Evidence map›Paper›PMID 24038026›Full record

Trial reportHaematologica2013

Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I.

Srdan Verstovsek, Ruben A Mesa, Jason Gotlib, Richard S Levy, Vikas Gupta, John F DiPersio, John V Catalano, Michael W N Deininger, Carole B Miller, Richard T Silver and 13 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Haematologica, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00952289 (A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor INCB018424 Tablets Administered Orally to Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis), which is not on this map. Cited by 83 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00952289 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor INCB018424 Tablets Administered Orally to Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

TypeinterventionalSponsorIncyte CorporationRan2009 to 2015Enrolled309ConditionsMPN (Myeloproliferative Neoplasms)ArmsRuxolitinib, Placebo
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Janus kinase-1 and Janus kinase-2 inhibitors for treating myelofibrosis.The Cochrane database of systematic reviews · 2015
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23 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Srdan Verstovseksverstov@mdanderson.org.
Ruben A Mesa
Jason Gotlib
Richard S Levy
Vikas Gupta
John F DiPersio
John V Catalano
Michael W N Deininger
Carole B Miller
Richard T Silver
Moshe Talpaz
Elliott F Winton
Jimmie H Harvey
Murat O Arcasoy
Elizabeth O Hexner
Roger M Lyons
Ronald Paquette
Azra Raza
Kris Vaddi
Susan Erickson-Viitanen
William Sun
Victor Sandor
Hagop M Kantarjian

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

AgedCross-Over StudiesDouble-Blind MethodFemaleFollow-Up StudiesHumansJanus KinasesMaleMiddle AgedNitrilesPrimary MyelofibrosisPyrazolesPyrimidinesSurvival RateTreatment OutcomeJanus KinasesNitrilesPyrazolesPyrimidinesruxolitinib

Identifiers

PMID24038026
PMCPMC3856961

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.