Nexavar

From May 2009 to June 2010, 38 patients with refractory HCC uncontrolled with standard therapeutic modalities received sorafenib (Nexavar; Bayer HealthCare Pharmaceuticals‐Onyx Pharmaceuticals, Leverkusen, Germany) at Kindai University. All pathological specimens of HCC were collected using needle biopsy before sorafenib treatment. Demographic profiles of patients were previously described.21 In addition, liver specimens were collected with needle biopsy in 13 patients who were clinically suspected of non‐alcoholic steatohepatitis. The study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki and was approved by the institutional review boards. Written informed consent was obtained from all patients for subsequent use of their resected tissues.
The eligibility criteria for sorafenib therapy were previously described.16 Sorafenib was administered orally at a daily dose of 800 mg divided into two equal doses. Treatment interruptions and up to two dose reductions (first to 400 mg once daily, followed by 400 mg every 2 days) were permitted for drug‐related adverse effects (National Cancer Institute‐Common Terminology Criteria [NCI‐CTC, version 3]). Treatment was continued until the occurrence of radiologic progression, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST, Version1.1).

Sorafenib (Nexavar; Bayer Healthcare Pharmaceuticals, Leverkusen, Germany) was administered orally to patients, initially at a dose of 400 mg, twice daily. All patients received sorafenib until unacceptable toxicity or patient refusal. The dosage of sorafenib could be reduced if grade 2 or 3 toxicity persisted.