Evidence map›Paper›PMID 27211272›Full record

Trial reportLeukemia2016

Long-term findings from COMFORT-II, a phase 3 study of ruxolitinib vs best available therapy for myelofibrosis.

C N Harrison, A M Vannucchi, J-J Kiladjian, H K Al-Ali, H Gisslinger, L Knoops, F Cervantes, M M Jones, K Sun, M McQuitty and 3 more

Erratum issued 2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Leukemia, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 269 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
269citing papers in PubMed, 3 pooled it
32.1field-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.

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
NCT04414098 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Safety and Efficacy Study of Ruxolitinib in the Treatment of Severe Acute Respiratory Syndrome Due to SARS-COV-2

TypeinterventionalSponsorMarcelo IastrebnerRan2020 to 2020Enrolled100ConditionsCOVID-19ArmsINC424 / Ruxolitinib
3 · Its place in the literature

Who cites it

269 citing papers in PubMed, 3 syntheses or guidelines pooled it, 500 citations in OpenAlex.

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  4. 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
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209 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 9 countries.

C N HarrisonGuy's and St Thomas' NHS Foundation Trust, Guy's Hospital, London, UK.
A M VannucchiCenter for Research and Innovation for Myeloproliferative Neoplasms-CRIMM, AOU Careggi, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
J-J KiladjianHôpital Saint-Louis et Université Paris Diderot, Paris, France.
H K Al-AliUniversity of Leipzig, Leipzig, Germany.
H GisslingerMedical University of Vienna, Vienna, Austria.
L KnoopsCliniques Universitaires Saint-Luc and de Duve Institute, Université catholique de Louvain, Brussels, Belgium.
F CervantesHospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
M M JonesIncyte Corporation, Wilmington, DE, USA.
K SunIncyte Corporation, Wilmington, DE, USA.
M McQuittyNovartis Pharma, Basel, Switzerland.
V StalbovskayaNovartis Pharma, Basel, Switzerland.
P GopalakrishnaNovartis Pharma, Basel, Switzerland.
T BarbuiResearch Foundation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
Novartis (Switzerland) · CHCliniques Universitaires Saint-Luc · BEDélégation Paris 7 · FRGuy's Hospital · GBConsorci Institut D'Investigacions Biomediques August Pi I Sunyer · ESIncyte (United States) · USMedical University of Vienna · ATOspedale Papa Giovanni XXIII · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ruxolitinib is a Janus kinase (JAK) (JAK1/JAK2) inhibitor that has demonstrated superiority over placebo and best available therapy (BAT) in the Controlled Myelofibrosis Study with Oral JAK Inhibitor Treatment (COMFORT) studies. COMFORT-II was a randomized (2:1), open-label phase 3 study in patients with myelofibrosis; patients randomized to BAT could crossover to ruxolitinib upon protocol-defined disease progression or after the primary end point, confounding long-term comparisons. At week 48, 28% (41/146) of patients randomized to ruxolitinib achieved ⩾35% decrease in spleen volume (primary end point) compared with no patients on BAT (P<0.001). Among the 78 patients (53.4%) in the ruxolitinib arm who achieved ⩾35% reductions in spleen volume at any time, the probability of maintaining response was 0.48 (95% confidence interval (CI), 0.35-0.60) at 5 years (median, 3.2 years). Median overall survival was not reached in the ruxolitinib arm and was 4.1 years in the BAT arm. There was a 33% reduction in risk of death with ruxolitinib compared with BAT by intent-to-treat analysis (hazard ratio (HR)=0.67; 95% CI, 0.44-1.02; P=0.06); the crossover-corrected HR was 0.44 (95% CI, 0.18-1.04; P=0.06). There was no unexpected increased incidence of adverse events with longer exposure. This final analysis showed that spleen volume reductions with ruxolitinib were maintained with continued therapy and may be associated with survival benefits.

Indexed as

AdultAgedAged, 80 and overCross-Over StudiesDisease ProgressionFemaleFollow-Up StudiesHumansMaleMiddle AgedNitrilesOrgan SizePrimary MyelofibrosisPyrazolesPyrimidinesSpleenNitrilesPyrazolesPyrimidinesruxolitinib

Identifiers

PMID27211272
PMCPMC5399157
OpenAlexW2405712018

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.