甲胎蛋白和异常凝血酶原水平降低可预测 HCC 患者抗 PD-1 免疫治疗的疗效。
Reductions in AFP and PIVKA-II can predict the efficiency of anti-PD-1 immunotherapy in HCC patients.
机构信息
Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, 510060, China.
Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Dongfeng East Road 651, Guangzhou, 510060, China.
出版信息
BMC Cancer. 2021 Jul 4;21(1):775. doi: 10.1186/s12885-021-08428-w.
BACKGROUND
Few biomarkers can predict the efficiency of PD-1 blockade in patients with hepatocellular carcinoma (HCC). This study aimed to investigate the prognostic role of AFP and PIVKA-II in HCC patients receiving anti-PD-1 immunotherapy.
METHODS
A total of 235 HCC patients treated with PD-1 blockade were enrolled. Serum AFP and PIVKA-II levels were collected before and after treatments. The patients were divided into groups based on the reduction in AFP and PIVKA-II: AFP reduction ≤50% vs AFP reduction > 50% and PIVKA-II reduction ≤50% vs PIVKA-II reduction > 50%. The primary endpoints included objective response rate (ORR), progression-free survival (PFS) and overall survival (OS). Binary logistic regression analyses were used to explore the related factors of ORR. A Cox proportional hazards model was employed to identify the potential prognostic factors of PFS and OS.
RESULTS
Among all the patients, 34.9% (82/235) achieved a complete or partial response. There was a positive correlation between AFP reduction > 50% or PIVKA-II reduction> 50% and the ORR of PD-1 blockade (P < 0.001 and = 0.003). PFS was significantly improved in patients with AFP reduction > 50% and PIVKA-II reduction > 50% (p < 0.001 and = 0.021). In addition, AFP reduction > 50% and PIVKA-II reduction> 50% were positively correlated with longer OS (p = 0.003 and 0.006).
CONCLUSION
Early reductions in AFP and PIVKA-II can be predictors of the efficacy of PD-1 blockade in HCC patients.
背景
目前仅有少数生物标志物可预测 PD-1 阻断疗法在肝细胞癌（HCC）患者中的疗效。本研究旨在探讨 AFP 和 PIVKA-II 在接受抗 PD-1 免疫治疗的 HCC 患者中的预后作用。
方法
共纳入 235 例接受 PD-1 阻断治疗的 HCC 患者。在治疗前后采集血清 AFP 和 PIVKA-II 水平。根据 AFP 和 PIVKA-II 的降低程度将患者分为两组：AFP 降低≤50%组与 AFP 降低>50%组，PIVKA-II 降低≤50%组与 PIVKA-II 降低>50%组。主要终点包括客观缓解率（ORR）、无进展生存期（PFS）和总生存期（OS）。采用二元逻辑回归分析探讨 ORR 的相关因素。采用 Cox 比例风险模型确定 PFS 和 OS 的潜在预后因素。
结果
所有患者中，34.9%（82/235）获得完全或部分缓解。AFP 降低>50%或 PIVKA-II 降低>50%与 PD-1 阻断的 ORR 呈正相关（P<0.001 和=0.003）。AFP 降低>50%和 PIVKA-II 降低>50%的患者 PFS 显著改善（p<0.001 和=0.021）。此外，AFP 降低>50%和 PIVKA-II 降低>50%与更长的 OS 呈正相关（p=0.003 和 0.006）。
结论
AFP 和 PIVKA-II 的早期降低可预测 HCC 患者接受 PD-1 阻断治疗的疗效。
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