Reproducible safety and efficacy of atezolizumab plus bevacizumab for HCC in clinical practice: Results of the AB-real study

Eur J Cancer. 2022 Nov:175:204-213. doi: 10.1016/j.ejca.2022.08.024. Epub 2022 Sep 20.

Abstract

Background: IMbrave150 has established the superiority of atezolizumab plus bevacizumab over sorafenib in patients with unresectable hepatocellular carcinoma (HCC).

Methods: We generated a prospectively maintained database including patients treated with atezolizumab plus bevacizumab for unresectable HCC across Europe, Asia and USA. Clinico-pathologic characteristics were assessed for their prognostic influence on overall survival (OS) and progression-free survival (PFS) in univariable and multivariate analyses. Overall response rate by RECIST v1.1 and treatment-related adverse events (TRAEs) per CTCAE v.5.0 were reported.

Results: Out of 433 patients, 296 Child-Pugh A and ECOG performance status01 patients received atezolizumab plus bevacizumab in first line and were included. Patients were mostly male (82.7%), cirrhotic (75%) with history of viral hepatitis (65.9%). Overall, 68.9% had Barcelona Clinic Liver Cancer C-stage HCC with portal vein tumour thrombosis (PVTT, 35%) and extrahepatic spread (EHS, 51.7%). After a median follow-up of 10.0 months (95% confidence interval (CI): 9.4-10.4), median OS and PFS were 15.7 (95% CI: 14.5-NE) and 6.9 months (95% CI: 6.1-8.3), respectively. In the response-evaluable patients (n = 273), overall response rate was 30.8%. Overall, 221 patients (74.6%) developed TRAEs, with 70 (23.6%) reporting grade 3 or higher TRAEs; 25 (8.4%) patients had bleeding events. OS was independently associated with baseline Albumin-bilirubin (ALBI) grade and PVTT. Shorter PFS was associated with AFP≥ 400 ng/ml, worse ALBI and presence of EHS.

Conclusion: This global observational study confirms the reproducible safety and efficacy of atezolizumab plus bevacizumab in routine clinical practice. Within Child-Pugh-A criteria, the presence of PVTT and higher ALBI grade identify patients with poorer survival.

Keywords: Advanced HCC; Atezolizumab; Bevacizumab; First line; Systemic treatment.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Albumins / therapeutic use
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents* / therapeutic use
  • Bevacizumab / adverse effects
  • Bilirubin
  • Carcinoma, Hepatocellular* / pathology
  • Female
  • Humans
  • Liver Neoplasms* / pathology
  • Male
  • Sorafenib / therapeutic use
  • Venous Thrombosis*
  • alpha-Fetoproteins

Substances

  • Albumins
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents
  • alpha-Fetoproteins
  • Bevacizumab
  • atezolizumab
  • Sorafenib
  • Bilirubin