Evidence map›Paper›PMID 27858987›Full record

Trial reportBritish journal of haematology2017

The efficacy and safety of continued hydroxycarbamide therapy versus switching to ruxolitinib in patients with polycythaemia vera: a randomized, double-blind, double-dummy, symptom study (RELIEF).

Ruben Mesa, Alessandro M Vannucchi, Abdulraheem Yacoub, Pierre Zachee, Mamta Garg, Roger Lyons, Steffen Koschmieder, Ciro Rinaldi, Jennifer Byrne, Yasmin Hasan and 7 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of haematology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 4 pooled it
5.8field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 4 syntheses or guidelines pooled it, 87 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Guideline
  5. Ruxolitinib Versus Best Available Therapy for Polycythemia Vera Intolerant or Resistant to Hydroxycarbamide in a Randomized Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  6. Trial
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. TheEJHaem · 2023
    Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Polycythemia Vera (PV): Update on Emerging Treatment Options.Therapeutics and clinical risk management · 2021
    Review
  20. Review
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

17 authors at 15 institutions in 5 countries.

Ruben MesaMayo Clinic Cancer Center, Scottsdale, AZ, USA.
Alessandro M VannucchiCenter for Research and Innovation of Myeloproliferative Neoplasms, AOU Careggi, University of Florence, Florence, Italy.
Abdulraheem YacoubUniversity of Kansas Medical Center, Westwood, KS, USA.
Pierre ZacheeZNA Stuivenberg, Antwerp, Belgium.
Mamta GargLeicester Royal Infirmary, Leicester, UK.
Roger LyonsTexas Oncology and US Oncology Research, San Antonio, TX, USA.
Steffen KoschmiederDepartment of Haematology, Oncology, Haemostaseology, and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University, Aachen, Germany.
Ciro RinaldiUniversity of Lincoln and United Lincolnshire Hospital Trust, Lincoln, UK.
Jennifer ByrneNottingham University Hospitals, Nottingham, UK.
Yasmin HasanSandwell and West Birmingham Hospitals NHS Trust, West Bromwich, UK.
Francesco PassamontiUniversity of Insubria, Varese, Italy.
Srdan VerstovsekUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.
Deborah HunterIncyte Corporation, Wilmington, DE, USA.
Mark M JonesIncyte Corporation, Wilmington, DE, USA.
Huiling ZhenIncyte Corporation, Wilmington, DE, USA.
Dany HabrNovartis Pharmaceuticals, East Hanover, NJ, USA.
Bruno MartinoAzienda Ospedaliera Bianchi Melacrino Morelli, Reggio Calabria, Italy.
Incyte (United States) · USAzienda ospedaliera "Bianchi-Melacrino-Morelli" · ITLeicester Royal Infirmary · GBMayo Clinic in Arizona · USNottingham University Hospitals NHS Trust · GBNovartis (United States) · USRWTH Aachen University · DESandwell & West Birmingham Hospitals NHS Trust · GBTexas Oncology · USThe University of Texas MD Anderson Cancer Center · USUnited Lincolnshire Hospitals NHS Trust · GBUniversity of Florence · ITUniversity of Insubria · ITUniversity of Kansas Medical Center · USZiekenhuisnetwerk Antwerpen Stuivenberg · BE

Funding

Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
NCATS NIH HHS UL1 TR000371
6 · The paper itself

Abstract

The randomized, double-blind, double-dummy, phase 3b RELIEF trial evaluated polycythaemia vera (PV)-related symptoms in patients who were well controlled with a stable dose of hydroxycarbamide (also termed hydroxyurea) but reported PV-related symptoms. Patients were randomized 1:1 to ruxolitinib 10 mg BID (n = 54) or hydroxycarbamide (prerandomization dose/schedule; n = 56); crossover to ruxolitinib was permitted after Week 16. The primary endpoint, ≥50% improvement from baseline in myeloproliferative neoplasm -symptom assessment form total symptom score cytokine symptom cluster (TSS-C; sum of tiredness, itching, muscle aches, night sweats, and sweats while awake) at Week 16, was achieved by 43·4% vs. 29·6% of ruxolitinib- and hydroxycarbamide-treated patients, respectively (odds ratio, 1·82; 95% confidence interval, 0·82-4·04; P = 0·139). The primary endpoint was achieved by 34% of a subgroup who maintained their hydroxycarbamide dose from baseline to Weeks 13-16. In a post hoc analysis, the primary endpoint was achieved by more patients with stable screening-to-baseline TSS-C scores (ratio ≤ 2) receiving ruxolitinib than hydroxycarbamide (47·4% vs. 25·0%; P = 0·0346). Ruxolitinib treatment after unblinding was associated with continued symptom score improvements. Adverse events were primarily grades 1/2 with no unexpected safety signals. Ruxolitinib was associated with a nonsignificant trend towards improved PV-related symptoms versus hydroxycarbamide, although an unexpectedly large proportion of patients who maintained their hydroxycarbamide dose reported symptom improvement.

Indexed as

Drug SubstitutionAdultAgedAged, 80 and overCross-Over StudiesDouble-Blind MethodFatigueFemaleHumansHydroxyureaMaleMiddle AgedNitrilesPolycythemia VeraPyrazolesPyrimidinesHydroxyureaNitrilesPyrazolesPyrimidinesruxolitinibhydroxycarbamideJanus kinasepolycythaemia veraquality of lifesigns and symptoms

Identifiers

PMID27858987
PMCPMC5215488
OpenAlexW2556415172

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.