Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay With Breast Ductal Carcinoma In Situ Treatment
Association of Magnetic Resonance Imaging and a 12-Gene Expression Assay With Breast Ductal Carcinoma In Situ Treatment
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DOI：
10.1001/jamaoncol.2018.6269
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发表时间：
2019-07-01
期刊：
影响因子：
28.4
通讯作者：
Comstock, Christopher
中科院分区：
文献类型：
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作者：
Lehman, Constance D.;Gatsonis, Constantine;Comstock, Christopher
重要性 先进的诊断技术，如磁共振成像 (MRI) 和基因表达谱，可能有助于指导导管原位癌 (DCIS) 患者的靶向治疗。 目的 检查 MRI 后转为乳房切除术的患者比例以及这些转变的原因，并根据 12 基因 DCIS 评分衡量患者对放疗的依从性。 设计、设置和参与者 对已入组的前瞻性、队列、非随机临床试验进行分析2015 年 3 月 25 日至 2016 年 4 月 27 日，通过东部肿瘤合作组-美国放射学院影像网络试验 E4112，从 75 个机构招募了接受核心活检的 DCIS 女性，这些女性是广泛局部切除术 (WLE) 的候选人。 干预措施 参与者在手术前接受了乳房 MRI，随后的管理将 MRI 结果纳入手术选择。 DCIS 评分用于指导以 WLE 作为最终手术且无肿瘤切除边缘为 2 毫米或更大的 DCIS 女性的放射治疗建议。 主要结果和测量 主要终点是估计乳房切除术的转换率以及转换的原因。 结果 339 名可评估女性（平均 [SD] 年龄，59.1 [10.1] 岁；262 名 [77.3%] 为欧洲血统）符合 MRI 前 WLE 条件的患者中有 65 名（19.2%；95% CI，15.3%-23.7%）转为乳房切除术。在这 65 名患者中，25 名患者 (38.5%) 的转换基于 MRI 结果，25 名患者的偏好 (38.5%)，10 名患者 (15.4%) 尝试 WLE 后的阳性切缘，3 名患者 (4.6%) 的基因检测结果呈阳性，以及 2 名患者 (3.1%) 存在放射治疗禁忌。在 MRI 作为第一次手术后进行 WLE 的 285 名患者中，274 名 (96.1%) 成功保乳。在 171 名符合 DCIS 评分（切缘清晰、无浸润性疾病和获得的评分）指导下放疗的女性中，89 名女性的评分较低 (= 39) (52.0%; 95% CI, 44.6%-59.4%)。在这 171 名患者中，159 名 (93.0%) 遵循建议。 结论和相关性 在基于传统影像学属于 WLE 候选者的 DCIS 女性中，多种因素与转为乳房切除术相关。这项研究可以为设计计划的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、放射治疗、整体资源使用和临床结果的影响，最终目标是实现更高的治疗精度。
IMPORTANCE 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).OBJECTIVES 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.INTERVENTIONS 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.MAIN OUTCOMES AND MEASURES The primary end point was to estimate the conversion rate to mastectomy and the reason for conversion.RESULTS 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 89 (52.0%; 95% CI, 44.6%-59.4%). Of these 171 patients, 159 (93.0%) were adherent with recommendations.CONCLUSIONS AND RELEVANCE 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.