Department of Gastroenterology, Japanese Red Cross Society Himeji Hospital, Hyogo, Japan.
Department of Nursing, Gifu Kyoritsu University, Gifu, Japan.
Aliment Pharmacol Ther. 2024 Jul;60(2):233-245. doi: 10.1111/apt.18037. Epub 2024 May 8.
BACKGROUND: Atezolizumab plus bevacizumab (Atezo/Bev) is frequently selected as the primary systemic therapy for hepatocellular carcinoma (HCC). AIMS: To investigate the outcomes of patients with HCC treated with Atezo/Bev in a real-world setting based on whether they met the inclusion criteria for the phase 3 IMbrave150 trial. METHODS: A total of 936 patients were enrolled. There were 404 patients who met the inclusion criteria of the phase 3 IMbrave150 trial (IMbrave150 group) and 532 who did not (non-IMbrave150 group). RESULTS: Median progression-free survival (PFS) in the IMbrave150 and non-IMbrave150 groups was 7.4 months and 5.6 months (p = 0.002). Multivariable analysis revealed that non-B, non-C HCC aetiology (hazard ratio [HR], 1.173), α-fetoprotein ≥100 ng/mL (HR, 1.472), Barcelona Clinic Liver Cancer stage ≥ C (HR, 1.318), and modified albumin-bilirubin (mALBI) grade 2b or 3 (HR, 1.476) are independently associated with PFS. Median overall survival (OS) in the IMbrave150 and non-Imbrave150 groups was 26.5 and 18.8 months (p < 0.001). Multivariable analysis revealed that Eastern Cooperative Oncology Group performance status ≥2 (HR, 1.986), α-fetoprotein ≥100 ng/mL (HR, 1.481), and mALBI grade 2b or 3 (HR, 2.037) are independently associated with OS. In subgroup analysis, there were no significant differences in PFS or OS between these groups among patients with mALBI grade 1 or 2a. CONCLUSIONS: Patients who are treated with Atezo/Bev and meet the inclusion criteria for the phase 3 IMbrave150 trial, as well as those who do not meet the inclusion criteria but have good liver function, have a good prognosis for survival.
背景:阿替利珠单抗联合贝伐珠单抗(Atezo/Bev)常被选为肝细胞癌(HCC)的一线系统治疗药物。
目的:根据是否符合 III 期 IMbrave150 试验的纳入标准,调查真实世界中接受 Atezo/Bev 治疗的 HCC 患者的结局。
方法:共纳入 936 例患者。其中 404 例符合 III 期 IMbrave150 试验的纳入标准(IMbrave150 组),532 例不符合(非 IMbrave150 组)。
结果:IMbrave150 组和非 IMbrave150 组的中位无进展生存期(PFS)分别为 7.4 个月和 5.6 个月(p=0.002)。多变量分析显示,非 B、非 C 型 HCC 病因(风险比 [HR],1.173)、甲胎蛋白(AFP)≥100ng/ml(HR,1.472)、巴塞罗那临床肝癌分期≥C(HR,1.318)和改良白蛋白-胆红素(mALBI)分级 2b 或 3(HR,1.476)与 PFS 独立相关。IMbrave150 组和非 IMbrave150 组的中位总生存期(OS)分别为 26.5 个月和 18.8 个月(p<0.001)。多变量分析显示,东部肿瘤协作组体力状态≥2(HR,1.986)、AFP≥100ng/ml(HR,1.481)和 mALBI 分级 2b 或 3(HR,2.037)与 OS 独立相关。亚组分析显示,在 mALBI 分级为 1 或 2a 的患者中,两组间的 PFS 或 OS 无显著差异。
结论:接受 Atezo/Bev 治疗且符合 III 期 IMbrave150 试验纳入标准的患者,以及不符合纳入标准但肝功能良好的患者,其生存预后良好。