The ITA.LI.CA prognostic system, a model integrating tumor staging, liver function, functional status, and alpha-fetoprotein level, builds on previous models of hepatocellular carcinoma (HCC) prognosis and shows superior survival prediction in Italian and Taiwanese cohorts, according to a study published this week in PLOS Medicine by Alessandro Vitale of Azienda Ospedaliera Universitaria di Padova, Italy, and colleagues.
Primary liver cancer is the sixth most common cancer and the second leading cause of cancer-related deaths worldwide. Current prognostic models for HCC (the most common liver cancer) do not integrate a number of patient-level factors that affect prognosis and treatment eligibility. Using the ITA.LI.CA dataset, prospectively collected from 5,290 consecutive patients with HCC from 19 institutions in Italy, Vitale and colleagues created an ITA.LI.CA staging system using tumor characteristics, and then developed a parametric multivariable survival model integrating ITA.LI.CA stage, Eastern Cooperative Oncology Group performance status, Child-Pugh score, and alpha-fetoprotein. The resulting prognostic score had concordance indices of 0.71 and 0.78 in internal (a subset of ITA.LI.CA) and external (Taiwanese, n=2,651) validation cohorts, respectively, and compared favorably (p < 0.001) to other prognostic systems for HCC (BCLC, HKLC, MESIAH, CLIP, JIS). Moreover, it allows a simple but accurate clinical description of each HCC patient, with the potential to be used for deciding treatment or designing clinical trials.
Prospective trials beyond the two populations studied are needed to validate the generalizability of the ITA.LI.CA prognostic score.
Nonetheless, strong performance in two distinct cohorts suggests that Vitale and colleagues have developed a promising tool. In a Perspective on the study, Neehar Parikh of University of Michigan, Ann Arbor, Michigan (US) and Amit Singal of UT Southwestern Medical Center, Dallas, Texas (US) (both uninvolved in the study) discuss why ITA.LI.CA is timely and provides an advance, and propose next steps. On this study's impact, they say, "[t]his system is an important iteration in the evolution of staging for HCC, and, while it enters a crowded field, the ITA.LI.CA staging system is a worthy entrant."
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Research Article
Funding:
The authors received no specific funding for this work.
Competing Interests:
I have read the journal's policy and the authors of this manuscript have the following competing interests: EG has received teaching and travel grants from Bayer AG. FP has received from Bayer and Bracco travel grants and honoraria for speaking or participation at meetings.
Citation:
Farinati F, Vitale A, Spolverato G, Pawlik TM, Huo T-l, Lee Y-H, et al. (2016) Development and Validation of a New Prognostic System for Patients with Hepatocellular Carcinoma. PLoS Med 13(4): e1002006. doi:10.1371/journal.pmed.1002006
Author Affiliations:
Department of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy
Department of Surgery, Johns Hopkins Hospital, Baltimore, Maryland, United States of America
National Yang-Ming University, Taipei City, Taiwan
Department of Medicine, Taipei Veterans General Hospital, Taipei City, Taiwan
Biostatistics Unit, University of Padua, Padua, Italy
Gastroenterology Unit, Department of Internal Medicine, IRCCS Azienda Ospedaliera Universitaria San Martino IST, University of Genoa, Genoa, Italy
Division of Surgery, San Marco Hospital, Zingonia, Italy
Division of Internal Medicine, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy
Division of Internal Medicine and Gastroenterology, Complesso Integrato Columbus, Università Cattolica del Sacro Cuore, Rome, Italy
Division of Medicine, Bolognini Hospital, Seriate, Italy
Division of Gastroenterology, Belcolle Hospital, Viterbo, Italy
Division of Radiology, Department of Medicine, Fatebenefratelli Hospital, Milan, Italy
Division of Gastroenterology, Biomedical Department of Internal and Specialistic Medicine, University of Palermo, Palermo, Italy
Division of Gastroenterology, Bolzano Regional Hospital, Bolzano, Italy
Division of Gastroenterology and Metabolic Diseases, University Hospital of Pisa, Pisa, Italy
Division of Gastroenterology, Department of Medicine and Surgery, University of Naples Federico II, Naples, Italy
Division of Infectious Diseases and Hepatology, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy
Department of Internal Medicine, Ospedale per gli Infermi di Faenza, Faenza, Italy
Division of Internal Medicine and Gastroenterology, Fondazione Policlinico Universitario A. Gemelli, Università Cattolica del Sacro Cuore, Roma, Italy
Division of Gastroenterology, Polytechnic University of Marche, Ancona, Italy
Division of Internal Medicine 2, Ospedali Riuniti Villa Sofia Cervello, Palermo, Italy
Gastroenterology Unit, Ospedale Sacro Cuore Don Calabria, Negrar, Italy
Division of Semeiotics, Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy
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Contact:
Alessandro Vitale, MD, PhD
Azienda Ospedaliera Universitaria di Padova
Unità di Chirurgia Epatobiliare e Trapianto Epatico
via Giustiniani 2
Padova 35128
ITALY
+39 049/821-8548
alessandro.vitale@unipd.it
Journal
PLOS Medicine