Evidence map›Paper›PMID 31175052›Full record

Trial reportClinical breast cancer2019

Personalized Decision Making in Early Stage Breast Cancer: Applying Clinical Prediction Models for Anthracycline Cardiotoxicity and Breast Cancer Mortality Demonstrates Substantial Heterogeneity of Benefit-Harm Trade-off.

Jenica N Upshaw, Robin Ruthazer, Kathy D Miller, Susan K Parsons, John K Erban, Anne M O'Neill, Biniyam Demissei, George Sledge, Lynne Wagner, Bonnie Ky and 1 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical breast cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 3 pooled it
–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

22 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
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  9. Review
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  13. Cardioprotection of High-Risk Individuals.Heart failure clinics · 2022
    Review
  14. Genetics of cancer therapy-associated cardiotoxicity.Journal of molecular and cellular cardiology · 2022
    Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Cardiovascular Disease Risk in Survivors of Breast Cancer.Current treatment options in cardiovascular medicine · 2019
    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.

Jenica N UpshawDivision of Cardiology, Tufts Medical Center, Boston, MA; The Predictive Analytics and Comparative Effectiveness Center Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA. Electronic address: jupshaw@tuftsmedicalcenter.org.
Robin RuthazerThe Predictive Analytics and Comparative Effectiveness Center Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA.
Kathy D MillerIndiana University Simon Cancer Center, Indianapolis, IN.
Susan K ParsonsThe Predictive Analytics and Comparative Effectiveness Center Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA; Division of Hematology/Oncology, Tufts Medical Center, Boston, MA.
John K ErbanDivision of Hematology/Oncology, Tufts Medical Center, Boston, MA.
Anne M O'NeillDana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA.
Biniyam DemisseiDivision of Cardiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
George SledgeStanford University Medical Center, Palo Alto, CA.
Lynne WagnerWake Forest University Health Services, Winston-Salem, NC.
Bonnie KyDivision of Cardiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA; Department of Biostatistics, Epidemiology & Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.
David M KentThe Predictive Analytics and Comparative Effectiveness Center Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA.

Funding

ECOG-ACRIN NCORP Research Base - TMISTUG1CA189828 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$199.7M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
Multimarker Risk Prediction in Cancer Therapy CardiotoxicityR01HL118018 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI KY, BONNIE · 2014 to 2018
$3.7M
Stanford University NCTN- Network Lead Academic SiteU10CA180816 · NCI · STANFORD UNIVERSITY · PI COUTRE, STEVEN EDWARD, LE, QUYNH-THU XUAN · 2014 to 2018
$2.8M
Building upon a tradition of excellence. The NCTN at Indiana UniversityU10CA180795 · NCI · INDIANA UNIVERSITY INDIANAPOLIS · PI MILLER, KATHY D. · 2014 to 2018
$2.6M
NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180795NCI NIH HHS U10 CA180816NCI NIH HHS U10 CA180820NCI NIH HHS UG1 CA189828NHLBI NIH HHS R01 HL118018
6 · The paper itself

Abstract

backgroundAnthracycline agents can cause cardiotoxicity. We used multivariable risk prediction models to identify a subset of patients with breast cancer at high risk of cardiotoxicity, for whom the harms of anthracycline chemotherapy may balance or exceed the benefits. PATIENTS AND

methodsA clinical prediction model for anthracycline cardiotoxicity was created in 967 patients with human epidermal growth factor receptor-negative breast cancer treated with doxorubicin in the ECOG-ACRIN study E5103. Cardiotoxicity was defined as left ventricular ejection fraction (LVEF) decline of ≥ 10% to < 50% and/or a centrally adjudicated clinical heart failure diagnosis. Patient-specific incremental absolute benefit of anthracyclines (compared with non-anthracycline taxane chemotherapy) was estimated using the PREDICT model to assess breast cancer mortality risk.

resultsOf the 967 women who initiated therapy, 51 (5.3%) developed cardiotoxicity (12 with clinical heart failure). In a multivariate model, increasing age (odds ratio [OR], 1.04; 95% confidence interval [CI], 1.01-1.08), higher body mass index (OR, 1.06; 95% CI, 1.02-1.10), and lower baseline LVEF (OR, 0.93; 95% CI, 0.89-0.98) at baseline were significantly associated with cardiotoxicity. The concordance statistic of the risk model was 0.70 (95% CI, 0.63-0.77). In patients with low anticipated treatment benefit (n = 176) from the addition of anthracycline (< 2% absolute risk difference of breast cancer mortality at 10 years), 16 (9%) of 176 had a > 10% risk of cardiotoxicity and 61 (35%) of 176 had a 5% to 10% risk of cardiotoxicity at 1 year.

conclusionOlder age, higher body mass index, and lower baseline LVEF were associated with increased risk of cardiotoxicity. We identified a subgroup with low predicted absolute benefit of anthracyclines but with high predicted risk of cardiotoxicity. Additional studies are needed incorporating long-term cardiac outcomes and cardiotoxicity model external validation prior to implementation in routine clinical practice.

Indexed as

Decision MakingModels, StatisticalPrecision MedicineAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCardiotoxicityCyclophosphamideDoxorubicinFemaleFollow-Up StudiesHeart FailureHumansIncidenceMiddle AgedPredictive Value of TestsRisk AssessmentCyclophosphamideDoxorubicinCardiomyopathyCardio-oncologyChemotherapyHeart failurePrediction model

Identifiers

PMID31175052
PMCPMC6667295

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.