Department of Gastroenterology, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.
Department of Medical oncology, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.
Cancer Med. 2023 Feb;12(3):2731-2738. doi: 10.1002/cam4.5161. Epub 2022 Aug 23.
Since atezolizumab plus bevacizumab (ATE+BEV) regimen for patients with unresectable hepatocellular carcinoma (HCC) was released quite recently, real-world data are lacking. We evaluated efficacy, safety, and predictive biomarkers for survival in patients receiving ATE+BEV.
Between 2020 and 2021, HCC patients receiving ATE+BEV at academic teaching hospitals were recruited. Treatment response was assessed using the Response Evaluation Criteria in Solid Tumors (version 1.1.).
Among 121 patients enrolled, the median age was 63 years, with male predominance (82.6%). Complete response, partial response, stable disease, and progressive disease were identified in 2.5%, 26.4%, 54.5%, and 16.6%, respectively. Patients with alpha-fetoprotein and des-gamma-carboxy prothrombin (DCP) response, defined as ≥30% and ≥50% decreases, respectively, at the first response evaluation relative to baseline, and those with neutrophil-to-lymphocyte ratio (NLR) <2.5, had significantly higher objective response rates (42.6% vs. 21.5%, 50.0% vs. 26.2%, and 39.0% vs. 19.4%, respectively; all p < 0.05). During follow-up, the median overall survival (OS) was not reached, and the median progression-free survival (PFS) was 5.7 months. Multivariable analyses showed that macrovascular invasion (adjusted hazard ratio [aHR] 2.541; p = 0.017), DCP ≥186 mAU/ml (aHR 5.102; p < 0.001), NLR ≥2.5 (aHR 3.584; p = 0.001), and an NLR decrease ≥10% at the first response (aHR 0.305; p = 0.002) were independent predictors of OS, and DCP ≥186 mAU (aHR 2.311; p = 0.002) and NLR ≥2.5 (aHR 1.938; p = 0.012) were independent predictors of PFS. Grade ≥3 treatment-related adverse events (AEs) occurred in 33 (27.3%) patients.
ATE+BEV showed favorable efficacy and safety. Baseline high DCP and NLR may be useful prognostic predictors for OS and PFS.
阿替利珠单抗联合贝伐珠单抗（ATE+BEV）方案用于不可切除肝细胞癌（HCC）患者的时间较短，目前缺乏真实世界的数据。我们评估了接受 ATE+BEV 治疗的患者的疗效、安全性和生存预测生物标志物。
2020 年至 2021 年，在学术教学医院接受 ATE+BEV 治疗的 HCC 患者入组。使用实体瘤反应评估标准（版本 1.1）评估治疗反应。
在纳入的 121 例患者中，中位年龄为 63 岁，男性居多（82.6%）。完全缓解、部分缓解、疾病稳定和疾病进展分别为 2.5%、26.4%、54.5%和 16.6%。与基线相比，首次反应评估时甲胎蛋白和去γ-羧基凝血酶原（DCP）分别下降≥30%和≥50%的患者，以及中性粒细胞与淋巴细胞比值（NLR）<2.5 的患者，客观缓解率显著更高（42.6%比 21.5%、50.0%比 26.2%和 39.0%比 19.4%；均 p<0.05）。在随访期间，中位总生存期（OS）未达到，中位无进展生存期（PFS）为 5.7 个月。多变量分析显示，大血管侵犯（调整后的危险比 [aHR] 2.541；p=0.017）、DCP≥186 mAU/ml（aHR 5.102；p<0.001）、NLR≥2.5（aHR 3.584；p=0.001）和首次反应时 NLR 下降≥10%（aHR 0.305；p=0.002）是 OS 的独立预测因素，DCP≥186 mAU（aHR 2.311；p=0.002）和 NLR≥2.5（aHR 1.938；p=0.012）是 PFS 的独立预测因素。33 例（27.3%）患者发生≥3 级治疗相关不良事件（AE）。
ATE+BEV 显示出良好的疗效和安全性。基线时高 DCP 和 NLR 可能是 OS 和 PFS 的有用预后预测因素。
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