Impact of 2013 American Society of Clinical Oncology/College of American Pathologists Guidelines on HER2 Fluorescent In Situ Hybridization Testing in Breast Cancers : Experience From a National Reference Laboratory.

OBJECTIVES

We compared the impact of 2013 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines on human epidermal growth factor receptor 2 (HER2) fluorescence in situ hybridization (FISH) testing results on breast cancers.

METHODS

HER2 FISH testing performed between May 2015 and April 2016 following 2013 ASCO/CAP guidelines was included. HER2 to control probe ratios, mean HER2, and control probe copy numbers were used to reassign HER2 status using 2007 ASCO/CAP and US Food and Drug Administration (FDA) guidelines.

RESULTS

HER2 FISH results were available in 2,017 cases. A total of 342 (17.0%) cases were amplified, 301 (14.9%) were equivocal, and 1,374 (68.1%) were nonamplified. After additional testing with the alternate probe, amplified cases increased to 21.6%. HER2 positivity rates following the 2013 ASCO/CAP guidelines were significantly higher compared with the 2007 ASCO/CAP and FDA guidelines.

CONCLUSIONS

The 2013 ASCO/CAP guidelines lead to a higher number of HER2 FISH positive and equivocal cases. In a reference laboratory setting where an alternative control probe was used to resolve equivocal FISH cases, 31.2% of patients with initial equivocal results became HER2 positive.