Douek Michael, Klaase Joost, Monypenny Ian, Kothari Ashutosh, Zechmeister Katalin, Brown Douglas, Wyld Lynda, Drew Philip, Garmo Hans, Agbaje Olorunsola, Pankhurst Quentin, Anninga Bauke, Grootendorst Maarten, Ten Haken Bennie, Hall-Craggs Margaret A, Purushotham Arnie, Pinder Sarah
Division of Cancer Studies, Department of Research Oncology, King's College London, London, UK,
Ann Surg Oncol. 2014 Apr;21(4):1237-45. doi: 10.1245/s10434-013-3379-6. Epub 2013 Dec 10.
BACKGROUND: The SentiMAG Multicentre Trial evaluated a new magnetic technique for sentinel lymph node biopsy (SLNB) against the standard (radioisotope and blue dye or radioisotope alone). The magnetic technique does not use radiation and provides both a color change (brown dye) and a handheld probe for node localization. The primary end point of this trial was defined as the proportion of sentinel nodes detected with each technique (identification rate). METHODS: A total of 160 women with breast cancer scheduled for SLNB, who were clinically and radiologically node negative, were recruited from seven centers in the United Kingdom and The Netherlands. SLNB was undertaken after administration of both the magnetic and standard tracers (radioisotope with or without blue dye). RESULTS: A total of 170 SLNB procedures were undertaken on 161 patients, and 1 patient was excluded, leaving 160 patients for further analysis. The identification rate was 95.0 % (152 of 160) with the standard technique and 94.4 % (151 of 160) with the magnetic technique (0.6 % difference; 95 % upper confidence limit 4.4 %; 6.9 % discordance). Of the 22 % (35 of 160) of patients with lymph node involvement, 16 % (25 of 160) had at least 1 macrometastasis, and 6 % (10 of 160) had at least a micrometastasis. Another 2.5 % (4 of 160) had isolated tumor cells. Of 404 lymph nodes removed, 297 (74 %) were true sentinel nodes. The lymph node retrieval rate was 2.5 nodes per patient overall, 1.9 nodes per patient with the standard technique, and 2.0 nodes per patient with the magnetic technique. CONCLUSIONS: The magnetic technique is a feasible technique for SLNB, with an identification rate that is not inferior to the standard technique.
背景:SentiMAG多中心试验评估了一种用于前哨淋巴结活检(SLNB)的新磁技术,并与标准技术(放射性同位素联合蓝色染料或仅使用放射性同位素)进行对比。磁技术不使用辐射,可提供颜色变化(棕色染料)以及用于淋巴结定位的手持探头。该试验的主要终点定义为每种技术检测到的前哨淋巴结比例(识别率)。 方法:从英国和荷兰的七个中心招募了160例计划进行SLNB的乳腺癌女性患者,这些患者临床及影像学检查均显示淋巴结阴性。在注射磁示踪剂和标准示踪剂(放射性同位素联合或不联合蓝色染料)后进行SLNB。 结果:共对161例患者进行了170次SLNB操作,排除1例患者,剩余160例患者进行进一步分析。标准技术的识别率为95.0%(160例中的152例),磁技术的识别率为94.4%(160例中的151例)(差异为0.6%;95%置信上限为4.4%;不一致率为6.9%)。在有淋巴结转移的22%(160例中的35例)患者中,16%(160例中的25例)有至少1个大转移灶,6%(160例中的10例)有至少1个微转移灶。另外2.5%(160例中的4例)有孤立肿瘤细胞。在切除的404个淋巴结中,297个(74%)是真正的前哨淋巴结。总体上每位患者的淋巴结检出率为2.5个,标准技术为每位患者1.9个,磁技术为每位患者2.0个。 结论:磁技术是一种可行的SLNB技术,其识别率不低于标准技术。
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