Kaiser Christina, Kehrer Christina, Keyver-Paik Mignon-Denise, Hecking Thomas, Ayub Tiyasha Hosne, Leutner Claudia, Schild Hans, Kuhn Walther
Department of Obstetrics and Gynecology, Centre for Integrated Oncology (CIO), University of Bonn, Sigmund-Freud-Straße 25, 53127 Bonn, Germany, Phone: 0049/228 287 15449, Fax: 0049/228 287 11489.
Department of Obstetrics and Gynecology, Centre for Integrated Oncology (CIO), University of Bonn, Bonn, Germany.
Horm Mol Biol Clin Investig. 2017 Nov 11;32(1):/j/hmbci.2017.32.issue-1/hmbci-2017-0041/hmbci-2017-0041.xml. doi: 10.1515/hmbci-2017-0041.
Background A published retrospective data of our study group demonstrated that premenopausal women, patients with lobular invasive breast cancer or patients with high breast density [American College of Radiology (ACR) classification 3+4] significantly benefit from magnetic resonance imaging (MRI) leading to additional detection of malignant foci of 20.2% in the index and 2.5% in the contralateral breast, which would otherwise not be detected by routine imaging. Critics of preoperative MRI focus on higher false-positive rates leading to unnecessary surgical procedures and mastectomies. Therefore, MRI in preoperative imaging remains controversial. Methods To validate our retrospective data we initiate a prospective one-armed multicenter trial for patients with histologically confirmed breast cancer performing routine imaging by ultrasound and mammography followed by MRI imaging based on menopause status, histologic subtype, ACR and Breast Imaging Reporting and Data System (BIRADS)-classification. Primary endpoint is the rate of additional findings and change of treatment strategy, secondary endpoints are local recurrence-free, distant recurrence-free and overall survival. Additional MRI findings are calculated to be above 10% with a number of 100 patients recruited and a power of 80%. Conclusion MRI is detecting more tumor foci than conventional imaging but remains controversial in primary breast cancer for preoperative imaging because of the fear of over-diagnosis and the increased morbidity of additional potentially unnecessary surgical procedures. This planned one-armed prospective multicenter trial is designed to confirm our retrospectively revealed data defining subgroups with significant benefit of preoperative MRI to come to a consensus avoiding over-diagnosis and false-positive results leading to clinically beneficial and cost-effective use of preoperative MRI.
我们研究组已发表的回顾性数据表明，绝经前女性、小叶浸润性乳腺癌患者或乳腺密度高（美国放射学会[ACR]分类为3 + 4）的患者从磁共振成像（MRI）中显著获益，这使得在索引乳房中额外检测到20.2%的恶性病灶，在对侧乳房中额外检测到2.5%的恶性病灶，而这些病灶用常规成像方法原本无法检测到。术前MRI的批评者关注其较高的假阳性率会导致不必要的手术和乳房切除术。因此，术前成像中的MRI仍存在争议。方法：为了验证我们的回顾性数据，我们启动了一项前瞻性单臂多中心试验，针对组织学确诊的乳腺癌患者，先通过超声和乳腺X线摄影进行常规成像，然后根据绝经状态、组织学亚型、ACR和乳腺影像报告和数据系统（BIRADS）分类进行MRI成像。主要终点是额外发现的比率和治疗策略的改变，次要终点是局部无复发生存率、远处无复发生存率和总生存率。预计招募100名患者，检验效能为80%，计算得出额外的MRI发现率高于10%。结论：MRI比传统成像能检测到更多的肿瘤病灶，但在原发性乳腺癌的术前成像中仍存在争议，因为担心过度诊断以及额外潜在不必要手术带来的发病率增加。这项计划中的前瞻性单臂多中心试验旨在确认我们回顾性揭示的数据，确定术前MRI有显著获益的亚组，以达成共识，避免过度诊断和假阳性结果，从而实现术前MRI的临床获益和成本效益。
