Alessandro Vitale1, Quirino Lai2, Fabio Farinati1, Laura Bucci3, Edoardo G Giannini4, Lucia Napoli5, Francesca Ciccarese6, Gian Lodovico Rapaccini7, Maria Di Marco8, Eugenio Caturelli9, Marco Zoli5, Franco Borzio10, Rodolfo Sacco11, Giuseppe Cabibbo12, Roberto Virdone13, Fabio Marra14, Martina Felder15, Filomena Morisco16, Luisa Benvegnù17, Antonio Gasbarrini18, Gianluca Svegliati-Baroni19, Francesco Giuseppe Foschi20, Gabriele Missale21, Alberto Masotto22, Gerardo Nardone23, Antonio Colecchia24, Mauro Bernardi3, Franco Trevisani3, Timothy M Pawlik25. 1. Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy. 2. Liver Transplant and Hepatobiliary Surgery Unit, Sapienza University of Rome, UmbertoI Policlinic of Rome, Viale delPoliclinico 155, 00161, Rome, Italy. lai.quirino@libero.it. 3. Department of Medical and Surgical Sciences, Division of Semeiotics, Alma Mater Studiorum-University of Bologna, Bologna, Italy. 4. Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Policlinico San Martino, Genoa, Italy. 5. Department of Medical and Surgical Sciences, Division of Internal Medicine, Alma Mater Studiorum-University of Bologna, Bologna, Italy. 6. Division of Surgery, San Marco Hospital, Zingonia, Italy. 7. Division of Internal Medicine and Gastroenterology, Complesso Integrato Columbus, Università Cattolica del Sacro Cuore, Rome, Italy. 8. Division of Medicine, Bolognini Hospital, Seriate, Italy. 9. Division of Gastroenterology, Belcolle Hospital, Viterbo, Italy. 10. Department of Medicine, Division of Radiology, Fatebenefratelli Hospital, Milan, Italy. 11. Division of Gastroenterology and Metabolic Diseases, University Hospital of Pisa, Pisa, Italy. 12. Biomedical Department of Internal and Specialistic Medicine, Division of Gastroenterology, University of Palermo, Palermo, Italy. 13. Division of Internal Medicine 2, Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy. 14. Internal Medicine and Hepatology, Department of Experimental and Clinical Medicine, University of Firenze, Florence, Italy. 15. Division of Gastroenterology, Bolzano Regional Hospital, Bolzano, Italy. 16. Department of Medicine and Surgery, Division of Gastroenterology, University of Naples, "Federico II", Naples, Italy. 17. Department of Molecular Medicine, University of Padua, Padua, Italy. 18. Division of Internal Medicine and Gastroenterology, Policlinico Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy. 19. Division of Gastroenterology, Polytechnic University of Marche, Ancona, Italy. 20. Department of Internal Medicine, Ospedale per gli Infermi di Faenza, Faenza, Italy. 21. Division of Infectious Diseases and Hepatology, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy. 22. Gastroenterology Unit, Ospedale Sacro Cuore Don Calabria, Negrar, Italy. 23. Department of Clinical Medicine and Surgery, Hepato-Gastroenterology Unit, University of Naples "Federico II", Naples, Italy. 24. Department of Surgical and Medical sciences, Gastroenterology Unit, Alma Mater Studiorum-Università of Bologna, Bologna, Italy. 25. Department of Surgery, Wexner Medical Center at The Ohio State University, Columbus, OH, USA.
Abstract
BACKGROUND: Dichotomous models like Milan Criteria represent the routinely used tools for predicting the outcome of patients with hepatocellular carcinoma (HCC). However, a paradigm shift from a dichotomous to continuous prognostic stratification should represent a good strategy for improving the prediction process. Recently, the tumor burden score (TBS) has been proposed for selecting patients with colorectal liver metastases. To date, TBS has not been validated in a large HCC population. The main objective of this study was to evaluate the prognostic power of TBS in an HCC population treated with different curative and palliative modalities. METHODS: Prospectively collected data from consecutive HCC patients managed in 24 institutions participating in the ITA.LI.CA group between Jan 2002 and Mar 2015 were analyzed (n = 4759). A sub-analysis focused on 3909 patients with the radiological evidence of vascular invasion or metastatic disease was also performed. RESULTS: TBS demonstrated the best discriminative ability when compared to MC and other tumor-specific scores. At multivariable Cox regression analysis, TBS was an independent risk factor of overall survival, with a 6% increased risk for patient death for each point increase in TBS. At survival analysis, when TBS ≥ 8 was connected with MELD ≥ 15 and alpha-fetoprotein ≥ 1000 ng/mL, patients presenting all these three risk factors presented the worst results (p value < 0.0001). CONCLUSIONS: Survival prediction of HCC patients was very well done using TBS model, even stratifying the population in relation to the presence of metastases and/or vascular invasion. TBS model was the best in terms of discriminatory ability and goodness of fit when compared with other continuous or binary variables. Its incorporation in a model composed by tumor- and liver function-related variables further increases its survival prediction.
BACKGROUND: Dichotomous models like Milan Criteria represent the routinely used tools for predicting the outcome of patients with hepatocellular carcinoma (HCC). However, a paradigm shift from a dichotomous to continuous prognostic stratification should represent a good strategy for improving the prediction process. Recently, the tumor burden score (TBS) has been proposed for selecting patients with colorectal liver metastases. To date, TBS has not been validated in a large HCC population. The main objective of this study was to evaluate the prognostic power of TBS in an HCC population treated with different curative and palliative modalities. METHODS: Prospectively collected data from consecutive HCC patients managed in 24 institutions participating in the ITA.LI.CA group between Jan 2002 and Mar 2015 were analyzed (n = 4759). A sub-analysis focused on 3909 patients with the radiological evidence of vascular invasion or metastatic disease was also performed. RESULTS:TBS demonstrated the best discriminative ability when compared to MC and other tumor-specific scores. At multivariable Cox regression analysis, TBS was an independent risk factor of overall survival, with a 6% increased risk for patient death for each point increase in TBS. At survival analysis, when TBS ≥ 8 was connected with MELD ≥ 15 and alpha-fetoprotein ≥ 1000 ng/mL, patients presenting all these three risk factors presented the worst results (p value < 0.0001). CONCLUSIONS: Survival prediction of HCC patients was very well done using TBS model, even stratifying the population in relation to the presence of metastases and/or vascular invasion. TBS model was the best in terms of discriminatory ability and goodness of fit when compared with other continuous or binary variables. Its incorporation in a model composed by tumor- and liver function-related variables further increases its survival prediction.
Entities:
Keywords:
Hepatocellular carcinoma; Milan Criteria; Outcomes; Prognosis; Tumor burden
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