Sequential azacitidine plus lenalidomide in previously treated elderly patients with acute myeloid leukemia and higher risk myelodysplastic syndrome. Issue 3 (3rd March 2016)

• Record Type: Journal Article
• Authors: Narayan, Rupa; Garcia, Jacqueline S.; Percival, Mary-Elizabeth M.; Berube, Caroline; Coutre, Steve; Gotlib, Jason; Greenberg, Peter; Liedtke, Michaela; Hewitt, Rhonda; Regan, Kathleen; Williamson, Charles; Doykan, Camille; Cardone, Michael H.; McMillan, Alex; Medeiros, Bruno C.
• Is Part Of: Leukemia & lymphoma. Volume 57:Issue 3(2016:Mar.)
• Page Start: 609
• Page End: 615
• Publication Date: 2016-03-03
• Subjects: Hypomethylating agent failure -- azacitidine -- lenalidomide -- AML -- MDS -- azanucleosides; Leukemia -- Periodicals; Lymphomas -- Periodicals; 616.99419
• DOI: 10.3109/10428194.2015.1091930
• Languages: English
• ISSNs: 1042-8194

Abstract

Abstract: The outcome of sequential azacitidine with lenalidomide has not been reported in previously treated patients with acute myeloid leukemia (AML) and higher risk myelodysplastic syndrome (MDS). This study describes a phase 2 study evaluating the safety and efficacy of this combination in elderly patients with AML and MDS with prior hypomethylating agent (HMA) and/or immunomodulatory agent exposure. Patients were treated on a 42-day cycle with azacitidine at 75 mg/m 2 SQ/IV daily on days 1–7, followed by lenalidomide 50 mg orally daily on days 8–28. The median number of treatment cycles on study was two (range = 1–11). Of 32 evaluable patients, the overall response rate was 25%. Neutropenic fever was the most common serious adverse event, but overall the combination was well-tolerated. The median overall survival (OS) for responders vs non-responders was 9.8 vs 4.0 months, respectively (HR = 0.36, p = 0.016). In conclusion, this combination demonstrated modest clinical activity in this poor risk population.