Medical Oncology, University Hospital of Cagliari, Cagliari, Italy.
Department of Medical Oncology, IRCCS San Raffaele Hospital, Via Olgettina n. 60, Milan, Italy.
J Cancer Res Clin Oncol. 2023 Aug;149(9):5591-5602. doi: 10.1007/s00432-022-04512-1. Epub 2022 Dec 13.
The purpose of this study is to compare response rates of lenvatinib and atezolizumab plus bevacizumab, in first-line real-world setting.
Overall cohort included Western and Eastern hepatocellular carcinoma (HCC) patient populations from 46 centres in 4 countries (Italy, Germany, Japan, and Republic of Korea).
1312 patients were treated with lenvatinib, and 823 patients were treated with atezolizumab plus bevacizumab. Objective response rate (ORR) was 38.6% for patients receiving lenvatinib, and 27.3% for patients receiving atezolizumab plus bevacizumab (p < 0.01; odds ratio 0.60). For patients who achieved complete response (CR), overall survival (OS) was not reached in both arms, but the result from univariate Cox regression model showed 62% reduction of death risk for patients treated with atezolizumab plus bevacizumab (p = 0.05). In all multivariate analyses, treatment arm was not found to be an independent factor conditioning OS. Comparing ORR achieved in the two arms, there was a statistically significant difference in favor of lenvatinib compared to atezolizumab plus bevacizumab in all subgroups except for Eastern patients, Child-Pugh B patients, presence of portal vein thrombosis, α-feto-protein ≥ 400 ng/mL, presence of extrahepatic disease, albumin-bilirubin (ALBI) grade 2, and no previous locoregional procedures.
Lenvatinib achieves higher ORR in all patient subgroups. Patients who achieve CR with atezolizumab plus bevacizumab can achieve OS so far never recorded in HCC patients. This study did not highlight any factors that could identify patient subgroups capable of obtaining CR.
本研究旨在比较仑伐替尼和阿替利珠单抗联合贝伐珠单抗在一线真实世界环境中的应答率。
总体队列包括来自 4 个国家（意大利、德国、日本和韩国）的 46 个中心的西方和东方肝细胞癌（HCC）患者人群。
1312 例患者接受仑伐替尼治疗，823 例患者接受阿替利珠单抗联合贝伐珠单抗治疗。接受仑伐替尼治疗的患者客观缓解率（ORR）为 38.6%，接受阿替利珠单抗联合贝伐珠单抗治疗的患者为 27.3%（p<0.01；优势比 0.60）。对于达到完全缓解（CR）的患者，两组的总生存（OS）均未达到，但单变量 Cox 回归模型的结果显示，接受阿替利珠单抗联合贝伐珠单抗治疗的患者死亡风险降低了 62%（p=0.05）。在所有多变量分析中，未发现治疗臂是影响 OS 的独立因素。比较两组达到的 ORR，除东方患者、Child-Pugh B 患者、门静脉血栓形成、α-胎蛋白≥400ng/mL、肝外疾病、白蛋白-胆红素（ALBI）分级 2 和无先前局部区域治疗外，仑伐替尼与阿替利珠单抗联合贝伐珠单抗相比，在所有亚组中均具有统计学意义。
仑伐替尼在所有患者亚组中均达到更高的 ORR。接受阿替利珠单抗联合贝伐珠单抗治疗达到 CR 的患者可以获得迄今为止在 HCC 患者中从未记录过的 OS。本研究没有突出任何可以识别能够获得 CR 的患者亚组的因素。
