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
Abstract Background The 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...
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BMC
2022-11-01
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Series: | Breast Cancer Research |
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Online Access: | https://doi.org/10.1186/s13058-022-01571-7 |
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author | Michael Crager Sameera R. Wijayawardana Aaron M. Gruver Andrea Blacklock Christy Russell Frederick L. Baehner Francisco Sapunar |
author_facet | Michael Crager Sameera R. Wijayawardana Aaron M. Gruver Andrea Blacklock Christy Russell Frederick L. Baehner Francisco Sapunar |
author_sort | Michael Crager |
collection | DOAJ |
description | Abstract Background The 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. Methods HR+, 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. Results The 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). Conclusions The 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. |
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language | English |
last_indexed | 2024-04-12T11:23:01Z |
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spelling | doaj.art-29436609f41c471aa39faa948b2588b32022-12-22T03:35:17ZengBMCBreast Cancer Research1465-542X2022-11-012411710.1186/s13058-022-01571-7Population-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 cancerMichael Crager0Sameera R. Wijayawardana1Aaron M. Gruver2Andrea Blacklock3Christy Russell4Frederick L. Baehner5Francisco Sapunar6Biostatistics – Exact Sciences CorporationGlobal Statistical Sciences – Oncology, Eli Lilly and CompanyClinical Diagnostics Laboratory, Eli Lilly and CompanyMedical – Exact SciencesMedical Affairs – Exact SciencesMedical – Exact SciencesGlobal Medical Affairs, Eli Lilly and CompanyAbstract Background The 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. Methods HR+, 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. Results The 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). Conclusions The 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.https://doi.org/10.1186/s13058-022-01571-7Early breast cancerImmunohistochemistryKi-67MIB-1Oncotype DxRecurrence score |
spellingShingle | Michael Crager Sameera R. Wijayawardana Aaron M. Gruver Andrea Blacklock Christy Russell Frederick L. Baehner Francisco Sapunar 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 Breast Cancer Research Early breast cancer Immunohistochemistry Ki-67 MIB-1 Oncotype Dx Recurrence score |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | population based estimate for the correlation of the oncotype dx breast recurrence score r result and ki 67 ihc mib 1 pharmdx in hr her2 node positive early breast cancer |
topic | Early breast cancer Immunohistochemistry Ki-67 MIB-1 Oncotype Dx Recurrence score |
url | https://doi.org/10.1186/s13058-022-01571-7 |
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