Department of Medicine, Division of Gastroenterology, Department of Obstetrics and Gynecology, University of British Columbia, Canada.
Sorafenib, an oral multityrosine kinase inhibitor, has been approved for treatment of unresectable hepatocellular carcinoma (HCC). British Columbia (BC) was the first province in Canada to provide drug coverage for sorafenib.
To review the BC experience with sorafenib to assess its effectiveness and tolerance in a 'real-world' clinical setting.
A retrospective clinic chart review identified 99 patients referred to the BC Cancer Agency from 2008 to 2010 with a diagnosis of HCC who qualified for treatment with sorafenib.
Therapy with sorafenib was initiated and continued at a reduced dosage of 400 mg⁄day in 66 of 99 patients, with 22 patients requiring further dose reduction. Full- and reduced-dose group patients had similar baseline characteristics, except for a higher proportion of female patients (P=0.02) and individuals with alcoholic liver disease (P=0.04) in the full-dose group. The incidence of any grade of adverse effects was higher in the full-dose group (94% versus 77% in the reduced-dose group; P=0.04). Dose reduction rates were significantly higher in the full-dose group, occurring in 66% versus 24% of reduced-dose group patients (P=0.001). The overall survival rates were similar between the two groups: 7.8 months versus 7.1 months in full- versus reduced-dose groups (P=0.14), as were radiological progression rates and alpha-fetoprotein levels.
In a review of 99 patients in a 'real-world' community setting, a sorafenib dose of 400 mg⁄day was better tolerated and had similar efficacy compared with a sorafenib dose of 800 mg⁄day with respect to survival and outcomes.