BACKGROUND. Reported rates of hepatocellular carcinoma (HCC) for LR-2 and LR-3 observations are generally greater than those expected on the basis of clinical experience, possibly reflecting some studies' requirement for pathologic reference. OBJECTIVE. The purpose of this study was to determine rates of progression to higher LI-RADS categories of LR-2 and LR-3 observations in patients at high risk of HCC. METHODS. This retrospective study included 91 patients (64 men, 27 women; mean age, 62 years) at high risk of HCC who had clinically reported LR-2 (n = 55) or LR-3 (n = 36) observations on MRI who also underwent follow-up CT or MRI at least 12 months after the observation was made. A study coordinator annotated the location of a single LR-2 or LR-3 observation per patient on the basis of the clinical reports. Using LI-RADS version 2018 criteria, two radiologists independently assigned LI-RADS categories on the follow-up examinations. Progression rates from LR-2 or LR-3 to higher categories were determined. A post hoc consensus review was performed of observations that progressed to LR-4 or LR-5. Subgroup analyses were performed with respect to presence of prior HCC (n = 34) or a separate baseline LR-5 observation (n = 12). RESULTS. For LR-2 observations, the rate of progression to LR-4 was 0.0% (95% CI, 0.0-6.7%) and to LR-5 was 3.6% (95% CI, 0.4-13.1%) for both readers. For LR-3 observations, the rate of progression to LR-4 was 22.2% (95% CI, 9.6-43.8%) and to LR-5 was 11.1% (95% CI, 3.0-28.4%) for both readers. Fourteen observations progressed to LR-4 or LR-5 for both readers. Post hoc analysis revealed no instances of progression from LR-2 to LR-4; two, from LR-2 to LR-5; eight, from LR-3 to LR-4; and four, from LR-3 to LR-5. The progression rate from LR-3 to LR-5 was higher (p < .001) among patients with (100.0%) than those without (3.0%) a separate baseline LR-5 observation for both readers. The progression rate from LR-2 to LR-5 was not associated with a separate baseline LR-5 observation for either reader (p = .30). Progression rates were not different (p > .05) between patients with versus those without prior HCC. CONCLUSION. On the basis of progression to LR-4 or LR-5, LR-2 and LR-3 observations had lower progression rates than reported in studies incorporating pathology results in determining progression. CLINICAL IMPACT. The findings refine understanding of the clinical significance of LR-2 and LR-3 observations.
Keywords: LI-RADS; LR-2; LR-3; diagnostic accuracy; hepatocellular carcinoma.