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

Carlo Saitta, Simone Sabbioni, Giorgia Ghittoni, Lorenzo Lani, Nicola Reggidori, Valentina Santi, Benedetta Stefanini, Antonio Gasbarrini, Giovanni Brandi, Alessandro Granito, Gerardo Nardone, Edoardo G Giannini, Filippo Pelizzaro, Giuseppe Cabibbo, Francesco Azzaroli, Gianpaolo Vidili, Mariella Di Marco, Franco Trevisani, Gianluca Svegliati-Baroni, Rodolfo Sacco, Laura Bucci, Alessandro Vitale, Francesco Giuseppe Foschi, Angelo Sangiovanni, Maria Guarino, Donatella Magalotti, Gian Ludovico Rapaccini, Claudia Campani, Alberto Masotto, Andrea Mega, Elisabetta Biasini

Journal: Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver 2024;56(9):1582-1591

PMID: 38341377

Full Text on Elsevier Science View on PubMed

Abstract

BACKGROUND AND AIMS

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

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

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

C-P B patients with aHCC undergoing BSC have poor survival. Both Sorafenib and MC treatment improve their prognosis.

Address: Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.; Division of Internal Medicine, Hepatobiliary Diseases and Immunoallergology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.; Department of Surgery, Oncology and Gastroenterology, Gastroenterology Unit, University of Padua, Padua, Italy.; Department of Health Promotion, Mother & Child Care, Internal Medicine & Medical Specialties, PROMISE, Gastroenterology & Hepatology Unit, University of Palermo, Palermo, Italy.; Medicine Unit, Bolognini Hospital, Seriate, Italy.; Gastroenterology Unit, Belcolle Hospital, Viterbo, Italy.; Department of Experimental and Clinical Medicine, Internal Medicine and Hepatology Unit, University of Florence, Florence, Italy.; Gastroenterology Unit, Polytechnic University of Marche, Ancona, Italy.; Department of Internal Medicine, Ospedale per gli Infermi di Faenza, Faenza, Italy.; Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy; Gastroenterology Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.; Infectious Diseases and Hepatology Unit, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.; Department of Clinical and Experimental Medicine, Clinical and Molecular Hepatology Unit, University of Messina, Messina, Italy.; Division of Internal Medicine, Neurovascular and Hepatometabolic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.; 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.; Department of Clinical Medicine and Surgery, Diseases of the Liver and Biliary System Unit, University of Naples "Federico II", Naples, Italy.; Internal Medicine and Gastroenterology, Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome - Università Cattolica del Sacro Cuore, Rome.; IRCCS San Raffaele Cassino, Rome, Italy.; Gastroenterology Unit, Ospedale Sacro Cuore Don Calabria, Negrar, Italy.; Gastroenterology and Digestive Endoscopy Unit, Foggia University Hospital, Foggia, Italy.; Department of Medical, Surgical and Experimental Sciences, Clinica Medica Unit, University of Sassari, Azienda Ospedaliero-Universitaria di Sassari, Sassari, Italy.; Gastroenterology Unit, Bolzano Regional Hospital, Bolzano, Italy.; Gastroenterology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.; Department of Clinical Medicine and Surgery, Hepato-Gastroenterology Unit, University of Naples "Federico II", Naples, Italy.; Unit of Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.; 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: [email protected].

DOI: 10.1016/j.dld.2024.01.199

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MeSH Terms: Humans, Sorafenib, Capecitabine, Male, Carcinoma, Hepatocellular, Female, Liver Neoplasms, Aged, Middle Aged, Administration, Metronomic, Retrospective Studies, Propensity Score, Palliative Care