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

  • Claudia Angela Maria Fulgenzi (Shared first author)
  • Jaekyung Cheon (Shared first author)
  • Antonio D'Alessio
  • Naoshi Nishida
  • Celina Ang
  • Thomas U Marron
  • Linda Wu
  • Anwaar Saeed
  • Brooke Wietharn
  • Antonella Cammarota
  • Tiziana Pressiani
  • Nicola Personeni
  • Matthias Pinter
  • Bernhard Scheiner
  • Lorenz Balcar
  • Andrea Napolitano
  • Yi-Hsiang Huang
  • Samuel Phen
  • Abdul Rafeh Naqash
  • Caterina Vivaldi
  • Francesca Salani
  • Gianluca Masi
  • Dominik Bettinger
  • Arndt Vogel
  • Martin Schönlein
  • Johann von Felden
  • Kornelius Schulze
  • Henning Wege
  • Peter R Galle
  • Masatoshi Kudo
  • Lorenza Rimassa
  • Amit G Singal
  • Rohini Sharma
  • Alessio Cortellini
  • Vincent E Gaillard
  • Hong Jae Chon
  • David James Pinato

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.

Bibliographical data

Original languageEnglish
ISSN0959-8049
DOIs
Publication statusPublished - 11.2022

Comment Deanary

Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

PubMed 36148739