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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
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 consecut...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9790703/ https://www.ncbi.nlm.nih.gov/pubmed/35313048 http://dx.doi.org/10.1002/hep.32468 |
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author | 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. |
author_facet | 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. |
author_sort | D’Alessio, Antonio |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9790703 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-97907032022-12-28 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. Hepatology Original Articles 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. John Wiley and Sons Inc. 2022-04-08 2022-10 /pmc/articles/PMC9790703/ /pubmed/35313048 http://dx.doi.org/10.1002/hep.32468 Text en © 2022 The Authors. Hepatology published by Wiley Periodicals LLC on behalf of American Association for the Study of Liver Diseases. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Articles 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. 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9790703/ https://www.ncbi.nlm.nih.gov/pubmed/35313048 http://dx.doi.org/10.1002/hep.32468 |
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