Is Sorafenib an acceptable treatment possibility for patients with advanced hepatocellular carcinoma?

Aims: Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide with an increasing incidence. For patients with advanced HCC Sorafenib is the treatment of choice since the SHARP study showed a survival benefit however daily clinical experience suggests that Sorafenib is much less effective than described in the SHARP study. Methods: Retrospectively, we analyzed 112 patients with advanced HCC treated with Sorafenib comparing overall survival (OS), time to progression (TTP) and frequency of adverse events of our study cohort with those of the SHARP and Asia – Pacific study. Patients receiving transarterial chemoembolisation or local ablative therapies in combination with Sorafenib were excluded from the study. Radiologic treatment response was evaluated using the modified RECIST 1.1 criteria. Results: The median duration of Sorafenib treatment was 3 months (0.4–45 months). 77 patients (68.8%) stopped Sorafenib as a result of adverse events.They are comparable to those of the SHARP and Asia- Pacific study with 32.1% of the patients having diarrhea, 15.2% hand-foot-syndrome and 13.4% having fatigue. Weight loss (8%), bleeding (3.6%), nausea and vomiting (5.4%) were less common adverse events. The median OS and TTP in our patients were 9.6 months and 3.9 months respectively. In 75 patients treatment response was evaluated using imaging studies. 24 patients (32.4%) had stable disease whereas in 50 patients (67.6%) disease progression was observed. None of our patients had complete or partial remission.Conclusions: We were able to reproduce the data from the SHARP study concerning OS and TTP. The distribution of adverse events was comparable to those in the SHARP and Asia- Pacific study. With regard to radiologic treatment response our patients reached stable disease less frequent than those in the SHARP and Asia- Pacific study probably as a result of our unselected study cohort. But concerning the endpoints our patients showed similar OS and TTP.

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Sorafenib treatment - advanced hepatocellular carcinoma