Evidence map›Paper›PMID 31605311›Full record

ArticleBreast cancer research and treatment2020

A pooled analysis of the cardiac events in the trastuzumab adjuvant trials.

Evandro de Azambuja, Noam Ponde, Marion Procter, Priya Rastogi, Reena S Cecchini, Matteo Lambertini, Karla Ballman, Alvaro Moreno Aspitia, Dimitrios Zardavas, Lise Roca and 3 more

Open access · bronzeAbstract read
In one paragraph

Article in Breast cancer research and treatment, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 41 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 9% 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

41 citing papers in PubMed, 3 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Pooled it
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  4. Trial
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  8. Article
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  14. Strategies to enhance management of HER2-positive breast cancer in the elderly: an expert consensus perspective.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Cancer and Heart Failure: Dangerous Liaisons.Journal of cardiovascular development and disease · 2024
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 7 countries.

Evandro de AzambujaInstitut Jules Bordet, Université Libre de Bruxelles (U.L.B), Boulevard de Waterloo, 121 (7th Floor), 1000, Brussels, Belgium. evandro.azambuja@bordet.be.ORCID http://orcid.org/0000-0001-9501-4509
Noam PondeInstitut Jules Bordet, Université Libre de Bruxelles (U.L.B), Boulevard de Waterloo, 121 (7th Floor), 1000, Brussels, Belgium.
Marion ProcterFrontier Science (Scotland), Kincraig, UK.
Priya RastogiNRG Oncology, and The University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Reena S CecchiniNRG Oncology, and the University of Pittsburgh, Pittsburgh, PA, USA.
Matteo LambertiniInstitut Jules Bordet, Université Libre de Bruxelles (U.L.B), Boulevard de Waterloo, 121 (7th Floor), 1000, Brussels, Belgium.
Karla BallmanNRG Oncology, and the University of Pittsburgh, Pittsburgh, PA, USA.
Alvaro Moreno AspitiaMayo Clinic, Jacksonville, FL, USA.
Dimitrios ZardavasBreast International Group (BIG), Brussels, Belgium.
Lise RocaInstitut Regional du Cancer Montpellier Val d'Aurelle, Montpellier, France.
Richard D GelberDana-Farber Cancer Institute, Harvard Medical School, Harvard TH Chan School of Public Health, and Frontier Science and Technology Research Foundation, Boston, MA, USA.
Martine Piccart-GebhartInstitut Jules Bordet, Université Libre de Bruxelles (U.L.B), Boulevard de Waterloo, 121 (7th Floor), 1000, Brussels, Belgium.
Thomas SuterUniversity Hospital Bern, Bern, Switzerland.
Université Libre de Bruxelles · BEUniversity of Pittsburgh · USBreast International Group · BEFrontier Agriculture (United Kingdom) · GBHarvard University · USInstitut de Recherche en Cancérologie de Montpellier · FRUniversity Hospital of Bern · CHUniversity of Pittsburgh Medical Center · USWinnMed · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
NRG Oncology Biospecimen BankU24CA196067 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Tanner J. Freeman, Nilsa Del Carmen Ramirez Milan · 2015 to 2026
$42.6M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
NCI NIH HHS Financial Disclosures The NSABP B-31 Trial was supported by NCI grants: U10CA180868, -180822, UG1-189867NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24-196067.NCI NIH HHS U24 CA196067NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233180
6 · The paper itself

Abstract

backgroundTrastuzumab-associated cardiotoxicity remains an issue for patients with HER2-positive breast cancer. This pooled analysis of 3 adjuvant trials investigated the incidence, timing, impact on treatment completion, and risk factors for trastuzumab-associated cardiotoxicity.

methodsThis is an individual patient data level pooled analysis of HERA, NSBAP B-31, and NCCTG 9831 (Alliance Trials). Definitions of cardiac events were as per each individual study.

resultsA total of 7445 patients enrolled in the 3 trials were included in the analysis, of which 4017 were in the trastuzumab and 3428 in the control (observation) arms, respectively. Median follow-up exceeded 10 years (119.2-137.2 months). Nearly all patients (97.4%) in the trastuzumab arms received anthracycline-based chemotherapy. In total, 452 patients in the trastuzumab arms experienced a cardiac event (11.3%), with most being mildly symptomatic or asymptomatic left ventricular ejection fraction (LVEF) decrease (351 patients, 8.7%). Severe congestive heart failure was more common in the trastuzumab arm (2.3%) than in the control arm (0.8%). Most cardiac events occurred during trastuzumab treatment (78.1%) and cardiac events were the main cause of discontinuation across the sample (10.0%); nevertheless, a large majority of patients completed trastuzumab treatment (76.2%). Baseline risk factors that were significantly associated with the development of cardiac events were baseline LVEF < 60%, hypertension, body mass index > 25, age ≥ 60 and, non-Caucasian ethnicity.

conclusionOne year of trastuzumab increases the risk of cardiac events, though most consist of asymptomatic or mildly symptomatic LVEF drops. Adjuvant trastuzumab should be considered a safe treatment from a cardiac standpoint for most patients. Trastuzumab-associated cardiotoxicity is the main cause of discontinuation and further research is needed to individualize prevention and management.

Indexed as

AdultAgedAntineoplastic Agents, ImmunologicalBreast NeoplasmsCase-Control StudiesFemaleHeart DiseasesHumansIncidenceMiddle AgedRandomized Controlled Trials as TopicTrastuzumabTreatment OutcomeAntineoplastic Agents, ImmunologicalTrastuzumabBreast cancerCardiotoxicityLVEFTrastuzumab

Identifiers

PMID31605311
PMCPMC6989393
OpenAlexW2980271263

What OpenQuestion holds

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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.