Evidence map›Paper›PMID 23589175›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2013

Electrocardiographic studies of romidepsin demonstrate its safety and identify a potential role for K(ATP) channel.

Anne M Noonan, Robin A Eisch, David J Liewehr, Tristan M Sissung, David J Venzon, Thomas P Flagg, Mark C Haigney, Seth M Steinberg, William D Figg, Richard L Piekarz and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00007345 (Phase II Trial of Depsipeptide in Patients With Cutaneous T-Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing 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.

NCT00007345 phase2completednot on this map

Phase II Trial of Depsipeptide in Patients With Cutaneous T-Cell Lymphoma and Relapsed Peripheral T-Cell Lymphoma

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2001 to 2015Enrolled131ConditionsCutaneous T Cell Lymphoma, Peripheral T Cell LymphomaArmsRomidepsin
3 · Its place in the literature

Who cites it

24 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Electrophysiologic Toxicity of Chemoradiation.Current oncology reports · 2018
    Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. Targeting Histone Deacetylases in Diseases: Where Are We?Antioxidants & redox signaling · 2015
    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

11 authors.

Anne M NoonanMedical Oncology Branch, National Cancer Institute, NIH, Bethesda, Maryland 20892, USA.
Robin A Eisch
David J Liewehr
Tristan M Sissung
David J Venzon
Thomas P Flagg
Mark C Haigney
Seth M Steinberg
William D Figg
Richard L Piekarz
Susan E Bates

Funding

Sample Processing and Analytical Methods Development for New Anticancer AgentsZICSC006536 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$18.1M
Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 2009 to 2025
$14.5M
Using Clinical Pharmacology Principles to Develop New Anticancer TherapiesZICSC006537 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$14.4M
Translational Studies of the Histone Deacetylase Inhibitor RomidepsinZIABC010621 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI BATES, SUSAN · 2009 to 2015
$6.2M
Intramural NIH HHS ZIC SC006537
6 · The paper itself

Abstract

purposeRomidepsin is a histone deacetylase inhibitor (HDI) approved for the treatment of both cutaneous and peripheral T-cell lymphoma (CTCL and PTCL). During development, a thorough assessment of cardiac toxicity was conducted. EXPERIMENTAL

designA phase II single-agent nonrandomized study of romidepsin was conducted in patients with CTCL or PTCL who had progressed after at least 1 prior systemic therapy.

resultsResults for the first 42 patients enrolled on the NCI 1312 phase II study of romidepsin in CTCL or PTCL showed no cardiac toxicity based on serial electrocardiograms (ECG), troponins, and MUGA scans/echocardiograms. The cardiac assessments reported herein confirm the safety of romidepsin among 131 enrolled patients, while supporting a role for electrolyte replacement. Heart rate increased an average 11 bpm following romidepsin infusion; there was no evidence of increased arrhythmia. Criteria for potassium/magnesium replacement were met before 55% of 1365 romidepsin doses; an association with hypoalbuminemia was confirmed. We propose a mechanism for ST segment flattening and depression, the most common ECG abnormalities observed: HDI-induced alteration of the activity or expression of KATP channels. In addition, examination of the variants of the active transporter of romidepsin, ABCB1, showed a trend toward smaller heart rate changes in the peri-infusion period among wild-type than variant diplotypes.

conclusionsWe conclude that in the context of appropriate attention to electrolyte levels, the data support the cardiac safety of romidepsin.

Indexed as

AdultAgedAged, 80 and overAntibiotics, AntineoplasticATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1DepsipeptidesElectrocardiographyFemaleGenotypeHeart RateHistone Deacetylase InhibitorsHumansLymphoma, T-Cell, CutaneousLymphoma, T-Cell, PeripheralMagnesiumABCB1 protein, humanAntibiotics, AntineoplasticATP Binding Cassette Transporter, Subfamily BATP Binding Cassette Transporter, Subfamily B, Member 1DepsipeptidesHistone Deacetylase InhibitorsMagnesiumPotassiumromidepsin

Identifiers

PMID23589175
PMCPMC6448401

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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.