背景:许多前瞻性研究表明,将基因组测定纳入临床实践显着影响早期乳腺癌患者辅助治疗的选择。然而,对于局部复发的治疗不存在相同的证据.
目的:这项工作的主要目的是确定临床病理,分子,和遗传参数,使患者可以更准确地分为风险组,为了创建一个局部区域复发风险分类工具,PersonalRT27
方法:为了创建PersonalRT27,我们回顾性评估了接受OncotypeDx®和MammaPrint®基因测试的早期乳腺癌患者(I期或II期)的变量。对测试中包含的这些变量和因素进行分类和加权,以获得1至5分之间的分数,以表示较低或较高的复发风险。分别,基于这些因素,并由研究人员确定。
结果:平均随访时间为60.5个月(范围25-96个月);分析时的局部无进展生存率为98.4%,总生存率为97.5%,其中0.6%的死亡是癌症特异性的。PersonalRT27的曲线下面积为0.76(95%CI[0.70,0.81]),灵敏度为78%,特异性为58.9%。我们使用这些因素来创建基于网络的医院列线图。
结论:PersonalRT27是一种新颖的工具,它整合了临床病理,分子,和遗传参数。实施其临床使用将需要外部和独立验证。
BACKGROUND: Numerous prospective studies have shown that the incorporation of genomic assays into clinical practice significantly impacts the choice of adjuvant treatments for patients with early-stage breast cancer. However, the same evidence does not exist for the treatment of locoregional recurrences.
OBJECTIVE: The main objective of this work was to identify the clinicopathological, molecular, and genetic parameters that allow patients to be more precisely categorised into risk groups, in order to create a locoregional recurrence riskclassification tool, the PersonalRT27.
METHODS: To create PersonalRT27, we retrospective assessed the variables of patients with early breast cancer (stages I or II) who had undergone the OncotypeDx ® and MammaPrint ® genetic tests. These variables and factors included in the tests were categorised and weighted to obtain scores between 1 and 5 pointsto represent a lower or higher risk of relapse, respectively, based on these factors and as determined by the researchers.
RESULTS: The mean follow-up time was 60.5 months (range 25-96 months); locoregional progression-free survival at the time of the analysis was 98.4%, and overall survival was 97.5%, of which 0.6% of the deaths had been cancer specific. The area under the curve for the PersonalRT27 was 0.76 (95% CI [0.70, 0.81]), sensitivity was 78%, and the specificity was 58.9%. We used these factors to create an inhospital web-based nomogram.
CONCLUSIONS: The PersonalRT27 is a novel tool that integrates clinical-pathological, molecular, and genetic parameters. External and independent validation will be required to implement its clinical use.