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Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma

机译:阿替利珠单抗联合贝伐珠单抗治疗韩国晚期肝细胞癌患者的疗效和安全性

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Abstract Background Aims Atezolizumab plus bevacizumab (Ate/Bev) has demonstrated efficacy and safety in patients with advanced hepatocellular carcinoma (HCC) in the phase III trial. Further evaluation is necessary to investigate the safety and efficacy of Ate/Bev in real settings. Methods This was a multicentre retrospective analysis. Between May 2020 and February 2021, 138 patients received Ate/Bev as first‐line treatment for advanced HCC from 11 institutions. We excluded patients with Child‐Pugh B or C and BCLC D stage, and the remaining 121 patients were included in this analysis. Results According to RECIST 1.1, the objective response and disease control rates were 24.0 and 76.0. The median follow‐up duration was 5.9?months (95 confidence interval CI, 5.4‐6.4), the median progression‐free survival (PFS) was 6.5?months (95 CI, 4.1‐9.0), and median overall survival (OS) was not reached (95 CI, not available). The most frequent grade 3‐4 adverse event was aspartate aminotransferase elevation (10.7). In the multivariate analyses, AFP increase (P?=?.037), baseline neutrophil‐to‐lymphocyte ratio (NLR) ≥ 5 (P?=?.023), and best response to stable disease or progressive disease (P?=?.019) were significantly associated with worse PFS. Macrovascular invasion (P?=?.048) and baseline NLR ≥5 (P?
机译:摘要:背景和目的:阿替利珠单抗联合贝伐珠单抗(Ate/Bev)在III期试验中证明了晚期肝细胞癌(HCC)患者的疗效和安全性。有必要进一步评估以调查 Ate/Bev 在真实环境中的安全性和有效性。方法 本研究采用多中心回顾性分析方法。2020 年 5 月至 2021 年 2 月期间,11 家机构的 138 名患者接受了 Ate/Bev 作为晚期 HCC 的一线治疗。我们排除了Child-Pugh B或C分期和BCLC D分期的患者,其余121例患者被纳入本分析。结果 根据RECIST 1.1,客观缓解率和疾病控制率分别为24.0%和76.0%。中位随访时间为5.9个月(95%置信区间[CI],5.4-6.4),中位无进展生存期(PFS)为6.5%(95%CI,4.1-9.0),中位总生存期(OS)未达到(95%CI,不可用)。最常见的 3-4 级不良事件是天冬氨酸转氨酶升高 (10.7%)。在多因素分析中,AFP升高(P?=?。037),基线中性粒细胞与淋巴细胞比值(NLR)≥5(P?=?。023),对疾病稳定或进展性疾病的最佳反应(P?=?.019)与较差的PFS显著相关。大血管浸润(P?=?.048)和基线NLR≥5(P?.001)与较差的OS显著相关。结论 Ate/Bev在韩国晚期HCC患者中显示出现实疗效和安全性,与III期试验结果一致。考虑到 Ate/Bev 在 NLR 升高患者中的不良生存结局,需要仔细评估该组的治疗反应。

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