Background & aims: Atezolizumab plus bevacizumab (AtezoBev) 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 & results: In 216 HCC patients consecutively treated with AtezoBev across 11 tertiary centres we retrospectively evaluated treatment-related adverse events (trAEs) graded (G) according to CTCAE 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 RECIST 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 to CP-A, CP-B patients showed comparable rates of trAEs. Presence and grade of varices at pre-treatment 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), while 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. CP-B patients reported similar tolerability compared to CP-A, warranting prospective evaluation of AtezoBev in this treatment-deprived population.
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 / D'Alessio, A., Fulgenzi, C.A.M., Nishida, N., Schönlein, M., Von Felden, J., Schulze, K., Wege, H., Gaillard, V.E., Saeed, A., Wietharn, B., Hildebrand, H., Wu, L., Ang, C., Marron, T.U., Weinmann, A., Galle, P.R., Bettinger, D., Bengsch, B., Vogel, A., Balcar, L., et al.. - In: HEPATOLOGY. - ISSN 0270-9139. - 76:4(2022), pp. 1000-1012. [10.1002/hep.32468]
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
Personeni, Nicola;
2022-01-01
Abstract
Background & aims: Atezolizumab plus bevacizumab (AtezoBev) 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 & results: In 216 HCC patients consecutively treated with AtezoBev across 11 tertiary centres we retrospectively evaluated treatment-related adverse events (trAEs) graded (G) according to CTCAE 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 RECIST 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 to CP-A, CP-B patients showed comparable rates of trAEs. Presence and grade of varices at pre-treatment 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), while 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. CP-B patients reported similar tolerability compared to CP-A, warranting prospective evaluation of AtezoBev in this treatment-deprived population.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
