背景:Lenvatinib(LEN)和atezolizumab+贝伐单抗(A+B)已经彻底改变了晚期肝细胞癌(HCC)的治疗模式。在这些具有里程碑意义的试验之前,索拉非尼(SOR)作为标准的一线治疗已有十年。我们的研究旨在评估在SOR时代(2008-2018)治疗的HCC患者的结果,与SOR时代(2018-2021)相比,其中主要的一线治疗是LEN或A+B。
方法:本研究的纳入标准是加拿大阿尔伯塔省的所有HCC患者,他们在2008年1月1日至2021年12月31日期间在癌症中心开始一线全身治疗。生存结果,包括总生存期(OS)和无进展生存期(PFS),以及临床医生评估的反应率(RR),进行回顾性分析。
结果:总共372名患者,230人在SOR时代接受治疗,142人在后SOR时代接受治疗。SOR时代和后SOR时代群体的人口统计学和临床特征如下,年龄中位数分别为63岁和64岁,80%和81%为男性,24%和11%是东亚种族。在接受全身治疗之前,40%和33%接受了TACE,7%和9%收到TARE,在这两个时代,分别有3%和14%收到SBRT,分别。在后SOR时代,患者接受了A+B(23%),LEN(51%),和SOR(23%)作为一线治疗。RR有统计学上显著的改善(15%vs.26%;p=0.02),中位PFS(3.8个月vs.7.9个月;p<0.0001),和中位OS(9.8个月与17.0个月;p<0.0001)。
结论:在这项回顾性多中心真实世界研究中,在SOR后时代接受治疗的HCC患者,LEN和A+B是常用的一线治疗方法,表现出卓越的操作系统,PFS,和RR与SOR时代接受治疗的患者相比。这项研究的结果肯定了在现实世界中取得的切实进展,通过在过去15年中的治疗进步,提高了HCC患者的结果。
BACKGROUND: Lenvatinib (LEN) and atezolizumab +
bevacizumab (A + B) have drastically changed the treatment paradigm for advanced hepatocellular carcinoma (HCC). Before these landmark trials, sorafenib (SOR) served as the standard first-line treatment for a decade. Our study aimed to assess the outcomes of HCC patients treated during the SOR era (2008-2018) in contrast to those in the post-SOR era (2018-2021), of which the predominant first-line treatments were LEN or A + B.
METHODS: Inclusion criteria of the study were all HCC patients in the Canadian province of Alberta who started first-line systemic therapy at cancer centers between 1 January 2008 and 31 December 2021. Survival outcomes, including overall survival (OS) and progression-free survival (PFS), along with clinician-assessed response rate (RR), were subject to retrospective analysis.
RESULTS: Of 372 total patients, 230 received treatment in the SOR era and 142 in the post-SOR era. The demographic and clinical characteristics for the SOR era and post-SOR era groups are as follows, respectively: the median age was 63 and 64 years, 80% and 81% were male, and 24% and 11% were of East Asian ethnicity. Before receiving systemic treatment, 40% and 33% received TACE, 7% and 9% received TARE, and 3% and 14% received SBRT in the two eras, respectively. In the post-SOR era, patients received A + B (23%), LEN (51%), and SOR (23%) as first-line treatment. There was a statistically significant improvement in RR (15% vs. 26%; p = 0.02), median PFS (3.8 months vs. 7.9 months; p < 0.0001), and median OS (9.8 months vs. 17.0 months; p < 0.0001).
CONCLUSIONS: In this retrospective multicenter real-world study, HCC patients treated in the post-SOR era, where LEN and A + B were commonly used first-line treatments, exhibited superior OS, PFS, and RR compared to patients treated in the SOR era. The findings of this study affirm the tangible progress achieved in the real world in enhancing outcomes for HCC patients through advancements in treatments over the past 15 years.