Radiotherapy With a 12-Gene Expression Assay for Ductal Carcinoma In Situ: A Randomized Clinical Trial.

This study reports the first prospective oncologic outcomes of radiotherapy decisions as guided by 12-gene molecular assay, the DCIS score (DS).

本研究报告了首次前瞻性放射治疗决策的肿瘤学结果，这些决策是根据12基因分子检测，即DCIS评分（DS）进行指导的。

Background

To assess surgical outcomes following preoperative breast magnetic resonance imaging (MRI) in women with DCIS and estimate 5-year and 10-year ipsilateral breast event (IBE) rates in participants given DS-based postoperative radiotherapy recommendations after local excision (WLE).

评估接受术前乳腺磁共振成像(MRI)的女性DCIS患者的手术结果，并估计在局部切除(WLE)后根据DS放射治疗建议给予的参与者5年和10年内侧乳腺事件(IBE)的发生率。

DESIGN, SETTING, AND PARTICIPANTS: Women with screen-detected DCIS who were eligible for WLE were enrolled to a single-arm, multicenter trial conducted at 75 institutions within the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (March 2015 to April 2016) and received a preoperative breast MRI-guided surgical treatment.

设计、环境和参与者：符合WLE条件的筛查发现的DCIS女性被纳入一项单臂、多中心试验，该试验在东部肿瘤协作组-美国放射学会成像网络(2015年3月至2016年4月)的75个机构进行，并接受了术前乳腺MRI引导的手术治疗。

Those who underwent successful WLE were advised to omit radiotherapy for low DS (<39) and receive radiotherapy for intermediate/high DS (≥39).

成功进行WLE的患者，如果DS评分较低（<39），则建议不进行放疗；如果DS评分中等或高（≥39），则建议接受放疗。

Those achieving WLE as final treatment and successful DS assay (n = 171) were included in a prespecified analysis.

那些将WLE作为最终治疗并成功进行DS检测的患者（n = 171）被纳入了预先设定的分析中。

Participants were followed up every 6 months for DCIS or invasive IBE, and 5-year IBE rates were analyzed from July to November 2023.

参与者每六个月进行一次DCIS或侵袭性IBE的随访，2023年7月至11月期间分析了5年的IBE率。

intervention

DS-based postoperative radiotherapy recommendations.

基于DS的术后放疗建议。

main_outcomes_and_measures

Five-year IBE rates, with 95% CIs.

5年IBR率及其95%置信区间。

Results

Among the 339 participants, the mean (SD) age was 59.1 (10.1) years.

在339名参与者中，平均（标准差）年龄为59.1（10.1）岁。

A total of 171 women (50.4%) received WLE for pure DCIS with free surgical margins and had DS data available.

共有171名女性（50.4%）接受了针对纯导管原位癌（DCIS）的局部扩大切除术（WLE），手术边缘无癌残留，并且有疾病特异性生存（DS）数据可供分析。

A total of 159 (93.0%) adhered to DS-based radiotherapy recommendations; 7 of 82 patients (8.5%) with a low DS underwent radiotherapy, and 5 of 89 patients (5.6%) with an intermediate/high DS declined radiotherapy.

共有159名患者（93.0%）遵循了基于疾病特异性生存（DS）的放射治疗建议；在82名DS评分低的患者中，有7名（8.5%）接受了放射治疗，而在89名DS评分中等或高的患者中，有5名（5.6%）拒绝了放射治疗。

Over median (range) follow-up of 5 (0.5-5.0) years, 8 of 171 women experienced IBEs (4.8%; 95% CI, 2.4%-9.4%).

在中位（范围）随访5（0.5-5.0）年期间，171名女性中有8人经历了侵入性乳腺事件（IBE）（4.8%；95% 置信区间，2.4%-9.4%）。

IBE rates were similar for participants with a low DS(5.1%; 95% CI, 1.9%-12.9%) and participants with an intermediate/high DS (4.5%; 95% CI, 1.7%-11.7%).

对于低DS评分的参与者（5.1%；95% 置信区间，1.9%-12.9%）和中高DS评分的参与者（4.5%；95% 置信区间，1.7%-11.7%），IBE的发生率相似。

Among the 159 women who had adhered to DS-based radiotherapy recommendations, IBE rates were similar for participants with a low DS (5.5%; 95% CI, 2.1%-14.1%) and intermediate/high DS (4.8%; 95% CI, 1.8%-12.3%).

在159名遵循基于DS的放疗建议的女性中，低DS组（5.5%；95%置信区间，2.1%-14.1%）和中/高DS组（4.8%；95%置信区间，1.8%-12.3%）的局部复发率相似。

conclusions_and_relevance

The findings of this prespecified analysis of a clinical trial suggest that DS-guided radiotherapy post-WLE for DCIS shows markedly lower 5-year IBE rates (approximately 5%) for intermediate/high DS than previously reported data following WLE alone.

这项临床试验的事先规定分析结果表明，与单纯WLE后的数据相比，DS指导下的放疗在WLE后对DCIS的治疗显示出显著较低的5年局部复发率（约5%）对于中/高DS的患者。

Despite a limited sample size, these data potentially provide support for radiotherapy use in patients with intermediate/high DS, and omission when DS is low, although confirmatory studies are needed.

尽管样本量有限，但这些数据可能为中/高DS患者使用放射治疗提供了支持，并且在DS低时可考虑省略放射治疗，尽管需要进一步的确认性研究。

trial_registration

ClinicalTrials.gov Identifier: NCT02352883.

ClinicalTrials.gov注册号：NCT02352883。