Albumin-Bilirubin Grade Analyses of Atezolizumab plus Bevacizumab versus Sorafenib in Patients with Unresectable Hepatocellular Carcinoma: A Post Hoc Analysis of the Phase III IMbrave150 Study.

IF 11.6 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Liver Cancer Pub Date : 2023-03-04 eCollection Date: 2023-10-01 DOI:10.1159/000529996

Masatoshi Kudo, Richard S Finn, Ann-Lii Cheng, Andrew X Zhu, Michel Ducreux, Peter R Galle, Naoya Sakamoto, Naoya Kato, Michitaka Nakano, Jing Jia, Arndt Vogel

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引用次数: 1

Abstract

Introduction: Atezolizumab + bevacizumab showed survival benefit in patients with unresectable hepatocellular carcinoma (HCC) versus sorafenib in the Phase III IMbrave150 study. This exploratory analysis examined the prognostic impact of a baseline albumin-bilirubin (ALBI) score.

Methods: Patients with treatment-naïve unresectable HCC, ≥1 measurable untreated lesion, and Child-Pugh class A liver function were randomized 2:1 to receive atezolizumab 1,200 mg + bevacizumab 15 mg/kg every 3 weeks or sorafenib 400 mg twice daily. Overall survival (OS) and progression-free survival (PFS) were assessed in the intention-to-treat population by ALBI/modified (m)ALBI grade. Time to deterioration (TTD; defined as time to 0.5-point increase from the baseline ALBI score over 2 visits or death) of liver function and safety were investigated.

Results: Of 501 enrolled patients, 336 were randomized to receive atezolizumab + bevacizumab (ALBI grade [G] 1: n = 191; G2: n = 144 [mALBI G2a: n = 72, G2b: n = 72]; missing ALBI grade: n = 1) and 165 to sorafenib (ALBI G1: n = 87; G2: n = 78 [mALBI G2a: n = 37; G2b: n = 41]). Median follow-up was 15.6 months. OS and PFS improved with atezolizumab + bevacizumab versus sorafenib in patients with ALBI G1 (OS HR: 0.50 [95% CI: 0.35, 0.72]; PFS HR: 0.61 [95% CI: 0.45, 0.82]). In patients with ALBI G2 or mALBI G2a or G2b, PFS was numerically longer with atezolizumab + bevacizumab versus sorafenib, but no OS benefit was seen. Median TTD in the intention-to-treat population was 10.2 months (95% CI: 8.0, 11.0) with atezolizumab + bevacizumab versus 8.6 months (95% CI: 6.2, 11.8) with sorafenib (HR: 0.82 [95% CI: 0.65, 1.03]). Safety profiles of atezolizumab and bevacizumab were consistent with previous analyses, regardless of ALBI grade.

Conclusion: ALBI grade appeared to be prognostic for outcomes with both atezolizumab + bevacizumab and sorafenib treatment in patients with HCC. Atezolizumab + bevacizumab preserved liver function for a numerically longer duration than sorafenib.

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阿替珠单抗联合贝伐单抗与索拉非尼治疗不可切除肝细胞癌患者的白蛋白-胆红素分级分析：IMbrave150 III期研究的事后分析。

引言：在IMbrave150 III期研究中，与索拉非尼相比，阿替佐利单抗+贝伐单抗在不可切除肝细胞癌（HCC）患者中显示出生存益处。这项探索性分析检查了基线白蛋白-胆红素（ALBI）评分对预后的影响。方法：将接受治疗的幼稚不可切除HCC、≥1个可测量的未经治疗的病变和Child-Pugh A级肝功能的患者以2:1随机分组，接受atezolizumab 1200 mg+贝伐单抗15 mg/kg，每3周一次或索拉非尼400 mg，每日两次。通过ALBI/改良（m）ALBI分级评估意向治疗人群的总生存率（OS）和无进展生存率（PFS）。研究了肝功能和安全性的恶化时间（TTD；定义为2次就诊或死亡后从基线ALBI评分增加0.5分的时间）。结果：在501名入选患者中，336名患者随机接受atezolizumab+bevacizumab治疗（ALBI分级[G]1:n=191；G2:n=144[mALBI G2a:n=72，G2b:n=72]；缺失ALBI分级：n=1），165名患者接受索拉非尼治疗（ALBI G1:n=87；G2:n=78[mALBI G2a:n=37；G2b:n=41]）。中位随访时间为15.6个月。在ALBI G1患者中，atezolizumab+bevacizumab与索拉非尼相比OS和PFS得到改善（OS HR:0.50[95%CI:0.35，0.72]；PFS HR:0.61[95%CI:445，0.82]）。在ALBI G2或mALBI G2a或G2b患者中，与索拉非尼相比，atezolazumab+贝伐单抗的PFS在数值上更长，但没有观察到OS益处。意向治疗人群中，atezolizumab+贝伐单抗的中位TTD为10.2个月（95%CI:8.0,11.0），而索拉非尼的中位TTP为8.6个月（95%CI:6.2,11.8）（HR:0.82[95%CI:0.65,1.03]）。无论ALBI分级如何，atezolazumab和贝伐珠单抗的安全性与先前的分析一致。结论：ALBI分级似乎是atezolizumab+贝伐单抗和索拉非尼治疗HCC患者的预后。阿替佐利单抗+贝伐单抗比索拉非尼在数值上更长的时间内保持肝功能。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Liver Cancer Medicine-Oncology

CiteScore

20.80

自引率

7.20%

发文量

审稿时长

16 weeks

期刊介绍： Liver Cancer is a journal that serves the international community of researchers and clinicians by providing a platform for research results related to the causes, mechanisms, and therapy of liver cancer. It focuses on molecular carcinogenesis, prevention, surveillance, diagnosis, and treatment, including molecular targeted therapy. The journal publishes clinical and translational research in the field of liver cancer in both humans and experimental models. It publishes original and review articles and has an Impact Factor of 13.8. The journal is indexed and abstracted in various platforms including PubMed, PubMed Central, Web of Science, Science Citation Index, Science Citation Index Expanded, Google Scholar, DOAJ, Chemical Abstracts Service, Scopus, Embase, Pathway Studio, and WorldCat.