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对于较小的乳腺导管原位癌，保乳手术＋术后放疗与乳房切除术的生存结局相似。不过，如果首次保乳手术切缘阳性或距离肿瘤小于2毫米，就需再次手术甚至切除乳房。 2019年2月27日，美国临床肿瘤学会《临床肿瘤学杂志》在线发表法国国家癌症研究所、古斯塔夫鲁西研究所、巴黎第十一大学、奥斯卡兰布雷特癌症中心、巴黎萨克雷大学、勒内于根南医院、居里研究所、洛林癌症研究所、巴黎特农医院、西部癌症研究所、保利卡尔梅特斯研究所、马赛癌症研究中心、马赛大学、莱昂贝拉尔癌症中心、亨利贝克勒尔癌症中心、安托万拉卡萨涅癌症中心的IRCIS研究报告，评估了保乳术前乳腺磁共振成像对乳腺导管原位癌患者再次手术率的影响。
该随机对照III期研究于2010年3月～2014年6月从法国10家医院入组经活检证实乳腺导管原位癌的单发微钙化病灶或肿瘤小于3厘米女性患者360例，随机分入磁共振组181例或标准评估对照组179例。主要研究终点为随机化后6个月内切缘阳性或距离肿瘤小于2毫米的再次干预率。 结果，剔除明显不符合入组标准、随机分组前未签署知情同意、肿瘤大于5厘米、多发病灶、其他恶性病变的患者后，可分析患者352例，其中磁共振组178例、对照组174例。 根据意向治疗分析，可评定终点患者345例（磁共振组173例、对照组127例），其中6个月内由于切缘阳性或距离肿瘤小于2毫米而再次手术82例，磁共振组、对照组分别为35例、47例，再次干预率分别为20%、27%，绝对差为7%（95%置信区间：-2%～16%），相对差为26%（分层比值比：0.68，95%置信区间：0.41～1.1，P=0.13）。 根据仅考虑有可评定终点的实际治疗人群分析，再次干预率的绝对差为9%，相对差为36%（分层比值比，0.59，95%置信区间：0.35～1.0，P=0.05）。 磁共振组、对照组的乳房切除率分别为18%、17%（分层后，P=0.93）。 磁共振发现病变的患者100例，其中非肿块样强化占82%、肿块强化占20%（部分患者兼有）。不过，未确定乳腺导管原位癌的特定形态和动力学参数。 因此，该研究结果表明，术前磁共振对于手术改善乳腺导管原位癌分期的临床意义不大。不过，这可以通过改进新的磁共振成像序列和新的磁共振技术模式重新考虑。 J Clin Oncol. 2019 Feb 27. [Epub ahead of print] Preoperative Breast Magnetic Resonance Imaging in Women With Local Ductal Carcinoma in Situ to Optimize Surgical Outcomes: Results From the Randomized Phase III Trial IRCIS. Balleyguier C, Dunant A, Ceugnart L, Kandel M, Chauvet MP, Chérel P, Mazouni C, Henrot P, Rauch P, Chopier J, Zilberman S, Doutriaux-Dumoulin I, Jaffre I, Jalaguier A, Houvenaeghel G, Guérin N, Callonnec F, Chapellier C, Raoust I, Mathieu MC, Rimareix F, Bonastre J, Garbay JR. Gustave Roussy, Villejuif, France; Paris-Sud University, Orsay, France; Centre Oscar Lambret, Lille, France; Université Paris-Saclay, Villejuif, France; René Huguenin/Curie, Saint-Cloud, France; Institut de Cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France; Tenon Hospital, Paris, France; Institut de Cancérologie de l'Ouest, Nantes, France; Institut Paoli Calmettes, Marseille, France; Cancer Research Center of Marseille, Marseille, France; Aix-Marseille Université, Marseille, France; Centre Léon Bérard, Lyon, France; Centre Henri Becquerel, Rouen, France; Centre Antoine Lacassagne, Nice, France. PURPOSE: We evaluated the addition of breast magnetic resonance imaging (MRI) to standard radiologic evaluation on the re-intervention rate in women with ductal carcinoma in situ (DCIS) undergoing breast-conserving surgery. PATIENTS AND METHODS: Women with biopsy-proven DCIS corresponding to a unifocal microcalcification cluster or a mass less than 30 mm were randomly assigned to undergo MRI or standard evaluation. The primary end point was the re-intervention rate for positive or close margins (< 2 mm) in the 6 months after randomization (ClinicalTrials.gov identifier: NCT01112254). RESULTS: A total of 360 patients from 10 hospitals in France were included in the study. Of the 352 analyzable patients, 178 were randomly assigned to the MRI arm, and 174 were assigned to the control arm. In the intent-to-treat analysis, 82 of 345 patients with the assessable end point were reoperated for positive or close margins within 6 months, resulting in a re-intervention rate of 20% (35 of 173) in the MRI arm and 27% (47 of 172) in the control arm. The absolute difference of 7% (95% CI, -2% to 16%) corresponded to a relative reduction of 26% (stratified odds ratio, 0.68; 95% CI, 0.41 to 1.1; P = .13). When considering only the per-protocol population with an assessable end point, the difference was 9% (stratified odds ratio, 0.59; 95% CI, 0.35 to 1.0; P = .05). Total mastectomy rates were 18% (31 of 176) in the MRI arm and 17% (30 of 173) in the control arm (stratified P = .93). For 100 lesions seen on MRI, nonmass-like enhancement was more predominant (82%) than mass enhancement (20%). Nevertheless, no specific morphologic and kinetic parameters for DCIS were identified. CONCLUSION: The study did not show sufficient surgical improvement with the use of preoperative MRI to be clinically relevant in DCIS staging. However, this could be reconsidered with the improvement of new MRI sequences and new modalities in magnetic resonance techniques. PMID: 30811290 DOI: 10.1200/JCO.18.00595
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