Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
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
_version_ 1784859238938443776
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
work_keys_str_mv AT dalessioantonio preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT fulgenziclaudiaangelamaria preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT nishidanaoshi preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT schonleinmartin preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT vonfeldenjohann preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT schulzekornelius preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT wegehenning preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT gaillardvincente preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT saeedanwaar preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT wietharnbrooke preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT hildebrandhannah preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT wulinda preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT angcelina preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT marronthomasu preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT weinmannarndt preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT gallepeterr preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT bettingerdominik preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT bengschbertram preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT vogelarndt preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT balcarlorenz preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT scheinerbernhard preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT leepeichang preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT huangyihsiang preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT amarasuneetha preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT muzaffarmahvish preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT naqashabdulrafeh preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT cammarotaantonella preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT personeninicola preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT pressianitiziana preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT sharmarohini preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT pintermatthias preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT cortellinialessio preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT kudomasatoshi preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT rimassalorenza preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy
AT pinatodavidj preliminaryevidenceofsafetyandtolerabilityofatezolizumabplusbevacizumabinpatientswithhepatocellularcarcinomaandchildpughaandbcirrhosisarealworldstudy