NEW YORK (Reuters Health) - Lenalidomide has “unprecedented” hematologic activity in patients with myelodysplastic syndromes and symptomatic anemia who do not respond to erythropoietin, according to Dr. Alan List, from the H. Lee Moffitt Cancer Center in Tampa, Florida.
Lenalidomide (Revlimid; Celgene), an analogue of thalidomide, has received fast track designation from the U.S. Food and Drug Administration for the treatment of myelodysplastic syndromes and could be available later this year, Dr. List told Reuters Health.
“Refractory anemia resulting from ineffective hematopoiesis is the principal therapeutic challenge for patients with myelodysplastic syndromes,” Dr. List and colleagues note in the February 10th issue of The New England Journal of Medicine.
Recombinant erythropoietin alone or with myeloid growth factors curbs anemia in some patients but is generally ineffective in patients who need multiple red-cell transfusions each month and it rarely leads to cytogenetic remissions.
Dr. List’s team evaluated the efficacy of lenalidomide -- 25 or 10 milligrams daily for 28 days or 10 milligrams daily for 21 days of every 28-day-cycle -- in 43 patients with myelodysplastic syndromes.
“These patients had either failed recombinant erythropoietin or were unlikely to benefit from it due to high endogenous erythropoietin levels or high transfusion burden,” the investigator explained.
Lenalidomide restored red blood cell production in 56% of patients overall, with the majority achieving hemoglobin levels within or near the normal range, eliminating the need for transfusions.
Cytogenetic remissions were observed in 55% of patients, which is “impressive,” the authors of an editorial write.
Patients with a clonal interstitial deletion involving chromosome 5q31.1 were particularly responsive to lenalidomide, with an 83% response rate and a cytogenetic remission rate of 75%.
Neutropenia and thrombocytopenia, the two most common side effects, occurred in 65% and 74% of subjects, respectively, and necessitated treatment interruption or dose reduction in 58%. “Patients on lenalidomide need to be closely monitored for neutropenia and thrombocytopenia, which appear to be dose-dependent,” Dr. List said.
Drs. Mario Cazzola and Luca Malcovati from the University of Pavia in Italy note in an editorial that lenalidomide’s apparent ability to offer many of these patients transfusion independence and induce cytogenetic remission are “major accomplishments” that might prolong life.
“In the past 20 years, several therapeutic meteors have passed through the dark sky of treatment for myelodysplastic syndromes, only to disappear,” they write, adding that they look forward to additional data that can “unequivocally confirm the hematologic activity of lenalidomide in these syndromes.”
Source: N Engl J Med 2005;352:536-538,549-557. [ Google search on this article ]
MeSH Headings:Biological Sciences: Biology: Cytogenetics: Genetics: Remission Induction: Therapeutics: analogs & derivatives: chemistry: Analytical, Diagnostic and Therapeutic Techniques and Equipment: Biological SciencesCopyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
