Sorafenib and Metronomic Capecitabine in Child-Pugh B patients with advanced HCC: A real-life comparison with best supportive care.

Child-Pugh B Hepatocellular carcinoma Metronomic capecitabine Sorafenib

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:
09 Feb 2024
Historique:
received: 26 09 2023
revised: 29 12 2023
accepted: 23 01 2024
medline: 11 2 2024
pubmed: 11 2 2024
entrez: 10 2 2024
Statut: aheadofprint

Résumé

The efficacy of systemic therapy for unresectable advanced hepatocellular carcinoma (aHCC) has not been proven in patients with Child-Pugh (C-P) B cirrhosis. Nevertheless, in real-world these patients are treated both with tyrosine kinase inhibitors (TKIs) and with metronomic capecitabine (MC). This study aimed to compare sorafenib and MC outcomes versus best supportive care (BSC) in C-P B patients. Between 2008 and 2020, among 774 C-P B patients with aHCC not amenable/responsive to locoregional treatments, 410 underwent sorafenib, 62 MC, and 302 BSC. The propensity score matching method was used to correct the baseline unbalanced prognostic factors. In the unmatched population, median OS was 9.7 months in patients treated with sorafenib, 8.0 with MC, and 3.9 months with BSC. In sorafenib vs. BSC-matched patients (135 couples), median OS was 7.3 (4.9-9.6) vs. 3.9 (2.6-5.2) months (p<0.001). ECOG-Performance Status, tumor size, macrovascular invasion, AFP, treatment-naive, and sorafenib were independent predictors of survival. In MC vs. BSC-matched patients (40 couples), median OS was 9.0 (0.2-17.8) vs.3.0 (2.2-3.8) months (p<0.001). Median OS did not differ (p = 0.283) in sorafenib vs. MC-matched patients (55 couples). C-P B patients with aHCC undergoing BSC have poor survival. Both Sorafenib and MC treatment improve their prognosis.

Sections du résumé

BACKGROUND AND AIMS OBJECTIVE
The efficacy of systemic therapy for unresectable advanced hepatocellular carcinoma (aHCC) has not been proven in patients with Child-Pugh (C-P) B cirrhosis. Nevertheless, in real-world these patients are treated both with tyrosine kinase inhibitors (TKIs) and with metronomic capecitabine (MC). This study aimed to compare sorafenib and MC outcomes versus best supportive care (BSC) in C-P B patients.
METHOD METHODS
Between 2008 and 2020, among 774 C-P B patients with aHCC not amenable/responsive to locoregional treatments, 410 underwent sorafenib, 62 MC, and 302 BSC. The propensity score matching method was used to correct the baseline unbalanced prognostic factors.
RESULTS RESULTS
In the unmatched population, median OS was 9.7 months in patients treated with sorafenib, 8.0 with MC, and 3.9 months with BSC. In sorafenib vs. BSC-matched patients (135 couples), median OS was 7.3 (4.9-9.6) vs. 3.9 (2.6-5.2) months (p<0.001). ECOG-Performance Status, tumor size, macrovascular invasion, AFP, treatment-naive, and sorafenib were independent predictors of survival. In MC vs. BSC-matched patients (40 couples), median OS was 9.0 (0.2-17.8) vs.3.0 (2.2-3.8) months (p<0.001). Median OS did not differ (p = 0.283) in sorafenib vs. MC-matched patients (55 couples).
CONCLUSION CONCLUSIONS
C-P B patients with aHCC undergoing BSC have poor survival. Both Sorafenib and MC treatment improve their prognosis.

Identifiants

pubmed: 38341377
pii: S1590-8658(24)00242-1
doi: 10.1016/j.dld.2024.01.199
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2024 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest GC declares consulting fees from Bayer, Roche, Ipsen, Merck Sharp & Dohme, Eisai, and AstraZeneca; FGF (advisory board, consulting fees): AbbVie, Bayer, Eisai, Gilead, MSD, and Intercept; EGG (advisory board, consulting fees): Astra Zeneca, Eisai, MSD, and Roche; GR (lectures, advisory board, consulting fees): Gilead, Alfa Wasserman, Intercept, and Eisai; FT (research grant, advisory board, consulting fees): Astra Zeneca, AbbVie, Bayer, Eisai, Gilead, MSD, and Roche. All other authors declare no conflict of interest.

Auteurs

Benedetta Stefanini (B)

Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Laura Bucci (L)

Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Valentina Santi (V)

Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Nicola Reggidori (N)

Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Lorenzo Lani (L)

Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Alessandro Granito (A)

Division of Internal Medicine, Hepatobiliary Diseases and Immunoallergology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Filippo Pelizzaro (F)

Department of Surgery, Oncology and Gastroenterology, Gastroenterology Unit, University of Padua, Padua, Italy.

Giuseppe Cabibbo (G)

Department of Health Promotion, Mother & Child Care, Internal Medicine & Medical Specialties, PROMISE, Gastroenterology & Hepatology Unit, University of Palermo, Palermo, Italy.

Mariella Di Marco (M)

Medicine Unit, Bolognini Hospital, Seriate, Italy.

Giorgia Ghittoni (G)

Gastroenterology Unit, Belcolle Hospital, Viterbo, Italy.

Claudia Campani (C)

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

Gianluca Svegliati-Baroni (G)

Gastroenterology Unit, Polytechnic University of Marche, Ancona, Italy.

Francesco Giuseppe Foschi (FG)

Department of Internal Medicine, Ospedale per gli Infermi di Faenza, Faenza, Italy.

Edoardo G Giannini (EG)

Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy; Gastroenterology Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

Elisabetta Biasini (E)

Infectious Diseases and Hepatology Unit, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.

Carlo Saitta (C)

Department of Clinical and Experimental Medicine, Clinical and Molecular Hepatology Unit, University of Messina, Messina, Italy.

Donatella Magalotti (D)

Division of Internal Medicine, Neurovascular and Hepatometabolic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Angelo Sangiovanni (A)

Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale maggiore Policlinico and C.R.C. "A.M. & A. Migliavacca Center for Liver Disease", Milan, Italy.

Maria Guarino (M)

Department of Clinical Medicine and Surgery, Diseases of the Liver and Biliary System Unit, University of Naples "Federico II", Naples, Italy.

Antonio Gasbarrini (A)

Internal Medicine and Gastroenterology, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome - Università Cattolica del Sacro Cuore, Rome.

Gian Ludovico Rapaccini (GL)

IRCCS San Raffaele Cassino, Rome, Italy.

Alberto Masotto (A)

Gastroenterology Unit, Ospedale Sacro Cuore Don Calabria, Negrar, Italy.

Rodolfo Sacco (R)

Gastroenterology and Digestive Endoscopy Unit, Foggia University Hospital, Foggia, Italy.

Gianpaolo Vidili (G)

Department of Medical, Surgical and Experimental Sciences, Clinica Medica Unit, University of Sassari, Azienda Ospedaliero-Universitaria di Sassari, Sassari, Italy.

Andrea Mega (A)

Gastroenterology Unit, Bolzano Regional Hospital, Bolzano, Italy.

Francesco Azzaroli (F)

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

Gerardo Nardone (G)

Department of Clinical Medicine and Surgery, Hepato-Gastroenterology Unit, University of Naples "Federico II", Naples, Italy.

Giovanni Brandi (G)

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

Simone Sabbioni (S)

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

Alessandro Vitale (A)

Department of Surgery, Oncology and Gastroenterology, Gastroenterology Unit, University of Padua, Padua, Italy.

Franco Trevisani (F)

Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Unit of Semeiotics, Liver and Alcohol-related diseases, Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Bologna, Italy. Electronic address: franco.trevisani@unibo.it.

Classifications MeSH