Evidence map›Paper›PMID 26064078›Full record

ReviewSarcoma2015

Medication Exposures and Subsequent Development of Ewing Sarcoma: A Review of FDA Adverse Event Reports.

Judith U Cope, Gregory H Reaman, Joseph M Tonning

Abstract readReview
In one paragraph

Review in Sarcoma, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

3 authors.

Judith U CopeOffice of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner/Food and Drug Administration, Building 32, Room 5156, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Gregory H ReamanOffice of Hematology and Oncology Products, OND, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak Bldg. 22, Room 2202, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.
Joseph M TonningU.S. Public Health Service Commissioned Corps, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak Bldg. 22, Room 3410, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background. Ewing sarcoma family of tumors (ESFT) are rare but deadly cancers of unknown etiology. Few risk factors have been identified. This study was undertaken to ascertain any possible association between exposure to therapeutic drugs and ESFT. Methods. This is a retrospective, descriptive study. A query of the FDA Adverse Event Reporting System (FAERS) was conducted for all reports of ESFT, January 1, 1998, through December 31, 2013. Report narratives were individually reviewed for patient characteristics, underlying conditions and drug exposures. Results. Over 16 years, 134 ESFT reports were identified, including 25 cases of ESFT following therapeutic drugs and biologics including immunosuppressive agents and hormones. Many cases were confounded by concomitant medications and other therapies. Conclusions. This study provides a closer look at medication use and underlying disorders in patients who later developed ESFT. While this study was not designed to demonstrate any clear causative association between ESFT and prior use of a single product or drug class, many drugs were used to treat immune-related disease and growth or hormonal disturbances. Further studies may be warranted to better understand possible immune or neuroendocrine abnormalities or exposure to specific classes of drugs that may predispose to the later development of ESFT.

Identifiers

PMID26064078
PMCPMC4439508

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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.