文章：

阿特珠单抗与贝伐珠单抗联合疗法治疗既往接受过仑伐替尼治疗的晚期肝细胞癌患者的II期研究

Phase II Study of Atezolizumab and Bevacizumab Combination Therapy for Patients with Advanced Hepatocellular Carcinoma Previously Treated with Lenvatinib

原文发布日期：16 January 2025

DOI: 10.3390/cancers17020278

类型: Article

开放获取: 是

英文摘要：

Background/Objectives: Atezolizumab and bevacizumab combination therapy has been established as a standard of care for first-line treatment; however, its efficacy and safety have not been fully evaluated for patients previously treated with systemic therapy.Methods: In this phase II trial, patients with advanced hepatocellular carcinoma previously treated with lenvatinib were enrolled to receive a dose of 1,200 mg of atezolizumab and 15 mg/kg of bevacizumab every 3 weeks. The primary endpoint was progression-free survival. The secondary endpoints included overall survival, objective response rate, disease control rate, subsequent therapy, and frequency of adverse events. The threshold and expected progression-free survival were 3 and 6.8 months, respectively. Considering a one-sided significance level of 0.05 and a statistical power of 80%, the minimum required sample size was 26 patients.Results: The median progression-free survival from the start of treatment was 9.70 [90% confidence interval, 5.10–14.24] months, and the lower limit of the 90% CI was above the predefined threshold. The objective response and disease control rates were 34.6% and 73.1%, respectively. Sixteen patients (61.5%) received subsequent therapies, and the median overall survival was 17.23 [90% confidence interval, 13.18–27.85] months. Severe adverse events, adverse events leading to treatment delays, and adverse events leading to treatment discontinuation occurred in eight (30.8%), fourteen (53.8%), and five (19.2%) patients, respectively, and no treatment-related deaths occurred.Conclusions: Atezolizumab and bevacizumab combination therapy is effective and can safely be administered to patients with advanced HCC previously treated with lenvatinib.

摘要翻译： 

背景/目的：阿特珠单抗联合贝伐珠单抗疗法已被确立为一线治疗的标准方案，但其在既往接受过全身治疗的晚期肝细胞癌患者中的疗效与安全性尚未得到充分评估。方法：在这项II期临床试验中，入组了既往接受过仑伐替尼治疗的晚期肝细胞癌患者，每3周接受1200 mg阿特珠单抗联合15 mg/kg贝伐珠单抗治疗。主要终点为无进展生存期，次要终点包括总生存期、客观缓解率、疾病控制率、后续治疗方案及不良事件发生率。预设的无进展生存期阈值与期望值分别为3个月和6.8个月。基于单侧显著性水平0.05和80%统计效能，计算得出最小样本量为26例患者。结果：治疗开始后的中位无进展生存期为9.70个月（90%置信区间：5.10-14.24），其90%置信区间下限超过预设阈值。客观缓解率与疾病控制率分别为34.6%和73.1%。16例患者（61.5%）接受了后续治疗，中位总生存期为17.23个月（90%置信区间：13.18-27.85）。严重不良事件、导致治疗延迟的不良事件及导致治疗终止的不良事件分别发生于8例（30.8%）、14例（53.8%）和5例（19.2%）患者中，未发生治疗相关死亡事件。结论：阿特珠单抗联合贝伐珠单抗疗法对既往接受过仑伐替尼治疗的晚期肝细胞癌患者具有显著疗效，且安全性可控。

原文链接：

Phase II Study of Atezolizumab and Bevacizumab Combination Therapy for Patients with Advanced Hepatocellular Carcinoma Previously Treated with Lenvatinib