Early response and safety of atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma in patients who do not meet IMbrave150 eligibility criteria
Early response and safety of atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma in patients who do not meet IMbrave150 eligibility criteria
复制标题
DOI：
10.1111/hepr.13693
复制
发表时间：
2021-07-20
影响因子：
4.2
通讯作者：
Sakamoto, Naoya
中科院分区：
文献类型：
--
作者：
Sho, Takuya;Suda, Goki;Sakamoto, Naoya
目的一项临床试验(IMbrave150)表明阿替唑单抗联合贝伐单抗治疗不能切除的肝细胞癌的疗效和安全性。在这项研究中，我们在现实环境中评估了这种治疗组合，重点是那些不符合IMbrave150资格标准的患者。方法在这项多中心研究中，对2020年10月至2021年5月期间接受阿替唑单抗联合贝伐单抗治疗的不能切除的肝癌患者进行筛选。在不符合IMbrave150资格标准的患者中，评估了6周和12周的治疗反应和安全性。结果阿替唑单抗联合贝伐单抗在患者中启动，其中46例(71.9%)患者不符合IMbrae150资格标准。这些患者大多有系统治疗史(44/46)。使用实体瘤1.1的反应评估标准观察到的客观有效率和疾病控制率在6周时分别为5.2%和82.8%，在12周时分别为10.0%和84.0%；在符合和不符合IMbrave150标准的患者中，这些比率相似。10例患者在6周时出现进展性疾病(PD)。门静脉癌栓与PD显著相关(p=0.039)；15例乙肝病毒相关性肝细胞癌患者中无一例发生PD(p=0.050)。最常见的3级或更高的不良反应是天冬氨酸氨基转移酶升高(n=8，13.8%)，符合和不符合IMbrave150标准的患者的安全性特征相似。结论阿替唑单抗联合贝伐单抗治疗大多数患者不符合IMbrave150标准，但联合治疗在早期阶段表现出良好的安全性和有效性。
Aim A clinical trial (IMbrave150) indicated the efficacy and safety of atezolizumab plus bevacizumab for patients with unresectable hepatocellular carcinoma (HCC). In this study, we evaluated this therapeutic combination in a real-world setting, with a focus on patients who did not meet the IMbrave150 eligibility criteria. Methods In this multicenter study, patients with unresectable HCC treated with atezolizumab plus bevacizumab between October 2020 and May 2021 were screened. In patients who did not meet IMbrave150 eligibility criteria, treatment responses and safety at 6 and 12 weeks were evaluated. Results Atezolizumab plus bevacizumab was initiated in 64 patients, including 46 patients (71.9%) who did not meet IMbrave150 eligibility criteria. Most of these patients had a history of systemic therapy (44/46). The objective response rate and disease control rate observed using Response Evaluation Criteria in Solid Tumors 1.1 were 5.2% and 82.8% at 6 weeks and 10.0% and 84.0% at 12 weeks, respectively; these rates were similar between patients who met and did not meet the IMbrave150 criteria. Ten patients experienced progressive disease (PD) at 6 weeks. Portal vein tumor thrombosis was significantly associated with PD (p = 0.039); none of the 15 patients with hepatitis B virus-related HCC experienced PD (p = 0.050). The most common adverse events of grade 3 or higher were aspartate aminotransferase elevation (n = 8, 13.8%) and the safety profile was similar between patients who met and did not meet the IMbrave150 criteria. Conclusion Most patients treated with atezolizumab plus bevacizumab did not meet the IMbrave150 criteria; however, the combination therapy showed good safety and efficacy at the early treatment phase.