JNCI：DCIS评分可预测乳腺导管原位癌患者局部复发风险

目前针对乳腺导管原位癌的治疗方案多样，既存在过度治疗也存在治疗不足。在无症状的女性中，经常将钼靶检查作为筛查手段。那么对于罹患乳腺导管原位癌的女性患者而言，在经过手术切除后，如果没有接受过放疗，则其发生患侧乳房病变（IBE）（定义为导管原位癌复发或侵袭性肿瘤）的风险究竟如何？至今为止，还没有研究针对上述情况的临床和病理特征进行相关探讨。为了试图找到上述问题的答案，来自费城Albert Einstein医学中心的Lawrence J. Solin等进行了相关研究，并将其研究结果发表在JNCI 4月的在线期刊上。

本研究的受试者来自于东部肿瘤协作组织（ECOG）E5194研究，她们都是乳腺导管原位癌患者，已经接受了手术切除但是没有进行放射治疗，在上述受试者中研究者进行了Onco型DX乳腺癌序列。研究者采用Cox回归模型前瞻性的评估发生患侧乳腺病变事件发生风险和导管原位癌（DCIS）评分（通过计算7个肿瘤相关的基因和5个参考基因而得到的评分）之间所存在的联系。所有的统计检验都在双侧进行。

共有327名患者的组织可用于最终的分析。研究者发现，在将他莫昔芬的应用作为变量进行调整之后，DICS评分与患侧乳腺病变的发生风险之间存在显著相关（HR为2.31，95%可信区间1.15-4.49），此外，DCIS评分也与侵袭性患侧乳腺病变的发生风险之间存在显著相关（未经调整的HR为3.68,95%可信区间1.34-9.62）。研究者预先将DCIS组分为低危组、中危组和高危组，在上述三组中，受试者10年患侧乳腺病变的发生率分别为10.6%、26.7%和25.9%，而对于侵袭性患侧乳腺病变而言，10年的发生率分别为3.7%、12.3%和19.2%。在多变量分析中，与患侧乳腺病变发生风险相关的因素包括DCIS评分、肿瘤体积和月经状态。

本研究结果指出DCIS评分能定量评价IBE和侵袭性IBE发病风险，该方法是对传统临床和病理预测因素的补充，同时也提供了一种新的临床工具来改善对DCIS女性的个体化的治疗方案的制定。

A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast.
Abstract
Background For women with ductal carcinoma in situ (DCIS) of the breast, the risk of developing an ipsilateral breast event (IBE; defined as local recurrence of DCIS or invasive carcinoma) after surgical excision without radiation is not well defined by clinical and pathologic characteristics. Methods The Oncotype DX breast cancer assay was performed for patients with DCIS treated with surgical excision without radiation in the Eastern Cooperative Oncology Group (ECOG) E5194 study. The association of the prospectively defined DCIS Score (calculated from seven cancer-related genes and five reference genes) with the risk of developing an IBE was analyzed using Cox regression. All statistical tests were two-sided. Results There were 327 patients with adequate tissue for analysis. The continuous DCIS Score was statistically significantly associated with the risk of developing an IBE (hazard ratio [HR] = 2.31, 95% confidence interval [CI] = 1.15 to 4.49; P = .02) when adjusted for tamoxifen use (prespecified primary analysis) and with invasive IBE (unadjusted HR = 3.68, 95% CI = 1.34 to 9.62; P = .01). For the prespecified DCIS risk groups of low, intermediate, and high, the 10-year risks of developing an IBE were 10.6%, 26.7%, and 25.9%, respectively, and for an invasive IBE, 3.7%, 12.3%, and 19.2%, respectively (both log rank P ≤ .006). In multivariable analyses, factors associated with IBE risk were DCIS Score, tumor size, and menopausal status (all P ≤ .02). Conclusions The DCIS Score quantifies IBE risk and invasive IBE risk, complements traditional clinical and pathologic factors, and provides a new clinical tool to improve selecting individualized treatment for women with DCIS who meet the ECOG E5194 criteria.