Gao Yuan, Cheng Ann-Lii, Li Lee X, Parent Natalie, Kichenadasse Ganessan, Karapetis Christos S, Rowland Andrew, Hopkins Ashley M, Sorich Michael J
College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
National Taiwan University Cancer Center, Taipei, Taiwan.
Int J Cancer. 2025 Jul 15;157(2):336-344. doi: 10.1002/ijc.35407. Epub 2025 Mar 13.
The use of Immune checkpoint inhibitors (ICIs) as monotherapy for patients with hepatocellular carcinoma (HCC) has been associated with an increased risk of hyperprogressive disease (HPD), the occurrence of which carries a poor prognosis. However, it is unknown whether contemporary frontline treatment with the combination of atezolizumab and bevacizumab causes significant HPD. This study conducted a secondary analysis of patient-level data from the IMbrave150 randomized controlled trial of atezolizumab plus bevacizumab versus sorafenib for frontline treatment of HCC. Multiple established definitions of early progression and treatment failure applicable to clinical trials were evaluated, including Response Evaluation Criteria in Solid Tumours (RECIST) HPD, HPD based on percent change of sum of longest diameter (SLD HPD), treatment failure HPD (TF HPD), and fast progression (FP). The incidence of these measures was compared between arms. The risk factors for and prognosis of TF HPD were evaluated. The risk of RECIST HPD and TF HPD was significantly lower with atezolizumab plus bevacizumab treatment than with sorafenib treatment-odds ratio for RECIST HPD: 0.29 (95% CI 0.01 to 0.82), TF HPD: 0.30 (0.17, 0.54). TF HPD was similarly associated with poor prognosis, irrespective of treatment arm. High blood alpha-fetoprotein and neutrophil-to-lymphocyte ratio were both associated with an increased risk of TF HPD. For all definitions of early progression/treatment failure, the risk was either significantly lower with atezolizumab plus bevacizumab than with sorafenib, or there were no differences. Atezolizumab plus bevacizumab treatment is unlikely to cause significant HPD.
免疫检查点抑制剂(ICI)作为肝细胞癌(HCC)患者的单一疗法与疾病超进展(HPD)风险增加相关,HPD的发生预后较差。然而,目前尚不清楚阿替利珠单抗联合贝伐单抗的当代一线治疗是否会导致显著的HPD。本研究对IMbrave150随机对照试验的患者层面数据进行了二次分析,该试验比较了阿替利珠单抗联合贝伐单抗与索拉非尼用于HCC一线治疗的疗效。评估了适用于临床试验的多种已确立的早期进展和治疗失败定义,包括实体瘤疗效评价标准(RECIST)HPD、基于最长径总和变化百分比的HPD(SLD HPD)、治疗失败HPD(TF HPD)和快速进展(FP)。比较了两组之间这些指标的发生率。评估了TF HPD的危险因素和预后。阿替利珠单抗联合贝伐单抗治疗的RECIST HPD和TF HPD风险显著低于索拉非尼治疗——RECIST HPD的优势比:0.29(95%CI 0.01至0.82),TF HPD:0.30(0.17,0.54)。无论治疗组如何,TF HPD均与不良预后相似相关。高血清甲胎蛋白和中性粒细胞与淋巴细胞比值均与TF HPD风险增加相关。对于所有早期进展/治疗失败的定义,阿替利珠单抗联合贝伐单抗治疗的风险要么显著低于索拉非尼,要么无差异。阿替利珠单抗联合贝伐单抗治疗不太可能导致显著的HPD。