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Low-dose thalidomide ameliorates cytopenias and splenomegaly in myelofibrosis with myeloid metaplasia: a phase II trial

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Authors:
  • Marchetti, Monia ;
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  • Barosi, Giovanni ;
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  • Balestri, Francesca ;
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  • Viarengo, Gianluca ;
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  • Gentili, Sara ;
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  • Barulli, Sara ;
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  • Demory, Jean-Loup ;
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  • Ilariucci, Fiorella ;
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  • Volpe, Antonio ;
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  • Bordessoule, Dominique ;
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  • Le Bousse-Kerdiles, Marie Caroline ;
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  • Caenazzo, Andrea ;
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  • Pecci, Alessandro ;
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  • Falcone, Antonietta ;
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  • Broccia, Giorgio ;
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  • Bendotti, Cesarina ;
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  • Bauduer, Fredric ;
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  • Buccisano, Francesco ;
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  • Dupriez, Brigitte
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DOI:
10.1200/jco.2004.08.160
Abstract:
PURPOSE: A phase II dose-escalation trial was conducted to ascertain low-dose thalidomide safety and response in patients with advanced myelofibrosis with myeloid metaplasia (MMM). PATIENTS AND METHODS: Thalidomide was administered together with current therapy to 63 patients, starting at 50 mg daily and increasing to 400 mg as tolerated. RESULTS: Half of the patients sustained daily doses more than 100 mg and the drop-out rate was 51% at 6 months: the drop-out rate was lower in patients with high baseline fatigue score. At efficacy analysis, anemia was ameliorated in 22% of the patients and transfusions were eliminated in 39% of transfusion-dependent patients. Platelet count increased by 50 x 10(9)/L or more in 22% of patients with an initial count lower than 100 x 10(9)/L. Splenomegaly decreased by more than 50% of the initial size in 19% of patients. Reduction of an overall disease severity score occurred in 31% of patients and was associated with a significant reduction of fatigue. Disease severity amelioration was independently predicted by a high baseline myeloproliferative index (ie, large splenomegaly, thrombocytosis, or leukocytosis). CONCLUSION: Low-dose thalidomide displays an acceptable toxicity profile and provides an objective and subjective advantage to a relevant portion of MMM patients.
Type:
Journal article
Language:
English
Published in:
Journal of Clinical Oncology, 2004, Vol 22, Issue 3, p. 424-31
Main Research Area:
Medical science
Publication Status:
Published
Review type:
Peer Review
Submission year:
2004
Scientific Level:
Scientific
ID:
108722459

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