Risk of hepatocellular cancer in patients with non-alcoholic fatty liver disease
Open accessAbstract
BACKGROUND & AIMS: There are limited data on the risk of hepatocellular cancer (HCC) in patients with non-alcoholic fatty liver disease (NAFLD). We aimed to estimate the risk of incident HCC among patients with NAFLD. METHODS: We conducted a retrospective cohort study from a total of 130 facilities in the Veterans Health Administration. Patients with NAFLD diagnosed between January 1, 2004 and December 31, 2008 were included and followed until HCC diagnosis, death, or December 31, 2015. We also identified a sex- and age-matched control cohort without NAFLD. We ascertained all new HCC cases from the Central Cancer Registry and manual chart reviews. We calculated incidence rates for HCC by NAFLD status, as well as in subgroups of NAFLD patients. We used competing risk models to compare the risk of HCC in patients with NAFLD vs those without NAFLD. We reviewed electronic medical records of all HCC cases that developed in NAFLD patients without cirrhosis. RESULTS: We compared 296,707 NAFLD patients with 296,707 matched controls. During 2,382,289 person-years [PYs] of follow-up, 490 NAFLD patients developed HCC (0.21/1000 PYs). HCC incidence was significantly higher among NAFLD patients vs controls (0.02/1000 PYs; hazard ratio, 7.62; 95% confidence interval, 5.76-10.09). Among patients with NAFLD, those with cirrhosis had the highest annual incidence of HCC (10.6/1000 PYs). Among patients with NAFLD cirrhosis, HCC risk ranged from 1.6 to 23.7 per 1000 PYs based on other demographic characteristics; risk of HCC was the highest in older Hispanics with cirrhosis. In medical record reviews, 20% of NAFLD patients with HCC had no evidence of cirrhosis. CONCLUSIONS: Risk of HCC was higher in NAFLD patients than that observed in general clinical population. Most HCC cases in NAFLD developed in patients with cirrhosis. The absolute risk of HCC was higher than the accepted thresholds for HCC surveillance for most patients with NAFLD cirrhosis.
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In the national Veterans Affairs study, a FIB-4 > 2.67, suggestive of advanced fibrosis (F3/F4), was associated with an increased risk of HCC (0.39/1,000 vs. 0.04/1,000 person-years in individuals with persistently low FIB-4) in the absence of cirrhosis.
“In the national Veterans Affairs study, a FIB-4 > 2.67, suggestive of advanced fi brosis (F3/ F4), was associated with an increased risk of HCC (0.39/1,000 vs . 0.04/1,000 PY in individuals with persistently low FIB-4) in the absence of cirrhosis. 244”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [244]
The Results (Sensitivity and Subgroup Analyses) report the stated HCC rates: 0.39 versus 0.04 per 1,000 person-years for high versus persistently low FIB-4. But these groups lacked a *documented cirrhosis diagnosis*, not necessarily cirrhosis itself; the same section reports that chart review found cirrhosis or possible cirrhosis in some patients without a documented diagnosis. (LLM, conf=0.86)
Experimental — accuracy not yet measuredThe HCC incidence in individuals without cirrhosis is very low, ranging from 0.08 to 0.63 per 1,000 person-years.
“the HCC incidence in individuals without cirrhosis is very low, ranging from 0.08 to 0.63 per 1,000 PY. 240 -244”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [244]
The Results (Sensitivity and Subgroup Analyses; page unavailable) report a low HCC incidence of 0.08 per 1,000 person-years in NAFLD patients without cirrhosis. The cited paper does not give the claimed upper endpoint of 0.63 per 1,000 person-years, so it supports the low incidence and lower endpoint but not the full range. (LLM, conf=0.88)
Experimental — accuracy not yet measuredStudies in MASLD indicate an elevated HCC risk with FIB-4 > 3.25 (risk > 1%/year) or change of LSM over time in individuals with histologic diagnosis of F3-F4 fibrosis and/or baseline LSM > 10 kPa (HR 1.72) in individuals without cirrhosis.
“Studies in MASLD indicate an elevated HCC risk with FIB-4 > 3.25 (risk > 1%/year) 244 or change of LSM over time in individuals with histologic diagnosis of F3-F4 fi brosis and/or baseline LSM > 10 kPa (HR 1.72) 185 in individuals without cirrhosis.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [244]
For the FIB-4 claim attached to this citation, the Methods (Variable Specification; page unavailable) use a high FIB-4 cutoff of ≥2.67, not >3.25. The Results (Sensitivity and Subgroup Analyses; page unavailable) report elevated HCC risk with high FIB-4, but the risk above 1% per year—13.5 per 1,000 person-years—was in patients with documented cirrhosis. The reported rate for high FIB-4 without a cirrhosis diagnosis was 0.39 per 1,000 person-years. The LSM claim is attached to a different citation and is not assessed here. (LLM, conf=0.90)
Experimental — accuracy not yet measuredFactors associated with a higher risk of HCC occurrence in MASLD include presence and duration of T2D, obesity or both, older age, concurrent alcohol intake and/or smoking, FIB-4 > 3.25, and LSM > 10 kPa and increasing change in LSM.
“Table 8. Factors associated with a higher risk of HCC occurrence in MASLD.”
From EASL-EASD-EASO Clinical Practice Guidelines on the management of metabolic dysfunction-associated steatotic liver disease (MASLD). (2024) · cites this paper as [244]
The Discussion reports higher HCC risk in older patients with NAFLD, and the Results associate high FIB-4 with higher risk. The paper uses a FIB-4 cutoff of ≥2.67, not >3.25. It does not establish the claimed effects of diabetes duration, obesity, concurrent alcohol intake or smoking in this population, or report LSM thresholds or changes. (LLM, conf=0.89)
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- Authors
- Kanwal, F., Kramer, J. R., Mapakshi, S., Natarajan, Y., Chayanupatkul, M., Richardson, P. A., Li, L., Desiderio, R., Thrift, A. P., Asch, S. M., Chu, J., & El-Serag, H. B.
- Affiliations
- Michael E. DeBakey VA Medical Center (US)
- The University of Texas MD Anderson Cancer Center (US)
- VA Palo Alto Health Care System (US)
- Corresponding author
- Kanwal, Fasiha
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2018-12
- Volume
- 155
- Issue
- 6
- Pages
- 1828-1837.e2
- ISSN
- 0016-5085 (ISSN-L)
- PMC
- PMC6279617
- OpenAlex
- W2888259312
- Cited by
- 795
- References
- 28
- Citations by year
- 2026: 58 · 2025: 106 · 2024: 120 · 2023: 124 · 2022: 129 · 2021: 105 · 2020: 95 · 2019: 54 · 2018: 3
- FWCI
- 50.17
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Gastroenterology (acceptedVersion, cc-by)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Naval Medical Center San Diego
- National Institute of Diabetes and Digestive and Kidney Diseases (P30 DK 56338)
- Cancer Prevention and Research Institute of Texas (RP150587)
- Topics
- Health Sciences › Medicine › Epidemiology › Liver Disease Diagnosis and Treatment
- Health Sciences › Medicine › Hepatology › Hepatocellular Carcinoma Treatment and Prognosis
- Health Sciences › Medicine › Hepatology › Hepatitis C virus research
- Keywords
- hepatocellular carcinoma, non-alcoholic fatty liver disease, HCC incidence, liver cirrhosis, HCC surveillance, veterans, Hispanic patients, competing risk model, HCC risk stratification, HCC mortality
- MeSH terms
- Adult, Female, Carcinoma, Hepatocellular, Humans, Liver Cirrhosis, Liver Neoplasms, Male, Middle Aged, Retrospective Studies, Risk Factors, Incidence, Proportional Hazards Models, Case-Control Studies, Non-alcoholic Fatty Liver Disease
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