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Leukemia & Lymphoma Volume 57, 2016 - Issue 3
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Original Articles: Clinical

Sequential azacitidine plus lenalidomide in previously treated elderly patients with acute myeloid leukemia and higher risk myelodysplastic syndrome

Rupa NarayanDivision of Hematology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA,
,
Jacqueline S. GarciaDivision of Hematologic Malignancies, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA,
,
Mary-Elizabeth M. PercivalDivision of Hematology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA,
,
Caroline BerubeDivision of Hematology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA,
,
Steve CoutreDivision of Hematology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA,
,
Jason GotlibDivision of Hematology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA,
,
Peter GreenbergDivision of Hematology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA,
,
Michaela LiedtkeDivision of Hematology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA,
,
Rhonda HewittDivision of Hematology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA,
,
Kathleen ReganDivision of Hematology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA,
,
Charles WilliamsonDivision of Hematology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA,
,
Camille DoykanEutropics Pharmaceuticals, Cambridge, MA, USA, and
,
Michael H. CardoneEutropics Pharmaceuticals, Cambridge, MA, USA, and
,
Alex McMillanDepartment of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA
&
Bruno C. MedeirosDivision of Hematology, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA, Correspondence[email protected]
 show all
Pages 609-615 | Received 27 May 2015, Accepted 29 Aug 2015, Published online: 13 Oct 2015
 
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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/m2 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.

Acknowledgments

The authors appreciate discussion with William Pierceall on BH3 profiling theory and data interpretation. R.N. is supported by the Stanford Cancer Center Fellowship Award and the TL1 component of the Stanford Clinical and Translational Science Award to Spectrum (NIH TL1 TR 001084). J.S.G. is supported by a Career Development Award for Special Fellows in Clinical Research from The Leukemia & Lymphoma Society and a Conquer Cancer Foundation of ASCO Young Investigator Award, supported by Mr Aaron Sasson. Any opinions, findings and conclusions expressed in this material are those of the authors and do not necessarily reflect those of the American Society of Clinical Oncology®, the Conquer Cancer Foundation or Mr Aaron Sasson. M.E.M.P. is supported by a Conquer Cancer Foundation of ASCO Young Investigator Award and a KL2 Mentored Career Development Award of the Stanford Clinical and Translational Science Award to Spectrum (NIH KL2 TR 001083). This study was funded by Celgene.

Potential conflict of interest

B.C.M. receives research support from Celgene. B.C.M. receives consultation funds from Celgene. C.D. and M.H.C. are employees of and hold equity in Eutropics Pharmaceuticals. Disclosure forms provided by the authors are available with the full text of this article at www.informahealthcare.com/lal

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