| Lenalidomide plus prednisone results in durable clinical, histopathologic, and molecular responses in patients with myelofibrosis. | |
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MedLine Citation:
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PMID: 19720904 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: To investigate the safety and efficacy of the combination of lenalidomide and prednisone in patients with myelofibrosis (MF). PATIENTS AND METHODS: Forty patients with MF were treated. Therapy consisted of lenalidomide 10 mg/d (5 mg/d if baseline platelet count < 100 x 10(9)/L) on days 1 through 21 of a 28-day cycle for six cycles, in combination with prednisone 30 mg/d orally during cycle 1, 15 mg/d during cycle 2, and 15 mg/d every other day during cycle 3. Lenalidomide therapy was continued indefinitely in patients exhibiting clinical benefit. RESULTS: The median follow-up was 22 months (range, 6 to 27). Responses were recorded in 12 patients (30%) and are ongoing in 10 (25%). The median time to response was 12 weeks (range, 2 to 32). According to the International Working Group for Myelofibrosis Research and Treatment consensus criteria, three patients (7.5%) had partial response and nine patients (22.5%) had clinical improvement durable for a median of 18 months (range, 3.5 to 24+). Overall response rates were 30% for anemia and 42% for splenomegaly. Moreover, 10 of 11 assessable responders who started therapy with reticulin fibrosis grade 4 experienced reductions to at least a score of 2. All eight JAK2(V617F)-positive responders experienced a reduction of the baseline mutant allele burden, which was greater than 50% in four, including one of whom the mutation became undetectable. Grade 3 to 4 hematologic adverse events included neutropenia (58%), anemia (42%), and thrombocytopenia (13%). CONCLUSION: The combination of lenalidomide and prednisone induces durable clinical, molecular, and pathologic responses in MF. |
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Authors:
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Alfonso Quintás-Cardama; Hagop M Kantarjian; Taghi Manshouri; Deborah Thomas; Jorge Cortes; Farhad Ravandi; Guillermo Garcia-Manero; Alessandra Ferrajoli; Carlos Bueso-Ramos; Srdan Verstovsek |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article Date: 2009-08-31 |
Journal Detail:
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Title: Journal of clinical oncology : official journal of the American Society of Clinical Oncology Volume: 27 ISSN: 1527-7755 ISO Abbreviation: J. Clin. Oncol. Publication Date: 2009 Oct |
Date Detail:
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Created Date: 2009-09-30 Completed Date: 2009-10-26 Revised Date: 2012-06-05 |
Medline Journal Info:
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Nlm Unique ID: 8309333 Medline TA: J Clin Oncol Country: United States |
Other Details:
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Languages: eng Pagination: 4760-6 Citation Subset: IM |
Affiliation:
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Department of Leukemia, University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00352794 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Anemia / chemically induced Antineoplastic Agents / administration & dosage, therapeutic use Drug Therapy, Combination Enzyme-Linked Immunosorbent Assay Female Fibroblast Growth Factor 2 / blood Glucocorticoids / therapeutic use Humans Janus Kinase 2 / genetics Male Middle Aged Mutation Neutropenia / chemically induced Platelet-Derived Growth Factor / metabolism Prednisone / therapeutic use* Primary Myelofibrosis / blood, drug therapy*, genetics Thalidomide / adverse effects, analogs & derivatives*, therapeutic use Thrombocytopenia / chemically induced Transforming Growth Factor beta / blood Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antineoplastic Agents; 0/Glucocorticoids; 0/Platelet-Derived Growth Factor; 0/Transforming Growth Factor beta; 103107-01-3/Fibroblast Growth Factor 2; 191732-72-6/lenalidomide; 50-35-1/Thalidomide; 53-03-2/Prednisone; EC 2.7.10.1/Janus Kinase 2; EC 2.7.10.2/JAK2 protein, human |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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