NOHA: A Promising Biomarker for Determining Estrogen Receptor Status Among Patients With Breast Cancer in Resource-Constrained Settings

PURPOSEChallenges to breast cancer control in low-and middle-income countries exist because of constrained access to care, including pathology services. Immunohistochemistry (IHC)–based estrogen receptor (ER) analysis is limited-nonexistent because of few and inadequately staffed and equipped pathol...

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Main Authors: Furaha Serventi, Augustine Musyoka, Jamie Saunders, Alex Mremi, Blandina Theophil Mmbaga, Elizabeth Patrick, Theresia Mwakyembe, Michael Jones, F. Lee. Lucas, Susan Miesfeldt, Srinidi Mohan
Format: Article
Language:English
Published: American Society of Clinical Oncology 2022-12-01
Series:JCO Global Oncology
Online Access:https://ascopubs.org/doi/10.1200/GO.22.00192
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author Furaha Serventi
Augustine Musyoka
Jamie Saunders
Alex Mremi
Blandina Theophil Mmbaga
Elizabeth Patrick
Theresia Mwakyembe
Michael Jones
F. Lee. Lucas
Susan Miesfeldt
Srinidi Mohan
author_facet Furaha Serventi
Augustine Musyoka
Jamie Saunders
Alex Mremi
Blandina Theophil Mmbaga
Elizabeth Patrick
Theresia Mwakyembe
Michael Jones
F. Lee. Lucas
Susan Miesfeldt
Srinidi Mohan
author_sort Furaha Serventi
collection DOAJ
description PURPOSEChallenges to breast cancer control in low-and middle-income countries exist because of constrained access to care, including pathology services. Immunohistochemistry (IHC)–based estrogen receptor (ER) analysis is limited-nonexistent because of few and inadequately staffed and equipped pathology laboratories. We have identified Nw-hydroxy-L-Arginine (NOHA) as a blood-based biomarker to distinguish ER status in US patients with breast cancer. Here, we examine NOHA's clinical utility as an ER IHC alternative in Tanzanian patients.MATERIALS AND METHODSFollowing informed consent, 70 newly diagnosed, known or suspected patients with breast cancer were enrolled at Kilimanjaro Christian Medical Center; basic, deidentified clinical and sociodemographic data were collected. For each, a needle prick amount of blood was collected on a Noviplex plasma card and stored at −80°C. Plasma cards and unstained tumor pathology slides were shipped regularly to US laboratories for NOHA, histologic and IHC analysis. NOHA and IHC assay operators were blinded to each other's result and patient clinical status. Paired NOHA and IHC results were compared.RESULTSSlides from 43 participants were available for pathological analysis in the United States. Of those with confirmed malignancy (n = 39), 44%, 51%, 5% were ER-positive, ER-negative, and ER inconclusive, respectively. NOHA levels were available among 33 of 43 of those with pathological data and showed distinct threshold levels correlating 100% to tumor ER IHC and disease categorization where a level below 4 nM, from 4 to 8 nM, and above 8 nM signified ER-negative, ER-positive, and no cancer, respectively.CONCLUSIONThe results are consistent with findings from US patients and suggest NOHA's clinical utility as an accessible IHC replacement in determining ER status among low-and middle-income country patients with breast cancer, promising to extend access to cost-efficient, available hormonal agents and improve outcomes.
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spelling doaj.art-24573570c3af49a5907f95ee9da256752022-12-22T13:11:21ZengAmerican Society of Clinical OncologyJCO Global Oncology2687-89412022-12-01810.1200/GO.22.00192NOHA: A Promising Biomarker for Determining Estrogen Receptor Status Among Patients With Breast Cancer in Resource-Constrained SettingsFuraha Serventi0Augustine Musyoka1Jamie Saunders2Alex Mremi3Blandina Theophil Mmbaga4Elizabeth Patrick5Theresia Mwakyembe6Michael Jones7F. Lee. Lucas8Susan Miesfeldt9Srinidi Mohan10Kilimanjaro Christian Medical Center, Kilimanjaro Clinical Research Institute, and Kilimanjaro Christian Medical University College, Moshi, TanzaniaKilimanjaro Christian Medical Center, Kilimanjaro Clinical Research Institute, and Kilimanjaro Christian Medical University College, Moshi, TanzaniaMaine Medical Center Research Institute, Scarborough, MEKilimanjaro Christian Medical Center, Kilimanjaro Clinical Research Institute, and Kilimanjaro Christian Medical University College, Moshi, TanzaniaKilimanjaro Christian Medical Center, Kilimanjaro Clinical Research Institute, and Kilimanjaro Christian Medical University College, Moshi, TanzaniaKilimanjaro Christian Medical Center, Kilimanjaro Clinical Research Institute, and Kilimanjaro Christian Medical University College, Moshi, TanzaniaKilimanjaro Christian Medical Center, Kilimanjaro Clinical Research Institute, and Kilimanjaro Christian Medical University College, Moshi, TanzaniaPathology Services, Spectrum Healthcare Partners, South Portland, MEMaine Medical Center Research Institute, Scarborough, MEMaine Medical Center, Portland, MEUniversity of New England, Westbrook College of Health Professions, School of Pharmacy, Department of Pharmaceutical Sciences, Portland, MEPURPOSEChallenges to breast cancer control in low-and middle-income countries exist because of constrained access to care, including pathology services. Immunohistochemistry (IHC)–based estrogen receptor (ER) analysis is limited-nonexistent because of few and inadequately staffed and equipped pathology laboratories. We have identified Nw-hydroxy-L-Arginine (NOHA) as a blood-based biomarker to distinguish ER status in US patients with breast cancer. Here, we examine NOHA's clinical utility as an ER IHC alternative in Tanzanian patients.MATERIALS AND METHODSFollowing informed consent, 70 newly diagnosed, known or suspected patients with breast cancer were enrolled at Kilimanjaro Christian Medical Center; basic, deidentified clinical and sociodemographic data were collected. For each, a needle prick amount of blood was collected on a Noviplex plasma card and stored at −80°C. Plasma cards and unstained tumor pathology slides were shipped regularly to US laboratories for NOHA, histologic and IHC analysis. NOHA and IHC assay operators were blinded to each other's result and patient clinical status. Paired NOHA and IHC results were compared.RESULTSSlides from 43 participants were available for pathological analysis in the United States. Of those with confirmed malignancy (n = 39), 44%, 51%, 5% were ER-positive, ER-negative, and ER inconclusive, respectively. NOHA levels were available among 33 of 43 of those with pathological data and showed distinct threshold levels correlating 100% to tumor ER IHC and disease categorization where a level below 4 nM, from 4 to 8 nM, and above 8 nM signified ER-negative, ER-positive, and no cancer, respectively.CONCLUSIONThe results are consistent with findings from US patients and suggest NOHA's clinical utility as an accessible IHC replacement in determining ER status among low-and middle-income country patients with breast cancer, promising to extend access to cost-efficient, available hormonal agents and improve outcomes.https://ascopubs.org/doi/10.1200/GO.22.00192
spellingShingle Furaha Serventi
Augustine Musyoka
Jamie Saunders
Alex Mremi
Blandina Theophil Mmbaga
Elizabeth Patrick
Theresia Mwakyembe
Michael Jones
F. Lee. Lucas
Susan Miesfeldt
Srinidi Mohan
NOHA: A Promising Biomarker for Determining Estrogen Receptor Status Among Patients With Breast Cancer in Resource-Constrained Settings
JCO Global Oncology
title NOHA: A Promising Biomarker for Determining Estrogen Receptor Status Among Patients With Breast Cancer in Resource-Constrained Settings
title_full NOHA: A Promising Biomarker for Determining Estrogen Receptor Status Among Patients With Breast Cancer in Resource-Constrained Settings
title_fullStr NOHA: A Promising Biomarker for Determining Estrogen Receptor Status Among Patients With Breast Cancer in Resource-Constrained Settings
title_full_unstemmed NOHA: A Promising Biomarker for Determining Estrogen Receptor Status Among Patients With Breast Cancer in Resource-Constrained Settings
title_short NOHA: A Promising Biomarker for Determining Estrogen Receptor Status Among Patients With Breast Cancer in Resource-Constrained Settings
title_sort noha a promising biomarker for determining estrogen receptor status among patients with breast cancer in resource constrained settings
url https://ascopubs.org/doi/10.1200/GO.22.00192
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