Evidence map›Paper›PMID 35438771›Full record

ArticleThe oncologist2022

Signal Detection of Adverse Events Associated with Trastuzumab in a Cohort of Elderly Patients with Breast Cancer.

Efstathia Polychronopoulou, Sharon H Giordano, Lin-Na Chou, Xiaoying Yu, Yong-Fang Kuo

Open access · goldAbstract read
In one paragraph

Article in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 51% of its field
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

4 citing papers in PubMed, 3 citations in OpenAlex.

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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 at 2 institutions in 1 country.

Efstathia PolychronopoulouOffice of Biostatistics, University of Texas Medical Branch, Galveston, TX, USA.ORCID 0000-0002-6126-6465
Sharon H GiordanoDepartment of Health Services Research, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Lin-Na ChouOffice of Biostatistics, University of Texas Medical Branch, Galveston, TX, USA.
Xiaoying YuOffice of Biostatistics, University of Texas Medical Branch, Galveston, TX, USA.
Yong-Fang KuoOffice of Biostatistics, University of Texas Medical Branch, Galveston, TX, USA.ORCID 0000-0003-1927-0927
The University of Texas Medical Branch at Galveston · USThe University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
UTMB WOMEN'S HEALTH RESEARCH SCHOLARS PROGRAMK12HD052023 · NICHD · UNIVERSITY OF TEXAS MEDICAL BR GALVESTON · PI BERENSON, ABBEY B · 2005 to 2023
$8.1M
NCI NIH HHS P30 CA016672NICHD NIH HHS K12 HD052023
6 · The paper itself

Abstract

aimUtilization of signal detection methods in longitudinal claims data can improve post-marketing drug surveillance, but to date there has been limited application. The aim of this study is to use 3 approaches, the proportional reporting ratio, Gamma Poisson Shrinker, and tree-based scan statistic in detecting adverse drug events (ADEs) attributed to trastuzumab using an administrative claims dataset.

methodsUsing data from the Texas Cancer Registry and SEER linked to Medicare from 2010 to 2013, we conducted 1:2 propensity score matching. Breast cancer HER2+ patients treated with trastuzumab in addition to standard chemotherapy were matched to HER2- patients treated with standard chemotherapy. Inpatient and outpatient encounters up to 6 months from start of therapy were used to identify adverse events.

resultsA total of 4191 patients were included in the study. Across all methods, use of trastuzumab generated signals on 9 distinct body systems. Cardiomyopathy and heart valve disease were the most consistently detected signals. Clinical review determined that most signals represented known ADEs.

conclusionsWe showed that claims data can be used to complement current ADE monitoring using common data mining methods with propensity score matching. Our analysis identified all expected ADEs associated with trastuzumab, and additional signals of valvular heart disorders.

Indexed as

Breast NeoplasmsDrug-Related Side Effects and Adverse ReactionsAgedCohort StudiesFemaleHumansMedicareTrastuzumabUnited StatesTrastuzumabadverse drug reactionsbreast cancerdrug safetypharmacovigilancesignal detectiontrastuzumab

Identifiers

PMID35438771
PMCPMC9177105
OpenAlexW4224281731

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.