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一项比较不同剂量超顺磁性氧化铁示踪剂用于乳腺癌前哨淋巴结活检的随机研究:SUNRISE 研究。

A randomized study comparing different doses of superparamagnetic iron oxide tracer for sentinel lymph node biopsy in breast cancer: The SUNRISE study.

机构信息

Breast Surgical Oncology, Clinica Universidad de Navarra, Madrid, Spain; Universidad de Navarra, Spain.

Breast Center, Lucerne Cantonal Hospital, Lucerne, Switzerland.

出版信息

Eur J Surg Oncol. 2020 Dec;46(12):2195-2201. doi: 10.1016/j.ejso.2020.06.018. Epub 2020 Jun 18.


DOI:10.1016/j.ejso.2020.06.018
PMID:32631710
Abstract

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.

摘要

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。

相似文献

[1]
A randomized study comparing different doses of superparamagnetic iron oxide tracer for sentinel lymph node biopsy in breast cancer: The SUNRISE study.

Eur J Surg Oncol. 2020-12

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引用本文的文献

[1]
Magnetic Sentinel Lymph Node Biopsy in Early Breast Cancer Patients: An Individual Patient Data Meta-analysis of Tracer Uptake.

Ann Surg Oncol. 2025-3

[2]
Recent trends in preparation and biomedical applications of iron oxide nanoparticles.

J Nanobiotechnology. 2024-1-8

[3]
Ultra-Low Dose of Superparamagnetic Iron Oxide Nanoparticles for Sentinel Lymph Node Detection in Patients with Breast Cancer.

Ann Surg Oncol. 2023-9

[4]
Evolution and refinement of magnetically guided sentinel lymph node detection in breast cancer: meta-analysis.

Br J Surg. 2023-3-30

[5]
The Application of Magnetic Nanoparticles for Sentinel Lymph Node Detection in Clinically Node-Negative Breast Cancer Patients: A Systemic Review and Meta-Analysis.

Cancers (Basel). 2022-10-14

[6]
Exploratory Study of Superparamagnetic Iron Oxide Dose Optimization in Breast Cancer Sentinel Lymph Node Identification Using a Handheld Magnetic Probe and Iron Quantitation.

Cancers (Basel). 2022-3-10

[7]
Emerging Application of Magnetic Nanoparticles for Diagnosis and Treatment of Cancer.

Polymers (Basel). 2021-11-27

[8]
Optimization of SPIO Injection for Sentinel Lymph Node Dissection in a Rat Model.

Cancers (Basel). 2021-10-8

[9]
Optimizing Dose and Timing in Magnetic Tracer Techniques for Sentinel Lymph Node Detection in Early Breast Cancers: The Prospective Multicenter SentiDose Trial.

Cancers (Basel). 2021-2-9

[10]
Re-evaluation of Sentinel Lymph Node Biopsy for Melanoma.

Curr Treat Options Oncol. 2021-2-9

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