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Haematologica. 2015 Apr;100(4):479-88. doi: 10.3324/haematol.2014.115840. Epub 2015 Jan 23.

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

Author information

1
The University of Texas MD Anderson Cancer Center, Houston, TX, USA sverstov@mdanderson.org.
2
Mayo Clinic, Scottsdale, AZ, USA.
3
Stanford Cancer Institute, Stanford, CA, USA.
4
Incyte Corporation, Wilmington, DE, USA.
5
Princess Margaret Cancer Center, University of Toronto, ON, Canada.
6
Washington University School of Medicine, St. Louis, MO, USA.
7
Frankston Hospital and Department of Clinical Haematology, Monash University, Frankston, Australia.
8
*Oregon Health and Science University, Portland, OR, USA.
9
Saint Agnes Cancer Institute, Baltimore, MD, USA.
10
Weill Cornell Medical Center, New York, NY, USA.
11
University of Michigan, Ann Arbor, MI, USA.
12
Emory University School of Medicine, Atlanta, GA, USA.
13
Birmingham Hematology and Oncology, Birmingham, AL, USA.
14
Duke University Health System, Durham, NC, USA.
15
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA, USA.
16
Cancer Care Centers of South Texas/US Oncology, San Antonio, TX, USA.
17
Columbia Presbyterian Medical Center, New York, NY, USA.
18
The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Abstract

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.

PMID:
25616577
PMCID:
PMC4380721
DOI:
10.3324/haematol.2014.115840
[Indexed for MEDLINE]
Free PMC Article

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