Surgery, Division of Surgical Oncology, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Breast J. 2013 Jul-Aug;19(4):357-64. doi: 10.1111/tbj.12126. Epub 2013 May 23.
Oncotype DX has been criticized for not providing significantly more prognostic information than histopathologic analysis. Oncotype DX was validated in cohorts that included poor prognostic factors (HER2-positive, low-estrogen receptor [ER] expression), raising the question: if patients with known high recurrence rates are excluded, is the Recurrence Score (RS) still valid? Our purpose was to determine if RS can be predicted with readily available measures. One hundred and twenty samples from August 2006 to November 2010 that underwent Oncotype DX testing were analyzed. Data included RS, ER, progesterone receptor (PR), HER2, and Ki67 status by immunohistochemistry (IHC). IHC data were used to create two linear regression models to predict RS. SAS's JMP-7 was used for statistical analysis. When comparing Oncotype DX- and IHC-derived ER and PR values, there were 21 discordant samples. The linear regression model PRS-F created with IHC data (ER, PR, HER2, Ki67) from all samples (n = 120) had an adjusted R(2) = 0.60 indicating a good model for predicting RS. The PRS-R model was built without low-ER and HER2-positive samples (n = 110). It had an adjusted R(2) = 0.38 indicating poor prediction of RS. Oncotype DX data showed good concordance with IHC for ER- and PR-expression in this cohort. Low-ER samples had high RS. After removing low-ER and HER2-positives, calculating RS with PRS-R from remaining data showed poor predictive power for RS (adjusted R(2) = 0.38). This result questions whether RS is prognostic in this subgroup (who would most benefit from further clarification of recurrence risk) and independent of pathology, or is simply producing random RS values. Data bases available to Genomic Health can resolve this issue.
Oncotype DX 因未能提供比组织病理学分析更显著的预后信息而受到批评。Oncotype DX 在包含不良预后因素（HER2 阳性、低雌激素受体 [ER] 表达）的队列中得到验证，这引发了一个问题：如果排除已知复发率高的患者，复发评分（RS）是否仍然有效？我们的目的是确定 RS 是否可以通过现成的方法进行预测。对 2006 年 8 月至 2010 年 11 月进行 Oncotype DX 检测的 120 个样本进行了分析。数据包括 RS、ER、孕激素受体（PR）、HER2 和免疫组织化学（IHC）的 Ki67 状态。使用 IHC 数据创建了两个线性回归模型来预测 RS。SAS 的 JMP-7 用于统计分析。当比较 Oncotype DX 和 IHC 衍生的 ER 和 PR 值时，有 21 个不一致的样本。使用所有样本（n = 120）的 IHC 数据（ER、PR、HER2、Ki67）创建的线性回归模型 PRS-F 的调整 R（2）为 0.60，表明这是一个预测 RS 的良好模型。PRS-R 模型是在没有低 ER 和 HER2 阳性样本的情况下构建的（n = 110），其调整 R（2）为 0.38，表明 RS 的预测能力较差。在该队列中，Oncotype DX 数据与 ER 和 PR 表达的 IHC 显示出良好的一致性。低 ER 样本的 RS 较高。在去除低 ER 和 HER2 阳性样本后，使用剩余数据中的 PRS-R 计算 RS 显示出对 RS 的预测能力较差（调整 R（2）= 0.38）。这一结果质疑 RS 是否在该亚组（最需要进一步明确复发风险的人群）中具有预后意义，以及是否独立于病理学，或者是否只是产生随机的 RS 值。Genomic Health 可用的数据可以解决这个问题。
