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

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

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Primary Myelofibrosis
Prednisone
Anemia
Reticulin
Splenomegaly
Therapeutics
lenalidomide
Neutropenia
Platelet Count
Thrombocytopenia
Fibrosis
Alleles
Safety
Mutation
Research

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Lenalidomide plus prednisone results in durable clinical, histopathologic, and molecular responses in patients with myelofibrosis. / Quintás-Cardama, Alfonso; Kantarjian, Hagop M.; Manshouri, Taghi; Thomas, Deborah; Cortes, Jorge; Ravandi, Farhad; Garcia-Manero, Guillermo; Ferrajoli, Alessandra; Bueso-Ramos, Carlos; Verstovsek, Srdan.

In: Journal of Clinical Oncology, Vol. 27, No. 28, 01.10.2009, p. 4760-4766.

Research output: Contribution to journalArticle

Quintás-Cardama, A, Kantarjian, HM, 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, vol. 27, no. 28, pp. 4760-4766. https://doi.org/10.1200/JCO.2009.22.6548
Quintás-Cardama, Alfonso ; Kantarjian, Hagop M. ; Manshouri, Taghi ; Thomas, Deborah ; Cortes, Jorge ; Ravandi, Farhad ; Garcia-Manero, Guillermo ; Ferrajoli, Alessandra ; Bueso-Ramos, Carlos ; Verstovsek, Srdan. / Lenalidomide plus prednisone results in durable clinical, histopathologic, and molecular responses in patients with myelofibrosis. In: Journal of Clinical Oncology. 2009 ; Vol. 27, No. 28. pp. 4760-4766.
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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.",
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T1 - Lenalidomide plus prednisone results in durable clinical, histopathologic, and molecular responses in patients with myelofibrosis

AU - Quintás-Cardama, Alfonso

AU - Kantarjian, Hagop M.

AU - Manshouri, Taghi

AU - Thomas, Deborah

AU - Cortes, Jorge

AU - Ravandi, Farhad

AU - Garcia-Manero, Guillermo

AU - Ferrajoli, Alessandra

AU - Bueso-Ramos, Carlos

AU - Verstovsek, Srdan

PY - 2009/10/1

Y1 - 2009/10/1

N2 - 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.

AB - 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.

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