Closing the personalized medicine information gap: HER2 test documentation practice

Abstract

Background: Uncertainty about human epidermal growth factor receptor-2 (HER2) testing practice in Canada continues to hinder efforts to improve personalized medicine. Pathologists routinely perform HER2 assessment for all tumors > 1 cm, and pathology is reported centrally to the provincial cancer registry.

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

Study design: Retrospective cohort study of central HER2 test documentation in early-stage BC patients diagnosed in 2006-2007.

Methods: Cohort and staging information was derived from cancer registry and admissions data. Linkage across administrative databases provided data on surgical and radiologic treatment, sociodemographic factors, diagnosis setting, and comorbidities. Pathology reports from the provincial cancer registry were reviewed for HER2 testing, hormone receptor, and grade. Unadjusted and adjusted odds ratios were calculated to determine factors related to HER2 documentation.

Results: A HER2 test was documented for 66% of 13,396 patients. HER2 documentation was associated with stage, hormone receptor, and tumor grade documentation. Higher stage and grade at diagnosis were also associated with HER2 documentation. All models suggested variable regional documentation patterns. Documentation did not differ by sociodemographic factors, presence of comorbidities, or surgical procedure.

Conclusions: Despite a universal testing policy, the rate of centralized HER2 test documentation was lower than expected and related to disease severity. Differences in regional reporting likely reflect ascertainment bias inherent to centralized pathology reporting rather than testing access. Improved HER2 reporting is encouraged for cancer registration, quality-of-care measurement, and program evaluation.

Figure 1

Time Frame Definitions for Selection of the Early-Stage Breast Cancer Cohort and Follow-up Data BC indicates breast cancer.

Figure 2

Flow Diagram of Patient Exclusions From the Cohort and Pathology Reports Reviewed^a BC indicates breast cancer. ^aPercentages shown were calculated on the basis of eligible patients diagnosed with breast cancer.