Evidence map›Paper›PMID 30086777›Full record

Trial reportJournal of hematology & oncology2018

Evaluation of an alternative ruxolitinib dosing regimen in patients with myelofibrosis: an open-label phase 2 study.

Moshe Talpaz, Susan Erickson-Viitanen, Kevin Hou, Solomon Hamburg, Maria R Baer

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of hematology & oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01445769 (An Open-label Assessment of an Alternative Dosing Strategy of Ruxolitinib in Patients With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, and Post-essential Thrombocythemia Myelofibrosis), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–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.

NCT01445769 phase2completednot on this map

An Open-label Assessment of an Alternative Dosing Strategy of Ruxolitinib in Patients With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, and Post-essential Thrombocythemia Myelofibrosis

TypeinterventionalSponsorIncyte CorporationRan2011 to 2013Enrolled45ConditionsPrimary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia MyelofibrosisArmsRuxolitinib
3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

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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

5 authors.

Moshe TalpazUniversity of Michigan, Ann Arbor, MI, USA.
Susan Erickson-ViitanenIncyte Corporation, Wilmington, DE, USA.
Kevin HouIncyte Corporation, Wilmington, DE, USA.
Solomon HamburgTower Hematology Oncology Medical Group, Beverly Hills, CA, USA.
Maria R BaerUniversity of Maryland, Greenebaum Comprehensive Cancer Center, 22 S. Greene St, Baltimore, MD, 21201, USA. mbaer@umm.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRuxolitinib improves splenomegaly and symptoms in patients with intermediate-2 or high-risk myelofibrosis; however, nearly half develop grade 3/4 anemia and/or thrombocytopenia, necessitating dose reductions and/or transfusions. We report findings from an open-label phase 2 study exploring a dose-escalation strategy aimed at preserving clinical benefit while reducing hematological adverse events early in ruxolitinib treatment.

methodsPatients with myelofibrosis received ruxolitinib 10 mg twice daily (BID), with incremental increases of 5 mg BID at weeks 12 and 18 for lack of efficacy (maximum, 20 mg BID). Symptom severity was measured using the Myelofibrosis Symptom Assessment Form Total Symptom Score (MFSAF TSS).

resultsForty-five patients were enrolled, 68.9% of whom had a Dynamic International Prognostic Scoring System score of 1 to 2 (i.e., intermediate-1 disease risk). Median percentage change in spleen volume from baseline to week 24 was - 17.3% (≥ 10% reduction achieved by 26 patients [57.8%]), with a clear dose response. Median percentage change in MFSAF TSS from baseline at week 24 was - 45.6%, also with a dose response. The most frequent treatment-emergent adverse events were anemia (26.7%), fatigue (22.2%), and arthralgias (20.0%). Grade 3/4 anemia (20.0%) and dose decreases due to anemia (11.1%) or thrombocytopenia (6.7%) were infrequent.

conclusionsA dose-escalation approach may mitigate worsening anemia during early ruxolitinib therapy in some patients with myelofibrosis.

trial registrationClinicalTrials.gov identifier, NCT01445769 . Registered September 23, 2011.

Indexed as

AgedAged, 80 and overFemaleHumansJanus KinasesMaleMiddle AgedNitrilesPrimary MyelofibrosisPyrazolesPyrimidinesJanus KinasesNitrilesPyrazolesPyrimidinesruxolitinibAnemiaJanus kinaseMyelofibrosisRuxolitinibThrombocytopeniaTransfusion

Identifiers

PMID30086777
PMCPMC6081850

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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.