Lenalidomide for second-line treatment of advanced hepatocellular cancer (HCC): A Brown University Oncology Group phase II study.

4098 Background: Lenalidomideinhibits fibroblast growth factor(FGF), vascular endothelial growth factor (VEGF) and multiple tumor growth pathways. There is no standard of care for patients who progress after sorafenib. Therefore, we performed a phase II study to determine the activity of lenalidomidein second-line HCC therapy. Methods: Patients with advanced HCC who progressed on or were intolerant to sorafenibwere eligible. Prior chemoembolization, RFA, or surgery were allowed. Eligibility criteria also included bilirubin 60,000/mm3, absolute neutrophil count>1000/mm3, and creatinine <2mg/dL. Patients were treated with lenalidomide25mg orally days 1-21 of a 28 day cycle until disease progression or unacceptable toxicities. The planned original sample size was 25 patients but when early activity was demonstrated the study was expanded to 40 patients. Results: The study has completed accrualof 40 patie...