Evidence map›Paper›PMID 33054051›Full record

Trial reportHaematologica2020

Ruxolitinib and interferon-α2 combination therapy for patients with polycythemia vera or myelofibrosis: a phase II study.

Anders Lindholm Sørensen, Stine Ulrik Mikkelsen, Trine Alma Knudsen, Mads Emil Bjørn, Christen Lykkegaard Andersen, Ole Weis Bjerrum, Nana Brochmann, Dustin Andersen Patel, Lise Mette Rahbek Gjerdrum, Daniel El Fassi and 10 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Haematologica, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing 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.

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

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

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6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Anders Lindholm SørensenDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark; Institute for Inflammation Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark. anderslindholmsorensen@hotmail.com.
Stine Ulrik MikkelsenDepartment of Hematology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; Biotech Research and Innovation Center, University of Copenhagen, Copenhagen, Denmark.
Trine Alma KnudsenDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.
Mads Emil BjørnHerlev University Hospital, Copenhagen, Denmark.
Christen Lykkegaard AndersenDepartment of Hematology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark; Department of Public Health, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
Ole Weis BjerrumDepartment of Hematology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Nana BrochmannDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.
Dustin Andersen PatelDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark; Institute for Inflammation Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Lise Mette Rahbek GjerdrumDepartment of Pathology, Zealand University Hospital, Roskilde, Denmark.
Daniel El FassiHerlev University Hospital, Copenhagen, Denmark.
Torben A KruseDepartment of Clinical Genetics, Odense University Hospital, Odense, Denmark.
Thomas Stauffer LarsenDepartment of Hematology, Odense University Hospital, Odense, Denmark.
Hans Torben Mourits-AndersenDepartment of Hematology, South-West Jutlandic Hospital, Esbjerg, Denmark.
Claus Henrik NielsenInstitute for Inflammation Research, Center for Rheumatology and Spine Diseases, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Christina EllervikHerlev University Hospital, Copenhagen, Denmark; Department of Laboratory Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA; Data and Development Support, Region Zealand, Sorø, Denmark.
Niels PallisgaardDepartment of Pathology, Zealand University Hospital, Roskilde, Denmark.
Mads ThomassenDepartment of Clinical Genetics, Odense University Hospital, Odense, Denmark.
Lasse KjærDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.
Vibe SkovDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.
Hans Carl HasselbalchDepartment of Hematology, Zealand University Hospital, Roskilde, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We report the final 2-year end-of-study results from the first clinical trial investigating combination treatment with ruxolitinib and low-dose pegylated interferon-α2 (PEG-IFNα2). The study included 32 patients with polycythemia vera and 18 with primary or secondary myelofibrosis; 46 patients were previously intolerant of or refractory to PEGIFNα2. The primary outcome was efficacy, based on hematologic parameters, quality of life measurements, and JAK2 V617F allele burden. We used the 2013 European LeukemiaNet and International Working Group- Myeloproliferative Neoplasms Research and Treatment response criteria, including response in symptoms, splenomegaly, peripheral blood counts, and bone marrow. Of 32 patients with polycythemia vera, ten (31%) achieved a remission which was a complete remission in three (9%) cases. Of 18 patients with myelofibrosis, eight (44%) achieved a remission; five (28%) were complete remissions. The cumulative incidence of peripheral blood count remission was 0.85 and 0.75 for patients with polycythemia vera and myelofibrosis, respectively. The Myeloproliferative Neoplasm Symptom Assessment Form total symptom score decreased from 22 [95% confidence interval (95% CI):, 16-29] at baseline to 15 (95% CI: 10-22) after 2 years. The median JAK2 V617F allele burden decreased from 47% (95% CI: 33-61%) to 12% (95% CI: 6-22%), and 41% of patients achieved a molecular response. The drop-out rate was 6% among patients with polycythemia vera and 32% among those with myelofibrosis. Of 36 patients previously intolerant of PEG-IFNα2, 31 (86%) completed the study, and 24 (67%) of these received PEG-IFNα2 throughout the study. In conclusion, combination treatment improved cell counts, reduced bone marrow cellularity and fibrosis, decreased JAK2 V617F burden, and reduced symptom burden with acceptable toxicity in several patients with polycythemia vera or myelofibrosis. #EudraCT2013-003295-12.

Indexed as

Polycythemia VeraPrimary MyelofibrosisHumansJanus Kinase 2NitrilesPyrazolesPyrimidinesQuality of LifeJanus Kinase 2NitrilesPyrazolesPyrimidinesruxolitinib

Identifiers

PMID33054051
PMCPMC7556624

What OpenQuestion holds

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Registered trials

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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.