在 III 期 IMbrave150 研究中，与索拉非尼相比，Atezolizumab 贝伐单抗在不可切除的肝细胞癌 (HCC) 患者中显示出生存获益。这项探索性分析检查了基线白蛋白-胆红素 (ALBI) 评分的预后影响。未接受治疗的不可切除 HCC、≥1 个可测量的未治疗病灶以及 Child-Pugh A 级肝功能的患者按 2:1 随机分配接受 atezolizumab 1,200 mg贝伐珠单抗 15 mg/kg 每 3 周一次，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)。对肝功能恶化的时间（TTD；定义为 2 次就诊或死亡期间 ALBI 评分从基线增加 0.5 分的时间）和安全性进行了调查。 在 501 名入组患者中，336 名患者随机接受阿特珠单抗贝伐珠单抗治疗（ALBI 等级 [G] ] 1：n = 191；G2：n = 144 [mALBI G2a：n = 72，G2b：n = 72]；缺少 ALBI 等级：n = 1）和 165 至索拉非尼（ALBI G1：n = 87；G2：n = 78 [mABI G2a：n = 37；G2b：n = 41]）。中位随访时间为 15.6 个月。与索拉非尼治疗 ALBI G1 患者相比，阿特珠单抗贝伐单抗的 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，与索拉非尼相比，阿特珠单抗贝伐单抗的 PFS 在数值上更长，但没有观察到 OS 获益。在意向治疗人群中，阿特珠单抗贝伐珠单抗的中位 TTD 为 10.2 个月（95% CI：8.0, 11.0），而索拉非尼的中位 TTD 为 8.6 个月（95% CI：6.2, 11.8）（HR：0.82 [95% CI：0.65， 1.03]）。无论 ALBI 等级如何，阿特朱单抗和贝伐单抗的安全性均与之前的分析一致。ALBI 等级似乎可以预测 HCC 患者阿特朱单抗、贝伐单抗和索拉非尼治疗的结果。 Atezolizumab 贝伐珠单抗保留肝功能的持续时间比索拉非尼更长。© 2023 作者。由巴塞尔 S. Karger AG 出版。

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.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.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.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.© 2023 The Author(s). Published by S. Karger AG, Basel.