Liver and Bile

Hepatology. 2022;76(4):1000–12

D’Alessio A, Fulgenzi CAM, Nishida N, Schönlein M, von Felden J, Schulze K, Wege H, Gaillard VE, Saeed A, Wietharn B, Hildebrand H, Wu L, Ang C, Marron TU, Weinmann A, Galle PR, Bettinger D, Bengsch B, Vogel A, Balcar L, Scheiner B, Lee PC, Huang YH, Amara S, Muzaffar M, Naqash AR, Cammarota A, Personeni N, Pressiani T, Sharma R, Pinter M, Cortellini A, Kudo M, Rimassa L, Pinato DJ

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

Background and aims: Atezolizumab plus bevacizumab is the standard of care for first-line treatment of unresectable hepatocellular carcinoma (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 atezolizumab plus bevacizumab across 11 tertiary centers, the authors 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%). They 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% confidence interval [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 atezolizumab plus bevacizumab in routine practice. Patients with Child-Pugh-B reported similar tolerability compared with Child-Pugh-A, warranting prospective evaluation of atezolizumab plus bevacizumab in this treatment-deprived population.

DOI: DOI: 10.1002/hep.32468