Institute of Hepatobiliary Surgery, Southwest Hospital, Army Medical University, Chongqing, 400038, China.
Department of Surgical Anesthesiology, Southwest Hospital, Army Medical University, Chongqing, 400038, China.
BMC Cancer. 2024 Aug 22;24(1):1036. doi: 10.1186/s12885-024-12779-5.
The combination of targeted therapy and immunotherapy has improved the clinical outcomes of unresectable hepatocellular Carcinoma (HCC). However, the overall prognosis remains suboptimal. This study aims to evaluate the efficacy and safety of a novel combination of radiofrequency ablation (RFA) with lenvatinib plus sintilimab in unresectable HCC.
In this retrospective study, patients diagnosed with unresectable HCC were included and divided into two cohorts: RFA combined with lenvatinib plus sintilimab (R-L-S group) and lenvatinib plus sintilimab (L-S group). The primary efficacy endpoints were objective response rate (ORR) and progression free survival (PFS). Adverse events were analyzed to assess the safety profiles.
The median follow-up periods for the entire cohort were 14.0 months. The R-L-S group (n = 60) had a significantly higher ORR than those with L-S alone (n = 62) (40.0% vs. 20.9%; p = 0.022). Moreover, patients in the R-L-S group had improved median PFS (12 vs. 8 months; p = 0.013) and median overall survival (24 vs. 18 months; p = 0.037), as compared with lenvatinib and sintilimab alone. No significant difference in treatment related adverse event (TRAE) of any grade between the two groups. The most common TRAEs of grade ≥ 3 were fatigue 10.0% (6/60) and hand-foot skin reaction 10.0% (6/60) in the R-L-S group and hand-foot skin reaction 11.3% (7/62) in the L-S group.
In unresectable HCC patients, the incorporation of RFA to lenvatinib plus sintilimab demonstrated improved efficacy without compromising safety compared with lenvatinib plus sintilimab alone.
靶向治疗和免疫治疗的联合应用改善了不可切除肝细胞癌（HCC）的临床结局。然而，整体预后仍不理想。本研究旨在评估射频消融（RFA）联合仑伐替尼和信迪利单抗在不可切除 HCC 中的疗效和安全性。
这是一项回顾性研究，纳入了诊断为不可切除 HCC 的患者，并分为两组：RFA 联合仑伐替尼和信迪利单抗（R-L-S 组）和仑伐替尼和信迪利单抗（L-S 组）。主要疗效终点为客观缓解率（ORR）和无进展生存期（PFS）。分析不良事件以评估安全性。
全队列的中位随访时间为 14.0 个月。R-L-S 组（n=60）的 ORR 明显高于单独使用 L-S 组（n=62）（40.0% vs. 20.9%；p=0.022）。此外，R-L-S 组的中位 PFS（12 个月 vs. 8 个月；p=0.013）和中位总生存期（24 个月 vs. 18 个月；p=0.037）均优于单独使用仑伐替尼和信迪利单抗。两组间任何级别治疗相关不良事件（TRAE）无显著差异。最常见的 3 级 TRAE 为 R-L-S 组的疲劳 10.0%（6/60）和手足皮肤反应 10.0%（6/60），L-S 组的手足皮肤反应 11.3%（7/62）。
在不可切除 HCC 患者中，与单独使用仑伐替尼和信迪利单抗相比，RFA 联合仑伐替尼和信迪利单抗可提高疗效而不影响安全性。
