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Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I.

Publication ,  Journal Article
Verstovsek, S; Mesa, RA; Gotlib, J; Levy, RS; Gupta, V; DiPersio, JF; Catalano, JV; Deininger, MWN; Miller, CB; Silver, RT; Talpaz, M; Raza, A ...
Published in: Haematologica
April 2015

In the phase III COMFORT-I study, the Janus kinase 1 (JAK1)/JAK2 inhibitor ruxolitinib provided significant improvements in splenomegaly, key symptoms, and quality-of-life measures and was associated with an overall survival benefit relative to placebo in patients with intermediate-2 or high-risk myelofibrosis. This planned analysis assessed the long-term efficacy and safety of ruxolitinib at a median follow-up of 149 weeks. At data cutoff, approximately 50% of patients originally randomized to ruxolitinib remained on treatment whereas all patients originally assigned to placebo had discontinued or crossed over to ruxolitinib. At week 144, mean spleen volume reduction was 34% with ruxolitinib. Previously observed improvements in quality-of-life measures were sustained with longer-term ruxolitinib therapy. Overall survival continued to favor ruxolitinib despite the majority of placebo patients crossing over to ruxolitinib [hazard ratio 0.69 (95% confidence interval: 0.46-1.03); P = 0.067]. Exploratory analyses suggest that crossover may have contributed to an underestimation of the true survival difference between the treatment groups. Ruxolitinib continued to be generally well tolerated; there was no pattern of worsening grade ≥ 3 anemia or thrombocytopenia with longer-term ruxolitinib exposure. These longer-term data continue to support the efficacy and safety of ruxolitinib in patients with myelofibrosis. The study is registered at clinicaltrials.gov: NCT00952289.

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Published In

Haematologica

DOI

EISSN

1592-8721

Publication Date

April 2015

Volume

100

Issue

4

Start / End Page

479 / 488

Location

Italy

Related Subject Headings

  • Treatment Outcome
  • Spleen
  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Pyrimidines
  • Pyrazoles
  • Protein Kinase Inhibitors
  • Primary Myelofibrosis
  • Organ Size
  • Nitriles
 

Citation

APA
Chicago
ICMJE
MLA
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Verstovsek, S., Mesa, R. A., Gotlib, J., Levy, R. S., Gupta, V., DiPersio, J. F., … COMFORT-I investigators, . (2015). Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I. Haematologica, 100(4), 479–488. https://doi.org/10.3324/haematol.2014.115840
Verstovsek, Srdan, Ruben A. Mesa, Jason Gotlib, Richard S. Levy, Vikas Gupta, John F. DiPersio, John V. Catalano, et al. “Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I.Haematologica 100, no. 4 (April 2015): 479–88. https://doi.org/10.3324/haematol.2014.115840.
Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, et al. Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I. Haematologica. 2015 Apr;100(4):479–88.
Verstovsek, Srdan, et al. “Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I.Haematologica, vol. 100, no. 4, Apr. 2015, pp. 479–88. Pubmed, doi:10.3324/haematol.2014.115840.
Verstovsek S, Mesa RA, Gotlib J, Levy RS, Gupta V, DiPersio JF, Catalano JV, Deininger MWN, Miller CB, Silver RT, Talpaz M, Winton EF, Harvey JH, Arcasoy MO, Hexner EO, Lyons RM, Raza A, Vaddi K, Sun W, Peng W, Sandor V, Kantarjian H, COMFORT-I investigators. Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: results of a median 3-year follow-up of COMFORT-I. Haematologica. 2015 Apr;100(4):479–488.

Published In

Haematologica

DOI

EISSN

1592-8721

Publication Date

April 2015

Volume

100

Issue

4

Start / End Page

479 / 488

Location

Italy

Related Subject Headings

  • Treatment Outcome
  • Spleen
  • Randomized Controlled Trials as Topic
  • Quality of Life
  • Pyrimidines
  • Pyrazoles
  • Protein Kinase Inhibitors
  • Primary Myelofibrosis
  • Organ Size
  • Nitriles