Julian C Schink1, Julia R Trosman2, Christine B Weldon2, Kalliopi P Siziopikou2, Gregory J Tsongalis2, Alfred W Rademaker2, Jyoti D Patel2, Al B Benson2, Edith A Perez2, William J Gradishar3. 1. * Current affiliation: Spectrum Health Medical Group, Grand Rapids, MI. 2. Northwestern 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. 3. Northwestern 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 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.
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 humanepidermal 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.
Authors: Sunil Verma; David Miles; Luca Gianni; Ian E Krop; Manfred Welslau; José Baselga; Mark Pegram; Do-Youn Oh; Véronique Diéras; Ellie Guardino; Liang Fang; Michael W Lu; Steven Olsen; Kim Blackwell Journal: N Engl J Med Date: 2012-10-01 Impact factor: 91.245
Authors: Phillip G Febbo; Marc Ladanyi; Kenneth D Aldape; Angelo M De Marzo; M Elizabeth Hammond; Daniel F Hayes; A John Iafrate; R Kate Kelley; Guido Marcucci; Shuji Ogino; William Pao; Dennis C Sgroi; Marian L Birkeland Journal: J Natl Compr Canc Netw Date: 2011-11 Impact factor: 11.908
Authors: Katrina A B Goddard; Erin J Aiello Bowles; Heather Spencer Feigelson; Laurel A Habel; Sharon Hensley Alford; Catherine A McCarty; Larissa Nekhlyudov; Adedayo A Onitilo; Alanna K Rahm; Jennifer A Webster Journal: Am J Manag Care Date: 2012-11 Impact factor: 2.229
Authors: Stacy W Gray; Benjamin Kim; Lynette Sholl; Angel Cronin; Aparna R Parikh; Carrie N Klabunde; Katherine L Kahn; David A Haggstrom; Nancy L Keating Journal: J Oncol Pract Date: 2017-01-17 Impact factor: 3.840
Authors: Madison M Wempe; Mark D Stewart; Daniel Glass; Laura Lasiter; Diana Merino Vega; Nisha Ramamurthy; Jeff Allen; Ellen V Sigal Journal: Am Health Drug Benefits Date: 2020-06
Authors: Daan van den Broek; T Jeroen N Hiltermann; Bonne Biesma; Winand N M Dinjens; Nils A 't Hart; John W J Hinrichs; Mathie P G Leers; Kim Monkhorst; Matthijs van Oosterhout; Volkher Scharnhorst; Ed Schuuring; Ernst-Jan M Speel; Michel M van den Heuvel; Ron H N van Schaik; Jan von der Thüsen; Stefan M Willems; Leonie de Visser; Marjolijn J L Ligtenberg Journal: Front Oncol Date: 2020-01-22 Impact factor: 6.244