Evidence map›Paper›PMID 36875913›Full record

ArticleJACC. CardioOncology2023

Pharmacovigilance Analysis of Heart Failure Associated With Anti-HER2 Monotherapies and Combination Regimens for Cancer.

Sarah Waliany, Jennifer Caswell-Jin, Fauzia Riaz, Nathaniel Myall, Han Zhu, Ronald M Witteles, Joel W Neal

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JACC. CardioOncology, 2023. 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
6.2field-weighted citation impact, top 3% 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

19 citing papers in PubMed, 27 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

7 authors at 3 institutions in 1 country.

Sarah WalianyDepartment of Medicine, Stanford University School of Medicine, Palo Alto, California, USA.
Jennifer Caswell-JinDivision of Oncology, Stanford University School of Medicine, Palo Alto, California, USA.
Fauzia RiazDivision of Oncology, Stanford University School of Medicine, Palo Alto, California, USA.
Nathaniel MyallDivision of Oncology, Stanford University School of Medicine, Palo Alto, California, USA.
Han ZhuDivision of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto, California, USA.
Ronald M WittelesDepartment of Medicine, Stanford University School of Medicine, Palo Alto, California, USA.
Joel W NealDivision of Oncology, Stanford University School of Medicine, Palo Alto, California, USA.
Palo Alto Institute · USStanford University · USCardiovascular Institute of the South · US

Funding

Identification of Causal T-Cell Mechanisms in Immune Checkpoint Inhibitor Induced MyocarditisK08HL161405 · NHLBI · STANFORD UNIVERSITY · PI Han Zhu · 2022 to 2026
$880k
NHLBI NIH HHS K08 HL161405
6 · The paper itself

Abstract

Background: Trastuzumab improves outcomes in patients with HER2-overexpressing malignancies but is associated with decreases in left ventricular ejection fraction. Heart failure (HF) risks from other anti-HER2 therapies are less clear. Objectives: Using World Health Organization pharmacovigilance data, the authors compared HF odds across anti-HER2 regimens. Methods: In VigiBase, 41,976 patients had adverse drug reactions (ADRs) with anti-HER2 monoclonal antibodies (trastuzumab, n = 16,900; pertuzumab, n = 1,856), antibody-drug conjugates (trastuzumab emtansine [T-DM1], n = 3,983; trastuzumab deruxtecan, n = 947), and tyrosine kinase inhibitors (afatinib, n = 10,424; lapatinib, Results: Of 16,900 patients with trastuzumab-associated ADRs, 2,034 (12.04%) had HF reports (median time to onset 5.67 months; IQR: 2.85-9.32 months) compared with 1% to 2% with antibody-drug conjugates. Trastuzumab had higher odds of HF reporting relative to other anti-HER2 therapies collectively in the overall cohort (reporting OR [ROR]: 17.37; 99% CI: 14.30-21.10) and breast cancer subgroup (ROR: 17.10; 99% CI: 13.12-22.27). Pertuzumab/T-DM1 had 3.4 times higher odds of HF reporting than T-DM1 monotherapy; tucatinib/trastuzumab/capecitabine had similar odds as tucatinib. Among metastatic breast cancer regimens, HF odds were highest with trastuzumab/pertuzumab/docetaxel (ROR: 1.42; 99% CI: 1.17-1.72) and lowest with lapatinib/capecitabine (ROR: 0.09; 99% CI: 0.04-0.23). Conclusions: Trastuzumab and pertuzumab/T-DM1 had higher odds of HF reporting than other anti-HER2 therapies. These data provide large-scale, real-world insight into which HER2-targeted regimens would benefit from left ventricular ejection fraction monitoring.

Indexed as

ACTH, doxorubicin/cyclophosphamide followed by trastuzumab/paclitaxelAC-THP, doxorubicin/cyclophosphamide followed by paclitaxel/trastuzumab/pertuzumabADC, antibody-drug conjugateADR, adverse drug reactionAI, aromatase inhibitorantibody-drug conjugatesFDA, U.S. Food and Drug Administrationheart failureHER2HF, heart failureIC, information componentLVEF, left ventricular ejection fractionROR, reporting odds ratioT-DM1, trastuzumab emtansineT-DXd, trastuzumab deruxtecantrastuzumabtyrosine kinase inhibitors

Identifiers

PMID36875913
PMCPMC9982216
OpenAlexW4316881713

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.