Discordance between original and central laboratories in ER and HER2 results in a diverse, population-based sample
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To investigate the discordance between original and central laboratories in estrogen receptor (ER) status, in tumors originally deemed to be ER-negative, and in HER2 status in a diverse population-based sample.
In a follow-up study of 1785 women with Stage I–III breast cancer diagnosed between 2005 and 2007 in the Detroit and Los Angeles County SEER registry catchment areas, participants were asked to consent to reassessment of ER (in tumors originally deemed to be ER-negative) and HER2 status on archival tumor samples approximately four years after diagnosis. Blocks were centrally prepared and analyzed for ER and HER2 using standardized methods and the guidelines of the American Society of Clinical Oncology and the College of American Pathologists. Analyses determined the discordance between original and central laboratories.
132 (31%) of those eligible for ER reassessment and 367 (21%) eligible for HER2 reassessment had archival blocks reassessed centrally. ER discordance was only 6%. HER2 discordance by immunohistochemistry (IHC) was 26%, but final HER2 results—employing FISH in tumors that were IHC 2+ at the central laboratory—were discordant in only 6%. Half of the original laboratories did not perform their own assays.
Discordance between original and central laboratories in two large metropolitan areas was low in this population-based sample compared to previously reported patient samples. Centralization of testing for key pathology variables appears to be occurring in many hospitals. In addition, quality improvement efforts may have preceded the publication and dissemination of specialty society guidelines.
KeywordsBreast cancer Estrogen receptor HER2 SEER registry Pathology
This work was funded by Grant R01 CA139014 from the National Cancer Institute to the University of Michigan (Principal Investigators Dr. Griggs and Dr. Katz). Dr. Katz was supported by an Established Investigator Award in Cancer Prevention, Control, Behavioral, and Populations Sciences Research from the National Cancer Institute (K05 CA111340). Dr. Thomas was supported by The Fashion Footwear Charitable Foundation of New York/QVC Presents Shoes on Sale. The collection of Los Angeles County cancer incidence data was supported by the California Department of Public Health as part of the statewide cancer reporting program mandated by California Health and Safety Code §103885. The National Cancer Institute’s Surveillance, Epidemiology, and End Results Program under contract N01-PC-35139 was awarded to the University of Southern California Contract N01-PC-54404, and agreement 1U58DP0087-01 was awarded to the Public Health Institute. The collection of metropolitan Detroit cancer incidence data was supported by the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program under contract N01-PC-35145. The authors wish to acknowledge the contributions of Polaris Core Facility technical staff at the Ohio State University.
Compliance with Ethical Standards
Conflict of interest
The authors declare that they have no conflict of interest.
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