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Blood, 15 August 2001, Vol. 98, No. 4, pp. 958-965
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Thalidomide produces transfusion independence in long-standing
refractory anemias of patients with myelodysplastic syndromes
Azra Raza,
Peter Meyer,
Diya Dutt,
Francesca Zorat,
Laurie Lisak,
Fabiana Nascimben,
Morne du
Randt,
Christopher Kaspar,
Cathryn Goldberg,
Jerome Loew,
Saleem Dar,
Sefer Gezer,
Parameswaran Venugopal, and
Jerome Zeldis
From the Rush Cancer Institute, Rush-Presbyterian-St
Luke's Medical Center, Chicago, IL, and the Celgene Corporation,
Warren, NJ.
Thalidomide was administered to 83 patients with
myelodysplastic syndrome (MDS), starting at 100 mg by mouth daily and
increasing to 400 mg as tolerated. Thirty-two patients stopped therapy
before 12 weeks (minimum period for response evaluation), and 51 completed 12 weeks of therapy. International Working Group response
criteria for MDS were used to evaluate responses. Intent-to-treat (ITT) analysis classified all off-study patients as nonresponders. Off-study patients belonged to a higher risk category
(P = .002) and had a higher percentage of blasts in
their pretherapy bone marrow than patients who completed 12 weeks of
therapy (P = .003). No cytogenetic or complete responses
were seen, but 16 patients showed hematologic improvement, with 10 previously transfusion-dependent patients becoming transfusion
independent. Responders had lower pretherapy blasts
(P = .016), a lower duration of pretherapy platelet transfusions (P = .013), and higher pretherapy platelets
(P = .003). Among responders, 9 had refractory anemia
(RA); 5 had RA with ringed sideroblasts; and 2 had RA with excess
blasts. By ITT analysis, 19% of patients (16 of 83) responded, and
when only evaluable patients were analyzed, 31% (16 of 51) responded.
It was concluded that thalidomide, as a single agent, is
effective in improving cytopenias of some MDS patients, especially
those who present without excess blasts.
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