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Blood, 15 August 2006, Vol. 108, No. 4, pp. 1158-1164.
Prepublished online as a Blood First Edition Paper on April 11, 2006; DOI 10.1182/blood-2006-02-004572.
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Submitted February 21, 2006
Accepted March 24, 2006
Lenalidomide therapy in myelofibrosis with myeloid metaplasia
Ayalew Tefferi*, Jorge Cortes, Srdan Verstovsek, Ruben A Mesa, Deborah Thomas, Terra L Lasho, William J Hogan, Mark R Litzow, Jacob B Allred, Dan Jones, Catriona Byrne, Jerome B Zeldis, Rhett P Ketterling, Rebecca F McClure, Francis Giles, and Hagop M Kantarjian
Mayo Clinic, Rochester, MN
The University of Texas, MD Anderson Cancer Center, Houston, TX
Celgene Corporation, Summit, NJ
* Corresponding author; email: tefferi.ayalew{at}mayo.edu.
We present results of two similarly designed but separate phase II studies, involving single agent lenalidomide (CC-5013, Revlimid ® ), in a total of 68 patients with symptomatic MMM. Protocol treatment consisted of oral lenalidomide at 10 mg/day (5 mg/day if baseline platelet count < 100 x 109/L) for 3-4 months with a plan to continue treatment for either 3 or 24 additional months, in case of response. Overall response rates were 22% for anemia, 33% for splenomegaly, and 50% for thrombocytopenia. Response in anemia was deemed impressive in 8 patients who normalized their hemoglobin from a baseline of either transfusion dependency or hemoglobin level < 10 g/dL. Additional treatment effects in these patients included resolution of leukoerythroblastosis (4 patients), a decrease in medullary fibrosis and angiogenesis (2 patients), and del(5)(q13q33) cytogenetic remission accompanied by a reduction in JAK2V617F mutation burden (1 patient). Grade 3 or 4 adverse events included neutropenia (31%) and thrombocytopenia (19%). We conclude that lenalidomide engenders an intriguing treatment activity, in a subset of patients with MMM, that includes an unprecedented effect on peripheral blood and bone marrow abnormalities.
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