放疗联合抗 PD-1 与经导管动脉化疗栓塞联合索拉非尼治疗晚期肝细胞癌的疗效和安全性：一项真实世界研究。
Efficacy and safety of radiotherapy plus anti-PD1 versus transcatheter arterial chemoembolization plus sorafenib for advanced hepatocellular carcinoma: a real-world study.
机构信息
Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, 530021, China.
School of Public Health, Guangxi Medical University, Nanning, 530021, China.
出版信息
Radiat Oncol. 2022 Jun 11;17(1):106. doi: 10.1186/s13014-022-02075-6.
BACKGROUND
The combination of transcatheter arterial chemoembolization (TACE) plus sorafenib prolonged progression-free survival (PFS) and overall survival (OS) than sorafenib or TACE monotherapy for patients with hepatocellular carcinoma (HCC). This study assessed the efficacy and safety of radiotherapy (RT) plus monoclonal antibody against programmed cell death 1 (anti-PD1) versus TACE plus sorafenib for patients with advanced HCC.
METHODS
Patients with advanced HCC who treated with RT plus anti-PD1 and TACE plus sorafenib were enrolled. Objective response rate (ORR), PFS, disease control rate (DCR) and OS were calculated to assess the antitumor response and the treatment-related adverse events to the safety.
RESULTS
Between January 2018 to March 2021, 37 patients underwent RT plus anti-PD1 and 41 patients underwent TACE plus sorafenib. The baseline characteristics between the two groups were comparable. The ORR and DCR were significantly higher in the RT + PD1 group than the TACE plus sorafenib group according to RECIST 1.1 (54.05% vs. 12.20%, P < 0.001; 70.27% vs. 46.37%, P = 0.041; respectively) and according to mRECIST (56.76% vs. 31.71%, P = 0.039; 70.27% vs. 46.37%, P = 0.041; respectively). RT plus anti-PD1 provided significantly better PFS (HR, 0.51; 95% CI 0.30-0.86; P = 0.017) than TACE plus sorafenib. Moreover, patients with RT plus anti-PD1 had significantly higher 3-, 6-, and 9-month OS rates than those with TACE plus sorafenib(97.3% vs. 92.30%, P < 0.001; 91.89% vs. 68.60%, P < 0.001; 75.5% vs. 60.60%, P < 0.001; respectively). The median OS was more favorable 17.4 months for the RT + PD1 group and 11.9 months for the TACE plus sorafenib group. No treatment-related death was observed. Grade 3 or more treatment-related adverse events (TRAEs) occurred significantly less in patients in the RT + PD1 group than the TACE plus sorafenib group (29.7% vs. 75.6%, P < 0.001), and all TRAEs were manageable.
CONCLUSIONS
In this real-world study, RT plus anti-PD1 showed significantly promising efficacy and manageable safety than TACE plus sorafenib in patients with advanced HCC. Toxicities were manageable, with no unexpected safety signals. The study provides evidence on a new therapeutic method in the treatment of advanced HCC.
背景
与索拉非尼单药治疗或经导管动脉化疗栓塞（TACE）单药治疗相比，TACE 联合索拉非尼可延长肝细胞癌（HCC）患者的无进展生存期（PFS）和总生存期（OS）。本研究评估了放疗（RT）联合抗程序性死亡 1 单克隆抗体（anti-PD1）与 TACE 联合索拉非尼治疗晚期 HCC 患者的疗效和安全性。
方法
本研究纳入了接受 RT 联合抗 PD1 和 TACE 联合索拉非尼治疗的晚期 HCC 患者。计算客观缓解率（ORR）、PFS、疾病控制率（DCR）和 OS，以评估抗肿瘤反应和与治疗相关的不良反应的安全性。
结果
2018 年 1 月至 2021 年 3 月，37 例患者接受 RT 联合抗 PD1 治疗，41 例患者接受 TACE 联合索拉非尼治疗。两组患者的基线特征相当。根据 RECIST 1.1，RT+PD1 组的 ORR 和 DCR 明显高于 TACE+索拉非尼组（54.05% vs. 12.20%，P<0.001；70.27% vs. 46.37%，P=0.041；分别）；根据 mRECIST，RT+PD1 组的 ORR 和 DCR 也明显高于 TACE+索拉非尼组（56.76% vs. 31.71%，P=0.039；70.27% vs. 46.37%，P=0.041；分别）。RT 联合抗 PD1 组的 PFS（HR，0.51；95%CI，0.30-0.86；P=0.017）明显优于 TACE 联合索拉非尼组。此外，与 TACE 联合索拉非尼组相比，接受 RT 联合抗 PD1 治疗的患者具有更高的 3 个月、6 个月和 9 个月 OS 率（97.3% vs. 92.30%，P<0.001；91.89% vs. 68.60%，P<0.001；75.5% vs. 60.60%，P<0.001；分别）。RT+PD1 组的中位 OS 为 17.4 个月，TACE 联合索拉非尼组为 11.9 个月。未观察到与治疗相关的死亡。与 TACE 联合索拉非尼组相比，RT+PD1 组的 3 级或更高级别的治疗相关不良事件（TRAEs）发生率显著较低（29.7% vs. 75.6%，P<0.001），且所有 TRAEs 均可管理。
结论
在这项真实世界研究中，与 TACE 联合索拉非尼相比，RT 联合抗 PD1 在晚期 HCC 患者中显示出显著更有希望的疗效和可管理的安全性。毒性可管理，无意外安全信号。该研究为晚期 HCC 的治疗提供了新的治疗方法。
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