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

Claudia Angela Maria Fulgenzi, Jaekyung Cheon, 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 VivaldiFrancesca 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

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish
Pages (from-to)204-213
Number of pages10
JournalEuropean Journal of Cancer
Volume175
DOIs
StatePublished - 1 Nov 2022

Keywords

  • Advanced HCC
  • Atezolizumab
  • Bevacizumab
  • First line
  • Systemic treatment

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