Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston.
Center for Statistical Sciences, Brown University School of Public Health, Providence, Rhode Island.
JAMA Oncol. 2019 Jul 1;5(7):1036-1042. doi: 10.1001/jamaoncol.2018.6269.
Advanced diagnostics, such as magnetic resonance imaging (MRI) and gene expression profiles, are potentially useful to guide targeted treatment in patients with ductal carcinoma in situ (DCIS).
To examine the proportion of patients who converted to mastectomy after MRI and the reasons for those conversions and to measure patient adherence to radiotherapy guided by the 12-gene DCIS score.
DESIGN, SETTING, AND PARTICIPANTS: Analysis of a prospective, cohort, nonrandomized clinical trial that enrolled women with DCIS on core biopsy who were candidates for wide local excision (WLE) from 75 institutions from March 25, 2015, to April 27, 2016, through the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network trial E4112.
Participants underwent breast MRI before surgery, and subsequent management incorporated MRI findings for choice of surgery. The DCIS score was used to guide radiotherapy recommendations among women with DCIS who had WLE as the final procedure and had tumor-free excision margins of 2 mm or greater.
The primary end point was to estimate the conversion rate to mastectomy and the reason for conversion.
Of 339 evaluable women (mean [SD] age, 59.1 [10.1] years; 262 [77.3%] of European descent) eligible for WLE before MRI, 65 (19.2%; 95% CI, 15.3%-23.7%) converted to mastectomy. Of these 65 patients, conversion was based on MRI findings in 25 (38.5%), patient preference in 25 (38.5%), positive margins after attempted WLE in 10 (15.4%), positive genetic test results in 3 (4.6%), and contraindication to radiotherapy in 2 (3.1%). Among the 285 who had WLE performed after MRI as the first surgical procedure, 274 (96.1%) achieved successful breast conservation. Of 171 women eligible for radiotherapy guided by DCIS score (clear margins, absence of invasive disease, and score obtained), the score was low (<39) in 82 (48.0%; 95% CI, 40.6%-55.4%) and intermediate-high (≥39) in 89 (52.0%; 95% CI, 44.6%-59.4%). Of these 171 patients, 159 (93.0%) were adherent with recommendations.
Among women with DCIS who were WLE candidates based on conventional imaging, multiple factors were associated with conversion to mastectomy. This study may provide useful preliminary information required for designing a planned randomized clinical trial to determine the effect of MRI and DCIS score on surgical management, radiotherapy, overall resource use, and clinical outcomes, with the ultimate goal of achieving greater therapeutic precision.
ClinicalTrials.gov identifier: NCT02352883.
磁共振成像（MRI）和基因表达谱等先进诊断方法，可能有助于指导导管原位癌（DCIS）患者的靶向治疗。
检查 MRI 后转为乳房切除术的患者比例，以及这些转化的原因，并衡量 12 基因 DCIS 评分指导下放疗的患者依从性。
设计、地点和参与者：这是一项前瞻性、队列、非随机临床试验的分析，纳入了 2015 年 3 月 25 日至 2016 年 4 月 27 日期间，来自 75 个机构的符合条件的 DCIS 患者，这些患者在核心活检时为 DCIS，适合广泛局部切除（WLE），这些患者来自东部合作肿瘤学组-美国放射肿瘤学会成像网络试验 E4112。
参与者在手术前接受乳房 MRI，随后的治疗方案结合了 MRI 检查结果，以选择手术方式。在接受 WLE 作为最终手术的 DCIS 患者中，使用 DCIS 评分来指导放疗建议，这些患者的肿瘤切缘无肿瘤，切缘宽度为 2 毫米或以上。
主要终点是估计乳房切除术的转化率和转化率的原因。
在 339 名可评估女性（平均[SD]年龄，59.1[10.1]岁；262[77.3%]为欧洲血统）中，有 65 名（19.2%；95%CI，15.3%-23.7%）在 MRI 前适合 WLE 治疗，转换为乳房切除术。在这 65 名患者中，25 名（38.5%）是基于 MRI 发现，25 名（38.5%）是基于患者的偏好，10 名（15.4%）是因为尝试 WLE 后切缘阳性，3 名（4.6%）是因为基因检测结果阳性，2 名（3.1%）是因为放疗禁忌。在 285 名女性中，有 285 名女性在 MRI 指导下进行了第一次手术，274 名（96.1%）成功实现了乳房保留。在 171 名有资格接受 DCIS 评分指导的放疗的女性中（切缘清晰、无侵袭性疾病和获得评分），82 名（48.0%；95%CI，40.6%-55.4%）的评分较低，89 名（52.0%；95%CI，44.6%-59.4%）的评分较高。在这 171 名患者中，159 名（93.0%）符合推荐意见。
在接受传统影像学检查适合 WLE 的 DCIS 女性中，多种因素与乳房切除术的转化有关。本研究可能为设计一项前瞻性随机临床试验提供有用的初步信息，以确定 MRI 和 DCIS 评分对手术管理、放疗、整体资源利用和临床结果的影响，最终目标是实现更大的治疗精度。
ClinicalTrials.gov 标识符：NCT02352883。
