Suboptimal outcomes of sorafenib as a second-line treatment after atezolizumab-bevacizumab for unresectable hepatocellular carcinoma.

Hepatocellular carcinoma Immunotherapy Outcome Sorafenib Tyrosine kinase inhibitors

Journal

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385

Informations de publication

Date de publication:
20 Aug 2024
Historique:
received: 18 04 2024
revised: 21 07 2024
accepted: 30 07 2024
medline: 22 8 2024
pubmed: 22 8 2024
entrez: 21 8 2024
Statut: aheadofprint

Résumé

Most patients receiving atezolizumab-bevacizumab (AB) for hepatocellular carcinoma will eventually experience disease progression. Randomized clinical trials (RCTs) are undergoing to identify second-line treatments. Where RCTs are unavailable or patients are non-eligible, sorafenib is often prescribed based on approval and reimbursement policies. However, evidence supporting this approach is minimal. To assess the efficacy and safety of sorafenib in patients who permanently discontinued AB. The ARTE database prospectively collects patients treated with AB in a real-life setting. We analysed the outcome of patients who received sorafenib as second-line treatment. Amongst 213 patients, 130 (61.0 %) permanently discontinued AB. Of them, 54 received second- line treatments, and sorafenib was prescribed in 40 patients. The disease control rate (DCR) was 10.0 %. The median progression-free (PFS) and overall survival were 3.3 (95 % confidence interval [CI] 2.7-3.9) and 6.9 months (95 % CI 2.7-11.1), respectively. In patients progressing under AB, the efficacy of sorafenib on different outcomes is limited.

Sections du résumé

BACKGROUND BACKGROUND
Most patients receiving atezolizumab-bevacizumab (AB) for hepatocellular carcinoma will eventually experience disease progression. Randomized clinical trials (RCTs) are undergoing to identify second-line treatments. Where RCTs are unavailable or patients are non-eligible, sorafenib is often prescribed based on approval and reimbursement policies. However, evidence supporting this approach is minimal.
OBJECTIVE OBJECTIVE
To assess the efficacy and safety of sorafenib in patients who permanently discontinued AB.
METHODS METHODS
The ARTE database prospectively collects patients treated with AB in a real-life setting. We analysed the outcome of patients who received sorafenib as second-line treatment.
RESULTS RESULTS
Amongst 213 patients, 130 (61.0 %) permanently discontinued AB. Of them, 54 received second- line treatments, and sorafenib was prescribed in 40 patients. The disease control rate (DCR) was 10.0 %. The median progression-free (PFS) and overall survival were 3.3 (95 % confidence interval [CI] 2.7-3.9) and 6.9 months (95 % CI 2.7-11.1), respectively.
CONCLUSIONS CONCLUSIONS
In patients progressing under AB, the efficacy of sorafenib on different outcomes is limited.

Identifiants

pubmed: 39168753
pii: S1590-8658(24)00919-8
doi: 10.1016/j.dld.2024.07.035
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest FT: Consultant for Ipsen, Roche, Eisai, AstraZeneca, Bayer; AG: consultant for Bayer; FM: Consultant for Ipsen, Roche, MSD, AstraZeneca, Bayer; BD: consultant for Astrazeneca, IPSEN, EISAI, MSD, Roche, Amgen, Incyte, Sanofi; FP: honoraria for lecturing or advisory boards from Astrazeneca, Bayer, Bracco, ESAOTE, EISAI, Exact Sciences, IPSEN, MSD, Roche, Samsung, Siemens Healthineers. The other authors have no conflict of interest.

Auteurs

Francesco Tovoli (F)

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy; Unit of Internal Medicine, Hepatobiliary and Immunoallergic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy. Electronic address: francesco.tovoli@unibo.it.

Dante Pio Pallotta (DP)

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Caterina Vivaldi (C)

Unit of Medical Oncology 2, Azienda Ospedaliero- Universitaria Pisana, Pisa, Italy.

Claudia Campani (C)

Department of Experimental and Clinical Medicine, Internal Medicine and Hepatology Unit, University of Florence, Florence, Italy.

Piera Federico (P)

Medical Oncology Unit, Ospedale del Mare, Napoli, Italy.

Andrea Palloni (A)

Oncology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Andrea Dalbeni (A)

Liver Unit, Medicine Department, University of Verona and University and Hospital Trust (AOUI) of Verona, Verona, Italy; Unit of General Medicine C, Medicine Department, University of Verona and Hospital Trust (AOUI) of Verona, Verona, Italy.

Caterina Soldà (C)

Oncology Unit 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.

Lorenzo Lani (L)

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Gianluca Svegliati-Baroni (G)

Liver Injury and Transplant Unit, Azienda Ospedaliero-Universitaria delle Marche, Ancona, Italy.

Ingrid Garajova (I)

Medical Oncology Unit, University Hospital of Parma, Parma, Italy.

Luca Ielasi (L)

Department of Internal Medicine, Ospedale degli Infermi di Faenza, Faenza, Italy.

Stefania De Lorenzo (S)

Oncology Unit, Azienda USL Bologna, Bologna, Italy.

Alessandro Granito (A)

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy; Unit of Internal Medicine, Hepatobiliary and Immunoallergic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Bernardo Stefanini (B)

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Gianluca Masi (G)

Unit of Medical Oncology 2, Azienda Ospedaliero- Universitaria Pisana, Pisa, Italy.

Fabio Marra (F)

Department of Experimental and Clinical Medicine, Internal Medicine and Hepatology Unit, University of Florence, Florence, Italy.

Sara Lonardi (S)

Oncology Unit 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.

Giovanni Brandi (G)

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy; Oncology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Bruno Daniele (B)

Medical Oncology Unit, Ospedale del Mare, Napoli, Italy.

Alessandra Auriemma (A)

Section of Innovation Biomedicine-Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona and University and Hospital Trust (AOUI) of Verona, Verona, Italy.

Laura Schiadà (L)

Oncology Unit 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy.

Rusi Chen (R)

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.

Fabio Piscaglia (F)

Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy; Unit of Internal Medicine, Hepatobiliary and Immunoallergic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Classifications MeSH