Purpose: Sorafenib is an oral multikinase inhibitor of the vascular endothelial growth factor receptor, the platelet-derived growth factor receptor and Raf with demonstrated efficacy as first-line therapy for patients with inoperable hepatocellular carcinoma (HCC). We reported the preliminary results of this treatment to evaluate its safety, tolerability, and efficacy in patients with inoperable HCC.
Patients and Methods: Patients with inoperable HCC and a Karnofsky performance status (KPS) of ≥70, Child- Pugh (CP) score of A or B, an elevated alphafetoprotein (AFP) level and adequate hematologic, renal and hepatic functions; were enrolled. No Prior therapy was permitted. The regimen was sorafenib at a dose of 400 mg bid, given 7 days per week. Treatment was maintained until disease progression or unacceptable toxicity.
Results: Twenty one patients with a median age of 53 years (range, 39-73 years) were accrued at Clinical Oncology Department, Faculty of Medicine, Tanta University Hospital, Egypt and King Abd-Elaziz Hospital, Gedah, KSA. Previously, no Prior therapy was permitted. All patients who were entered on the study were assessable for toxicity and response of sorafenib. There were 2 clinical responses (9.5%) and another 8 (38.1%) had stable disease. Disease control rate was 47.6%. No Grade 3-4 hematologic toxicities were recorded. The most common grade 3-4 non-hematological toxicities were fatigue in 3 patients (14.3%), hand-foot skin reaction (HFS) in 2 patients (9.5%) and Diarrhea in 2 patients (9.5%).The estimated median progression-free and median overall survival times were 4 and 9 months, respectively, and the 1-year overall survival rate was 38.1%. There was no treatment-related death.
Conclusion: The results of this study suggested that, in the population with inoperable HCC, daily sorafenib regimen had good clinical activity with an acceptable toxicity.