Department of Radiation Oncology, Senior Department of Oncology, The Fifth Medical Center of PLA General Hospital, No. 100 Xi Si Huan Middle Road, Fengtai District, Beijing, 100039, China.
The Second School of Clinical Medicine, Southern Medical University, Guangzhou, China.
J Cancer Res Clin Oncol. 2023 Aug;149(10):7441-7452. doi: 10.1007/s00432-023-04652-y. Epub 2023 Mar 23.
Lack of evidence on the benefit of stereotactic body radiotherapy (SBRT) in combination with lenvatinib for advanced hepatocellular carcinoma (HCC). Our research compared the efficacy and safety of SBRT plus lenvatinib versus SBRT alone in clinical practice for the treatment of advanced HCC.
Propensity score matching (PSM) analysis was used to reduce selection bias. Overall survival (OS), progression-free survival (PFS), intrahepatic PFS (IHPFS), and objective response rate (ORR) were compared between the two groups. Additionally, safety profiles were also evaluated in the two groups.
After PSM, 35 patients from each group were selected and the date was compared. Compared with the SBRT alone group, the median OS, PFS, and IHPFS were significantly prolonged in SBRT plus lenvatinib group (median OS 16.8 vs. 11.0 months, pOS = 0.043; median PFS 9.1 vs. 3.7 months, pPFS < 0.001; median IHPFS 9.5 vs. 4.2 months, pIHPFS = 0.004). The 6- and 12-month OS rates were 91.4% and 68.6% in the combined therapy group and 82.9% and 48.6% in the monotherapy group, respectively. The 6- and 12-month PFS rates were 68.6% and 34.3% in the combined therapy group and 31.4% and 8.6% in the monotherapy group, respectively. Furthermore, a higher ORR was observed in SBRT plus lenvatinib group (54.29% vs. 22.86%, p = 0.007). Subgroup analysis of patients with macroscopic vascular invasion (MVI) also had similar results. Moreover, most adverse events (AEs) were mild-to-moderate and manageable in the SBRT plus lenvatinib group.
SBRT plus lenvatinib is expected to significantly improve OS, PFS, IHPFS, and ORR for patients with advanced HCC when compared to SBRT alone, with manageable adverse effects.
立体定向体放射治疗(SBRT)联合仑伐替尼治疗晚期肝细胞癌(HCC)的获益证据不足。本研究比较了 SBRT 联合仑伐替尼与单独 SBRT 在临床实践中治疗晚期 HCC 的疗效和安全性。
采用倾向评分匹配(PSM)分析减少选择偏倚。比较两组的总生存期(OS)、无进展生存期(PFS)、肝内无进展生存期(IHPFS)和客观缓解率(ORR)。此外,还评估了两组的安全性。
PSM 后,每组各选择 35 例患者进行比较。与单独 SBRT 组相比,SBRT 联合仑伐替尼组的中位 OS、PFS 和 IHPFS 显著延长(中位 OS:16.8 个月对 11.0 个月,pOS=0.043;中位 PFS:9.1 个月对 3.7 个月,pPFS<0.001;中位 IHPFS:9.5 个月对 4.2 个月,pIHPFS=0.004)。联合治疗组的 6 个月和 12 个月 OS 率分别为 91.4%和 68.6%,单药治疗组分别为 82.9%和 48.6%。联合治疗组的 6 个月和 12 个月 PFS 率分别为 68.6%和 34.3%,单药治疗组分别为 31.4%和 8.6%。此外,联合治疗组的 ORR 更高(54.29%对 22.86%,p=0.007)。有宏观血管侵犯(MVI)的患者亚组分析也有类似的结果。此外,联合治疗组的大多数不良事件(AE)为轻度至中度,且易于管理。
与单独 SBRT 相比,SBRT 联合仑伐替尼有望显著提高晚期 HCC 患者的 OS、PFS、IHPFS 和 ORR,且不良反应可管理。