Lenalidomide in solid tumors

Background: Lenalidomide is a thalidomide analogue with immunomodulatory and anti-angiogenic properties that include altering cytokine production, activating T cells, and augmenting natural killer cell function. Lenalidomide is approved by the U.S. Food and Drug Administration (FDA) for single-agent treatment of myelodysplastic syndromes associated with a 5q deletion and as a combination therapy with dexamethasone for the treatment of multiple myeloma. Methods: All prospective phase I-III clinical trials and preclinical data published until October 2011 and relevant literature were reviewed. Results: In phase I and/or II studies of single-agent lenalidomide in patients with advanced cancer, responses were reported in patients with prostate, thyroid, hepatocellular, pancreatic, and renal cancer and melanoma. The most common toxicities were hematologic, and in the first clinical trials, thrombotic events were noted. When anticoagulation prophylaxis and exclusion of patients with a history of thrombosis were implemented, thrombotic complications became uncommon. Conclusion: Monitoring of blood counts and for evidence of thromboembolic events is essential for patients treated with lenalidomide. Ongoing trials of lenalidomide combination therapy offer a treatment option for patients with advanced cancer and will better define the role of lenalidomide in solid tumors.