Sorafenib-Related Adverse Events in Predicting the Early Radiologic Responses of Hepatocellular Carcinoma.

BACKGROUND

Hepatocellular carcinoma (HCC) has a poor prognosis with low chemotherapeutic efficiency to medications except to sorafenib. Previous studies showed that adverse events (AEs) of sorafenib can predict therapy efficacy to HCC. The aim of the study is to evaluate the early efficacy and AEs of sorafenib therapy.

METHODS

The database of HCC patients receiving sorafenib at Taichung Veterans General Hospital during the period from June 2012 to October 2016 was analyzed. All HCC cases were Barcelona Clinic Liver Cancer (BCLC) classification stage C. The early efficacy of sorafenib was classified according to the mRECIST criteria as either partial response (PR), stable disease (SD) or progressive disease (PD). Responses were recorded within 6 weeks after the start of sorafenib treatment. AEs were defined as the appearance of hand-foot skin reaction (HFSR), hypertension (HTN) and diarrhea. Exclusion criteria were poor performance status, poor drug compliance, discontinued follow-up or mortality occurring within 1 day after medication.

RESULTS

From a total of 222 subjects, eight cases (3.6%) were classified as PR, 82 cases (36.9%) SD, and 132 cases (59.5%) PD. The PR group had the highest ratio of HFSR (62.4%) and hypertension (37.5%). Pooling cases of PR and SD together, the presence of HFSR adjusted odd ratio (aOR) 2.80, 95% confidence interval (CI) 1.52 - 5.16) and diarrhea (aOR 3.42, 95% CI 1.67 - 7.01) were good predictors of favorable responses to sorafenib therapy.

CONCLUSIONS

HFSR and diarrhea are good predictors of early therapy efficacy to the sorafenib treatment.