RATIONALE AND OBJECTIVES: The aim of this study was to compare tumor changes in patients with hepatocellular carcinoma receiving sorafenib using evaluation criteria of the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) as opposed to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
MATERIALS AND METHODS: Twenty-five patients with inoperable hepatocellular carcinoma receiving oral sorafenib underwent magnetic resonance imaging at baseline and follow-up every 8 weeks (range, 2-19 weeks; mean, 7.6 weeks). Data were evaluated retrospectively. Survey time until progression ranged from 5 to 102 weeks (mean, 25.6 weeks), with a total of 54 target lesions being monitored. Additionally, evaluation of serum α-fetoprotein was performed at follow-up.
RESULTS: The best response at follow-up using RECIST resulted in rates of 4% objective response (complete remission or partial remission), 24% (progressive disease), and 72% (stable disease). In contrast, AASLD and EASL criteria identified objective responses in 28% and 48%. Twenty percent of all patients classified as having progressive disease by RECIST were identified as having "pseudo"-progression due to extensive necrosis. Eleven percent of patients classified as having stable disease by RECIST were disclosed as essentially progressive. AASLD area and AASLD diameter disclosed 36% and 40% of patients as having partial remission, respectively, whereas EASL criteria discovered only 24%. There was no significant correlation between serum ?-fetoprotein progression and AASLD, EASL, or RECIST evaluation criteria.
CONCLUSIONS: Response monitoring via functional criteria such as AASLD or EASL criteria is likely to more accurately reflect vital tumor burden in hepatocellular carcinoma compared to RECIST.