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Lenalidomide for Second-line Treatment of Advanced Hepatocellular Cancer: A Brown University Oncology Group Phase II Study

Safran, Howard MD*; Charpentier, Kevin P. MD*; Kaubisch, Andreas MD; Mantripragada, Kalyan MD, MPH*; Dubel, Gregory MD*; Perez, Kimberly MD*; Faricy-Anderson, Katherine MD*; Miner, Thomas MD*; Eng, Yoko ANP; Victor, Joel MD; Plette, Angela MD*; Espat, Joseph MD*; Bakalarski, Pamela CCRP, MPA*; Wingate, Patti BS*; Berz, David MD*; Luppe, Denise BSN*; Martel, Diane RN*; Rosati, Kayla EdM*; Aparo, Santiago MD

American Journal of Clinical Oncology: February 2015 - Volume 38 - Issue 1 - p 1–4
doi: 10.1097/COC.0b013e3182868c66
Original Articles: Gastrointestinal

Purpose: To assess the activity and toxicity of lenalidomide for patients with advanced hepatocellular cancer (HCC) previously treated with sorafenib.

Materials and Methods: Patients with advanced HCC who progressed on or were intolerant to sorafenib were eligible. Patients received lenalidomide 25 mg orally for 1 to 21 days in a 28-day cycle until disease progression or unacceptable toxicities.

Results: Forty patients were enrolled and were classified according to the Child-Pugh score: 19 were Child-Pugh A, 16 patients were Child-Pugh B, and 5 were Child-Pugh C. Seventeen patients had extrahepatic disease. Grade 4 neutropenia occurred in 1 of 40 patients (2.5%). Grade 3 fatigue (n=3) and rash (n=4) were the most common nonhematologic toxicities attributable to lenalidomide. Six of 40 patients (15%) had a partial response. Two patients (5%) have not progressed at 36 and 32 months. The median progression-free survival was 3.6 months and the median overall survival was 7.6 months.

Conclusions: Lenalidomide can be administered to patients with advanced HCC and hepatic dysfunction. Promising, and in a small percentage of patients, durable activity has been demonstrated. Investigations are needed to explore the mechanism of action of lenalidomide in HCC.

*Brown University Oncology Group, Providence RI

Montefiore Medical Center, Bronx, NY

Supported in part by Celgene Corporation.

Presented in poster presentation at the 2012 annual American Society of Clinical Oncology meeting.

The authors declare no conflicts of interest.

Reprints: Howard Safran, MD, Department of Medicine, The Miriam Hospital, 168 Summit Ave. Providence, RI 02906. E-mail:

© 2015 by Lippincott Williams & Wilkins, Inc