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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

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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

Harvard

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, P-C, Huang, Y-H, Amara, S, Muzaffar, M, Naqash, AR, Cammarota, A, Personeni, N, Pressiani, T, Sharma, R, Pinter, M, Cortellini, A, Kudo, M, Rimassa, L & Pinato, DJ 2022, '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', HEPATOLOGY, Jg. 76, Nr. 4, S. 1000-1012. https://doi.org/10.1002/hep.32468

APA

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., ... Pinato, D. J. (2022). 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. HEPATOLOGY, 76(4), 1000-1012. https://doi.org/10.1002/hep.32468

Vancouver

D'Alessio A, Fulgenzi CAM, Nishida N, Schönlein M, von Felden J, Schulze K et al. 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. HEPATOLOGY. 2022 Okt;76(4):1000-1012. https://doi.org/10.1002/hep.32468

Bibtex

@article{0d931cd5fb3847f086d99cd155d6e170,
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",
abstract = "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.",
author = "Antonio D'Alessio and Fulgenzi, {Claudia Angela Maria} and Naoshi Nishida and Martin Sch{\"o}nlein and {von Felden}, Johann and Kornelius Schulze and Henning Wege and Gaillard, {Vincent E} and Anwaar Saeed and Brooke Wietharn and Hannah Hildebrand and Linda Wu and Celina Ang and Marron, {Thomas U} and Arndt Weinmann and Galle, {Peter R} and Dominik Bettinger and Bertram Bengsch and Arndt Vogel and Lorenz Balcar and Bernhard Scheiner and Pei-Chang Lee and Yi-Hsiang Huang and Suneetha Amara and Mahvish Muzaffar and Naqash, {Abdul Rafeh} and Antonella Cammarota and Nicola Personeni and Tiziana Pressiani and Rohini Sharma and Matthias Pinter and Alessio Cortellini and Masatoshi Kudo and Lorenza Rimassa and Pinato, {David J}",
note = "This article is protected by copyright. All rights reserved.",
year = "2022",
month = oct,
doi = "10.1002/hep.32468",
language = "English",
volume = "76",
pages = "1000--1012",
journal = "HEPATOLOGY",
issn = "0270-9139",
publisher = "John Wiley and Sons Ltd",
number = "4",

}

RIS

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 -