PO.CL09.02 · 临床研究
nivolumab + ipilimumab与atezolizumab + bevacizumab治疗晚期肝细胞癌的真实世界比较结局：一项TRINETX研究
Real-world comparative outcomes of nivolumab + ipilimumab vs. atezolizumab + bevacizumab in advanced hepatocellular carcinoma: A TRINETX study
作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
肝细胞癌（HCC）是癌症相关死亡的第二大原因。Atezolizumab联合Bevacizumab（ATZ+BEV）已改变晚期HCC的治疗格局，继IMbrave150试验后现已成为一线选择。Checkmate 040随机对照试验显示，Nivolumab联合Ipilimumab（NIVO+IPI）可改善长期生存获益。本研究旨在比较两种治疗方式治疗晚期HCC的结局。方法 这是一项利用TriNetX数据库的回顾性队列研究。纳入标准包括年龄>18岁、近期开始使用（ATZ+BEV）或（NIVO+IPI）的晚期HCC成年患者。结局指标为总生存期、最近一次AFP、AST、ALT、胆红素、INR和血小板计数水平，AFP降至0-40 ng/ml的时间，发生肝性脑病或昏迷、住院及不良事件的风险。针对人口统计学、实验室结果、MELD和ECOG评分及混杂合并症进行倾向评分匹配（PSM）。结果以风险差（RD）及95% CI表示。时间至事件终点采用Kaplan-Meier曲线和Cox比例风险模型，报告为风险比（HR）和log-rank P值。结果 匹配后，队列包括（ATZ+BEV）组1979例患者和（NIVO+IPI）组1973例患者。（ATZ+BEV）显示中位生存期显著延长，997对504天（HR 0.67，95% CI 0.61-0.74，log-rank p < 0.0001）。然而，平均AFP存在统计学差异，（ATZ+BEV）7,746对（NIVO+IPI）17,495，p = 0.006。AFP降至40以下的正常化时间无统计学意义（p = 0.196）。（ATZ+BEV）接受者住院就诊风险较高（RD 2.08%，95% CI -3.089，7.257，P = 0.43）。两方案间发生预定义不良事件的风险相似，RD无统计学意义。总之，在这一真实世界匹配队列中，（ATZ+BEV）带来更优的总生存期，但与更高的医疗资源利用相关，而两种治疗间不良事件发生率相当。
查看英文原文 English abstract
Hepatocellular carcinoma (HCC) is the second leading cause of cancer-related death. Atezolizumab plus Bevacizumab (ATZ+BEV) has transformed the treatment landscape for advanced HCC and is now a first-line option following the IMbrave150 trial. The Checkmate 040 randomized controlled trial has shown that Nivolumab plus Ipilimumab (NIVO+IPI) has improved long-term survival benefit. This study aims to compare outcomes of both treatment modalities for advanced HCC. Methods This is a retrospective cohort study utilizing the TriNetX database. Criteria included adult patients >18 years of age with Advanced HCC recently initiating (ATZ+BEV) or (NIVO+IPI). Outcomes are overall survival, the most recent AFP, AST, ALT, Bilirubin, INR, and Platelet count levels. Time to AFP to reach 0-40 ng/ml. Risk of developing hepatic encephalopathy or coma, hospitalization, and adverse events. Propensity score matching (PSM) was performed for demographics, lab results, MELD and ECOG scores, and confounding comorbidities. Results were expressed in the form of risk difference (RD) with 95% CI. Time to event endpoints using Kaplan-Meier curves and Cox proportional hazards models are reported as hazard ratios (HR) and log-rank P values. Results After matching, the cohort included 1979 patients in the (ATZ+BEV) group and 1973 patients in the (NIVO+IPI) group. (ATZ+BEV) showed significantly increased median survival 997 vs 504 days (HR 0.67, 95 % CI 0.61-0.74 log-rank p < 0.0001). However, mean AFP differed statistically (ATZ+BEV) 7,746 vs (NIVO+IPI) 17,495 p = 0.006. The time to normalization of AFP to below 40 was not significant (p = 0.196). (ATZ+BEV) Recipients experienced a high risk of inpatient visits (RD 2.08%, 95% CI -3.089, 7.257, P = 0.43). The risk of developing predefined adverse events was similar between regimens with nonsignificant RD. In conclusion, this real-world matched cohort (ATZ+BEV) conferred superior overall survival but was associated and greater healthcare utilization, while adverse event rates were comparable between treatments.
利益披露 Disclosure
S. Gomaa, None..
A. Omara, None..
H. Ahmed, None..
I. Alabdul Razzak, None..
P. Rashmika, None.