Centre for Evaluation of Medicines, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada.
Am J Manag Care. 2013 Jan;19(1):838-44.
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.
To understand patterns of HER2 test documentation for early-stage breast cancer (BC) patients in Ontario's centralized pathology reporting system.
Retrospective cohort study of central HER2 test documentation in early-stage BC patients diagnosed in 2006-2007.
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.
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.
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.
加拿大在人类表皮生长因子受体 2（HER2）检测实践方面存在不确定性，这仍然阻碍了个性化医疗的发展。病理学家通常对所有>1cm 的肿瘤进行 HER2 评估，并且病理学报告集中到省级癌症登记处。
了解安大略省集中病理学报告系统中早期乳腺癌（BC）患者 HER2 检测文件的模式。
对 2006-2007 年诊断的早期 BC 患者的中央 HER2 检测文件进行回顾性队列研究。
从癌症登记处和入院数据中获得队列和分期信息。通过行政数据库的链接提供了手术和放射治疗、社会人口因素、诊断环境以及合并症的数据。从省级癌症登记处的病理报告中审查了 HER2 检测、激素受体和分级情况。计算未调整和调整后的优势比，以确定与 HER2 文件记录相关的因素。
在 13396 名患者中，有 66%的患者记录了 HER2 检测。HER2 文件记录与分期、激素受体和肿瘤分级文件记录相关。诊断时的较高分期和分级也与 HER2 文件记录相关。所有模型均表明存在区域性文件记录模式的差异。文件记录与社会人口因素、合并症的存在或手术程序无关。
尽管有统一的检测政策，但集中 HER2 检测文件记录的比率低于预期，并且与疾病严重程度相关。区域报告的差异可能反映了集中病理学报告固有的确定偏差，而不是检测的可及性。鼓励提高癌症登记、护理质量衡量和计划评估的 HER2 报告。
