Evidence map›Paper›PMID 31428908›Full record

Trial reportBreast cancer research and treatment2019

Pathologic complete response and outcomes by intrinsic subtypes in NSABP B-41, a randomized neoadjuvant trial of chemotherapy with trastuzumab, lapatinib, or the combination.

Sandra M Swain, Gong Tang, Peter C Lucas, André Robidoux, David Goerlitz, Brent T Harris, Hanna Bandos, Charles E Geyer, Priya Rastogi, Eleftherios P Mamounas and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 4 pooled it
2.0field-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.

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

24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 38 citations in OpenAlex.

  1. Dual neoadjuvant blockade plus chemotherapy versus monotherapy for the treatment of women with non-metastatic HER2-positive breast cancer: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
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  9. NSABP B-41, a Randomized Neoadjuvant Trial: Genes and Signatures Associated with Pathologic Complete Response.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
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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

11 authors at 5 institutions in 2 countries.

Sandra M SwainNational Surgical Adjuvant Breast and Bowel Project (NSABP), Nova Tower 2, 100 Allegheny Square, Pittsburgh, PA, 15212, USA. sandra.swain@georgetown.edu.ORCID http://orcid.org/0000-0002-1320-3830
Gong TangNational Surgical Adjuvant Breast and Bowel Project (NSABP), Nova Tower 2, 100 Allegheny Square, Pittsburgh, PA, 15212, USA.
Peter C LucasNational Surgical Adjuvant Breast and Bowel Project (NSABP), Nova Tower 2, 100 Allegheny Square, Pittsburgh, PA, 15212, USA.
André RobidouxNational Surgical Adjuvant Breast and Bowel Project (NSABP), Nova Tower 2, 100 Allegheny Square, Pittsburgh, PA, 15212, USA.
David GoerlitzGeorgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, 4000 Reservoir Road NW, 120 Building D, Washington, DC, 20057, USA.
Brent T HarrisGeorgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, 4000 Reservoir Road NW, 120 Building D, Washington, DC, 20057, USA.
Hanna BandosNational Surgical Adjuvant Breast and Bowel Project (NSABP), Nova Tower 2, 100 Allegheny Square, Pittsburgh, PA, 15212, USA.
Charles E GeyerNational Surgical Adjuvant Breast and Bowel Project (NSABP), Nova Tower 2, 100 Allegheny Square, Pittsburgh, PA, 15212, USA.
Priya RastogiNational Surgical Adjuvant Breast and Bowel Project (NSABP), Nova Tower 2, 100 Allegheny Square, Pittsburgh, PA, 15212, USA.
Eleftherios P MamounasNational Surgical Adjuvant Breast and Bowel Project (NSABP), Nova Tower 2, 100 Allegheny Square, Pittsburgh, PA, 15212, USA.
Norman WolmarkNational Surgical Adjuvant Breast and Bowel Project (NSABP), Nova Tower 2, 100 Allegheny Square, Pittsburgh, PA, 15212, USA.
University of Pittsburgh · USGeorgetown University · USCentre Hospitalier de l’Université de Montréal · CAOrlando Health · USVirginia Commonwealth University · US

Funding

Tissue Culture Shared ResourceP30CA051008 · NCI · GEORGETOWN UNIVERSITY · PI Louis M Weiner · 1990 to 2026
$71.5M
Breast Cancer Research Foundation BCRF-16-190NCI NIH HHS P30 CA051008NCI NIH HHS P30-CA-51008 (P.I. Weiner)
6 · The paper itself

Abstract

purposeNSABP B-41, a phase three randomized trial, evaluated neoadjuvant lapatinib, trastuzumab, or the combination with chemotherapy in patients with HER2-positive operable breast cancer. Though no significant difference in pathologic complete response (pCR) was found among the three arms, pCR was associated with prolonged survival. We analyzed tumor intrinsic subtypes with Prediction Analysis of Microarray 50 in a subset of B-41 patients to determine their value in predicting HER2-targeting benefit.

methodsPearson's Chi square test and logistic regression were used to compare pCR in the breast and nodes (ypT0/Tis ypN0). Kaplan-Meier estimates and Cox models were used to compare event-free and overall survival among subtypes.

resultsIntrinsic subtypes were determined in 271 baseline core biopsy samples. The pCR rate among patients with HER2-enriched (HER2E) subtype was greater compared to other subtypes combined (120/197, 60.9% versus 19/74, 25.7%; p < 0.001). In multivariate analysis among patients receiving trastuzumab-containing regimens (with clinical factors and HER2E subtype as factors), HER2E subtype was most strongly associated with pCR [OR 8.41 (95% CI 2.52-28.1) p < 0.001]. Patients with HER2E tumors did not benefit more from dual HER2-targeted therapy versus trastuzumab. The pCR rate was higher among HER2E tumors versus other subtypes in both estrogen receptor-positive and -negative tumors (p ≤ 0.001). Higher ESR1 gene expression was associated with lower pCR rate. No association was observed between subtype and long-term outcomes.

conclusionPatients with HER2E tumors were most likely to attain pCR versus other subtypes. HER2E subtype represents a favorable marker for predicting HER2-targeting benefit, particularly with trastuzumab-based therapies.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBiopsyBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesFemaleGene Expression ProfilingHumansLapatinibNeoadjuvant TherapyProportional Hazards ModelsROC CurveTranscriptomeTrastuzumabTreatment OutcomeBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLapatinibTrastuzumabBreast cancerGenomicHER2 enrichedIntrinsic subtypeNeoadjuvantTrastuzumab

Identifiers

PMID31428908
PMCPMC6797698
OpenAlexW2969950347

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.