Evidence map›Paper›PMID 36320066›Full record

ArticleBreast cancer research : BCR2022

Population-based estimate for the correlation of the Oncotype Dx Breast Recurrence Score® result and Ki-67 IHC MIB-1 pharmDx in HR+, HER2-, node-positive early breast cancer.

Michael Crager, Sameera R Wijayawardana, Aaron M Gruver, Andrea Blacklock, Christy Russell, Frederick L Baehner, Francisco Sapunar

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Article in Breast cancer research : BCR, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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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

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3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

7 authors.

Michael CragerBiostatistics - Exact Sciences Corporation, Redwood City, CA, USA.
Sameera R WijayawardanaGlobal Statistical Sciences - Oncology, Eli Lilly and Company, Indianapolis, IN, USA.
Aaron M GruverClinical Diagnostics Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.
Andrea BlacklockMedical - Exact Sciences, Redwood City, CA, USA.
Christy RussellMedical Affairs - Exact Sciences, Redwood City, CA, USA.
Frederick L BaehnerMedical - Exact Sciences, Redwood City, CA, USA.
Francisco SapunarGlobal Medical Affairs, Eli Lilly and Company, Basingstoke, UK. sapunar_francisco@lilly.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe United States Food and Drug Administration recently approved a Ki-67 immunohistochemistry (IHC) assay to identify patients with early breast cancer at high disease recurrence risk. The Oncotype Dx Breast Recurrence Score® assay has been validated in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) invasive breast cancer (IBC) to predict chemotherapy benefit and distant recurrence risk, regardless of nodal status. This study assessed the correlation between Recurrence Score® (RS) results and the Ki-67 IHC MIB-1 pharmDx assay.

methodsHR+, HER2-, N1 IBC samples with RS results were examined by Ki-67 IHC; 311 specimens were collected, including 275 without regard to RS ("unselected RS") and 36 more with RS 26-100; 12 were lymph node negative upon pathology report review, and one had no Ki-67 score, leaving 262 unselected RS and 298 total samples. Spearman rank correlation was calculated using the unselected samples and a weighted rank correlation using all samples. A receiver operating characteristic (ROC) curve for predicting high RS (26-100) from Ki-67 was constructed.

resultsThe Spearman rank correlation between Ki-67 and RS results was moderately positive (unselected RS samples: 0.396; 95% confidence interval [CI] 0.288-0.493; all samples: 0.394; 95% CI 0.294-0.486). While 71% of samples with RS 26-100 had Ki-67 ≥ 20%, 75% with RS 0-25 had Ki-67 < 20%. ROC area under the curve was 0.792 (95% CI 0.725-0.859).

conclusionsThe moderately positive correlation is consistent with previous analyses suggesting the Oncotype Dx® assay and Ki-67 IHC MIB-1 assay should not be used interchangeably in clinical practice.

Indexed as

Breast NeoplasmsBiomarkers, TumorFemaleHumansImmunohistochemistryNeoplasm Recurrence, LocalPrognosisROC CurveBiomarkers, TumorEarly breast cancerImmunohistochemistryKi-67MIB-1Oncotype DxRecurrence score

Identifiers

PMID36320066
PMCPMC9623921

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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.