Evidence map›Paper›PMID 28962635›Full record

Trial reportJournal of hematology & oncology2017

Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses.

Srdan Verstovsek, Jason Gotlib, Ruben A Mesa, Alessandro M Vannucchi, Jean-Jacques Kiladjian, Francisco Cervantes, Claire N Harrison, Ronald Paquette, William Sun, Ahmad Naim and 4 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hematology & oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 174 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
174citing papers in PubMed, 1 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.

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
3 · Its place in the literature

Who cites it

174 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Pharmacologic Inhibition of JAK1/2 Potentiates Aminoglycoside-Induced Ototoxicity.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2026
    Article
  19. Article
  20. Article

114 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

14 authors.

Srdan VerstovsekThe University of Texas MD Anderson Cancer Center, Division of Cancer Medicine, 1515 Holcombe Blvd, Unit 418, Houston, TX, 77030, USA. sverstov@mdanderson.org.
Jason GotlibStanford Cancer Institute, Stanford, CA, USA.
Ruben A MesaUT Health San Antonio Cancer Center - An NCI Designated Cancer Center, San Antonio, TX, USA.
Alessandro M VannucchiCenter for Research and Innovation of Myeloproliferative Neoplasms, AOU Careggi, and Laboratorio Congiunto, University of Florence, Florence, Italy.
Jean-Jacques KiladjianCentre d'Investigations Cliniques (INSERM CIC 1427), Hôpital Saint-Louis and Université Paris Diderot, Paris, France.
Francisco CervantesHospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.
Claire N HarrisonGuy's and St. Thomas' NHS Foundation Trust, London, UK.
Ronald PaquetteCedars-Sinai Medical Center, Los Angeles, CA, USA.
William SunIncyte Corporation, Wilmington, DE, USA.
Ahmad NaimIncyte Corporation, Wilmington, DE, USA.
Peter LangmuirIncyte Corporation, Wilmington, DE, USA.
Tuochuan DongNovartis Pharmaceutical Corporation, East Hanover, NJ, USA.
Prashanth GopalakrishnaNovartis Pharma AG, Basel, Switzerland.
Vikas GuptaPrincess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMyelofibrosis (MF) is associated with a variety of burdensome symptoms and reduced survival compared with age-/sex-matched controls. This analysis evaluated the long-term survival benefit with ruxolitinib, a Janus kinase (JAK)1/JAK2 inhibitor, in patients with intermediate-2 (int-2) or high-risk MF.

methodsThis was an exploratory analysis of 5-year data pooled from the phase 3 COMFORT-I and -II trials. In both trials, patients could cross over to ruxolitinib from the control group (COMFORT-I, placebo; COMFORT-II, best available therapy). All continuing patients in the control groups crossed over to ruxolitinib by the 3-year follow-up. Overall survival (OS; a secondary endpoint in both trials) was evaluated using pooled intent-to-treat data from patients randomized to ruxolitinib or the control groups. OS was also evaluated in subgroups stratified by baseline anemia and transfusion status at week 24.

resultsA total of 528 patients were included in this analysis; 301 were originally randomized to ruxolitinib (COMFORT-I, n = 155; COMFORT-II, n = 146) and 227 to control (n = 154 and n = 73, respectively). The risk of death was reduced by 30% among patients randomized to ruxolitinib compared with patients in the control group (median OS, 5.3 vs 3.8 years, respectively; hazard ratio [HR], 0.70 [95% CI, 0.54-0.91]; P = 0.0065). After correcting for crossover using a rank-preserving structural failure time (RPSFT) method, the OS advantage was more pronounced for patients who were originally randomized to ruxolitinib compared with patients who crossed over from control to ruxolitinib (median OS, 5.3 vs 2.3 years; HR [ruxolitinib vs RPSFT], 0.35 [95% CI, 0.23-0.59]). An analysis of OS censoring patients at the time of crossover also demonstrated that ruxolitinib prolonged OS compared with control (median OS, 5.3 vs 2.4 years; HR [ruxolitinib vs censored at crossover], 0.53 [95% CI, 0.36-0.78]; P = 0.0013). The survival benefit with ruxolitinib was observed irrespective of baseline anemia status or transfusion requirements at week 24.

conclusionsThese findings support ruxolitinib treatment for patients with int-2 or high-risk MF, regardless of anemia or transfusion status. Further analyses will be important for exploring ruxolitinib earlier in the disease course to assess the effect on the natural history of MF.

trial registrationClinicalTrials.gov identifiers, NCT00952289 and NCT00934544 .

Indexed as

AnemiaDisease ProgressionDouble-Blind MethodFemaleHumansMaleNitrilesPrimary MyelofibrosisPyrazolesPyrimidinesSurvival AnalysisTreatment OutcomeNitrilesPyrazolesPyrimidinesruxolitinibAnemiaMyelofibrosisOverall survivalRuxolitinibTransfusion

Identifiers

PMID28962635
PMCPMC5622445

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.