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Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers

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Published on: December 5, 2017

Closing the personalized medicine information gap: HER2 test documentation practice.

Ilia L Ferrusi¹, Craig C Earle, Maureen Trudeau

¹Centre for Evaluation of Medicines, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada.

The American Journal of Managed Care

|February 6, 2013

Summary

Human Epidermal Growth Factor Receptor-2 (HER2) test documentation in early-stage breast cancer patients was documented in only 66% of cases, varying by region and disease severity. Improved reporting is crucial for cancer registration and quality assessment.

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Published on: May 9, 2025

Area of Science:

Oncology
Pathology
Health Services Research

Background:

Uncertainty in Human Epidermal Growth Factor Receptor-2 (HER2) testing practices in Canada impacts personalized medicine.
HER2 assessment is routinely performed for tumors > 1 cm, with central pathology reporting to provincial cancer registries.

Purpose of the Study:

To investigate patterns of HER2 test documentation for early-stage breast cancer (BC) patients within Ontario's centralized pathology reporting system.

Main Methods:

A retrospective cohort study analyzed central HER2 test documentation for early-stage BC patients diagnosed between 2006-2007.
Data linkage across administrative databases provided comprehensive patient information.
Pathology reports were reviewed for HER2 testing, hormone receptor status, and tumor grade.

Main Results:

HER2 testing was documented in 66% of 13,396 patients.
HER2 documentation correlated with documented stage, hormone receptor status, and tumor grade.
Regional variations in documentation were observed, but not associated with sociodemographic factors or comorbidities.

Conclusions:

Centralized HER2 test documentation rates were lower than anticipated, influenced by disease severity.
Observed regional differences likely indicate ascertainment bias in reporting, not testing access.
Enhanced HER2 reporting is recommended for accurate cancer registration, quality measurement, and program evaluation.