Preliminary evidence of safety and tolerability of atezolizumab plus bevacizumab in patients with hepatocellular carcinoma and Child-Pugh A and B cirrhosis: A real-world study

Antonio D’Alessio, Claudia Angela Maria Fulgenzi, Naoshi Nishida, Martin Schönlein, Johann von Felden, Kornelius Schulze, Henning Wege, Vincent E. Gaillard, Anwaar Saeed, Brooke Wietharn, Hannah Hildebrand, Linda Wu, Celina Ang, Thomas U. Marron, Arndt Weinmann, Peter R. Galle, Dominik Bettinger, Bertram Bengsch, Arndt Vogel, Lorenz BalcarBernhard Scheiner, Pei Chang Lee, Yi Hsiang Huang, Suneetha Amara, Mahvish Muzaffar, Abdul Rafeh Naqash, Antonella Cammarota, Nicola Personeni, Tiziana Pressiani, Rohini Sharma, Matthias Pinter, Alessio Cortellini, Masatoshi Kudo, Lorenza Rimassa, David J. Pinato

Research output: Contribution to journalArticlepeer-review

28 Scopus citations

Abstract

Background and Aims: Atezolizumab plus bevacizumab (AtezoBev) is the standard of care for first-line treatment of unresectable HCC. No evidence exists as to its use in routine clinical practice in patients with impaired liver function. Approach and Results: In 216 patients with HCC who were consecutively treated with AtezoBev across 11 tertiary centers, we retrospectively evaluated treatment-related adverse events (trAEs) graded (G) according to Common Terminology Criteria for Adverse Events v5.0, including in the analysis all patients treated according to label (n = 202, 94%). We also assessed overall survival (OS), progression-free survival (PFS), overall response (ORR), and disease control rates (DCR) defined by Response Evaluation Criteria in Solid Tumors v1.1. Disease was mostly secondary to viral hepatitis, namely hepatitis C (n = 72; 36%) and hepatitis B infection (n = 35, 17%). Liver function was graded as Child-Pugh (CP)-A in 154 patients (76%) and CP-B in 48 (24%). Any grade trAEs were reported by 143 patients (71%), of which 53 (26%) were G3 and 3 (2%) G4. Compared with CP-A, patients with CP-B showed comparable rates of trAEs. Presence and grade of varices at pretreatment esophagogastroduodenoscopy did not correlate with bleeding events. After a median follow-up of 9.0 months (95% CI, 7.8–10.1), median OS was 14.9 months (95% CI, 13.6–16.3), whereas median PFS was 6.8 months (95% CI, 5.2–8.5). ORR and DCR were respectively 25% and 73%, with no difference across CP classes. Conclusions: This study confirms reproducible safety and efficacy of AtezoBev in routine practice. Patients with CP-B reported similar tolerability compared with CP-A, warranting prospective evaluation of AtezoBev in this treatment-deprived population.

Original languageEnglish
Pages (from-to)1000-1012
Number of pages13
JournalHepatology
Volume76
Issue number4
DOIs
StatePublished - Oct 2022

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