Evidence map›Paper›PMID 32951084›Full record

Trial reportBreast cancer research and treatment2021

Tolerability and toxicity of trastuzumab or trastuzumab + lapatinib in older patients: a sub-analysis of the ALTTO trial (BIG 2-06; NCCTG (Alliance) N063D).

Noam Pondé, Dominique Agbor-Tarh, Lissandra Dal Lago, Larissa A Korde, Florentine Hilbers, Christian Jackisch, Olena Werner, Richard D Gelber, Aminah Jatoi, Amylou C Dueck and 4 more

Erratum issuedOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 42% 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

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 6 countries.

Noam PondéAC Camargo Cancer Center, Rua Pires da Mota, 1167, São Paulo, 01529-001, Brazil. noam.ponde@accamargo.org.br.ORCID http://orcid.org/0000-0003-4016-0407
Dominique Agbor-TarhFrontier Science Scotland (FSS), Kincraig, UK.
Lissandra Dal LagoInstitut Jules Bordet, Brussels, Belgium.
Larissa A KordeNational Cancer Institute, Bethesda, MD, USA.
Florentine HilbersBreast International Group, Brussels, Belgium.
Christian JackischSana Klinikum, Offenbach, Germany.
Olena WernerNovartis, Basel-City, Switzerland.
Richard D GelberDana-Farber Cancer Institute, Boston, USA.
Aminah JatoiMayo Clinic, Rochester, MN, USA.
Amylou C DueckMayo Clinic, Scottsdale, AZ, USA.
Alvaro Moreno-AspitiaMayo Clinic, Jacksonville, FL, USA.
Christos SotiriouInstitut Jules Bordet, Brussels, Belgium.
Evandro de AzambujaInstitut Jules Bordet, Brussels, Belgium.
Martine PiccartInstitut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium.
Institut Jules Bordet · BEMayo Clinic in Arizona · USBreast International Group · BEDana-Farber Cancer Institute · USFrontier Agriculture (United Kingdom) · GBNational Cancer Institute · USNovartis Foundation · CHSana Klinikum Offenbach · DEUniversité Libre de Bruxelles · BEWinnMed · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
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, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
NCI NIH HHS U10 CA180821NCI NIH HHS UG1 CA232760NCI NIH HHS UG1 CA233180
6 · The paper itself

Abstract

purposeLittle is known about the use of trastuzumab or trastuzumab + lapatinib in older patients. We have performed a sub-analysis of the Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation (ALTTO) trial focused on toxicity and treatment completion of both regimens in older patients (≥ 65 years old)

methodsThe ALTTO trial randomised 8381 patients with early HER2-positive BC in 4 arms. Eligible patients for this study were those having received at least one dose of assigned treatment in either the trastuzumab or trastuzumab + lapatinib arms. Treatment completion was evaluated through the rate of temporary treatment interruptions, permanent treatment discontinuations and lapatinib dose reductions. Toxicity was evaluated via a selected subset of adverse events of interest (AEI). Risk factors for both treatment completion outcomes and toxicity were investigated, including comorbidities and use of 5 or more co-medications at randomization.

resultsA total of 430 patients ≥ 65 year were eligible. Median age was 68 (range 65-80). In comparison with the younger cohort, older patients had a significantly higher number of comorbidities at randomization (p < 0.001). Treatment completion outcomes were worse, particularly in the trastuzumab + lapatinib arm. Adverse events of interest were likewise more common in the trastuzumab + lapatinib arm with higher AEI rates (63.4% in younger vs 78.0% in older, p < 0.001). Concomitant chemotherapy was associated with worse treatment completion outcomes among older patients.

conclusionTrastuzumab plus lapatinib was significantly more toxic among older patients and had worse treatment completion. Trastuzumab was generally well tolerated.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansLapatinibNeoadjuvant TherapyTrastuzumabErb-b2 Receptor Tyrosine KinasesLapatinibTrastuzumabAnti-HER2Breast cancerGeriatric oncology

Identifiers

PMID32951084
PMCPMC8521435
OpenAlexW3087356362

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.