Breast Surgical Oncology, Clinica Universidad de Navarra, Madrid, Spain; Universidad de Navarra, Spain.
Breast Center, Lucerne Cantonal Hospital, Lucerne, Switzerland.
Eur J Surg Oncol. 2020 Dec;46(12):2195-2201. doi: 10.1016/j.ejso.2020.06.018. Epub 2020 Jun 18.
INTRODUCTION: The non-radioactive method that uses the magnetic tracer (SPIO/Sienna) has shown to be a feasible technique for the SLN detection in breast cancer patients. The aim of this study is to assess the efficacy of different doses of a new magnetic tracer Sienna XP (Magtrace) compared to Tc-99 m and to evaluate its non-inferiority. METHODS: Patients diagnosed with early-stage breast cancer cT1-3 N0, from October 2016 to August 2018 were eligible and consecutively randomized to three different doses of new SPIO used: group 1 (1 mL), group 2 (1.5 mL) and group 3 (2 mL). RESULTS: A total of 135 patients were included in the study, 45 in each group. Detection of SLNs with the three doses of Sienna XP (1 mL, 1.5 mL and 2 mL) showed non-inferior rates compared to the conventional technique with radiotracer (p = 0.654). Concordance by patients with SLN positive was 100% for all groups. 83 (70.3%) patients reported skin staining at one month postoperatively, significantly lower in group 1 (p = 0.042). At 6 months follow up, group 1 remains with significantly lower skin discoloration (p = 0,01). In multivariate analysis, dose of 2 mL showed statistically significant for the skin staining. The majority of patients (70%) felt that skin discoloration does not represent a problem. CONCLUSION: The use of the Sienna XP magnetic tracer at 1 mL is not inferior to higher doses of magnetic tracer neither is inferior to radiotracer. 1 mL of magnetic tracer resulted in significantly less skin discoloration compared to higher doses.
简介:使用磁性示踪剂(SPIO/Sienna)的非放射性方法已被证明是一种可行的技术,可用于检测乳腺癌患者的前哨淋巴结。本研究的目的是评估新型磁性示踪剂 Sienna XP(Magtrace)的不同剂量与 Tc-99 m 相比的功效,并评估其非劣效性。 方法:2016 年 10 月至 2018 年 8 月,符合条件的患者为经组织学证实的早期乳腺癌 cT1-3 N0,连续随机分为三组,分别使用三种不同剂量的新型 SPIO:组 1(1 mL)、组 2(1.5 mL)和组 3(2 mL)。 结果:共有 135 例患者纳入研究,每组 45 例。与放射性示踪剂相比,使用三种剂量的 Sienna XP(1 mL、1.5 mL 和 2 mL)检测 SLN 均显示非劣效率(p = 0.654)。所有组中,SLN 阳性患者的一致性为 100%。83 例(70.3%)患者在术后一个月报告皮肤染色,组 1 显著降低(p = 0.042)。在 6 个月的随访中,组 1 的皮肤变色仍显著较低(p = 0.01)。多变量分析显示,2 mL 剂量与皮肤染色具有统计学意义。大多数患者(70%)认为皮肤变色不是问题。 结论:与较高剂量的磁性示踪剂相比,使用 1 mL 的 Sienna XP 磁性示踪剂不劣于较高剂量的磁性示踪剂,也不劣于放射性示踪剂。与较高剂量相比,1 mL 的磁性示踪剂导致皮肤变色明显减少。
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