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Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 2-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
December 2013

COMFORT-I is a randomized, double-blind, placebo-controlled trial of the Janus kinase 1/Janus kinase 2 inhibitor ruxolitinib in 309 patients with intermediate-2 or high-risk myelofibrosis. This analysis of COMFORT-I describes the long-term efficacy and safety of ruxolitinib (median follow-up, 2 years). Spleen volume was measured by magnetic resonance imaging, and quality of life was evaluated using the EORTC QLQ-C30. Overall survival was determined according to randomized treatment group. At the time of this analysis, 100 of 155 patients randomized to ruxolitinib were still receiving treatment. All patients randomized to placebo crossed over to ruxolitinib or discontinued within 3 months of the primary analysis (median time to crossover, 41 weeks). Mean spleen volume reductions in the ruxolitinib group were 31.6% at week 24 and 34.9% at week 96; improvements in quality of life measures were also maintained. Improved survival was observed for ruxolitinib (n=27 deaths) versus placebo (n=41 deaths) (hazard ratio=0.58; 95% confidence interval: 0.36, 0.95; P=0.03). The incidence of new-onset grade 3 or 4 anemia and thrombocytopenia decreased over time to levels observed in patients receiving placebo. These data indicate that ruxolitinib treatment provides durable reductions in spleen volume and improvements in quality of life and suggest a continued survival advantage for ruxolitinib over placebo.

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Published In

Haematologica

DOI

EISSN

1592-8721

Publication Date

December 2013

Volume

98

Issue

12

Start / End Page

1865 / 1871

Location

Italy

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Pyrimidines
  • Pyrazoles
  • Primary Myelofibrosis
  • Nitriles
  • Middle Aged
  • Male
  • Janus Kinases
  • Immunology
 

Citation

APA
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Verstovsek, S., Mesa, R. A., Gotlib, J., Levy, R. S., Gupta, V., DiPersio, J. F., … Kantarjian, H. M. (2013). Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I. Haematologica, 98(12), 1865–1871. https://doi.org/10.3324/haematol.2013.092155
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 2-year follow-up of COMFORT-I.Haematologica 98, no. 12 (December 2013): 1865–71. https://doi.org/10.3324/haematol.2013.092155.
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 2-year follow-up of COMFORT-I. Haematologica. 2013 Dec;98(12):1865–71.
Verstovsek, Srdan, et al. “Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I.Haematologica, vol. 98, no. 12, Dec. 2013, pp. 1865–71. Pubmed, doi:10.3324/haematol.2013.092155.
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, Paquette R, Raza A, Vaddi K, Erickson-Viitanen S, Sun W, Sandor V, Kantarjian HM. Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I. Haematologica. 2013 Dec;98(12):1865–1871.

Published In

Haematologica

DOI

EISSN

1592-8721

Publication Date

December 2013

Volume

98

Issue

12

Start / End Page

1865 / 1871

Location

Italy

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Pyrimidines
  • Pyrazoles
  • Primary Myelofibrosis
  • Nitriles
  • Middle Aged
  • Male
  • Janus Kinases
  • Immunology