatinib with or without RT in advanced BTC.
This study involved 88 patients with advanced BTC receiving toripalimab plus lenvatinib with or without RT from the clinical trials (NCT03892577). Propensity score matching (PSM) (1:1) analysis was used to balance potential bias. The overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs) were evaluated.
After PSM, the final analysis included 40 patients: 20 receiving toripalimab plus lenvatinib without RT (NRT); 20 receiving toripalimab plus lenvatinib with RT. The AEs were more frequent in the RT group than in the NRT group without treatment-associated mortality. The addition of RT did not cause specific AEs. The median PFS was significantly longer with RT (10.8 versus 4.6 months, p<0.001). The median OS was 13.7 months with RT versus 9.2 months in the NRT group (p=0.008). The ORR was 35% (95% CI: 12.1-57.9) in the RT group versus 20% (95% CI: 0.8-39.2) in the NRT group.
The addition of RT may enhance the efficacy of toripalimab plus lenvatinib. Toripalimab plus lenvatinib with RT have a good safety profile without an increase in specific toxicities in advanced BTC patients.
特瑞普利单抗在胆管癌中显示出抗肿瘤疗效。放疗（RT）可能增强 PD-1 抑制剂和仑伐替尼的全身反应。本研究旨在评估特瑞普利单抗联合仑伐替尼加或不加 RT 治疗晚期 BTC 的安全性和可行性。
本研究涉及 88 名接受特瑞普利单抗联合仑伐替尼加或不加 RT 的晚期 BTC 患者，来自临床试验（NCT03892577）。采用倾向评分匹配（PSM）（1:1）分析来平衡潜在的偏倚。评估总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）和不良事件（AE）。
经过 PSM，最终分析包括 40 名患者：20 名接受特瑞普利单抗联合仑伐替尼不加 RT（NRT）治疗；20 名接受特瑞普利单抗联合仑伐替尼加 RT 治疗。RT 组的 AE 发生率高于 NRT 组，但无治疗相关死亡。加用 RT 不会引起特定的 AE。加用 RT 的中位 PFS 明显延长（10.8 个月比 4.6 个月，p<0.001）。RT 组的中位 OS 为 13.7 个月，NRT 组为 9.2 个月（p=0.008）。RT 组的 ORR 为 35%（95%CI：12.1-57.9），NRT 组为 20%（95%CI：0.8-39.2）。
加用 RT 可能增强特瑞普利单抗联合仑伐替尼的疗效。在晚期 BTC 患者中，特瑞普利单抗联合仑伐替尼加 RT 具有良好的安全性，且无特定毒性增加。
