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
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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, Antonio; Fulgenzi, Claudia Angela Maria; Nishida, Naoshi; Schönlein, Martin; von Felden, Johann; Schulze, Kornelius; Wege, Henning; Gaillard, Vincent E; Saeed, Anwaar; Wietharn, Brooke; Hildebrand, Hannah; Wu, Linda; Ang, Celina; Marron, Thomas U; Weinmann, Arndt; Galle, Peter R; Bettinger, Dominik; Bengsch, Bertram; Vogel, Arndt; Balcar, Lorenz; Scheiner, Bernhard; Lee, Pei-Chang; Huang, Yi-Hsiang; Amara, Suneetha; Muzaffar, Mahvish; Naqash, Abdul Rafeh; Cammarota, Antonella; Personeni, Nicola; Pressiani, Tiziana; Sharma, Rohini; Pinter, Matthias; Cortellini, Alessio; Kudo, Masatoshi; Rimassa, Lorenza; Pinato, David J.
in: HEPATOLOGY, Jahrgang 76, Nr. 4, 10.2022, S. 1000-1012.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - 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
AU - D'Alessio, Antonio
AU - Fulgenzi, Claudia Angela Maria
AU - Nishida, Naoshi
AU - Schönlein, Martin
AU - von Felden, Johann
AU - Schulze, Kornelius
AU - Wege, Henning
AU - Gaillard, Vincent E
AU - Saeed, Anwaar
AU - Wietharn, Brooke
AU - Hildebrand, Hannah
AU - Wu, Linda
AU - Ang, Celina
AU - Marron, Thomas U
AU - Weinmann, Arndt
AU - Galle, Peter R
AU - Bettinger, Dominik
AU - Bengsch, Bertram
AU - Vogel, Arndt
AU - Balcar, Lorenz
AU - Scheiner, Bernhard
AU - Lee, Pei-Chang
AU - Huang, Yi-Hsiang
AU - Amara, Suneetha
AU - Muzaffar, Mahvish
AU - Naqash, Abdul Rafeh
AU - Cammarota, Antonella
AU - Personeni, Nicola
AU - Pressiani, Tiziana
AU - Sharma, Rohini
AU - Pinter, Matthias
AU - Cortellini, Alessio
AU - Kudo, Masatoshi
AU - Rimassa, Lorenza
AU - Pinato, David J
N1 - This article is protected by copyright. All rights reserved.
PY - 2022/10
Y1 - 2022/10
N2 - 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.
AB - 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.
U2 - 10.1002/hep.32468
DO - 10.1002/hep.32468
M3 - SCORING: Journal article
C2 - 35313048
VL - 76
SP - 1000
EP - 1012
JO - HEPATOLOGY
JF - HEPATOLOGY
SN - 0270-9139
IS - 4
ER -