Complete response under sorafenib in patients with hepatocellular carcinoma: Relationship with dermatologic adverse events

Background-aims: The clinical benefit of sorafenib in patients with hepatocellular carcinoma (HCC) has been undervalued due to the absence of complete responses even though patients who develop early dermatologic reactions have shown very positive outcome. In addition, sorafenib is described as an antiangiogenic drug, but it also acts on immunological cells. Thus, the aim is to assess the complete response rate in a retrospective cohort of HCC patients treated with sorafenib and to describe the profile of the patients who achieve complete response for identifying factors related to this event and their connection with the immunological profile of sorafenib. Methods: Ten Spanish centres submitted cases of complete response under sorafenib. The baseline characteristics, development of early dermatologic reactions and cause of treatment discontinuation were annotated. Radiological images pre-sorafenib, at first control, after starting sorafenib, at the time of complete response and at least 1 month after, were centrally reviewed. Results: 20/1119 patients had been classified as complete responders by the centres, but 8 were excluded after central review. Ten patients had complete disappearance of all tumor sites and two had just a small residual fibrotic scar. Thus, 12 patients were classified as complete responders [58% HCV, median age 59.7 years, 83.4% Child-Pugh A, ECOG-PS 0 91.7% and BCLC-C 83.3%]. Median overall survival and treatment duration were 85.8 and 40.1 months respectively. All but one patient, developed early dermatologic reactions and 7 patients discontinued sorafenib after achieving complete response due to adverse events, patient decision or liver decompensation. Conclusion: Complete response affects 1% of the patients. Its association with early dermatologic reactions supports the role of a specific immune/inflammatory patient profile in the improved response to sorafenib This article is protected by copyright. All rights reserved.