Thill Marc, Kurylcio Andrzej, Welter Rebekka, van Haasteren Viviana, Grosse Britta, Berclaz Gilles, Polkowski Wojciech, Hauser Nik
Department of Gynaecology and Obstetrics, Breast Cancer Centre, Agaplesion Markus Hospital, Frankfurt, Germany.
Department of Surgical Oncology, Medical University of Lublin, Poland.
Breast. 2014 Apr;23(2):175-9. doi: 10.1016/j.breast.2014.01.004. Epub 2014 Jan 29.
Sentinel lymph node biopsy (SLNB) is the standard surgical procedure for the axilla in early node-negative breast cancer. To date, the "gold standard" to localize the sentinel lymph node (SLN) is the radiotracer (99m)Tc with or without blue dye. The aim of this study was to evaluate potential equivalency of the new SentiMag(®) technique in comparison to the "gold standard". Within this prospective, multicentric and multinational non-inferiority study including 150 patients (99m)Tc was compared with the magnetic technique, using superparamagnetic iron oxide particles (SPIOs, Sienna+(®)) for localization of SLNs. The results showed a detection rate per patient of 97.3% (146/150) for (99m)Tc vs. 98.0% (147/150) for Sienna+(®) with a similar average number of removed SLNs per patient and a higher per patient malignancy detection rate for the SPIO tracer. We obtained convincing results that magnetic SLNB can be performed easily, safely and equivalently well in comparison to the radiotracer method.
前哨淋巴结活检（SLNB）是早期腋窝淋巴结阴性乳腺癌腋窝手术的标准术式。迄今为止，定位前哨淋巴结（SLN）的“金标准”是放射性示踪剂（99m）Tc，可联合或不联合蓝色染料。本研究旨在评估新型SentiMag(®)技术与“金标准”相比的潜在等效性。在这项前瞻性、多中心、跨国非劣效性研究中，纳入150例患者，将（99m）Tc与使用超顺磁性氧化铁颗粒（SPIOs，Sienna+(®)）定位SLN的磁性技术进行比较。结果显示，（99m）Tc的患者检测率为97.3%（146/150），Sienna+(®)为98.0%（147/150），每位患者切除的SLN平均数量相似，且SPIO示踪剂的每位患者恶性肿瘤检测率更高。我们得到了令人信服的结果，与放射性示踪剂方法相比，磁性SLNB操作简便、安全且等效性良好。
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