Introduction: Atezolizumab + bevacizumab showed survival benefit in patients with unresectable hepatocellular carcinoma (HCC) vs sorafenib in the Phase III IMbrave150 study. This exploratory analysis examined the prognostic impact of 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 1200 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 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 vs 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 vs 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 vs 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. Discussion/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.


中文翻译：

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Atezolizumab 加贝伐珠单抗与索拉非尼在不可切除肝细胞癌患者中的白蛋白-胆红素等级分析：III 期 IMbrave150 研究的事后分析

简介：在 III 期 IMbrave150 研究中，与索拉非尼相比，Atezolizumab + 贝伐珠单抗在无法切除的肝细胞癌 (HCC) 患者中显示出生存获益。该探索性分析检查了基线白蛋白胆红素 (ALBI) 评分的预后影响。方法：未接受过治疗且无法切除的 HCC、≥1 个可测量的未治疗病变和 Child-Pugh A 级肝功能的患者被随机分配 2:1 接受每 3 周一次的阿替利珠单抗 1200 mg + 贝伐珠单抗 15 mg/kg 或索拉非尼 400 mg 每天两次。通过 ALBI/改良 (m)ALBI 等级评估意向治疗人群的总生存期 (OS) 和无进展生存期 (PFS)。对肝功能和安全性的恶化时间（TTD；定义为 ALBI 评分从基线 2 次就诊或死亡到增加 0.5 分的时间）进行了调查。结果：在 501 名登记的患者中，336 名被随机分配接受 atezolizumab + 贝伐珠单抗（ALBI 等级 (G) 1：n=191；G2：n=144（mALBI G2a：n=72，G2b：n=72）；缺失 ALBI 等级：n =1) 和 165 到索拉非尼 (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 + 贝伐珠单抗与索拉非尼相比，OS 和 PFS 有所改善（OS HR，0.50（95% CI：0.35，0.72）；PFS HR，0.61（95% CI：0.45，0.82））。在 ALBI G2 或 mALBI G2a 或 G2b 患者中，atezolizumab + 贝伐珠单抗与索拉非尼相比，PFS 在数值上更长，但未观察到 OS 获益。意向治疗人群的中位 TTD 为 10.2 个月（95% CI：8.0，11.0），使用阿替利珠单抗 + 贝伐珠单抗 vs 8.6 个月（95% CI：6.2，11.8），使用索拉非尼（HR，0.82（95% CI：0.65） , 1.03)). 无论 ALBI 等级如何，atezolizumab 和贝伐珠单抗的安全性与之前的分析一致。讨论/结论：ALBI 分级似乎可以预测 HCC 患者使用阿替利珠单抗 + 贝伐珠单抗和索拉非尼治疗的结局。与索拉非尼相比，Atezolizumab + 贝伐珠单抗可在数值上更长时间地保护肝功能。