Lenalidomide plus prednisone results in durable clinical, histopathologic, and molecular responses in patients with myelofibrosis

Alfonso Quintás-Cardama, Hagop M. Kantarjian, Taghi Manshouri, Deborah Thomas, Jorge Cortes, Farhad Ravandi, Guillermo Garcia-Manero, Alessandra Ferrajoli, Carlos Bueso-Ramos, Srdan Verstovsek

Research output: Contribution to journalArticle

133 Scopus citations

Abstract

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 109/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 JAK2V617F-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.

Original languageEnglish (US)
Pages (from-to)4760-4766
Number of pages7
JournalJournal of Clinical Oncology
Volume27
Issue number28
DOIs
StatePublished - Oct 1 2009
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Quintás-Cardama, A., Kantarjian, H. M., Manshouri, T., Thomas, D., Cortes, J., Ravandi, F., Garcia-Manero, G., Ferrajoli, A., Bueso-Ramos, C., & Verstovsek, S. (2009). Lenalidomide plus prednisone results in durable clinical, histopathologic, and molecular responses in patients with myelofibrosis. Journal of Clinical Oncology, 27(28), 4760-4766. https://doi.org/10.1200/JCO.2009.22.6548