Department of Hepatobiliary Surgery, Hepatobiliary Surgery Center, The Fifth Medical Center of PLA General Hospital, Beijing, 100039, China.
Department of Geriatric Medicine, The Fifth Medical Center of PLA General Hospital, Beijing, 100039, China.
Cancer Immunol Immunother. 2024 Nov 5;74(1):13. doi: 10.1007/s00262-024-03857-5.
The integration of transarterial chemoembolization (TACE) with systemic therapy has demonstrated improved survival outcomes in patients with unresectable hepatocellular carcinoma (HCC). However, there is limited evidence evaluating the combination of TACE with the systemic regimen of anti-PD-1/L1 inhibitor plus lenvatinib. This study aims to assess the efficacy and safety of TACE combined with lenvatinib and sintilimab in unresectable HCC patients.
Unresectable HCC patients who received TACE in combination with sintilimab plus Lenvatinib as first-line treatment from 1 January 2020 to 31 March 2023 were included for the analysis. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR) were evaluated by modified Response Evaluation Criteria in Solid Tumors criteria. Exploratory biomarker analysis was conducted.
The study included 70 patients with unresectable HCC, predominantly male and infected with Hepatitis B. The median follow-up duration for the whole cohort was 13.8 months (95% CI 11.08-16.7). The ORR was 61.4% (95% CI, 49.0%-72.8%) and the DCR was 68.6% (95%CI, 56.4%-79.2%). The median PFS was 13.2 months (95% CI 11.0-NA), with a corresponding 1-year PFS rate of 50.3% (95% CI 39.7%-65.5%). The median OS was not reached, and the 1-year OS rate was 89.3% (95% CI 81.4%-97.9%). The most common treatment-related adverse events (TRAEs) were fatigue 38.6% (27/70), hypertension 32.9% (23/70), and hand-foot syndrome 31.4% (22/70). Most TRAEs were mild-to-moderate and manageable. In addition, significant predictive value was found in alpha-fetoprotein levels (AFP), with patients showing a level of decrease post-treatment having better PFS.
The combination regimen demonstrated promising efficacy in treating unresectable HCC, accompanied by manageable safety profiles. Furthermore, the results of this investigation suggest that AFP holds promise as predictive biomarkers for this treatment strategy.
经动脉化疗栓塞术（TACE）联合系统治疗已显示可改善不可切除肝细胞癌（HCC）患者的生存结局。然而，目前评估 TACE 联合抗 PD-1/L1 抑制剂加仑伐替尼系统治疗方案的证据有限。本研究旨在评估 TACE 联合仑伐替尼和信迪利单抗在不可切除 HCC 患者中的疗效和安全性。
纳入 2020 年 1 月 1 日至 2023 年 3 月 31 日接受 TACE 联合信迪利单抗加仑伐替尼作为一线治疗的不可切除 HCC 患者进行分析。采用实体瘤反应评价标准（mRECIST）评估总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）和疾病控制率（DCR）。进行了探索性生物标志物分析。
该研究纳入了 70 例不可切除 HCC 患者，主要为男性，乙型肝炎感染。全队列的中位随访时间为 13.8 个月（95%CI 11.08-16.7）。ORR 为 61.4%（95%CI，49.0%-72.8%），DCR 为 68.6%（95%CI，56.4%-79.2%）。中位 PFS 为 13.2 个月（95%CI 11.0-NA），相应的 1 年 PFS 率为 50.3%（95%CI 39.7%-65.5%）。中位 OS 未达到，1 年 OS 率为 89.3%（95%CI 81.4%-97.9%）。最常见的治疗相关不良事件（TRAEs）是乏力 38.6%（27/70）、高血压 32.9%（23/70）和手足综合征 31.4%（22/70）。大多数 TRAEs 为轻度至中度，且可管理。此外，甲胎蛋白（AFP）水平具有显著的预测价值，治疗后 AFP 下降的患者具有更好的 PFS。
该联合治疗方案在治疗不可切除 HCC 方面显示出良好的疗效，且安全性可管理。此外，本研究结果表明，AFP 可能是该治疗策略的有前途的预测生物标志物。
