Division of Cancer Control and Population Sciences, National Cancer Institute, 6130 Executive Boulevard, Suite 6138, Rockville, MD 20852, USA.
Cancer Epidemiol Biomarkers Prev. 2010 Jan;19(1):144-7. doi: 10.1158/1055-9965.EPI-09-0807.
The clinical importance of human epidermal growth factor receptor-2 (HER2) in breast cancer is now clearly established, given that expression of this tumor marker is used to guide therapy and as a prognostic indicator. Despite its now routine evaluation in breast cancer patients, population-based data are lacking because information on HER2 status is not routinely collected in the majority of population-based cancer registries. We assessed the feasibility of collecting HER2 data and its completeness in three registries in the Surveillance Epidemiology and End Results (SEER) Program. Among a sample of invasive first primary breast cancer patients diagnosed between June and December 2007, HER2 tests had been done on 96.5% (n = 522), and test results were available for 95.2% (n = 515) of patients. The majority of HER2 tests were performed by immunohistochemistry alone (50.9%), 35.3% by both immunohistochemistry and fluorescence in situ hybridization (FISH), and 11.8% of tests by FISH alone. As a result of these findings, SEER registries will collect HER2 data on all invasive breast cancer patients as an optional data element for those diagnosed in 2009 and HER2 will likely be a required data element for these patients in 2010.
人表皮生长因子受体-2（HER2）在乳腺癌中的临床重要性现在已经明确，因为这种肿瘤标志物的表达被用于指导治疗和作为预后指标。尽管目前在乳腺癌患者中常规评估，但由于大多数基于人群的癌症登记处并未常规收集 HER2 状态信息，因此缺乏基于人群的数据。我们评估了在监测、流行病学和最终结果（SEER）计划中的三个登记处收集 HER2 数据及其完整性的可行性。在 2007 年 6 月至 12 月间诊断的浸润性原发性乳腺癌患者样本中，HER2 检测已在 96.5%（n=522）的患者中进行，并且 95.2%（n=515）的患者可获得检测结果。大多数 HER2 检测仅通过免疫组织化学进行（50.9%），35.3%通过免疫组织化学和荧光原位杂交（FISH）进行，11.8%的检测通过 FISH 进行。基于这些发现，SEER 登记处将对所有浸润性乳腺癌患者收集 HER2 数据，作为 2009 年诊断患者的可选数据元素，并且 HER2 可能成为这些患者的必填数据元素。
