Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma
Efficacy and safety of atezolizumab plus bevacizumab in Korean patients with advanced hepatocellular carcinoma
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DOI：
10.1111/liv.15102
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发表时间：
2021-11-29
影响因子：
6.7
通讯作者：
Lim, Ho Yeong
中科院分区：
文献类型：
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作者：
Cheon, Jaekyung;Yoo, Changhoon;Lim, Ho Yeong
Atezolizumab联合贝伐单抗（Ate/Bev）在晚期肝细胞癌（HCC）患者中的III期临床试验已证实有效性和安全性。需要进一步评价，以研究Ate/Bev在真实的环境中的安全性和有效性。方法采用多中心回顾性分析。2020年5月至2021年2月期间，来自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和BCLC D分期的患者，其余121例患者纳入本分析。结果按RECIST1.1标准评价，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个月（95% CI，4.1-9.0），未达到中位总生存期（OS）（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%）。在多变量分析中，AFP升高（P = 0.037）、基线嗜中性粒细胞/淋巴细胞比值（NLR）>= 5（P = 0.023）和疾病稳定或疾病进展的最佳缓解（P = 0.019）与PFS恶化显著相关。大血管侵犯（P = .048）和基线NLR >= 5（P < .001）与OS恶化显著相关。结论Ate/Bev在韩国晚期HCC患者中显示了真实的疗效和安全性，与III期试验的结果一致。考虑到在NLR升高的患者中Ate/Bev的不利生存结局，需要在该组中仔细评估治疗反应。
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 < .001) were significantly associated with worse OS. Conclusions Ate/Bev showed real-life efficacy and safety in Korean patients with advanced HCC, in line with results from phase III trial. Considering unfavourable survival outcomes of Ate/Bev in patients with elevated NLR, careful assessment of treatment response needs to be performed in this group.