Evidence map›Paper›PMID 25914207›Full record

ArticleCancer medicine2015

Electrocardiographic effects of class 1 selective histone deacetylase inhibitor romidepsin.

Philip T Sager, Barbara Balser, Julie Wolfson, Jean Nichols, Richard Pilot, Suzanne Jones, Howard A Burris

Abstract read
In one paragraph

Article in Cancer medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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.

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

19 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

7 authors.

Philip T SagerStanford University School of Medicine, San Francisco, California.
Barbara BalserVeristat, LLC, Holliston, Massachusetts.
Julie WolfsonVeristat, LLC, Holliston, Massachusetts.
Jean NicholsJean Nichols LLC, Swampscott, Massachusetts.
Richard PilotCelgene Corporation, Summit, New Jersey.
Suzanne JonesSarah Cannon Research Institute, Nashville, Tennessee.
Howard A BurrisSarah Cannon Research Institute, Nashville, Tennessee.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Romidepsin is a histone deacetylase inhibitor approved by the FDA for the treatment of patients with cutaneous or peripheral T-cell lymphoma who have received prior systemic therapy. The objective of this analysis was to evaluate the potential QTc effects of romidepsin. Patients with advanced malignancy received 4-h infusions of 14 mg/m(2) romidepsin on days 1, 8, and 15 of a 28-day cycle. In cycle 2, a subset of patients received 1-h infusions of 8-12 mg/m(2) romidepsin. Patients were administered antiemetics before each romidepsin dose and electrolyte supplementation as needed. Electrocardiogram readings were performed prior to antiemetic administration, prior to romidepsin administration, and at specified time points over the subsequent 24 h. Romidepsin exposure and heart rate were also assessed. In the electrocardiogram-evaluable population, 26 patients received romidepsin at 14 mg/m(2) over 4 h. The maximum mean increases from the preantiemetic baseline for QTcF and heart rate were 10.1 msec (upper 90% CI, 14.5 msec) and 18.2 beats per minute, respectively. No patient in this study had an absolute QTcF value >450 msec and only one patient had an increase from the preantiemetic baseline of >60 msec. There was a mild reduction in the PR interval and no meaningful changes in the QRS interval. Despite the use of QT-prolonging antiemetics, treatment with romidepsin did not markedly prolong the QTc interval through 24 h. Increases in calculated QTc may have been exaggerated as a consequence of transient increases in heart rate.

Indexed as

AdultAgedAged, 80 and overAntibiotics, AntineoplasticCardiotoxicityDepsipeptidesElectrocardiographyFemaleHeart RateHistone Deacetylase InhibitorsHumansMaleMiddle AgedNeoplasmsAntibiotics, AntineoplasticDepsipeptidesHistone Deacetylase InhibitorsromidepsinAntiemeticselectrocardiographyelectrolyteslymphomaQTcromidepsinT-cell

Identifiers

PMID25914207
PMCPMC4559029

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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.