title: Lack of evidence that adherence to standard of care therapy improves survival in subjects with hepatocellular carcinoma in clinical practice.
abstract: Currently, the BCLC classification, which links tumor stage with treatment option, is the standard system for clinical management of HCC. Thus far, this approach has been considered the standard of care worldwide. This study aimed to evaluate the survival of patients with HCC according to the BCLC Stage, surveillance, and adherence to standards of care. A 3-year prospective study enrolled 92 consecutive patients with HCC in the Gastroenterology Unit of the University of Naples "Federico II". Predictors of the likelihood of death were evaluated by the multivariate Cox model. Forty out of 92 (43%) subjects died during three years of follow up. The overall mortality rate per 100 person-years was 16.7, while the mortality rate for hepatic causes was only 14.2; it was lower in subjects under surveillance (11.4 vs. 28.2), in subjects adherent to standards of care (12.0 vs. 21.1), and in those who were in a better BCLC stage (10.6 vs. 45.8). The multivariate Cox model showed that advanced BCLC stage (HR 4.1, 95% C.I. = 1.8-9.4) was the sole independent predictor of the likelihood of mortality. In this regard, we observed lack of evidence that the adherence to the BCLC recommendations reduces the mortality of patients with HCC; and that the BCLC system cannot be accepted as a "commandment" to be invariably followed in everyday practice. Strategies to help improve adherence to international guidelines for HCC in clinical practice are required.
authors: Department of Clinical Medicine and Surgery, Gastroenterology Unit, University of Naples "Federico II", Italy.
authors: Maria
authors: M
authors: Guarino
authors: Department of Infectious and Tropical Diseases, University "La Sapienza" Rome, Italy.
authors: Tommaso
authors: T
authors: Stroffolini
authors: National Centre for Epidemiology, Surveillance and Health Promotion, National Institute of Health, Rome.
authors: Flavia Lucia
authors: FL
authors: Lombardo
authors: Department of Clinical Medicine and Surgery, Gastroenterology Unit, University of Naples "Federico II", Italy.
authors: Ilaria
authors: I
authors: Loperto
authors: Department of Clinical Medicine and Surgery, Gastroenterology Unit, University of Naples "Federico II", Italy.
authors: Francesco
authors: F
authors: Auriemma
authors: Department of Public Medicine and Social Security, Section of Infectious Diseases, University of Naples "Federico II", Italy.
authors: Ivan
authors: I
authors: Gentile
authors: Department of Clinical Medicine and Surgery, Gastroenterology Unit, University of Naples "Federico II", Italy.
authors: Nicola
authors: N
authors: Caporaso
authors: Department of Clinical Medicine and Surgery, Gastroenterology Unit, University of Naples "Federico II", Italy.
authors: Filomena
authors: F
authors: Morisco
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000401:mortality* / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D019983:Guideline Adherence; D006801:Humans; D007558:Italy; D008113:Liver Neoplasms / Q000401:mortality* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D059039:Standard of Care; D016019:Survival Analysis; D016896:Treatment Outcome
keywords: hepatocellular carcinoma; standard of care; surveillance; survival