Lenalidomide modestly effective in second-line treatment of advanced HCC
Lenalidomide as second-line agent in the treatment of advanced hepatocellular carcinoma (HCC) is safe and demonstrates moderate activity, according to a study.
The study included 55 advanced HCC patients with documented progression on sorafenib and Child-Pugh class A liver function. All patients were given oral lenalidomide 25 mg daily on days 1 to 21 every 4 weeks.
Assessments included survival, early α-fetoprotein response (defined as a >20-percent decline of α-fetoprotein levels from baseline within the first 4 weeks of treatment), vascular response (defined as a >40-percent decline in Ktrans after 2 weeks of treatment) and percentage of peripheral blood lymphocyte subsets.
Response and disease-control rates were 13 and 53 percent, respectively. The primary endpoint of 6-month progression-free survival rate was 9.1 percent. Median progression-free survival was 1.8 months, while median overall survival was 8.9 months.
Early α-fetoprotein response showed a significant association with higher disease-control rate (p=0.001) and longer progression-free survival (p=0.020). On the other hand, vascular response was not associated with any treatment outcomes.
High pretreatment B cell percentage was associated with a higher likelihood of having disease control (70 vs 36 percent; p=0.010) and longer progression-free (p<0.001) and overall survival (p=0.042).
In terms of safety, 26 patients needed dose interruption and 10 needed dose reduction. The most frequently reported reasons for interruption and reduction were neutropaenia and elevated transaminase level. Hyperbilirubinaemia and neutropaenia resulted in treatment discontinuation in three patients.
“The short progression-free survival found in our study indicated that resistance to lenalidomide therapy may develop rapidly, and combination therapy must be explored to provide more sustained therapeutic benefit,” researchers said.