Biomarker testing for breast, lung, and gastroesophageal cancers at NCI designated cancer centers

Julian C. Schink, Julia R. Trosman, Christine B. Weldon, Kalliopi P. Siziopikou, Gregory J. Tsongalis, Alfred W. Rademaker, Jyoti D. Patel, A. B. Benson, Edith A. Perez, William J. Gradishar*

*Corresponding author for this work

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

Background Molecular biomarkers, a cornerstone of precision oncology, are critical in breast, gastroesophageal, and non small cell lung cancer management (BC, GEC, NSCLC). Testing practices are intensely debated, impacting diagnostic quality and affecting pathologists, oncologists and patients. However, little is known about testing approaches used in practice. Our study described biomarker practices in BC, GEC, and NSCLC at the leading US cancer centers. Methods We conducted a survey of the National Cancer Institute (NCI) designated centers on BC, GEC, and NSCLC biomarker testing. We used simple frequencies to describe practices, two-sided Fisher s exact test and two-sided McNemar s test for cross-cancer comparison. All statistical tests were two-sided. Results For BC human epidermal growth factor receptor 2 (HER2), 39% of centers combine guidelines by using in situ hybridization (ISH) and immunohistochemistry (IHC) concurrently, and 21% reflex-test beyond guideline-recommended IHC2+. For GEC HER2, 44% use ISH and IHC concurrently, and 28% reflex-test beyond IHC2+. In NSCLC, the use of IHC is limited to 4% for epidermal growth factor receptor (EGFR) and 7% for anaplastic lymphoma kinase (ALK). 43.5% test NSCLC biomarkers on oncologist order; 34.5% run all biomarkers upfront, and 22% use a sequential protocol. NSCLC external testing is statistically significantly higher than BC (P > .0001) and GEC (P > .0001). NSCLC internally developed tests are statistically significantly more common than BC (P > .0001) and GEC (P > .0001). Conclusions At the NCI cancer centers, biomarker testing practices vary, but exceeding guidelines is a common practice for established biomarkers and emerging practice for newer biomarkers. Use of internally developed tests declines as biomarkers mature. Implementation of multibiomarker protocols is lagging. Our study represents a step toward developing a biomarker testing practice landscape.

Original languageEnglish (US)
Article numberdju256
JournalJournal of the National Cancer Institute
Volume106
Issue number10
DOIs
StatePublished - Oct 1 2014

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National Cancer Institute (U.S.)
Lung Neoplasms
Breast
Biomarkers
Neoplasms
Immunohistochemistry
Guidelines
In Situ Hybridization
Reflex
Tumor Biomarkers
Epidermal Growth Factor Receptor
Non-Small Cell Lung Carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Schink, Julian C. ; Trosman, Julia R. ; Weldon, Christine B. ; Siziopikou, Kalliopi P. ; Tsongalis, Gregory J. ; Rademaker, Alfred W. ; Patel, Jyoti D. ; Benson, A. B. ; Perez, Edith A. ; Gradishar, William J. / Biomarker testing for breast, lung, and gastroesophageal cancers at NCI designated cancer centers. In: Journal of the National Cancer Institute. 2014 ; Vol. 106, No. 10.
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title = "Biomarker testing for breast, lung, and gastroesophageal cancers at NCI designated cancer centers",
abstract = "Background Molecular biomarkers, a cornerstone of precision oncology, are critical in breast, gastroesophageal, and non small cell lung cancer management (BC, GEC, NSCLC). Testing practices are intensely debated, impacting diagnostic quality and affecting pathologists, oncologists and patients. However, little is known about testing approaches used in practice. Our study described biomarker practices in BC, GEC, and NSCLC at the leading US cancer centers. Methods We conducted a survey of the National Cancer Institute (NCI) designated centers on BC, GEC, and NSCLC biomarker testing. We used simple frequencies to describe practices, two-sided Fisher s exact test and two-sided McNemar s test for cross-cancer comparison. All statistical tests were two-sided. Results For BC human epidermal growth factor receptor 2 (HER2), 39{\%} of centers combine guidelines by using in situ hybridization (ISH) and immunohistochemistry (IHC) concurrently, and 21{\%} reflex-test beyond guideline-recommended IHC2+. For GEC HER2, 44{\%} use ISH and IHC concurrently, and 28{\%} reflex-test beyond IHC2+. In NSCLC, the use of IHC is limited to 4{\%} for epidermal growth factor receptor (EGFR) and 7{\%} for anaplastic lymphoma kinase (ALK). 43.5{\%} test NSCLC biomarkers on oncologist order; 34.5{\%} run all biomarkers upfront, and 22{\%} use a sequential protocol. NSCLC external testing is statistically significantly higher than BC (P > .0001) and GEC (P > .0001). NSCLC internally developed tests are statistically significantly more common than BC (P > .0001) and GEC (P > .0001). Conclusions At the NCI cancer centers, biomarker testing practices vary, but exceeding guidelines is a common practice for established biomarkers and emerging practice for newer biomarkers. Use of internally developed tests declines as biomarkers mature. Implementation of multibiomarker protocols is lagging. Our study represents a step toward developing a biomarker testing practice landscape.",
author = "Schink, {Julian C.} and Trosman, {Julia R.} and Weldon, {Christine B.} and Siziopikou, {Kalliopi P.} and Tsongalis, {Gregory J.} and Rademaker, {Alfred W.} and Patel, {Jyoti D.} and Benson, {A. B.} and Perez, {Edith A.} and Gradishar, {William J.}",
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Biomarker testing for breast, lung, and gastroesophageal cancers at NCI designated cancer centers. / Schink, Julian C.; Trosman, Julia R.; Weldon, Christine B.; Siziopikou, Kalliopi P.; Tsongalis, Gregory J.; Rademaker, Alfred W.; Patel, Jyoti D.; Benson, A. B.; Perez, Edith A.; Gradishar, William J.

In: Journal of the National Cancer Institute, Vol. 106, No. 10, dju256, 01.10.2014.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Biomarker testing for breast, lung, and gastroesophageal cancers at NCI designated cancer centers

AU - Schink, Julian C.

AU - Trosman, Julia R.

AU - Weldon, Christine B.

AU - Siziopikou, Kalliopi P.

AU - Tsongalis, Gregory J.

AU - Rademaker, Alfred W.

AU - Patel, Jyoti D.

AU - Benson, A. B.

AU - Perez, Edith A.

AU - Gradishar, William J.

PY - 2014/10/1

Y1 - 2014/10/1

N2 - Background Molecular biomarkers, a cornerstone of precision oncology, are critical in breast, gastroesophageal, and non small cell lung cancer management (BC, GEC, NSCLC). Testing practices are intensely debated, impacting diagnostic quality and affecting pathologists, oncologists and patients. However, little is known about testing approaches used in practice. Our study described biomarker practices in BC, GEC, and NSCLC at the leading US cancer centers. Methods We conducted a survey of the National Cancer Institute (NCI) designated centers on BC, GEC, and NSCLC biomarker testing. We used simple frequencies to describe practices, two-sided Fisher s exact test and two-sided McNemar s test for cross-cancer comparison. All statistical tests were two-sided. Results For BC human epidermal growth factor receptor 2 (HER2), 39% of centers combine guidelines by using in situ hybridization (ISH) and immunohistochemistry (IHC) concurrently, and 21% reflex-test beyond guideline-recommended IHC2+. For GEC HER2, 44% use ISH and IHC concurrently, and 28% reflex-test beyond IHC2+. In NSCLC, the use of IHC is limited to 4% for epidermal growth factor receptor (EGFR) and 7% for anaplastic lymphoma kinase (ALK). 43.5% test NSCLC biomarkers on oncologist order; 34.5% run all biomarkers upfront, and 22% use a sequential protocol. NSCLC external testing is statistically significantly higher than BC (P > .0001) and GEC (P > .0001). NSCLC internally developed tests are statistically significantly more common than BC (P > .0001) and GEC (P > .0001). Conclusions At the NCI cancer centers, biomarker testing practices vary, but exceeding guidelines is a common practice for established biomarkers and emerging practice for newer biomarkers. Use of internally developed tests declines as biomarkers mature. Implementation of multibiomarker protocols is lagging. Our study represents a step toward developing a biomarker testing practice landscape.

AB - Background Molecular biomarkers, a cornerstone of precision oncology, are critical in breast, gastroesophageal, and non small cell lung cancer management (BC, GEC, NSCLC). Testing practices are intensely debated, impacting diagnostic quality and affecting pathologists, oncologists and patients. However, little is known about testing approaches used in practice. Our study described biomarker practices in BC, GEC, and NSCLC at the leading US cancer centers. Methods We conducted a survey of the National Cancer Institute (NCI) designated centers on BC, GEC, and NSCLC biomarker testing. We used simple frequencies to describe practices, two-sided Fisher s exact test and two-sided McNemar s test for cross-cancer comparison. All statistical tests were two-sided. Results For BC human epidermal growth factor receptor 2 (HER2), 39% of centers combine guidelines by using in situ hybridization (ISH) and immunohistochemistry (IHC) concurrently, and 21% reflex-test beyond guideline-recommended IHC2+. For GEC HER2, 44% use ISH and IHC concurrently, and 28% reflex-test beyond IHC2+. In NSCLC, the use of IHC is limited to 4% for epidermal growth factor receptor (EGFR) and 7% for anaplastic lymphoma kinase (ALK). 43.5% test NSCLC biomarkers on oncologist order; 34.5% run all biomarkers upfront, and 22% use a sequential protocol. NSCLC external testing is statistically significantly higher than BC (P > .0001) and GEC (P > .0001). NSCLC internally developed tests are statistically significantly more common than BC (P > .0001) and GEC (P > .0001). Conclusions At the NCI cancer centers, biomarker testing practices vary, but exceeding guidelines is a common practice for established biomarkers and emerging practice for newer biomarkers. Use of internally developed tests declines as biomarkers mature. Implementation of multibiomarker protocols is lagging. Our study represents a step toward developing a biomarker testing practice landscape.

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