[Complete response after sorafenib therapy plus zoledronic acid for advanced hepatocellular carcinoma with bone...

Sorafenib is an oral multi-kinase inhibitor that targets tumor growth and angiogenesis signal transduction pathways. Two global phase III trials showed that sorafenib prolonged the survival of patients with advanced hepatocellular carcinoma (HCC). Based on the positive results of these trials, Japan approved sorafenib for advanced HCC in May 2009. However, in the SHARP trial and the Asia-Pacific trials, no cases of complete response(CR)were reported. Thereafter, only a relatively small number of CR cases were reported for sorafenib therapy. We herein report the case of a 64-year-old Japanese man infected with hepatitis B virus who developed bone metastasis 9 months after resection of HCC. Sorafenib therapy plus zoledronic acid was initiated. The patient achieved a CR after 15 months of therapy, and there has been no sign of recurrence 12 months following cessation of administration. Regarding toxicity, the patient developed a grade 2 hand foot skin reaction that required a temporary 50% dose reduction of sorafenib. To our knowledge, this is the first case of CR in advanced HCC with bone metastasis treated with sorafenib plus zoledronic acid.