Evidence map›Paper›PMID 26069290›Full record

Trial reportHaematologica2015

A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis.

Alessandro M Vannucchi, Hagop M Kantarjian, Jean-Jacques Kiladjian, Jason Gotlib, Francisco Cervantes, Ruben A Mesa, Nicholas J Sarlis, Wei Peng, Victor Sandor, Prashanth Gopalakrishna and 6 more

3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Haematologica, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 147 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
147citing papers in PubMed, 2 pooled it
17.8field-weighted citation impact, top 1% of its field
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.

NCT00934544 phase3completednot on this map

A Randomized Study of Ruxolitinib Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis

TypeinterventionalSponsorNovartis PharmaceuticalsRan2009 to 2015Enrolled219ConditionsMyelofibrosisArmsRuxolitinib, Best Available Therapy (BAT)
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
NCT03959371 unknown statusnot on this mapstarted 2017, after this paper: background citation

Observational, Retrospective and Prospective Study on the Use of Ruxolitinib in Myelofibrosis Patients in Lombardy, Italy

TypeobservationalSponsorMargherita MaffioliRan2017 to 2021Enrolled620ConditionsMyelofibrosisArmsRuxolitinib
3 · Its place in the literature

Who cites it

147 citing papers in PubMed, 2 syntheses or guidelines pooled it, 248 citations in OpenAlex.

  1. Pooled it
  2. Myeloproliferative Neoplasms, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2016
    Guideline
  3. Selinexor Plus Ruxolitinib in Janus Kinase Inhibitor-Naïve Myelofibrosis: Phase III SENTRY Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
    Trial
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  9. Efficacy of Ruxolitinib in Patients With Chronic Neutrophilic Leukemia and Atypical Chronic Myeloid Leukemia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
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  17. Article
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  20. Observational

87 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

16 authors at 10 institutions in 7 countries.

Alessandro M VannucchiUniversity of Florence, Italy amvannucchi@unifi.it.
Hagop M KantarjianThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jean-Jacques KiladjianHôpital Saint-Louis et Université Paris Diderot, Paris, France.
Jason GotlibStanford Cancer Institute, CA, USA.
Francisco CervantesHospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
Ruben A MesaMayo Clinic, Scottsdale, AZ, USA.
Nicholas J SarlisIncyte Corporation, Wilmington, DE, USA.
Wei PengIncyte Corporation, Wilmington, DE, USA.
Victor SandorIncyte Corporation, Wilmington, DE, USA.
Prashanth GopalakrishnaNovartis Pharma AG, Basel, Switzerland.
Abdel HmissiNovartis Pharma AG, Basel, Switzerland.
Viktoriya StalbovskayaNovartis Pharma AG, Basel, Switzerland.
Vikas GuptaPrincess Margaret Cancer Center, University of Toronto, Ontario, Canada.
Claire HarrisonGuy's and St. Thomas' NHS Foundation Trust, Guy's Hospital, London, UK.
Srdan VerstovsekThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
COMFORT Investigators
Incyte (United States) · USNovartis (Switzerland) · CHThe University of Texas MD Anderson Cancer Center · USConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESGuy's Hospital · GBMayo Clinic in Arizona · USStanford Cancer InstituteUniversité Paris Cité · FRUniversity of Florence · ITUniversity of Toronto · CA

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS CA016672NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Ruxolitinib, a potent Janus kinase 1/2 inhibitor, resulted in rapid and durable improvements in splenomegaly and disease-related symptoms in the 2 phase III COMFORT studies. In addition, ruxolitinib was associated with prolonged survival compared with placebo (COMFORT-I) and best available therapy (COMFORT-II). We present a pooled analysis of overall survival in the COMFORT studies using an intent-to-treat analysis and an analysis correcting for crossover in the control arms. Overall, 301 patients received ruxolitinib (COMFORT-I, n=155; COMFORT-II, n=146) and 227 patients received placebo (n=154) or best available therapy (n=73). After a median three years of follow up, intent-to-treat analysis showed that patients who received ruxolitinib had prolonged survival compared with patients who received placebo or best available therapy [hazard ratio=0.65; 95% confidence interval (95%CI): 0.46-0.90; P=0.01]; the crossover-corrected hazard ratio was 0.29 (95%CI: 0.13-0.63). Both patients with intermediate-2- or high-risk disease showed prolonged survival, and patients with high-risk disease in the ruxolitinib group had survival similar to that of patients with intermediate-2-risk disease in the control group. The Kaplan-Meier estimate of overall survival at week 144 was 78% in the ruxolitinib arm, 61% in the intent-to-treat control arm, and 31% in the crossover-adjusted control arm. While larger spleen size at baseline was prognostic for shortened survival, reductions in spleen size with ruxolitinib treatment correlated with longer survival. These findings are consistent with previous reports and support that ruxolitinib offers a survival benefit for patients with myelofibrosis compared with conventional therapies. (clinicaltrials.gov identifiers: COMFORT-I, NCT00952289; COMFORT-II, NCT00934544).

Indexed as

AgedAged, 80 and overDisease-Free SurvivalFemaleFollow-Up StudiesHumansJanus Kinase 1Janus Kinase 2MaleMiddle AgedNitrilesPrimary MyelofibrosisPyrazolesPyrimidinesRisk FactorsSurvival RateJAK1 protein, humanJAK2 protein, humanJanus Kinase 1Janus Kinase 2NitrilesPyrazolesPyrimidinesruxolitinib

Identifiers

PMID26069290
PMCPMC4800694
OpenAlexW2126532431

What OpenQuestion holds

Textmetadata
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.