J Natl Cancer Inst. 2014 Sep 12;106(10). pii: dju256. doi: 10.1093/jnci/dju256. Print 2014 Oct.

Biomarker Testing for Breast, Lung, and Gastroesophageal Cancers at NCI Designated Cancer Centers.

Schink JC1, Trosman JR2, Weldon CB2, Siziopikou KP2, Tsongalis GJ2, Rademaker AW2, Patel JD2, Benson AB 3rd2, Perez EA2, Gradishar WJ3.

Author information

• 1* Current affiliation: Spectrum Health Medical Group, Grand Rapids, MI.
• 2Northwestern University Feinberg School of Medicine, Chicago, IL (JCS, JRT, CBW, KPS, AWR, JDP, ABB, WJG); Center for Business Models in Healthcare, Chicago, IL (JRT, CBW); UCSF Center for Translational and Policy Research on Personalized Medicine, Department of Clinical Pharmacy, University of California, San Francisco, CA (JRT); Department of Pathology, Dartmouth Hitchcock Medical Center and the Audrey and Theodor Geisel School of Medicine, Dartmouth College, Lebanon, NH (GJT); Mayo Clinic Cancer Center, Mayo Clinic, Jacksonville, FL (EAP).* Current affiliation: Spectrum Health Medical Group, Grand Rapids, MI.
• 3Northwestern University Feinberg School of Medicine, Chicago, IL (JCS, JRT, CBW, KPS, AWR, JDP, ABB, WJG); Center for Business Models in Healthcare, Chicago, IL (JRT, CBW); UCSF Center for Translational and Policy Research on Personalized Medicine, Department of Clinical Pharmacy, University of California, San Francisco, CA (JRT); Department of Pathology, Dartmouth Hitchcock Medical Center and the Audrey and Theodor Geisel School of Medicine, Dartmouth College, Lebanon, NH (GJT); Mayo Clinic Cancer Center, Mayo Clinic, Jacksonville, FL (EAP).* Current affiliation: Spectrum Health Medical Group, Grand Rapids, MI. w-gradishar@northwestern.edu.

Abstract

BACKGROUND:

Molecular biomarkers, a cornerstone of precision oncology, are critical in breast, gastroesophageal, and non-small cell lung cancermanagement (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.