Evidence map›Paper›PMID 32203207›Full record

Trial reportBritish journal of cancer2020

Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial.

Daniel Eiger, Noam F Pondé, Dominique Agbor-Tarh, Alvaro Moreno-Aspitia, Martine Piccart, Florentine S Hilbers, Olena Werner, Saranya Chumsri, Amylou Dueck, Judith R Kroep and 6 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00490139 (A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer), which is not on this map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
1.8field-weighted citation impact, top 12% 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.

NCT00490139 phase3completednot on this map

A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

TypeinterventionalSponsorNovartis PharmaceuticalsRan2007 to 2021Enrolled8,381ConditionsNeoplasms, BreastArmsLapatinib, Trastuzumab
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 3 syntheses or guidelines pooled it, 35 citations in OpenAlex.

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  13. New Concepts in Cardio-Oncology.Cancer treatment and research · 2023
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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

16 authors at 12 institutions in 8 countries.

Daniel Eiger *Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.
Noam F Pondé *Institut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.
Dominique Agbor-TarhFrontier Science, Kingussie, United Kingdom.
Alvaro Moreno-AspitiaMayo Clinic, Jacksonville, FL, USA.
Martine PiccartInstitut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium.
Florentine S HilbersBreast International Group (BIG), Brussels, Belgium.
Olena WernerNovartis Pharma AG, Basel, Switzerland.
Saranya ChumsriMayo Clinic, Jacksonville, FL, USA.
Amylou DueckAlliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.
Judith R KroepDepartment of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.
Henry GomezInstituto Nacional de Enfermedades Neoplasicas, Lima, Peru.
István LángIstenhegyi Géndiagnosztika Private Health Center, Oncology Clinic, Budapest, Hungary.
Richard J RodehefferCardiovascular Department, Mayo Clinic, Rochester, MN, USA.
Michael S EwerMD Anderson Cancer Center, Houston, TX, USA.
Thomas SuterDepartment of Cardiology, lnselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Evandro de AzambujaInstitut Jules Bordet Institute and L'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium. evandro.azambuja@bordet.be.
Institut Jules Bordet · BEMayo Clinic in Arizona · USBreast International Group · BEFrontier Agriculture (United Kingdom) · GBInstituto Nacional de Enfermedades Neoplásicas · PELeiden University Medical Center · NLMayo Clinic in Florida · USNational Healthcare Service Center · HUNovartis (Switzerland) · CHThe University of Texas MD Anderson Cancer Center · USUniversity Hospital of Bern · CHWinnMed · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCardiotoxicity is the most significant adverse event associated with trastuzumab (T), the main component of HER2-positive breast cancer (BC) treatment. Less is known about the cardiotoxicity of dual HER2 blockade with T plus lapatinib (L), although this regimen is used in the metastatic setting.

methodsThis is a sub-analysis of the ALTTO trial comparing adjuvant treatment options for patients with early HER2-positive BC. Patients randomised to either T or concomitant T + L were eligible. Cardiac events (CEs) rates were compared according to treatment arm.

resultsWith 6.9 years of median follow-up (FU) and 4190 patients, CE were observed in 363 (8.6%): 166 (7.9%) of patient in T + L arm vs. 197 (9.3%) in T arm (OR = 0.85 [95% CI, 0.68-1.05]). During anti-HER2 treatment 270 CE (6.4%) occurred while 93 (2.2%) were during FU (median time to onset = 6.6 months [IQR = 3.4-11.7]). While 265 CEs were asymptomatic (73%), 94 were symptomatic (26%) and four were cardiac deaths (1%). Recovery was observed in 301 cases (83.8%). Identified cardiac risk factors were: baseline LVEF < 55% (vs > 64%, OR 3.1 [95% CI 1.54-6.25]), diabetes mellitus (OR 1.85 [95% CI 1.25-2.75]), BMI > 30 kg/m

conclusionsDual HER2 blockade with T + L is a safe regimen from a cardiac perspective, but cardiac-focused history for proper patient selection is crucial. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT00490139 (registration date: 22/06/2007); EudraCT Number: 2006-000562-36 (registration date: 04/05/2007); Sponsor Protocol Number: BIG2-06 /EGF106708/N063D.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedBiomarkers, TumorBreast NeoplasmsCardiotoxicityDisease-Free SurvivalDoxorubicinEpirubicinErb-b2 Receptor Tyrosine KinasesFemaleHumansLapatinibMiddle AgedNeoadjuvant TherapyQuinazolinesAntibodies, Monoclonal, HumanizedBiomarkers, TumorDoxorubicinEpirubicinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLapatinibQuinazolinesTrastuzumab

Identifiers

PMID32203207
PMCPMC7217956
OpenAlexW3010696655

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.