Compared the efficacy of mitoxantrone hydrochloride injection for tracing with radionuclide in sentinel lymph node biopsy of breast cancer

Benlong YANG; Dechuang JIAO; Jiajian CHEN; Chunjian WANG; Lidan JIN; Wenhe ZHAO; Xueqiang GAO; Haibo WANG; Jun LI; Haidong ZHAO; Di WU; Zhimin FAN; Shujun WANG; Zhenzhen LIU; Yongsheng WANG; Jiong WU

doi:10.19401/j.cnki.1007-3639.2023.02.005

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Compared the efficacy of mitoxantrone hydrochloride injection for tracing with radionuclide in sentinel lymph node biopsy of breast cancer

Specialists' Article | 更新时间：2025-12-31

- Compared the efficacy of mitoxantrone hydrochloride injection for tracing with radionuclide in sentinel lymph node biopsy of breast cancer
- China Oncology Vol. 33, Issue 2, Pages: 126-133(2023)
- 作者机构：
  
  1. 复旦大学附属肿瘤医院乳腺外科，复旦大学上海医学院肿瘤学系，上海 200032
  2. 中国上海肿瘤医学协同创新中心，上海 200032
  3. 郑州大学附属肿瘤医院，河南省肿瘤医院乳腺科，河南郑州 450003
  4. 山东省肿瘤医院乳腺外科，山东济南 250117
  5. 浙江大学医学院附属邵逸夫医院肿瘤外科，浙江杭州 310016
  6. 青岛大学附属医院乳腺外科，山东青岛 266000
  7. 大连医科大学附属第二医院乳腺外科，辽宁大连 116021
  8. 吉林大学白求恩第一医院乳腺外科，吉林长春 130021
  9. 沈阳药科大学药学院药剂学系，辽宁沈阳 110016
- 作者简介：
- 基金信息：
- DOI：10.19401/j.cnki.1007-3639.2023.02.005
  CLC： R737.9
- Received：27 December 2022，
  
  Revised：2023-02-03，
  
  Published：28 February 2023
- 稿件说明：
移动端阅览
Benlong YANG, Dechuang JIAO, Jiajian CHEN, et al. Compared the efficacy of mitoxantrone hydrochloride injection for tracing with radionuclide in sentinel lymph node biopsy of breast cancer[J]. China Oncology, 2023, 33(2): 126-133.
DOI：

Benlong YANG, Dechuang JIAO, Jiajian CHEN, et al. Compared the efficacy of mitoxantrone hydrochloride injection for tracing with radionuclide in sentinel lymph node biopsy of breast cancer[J]. China Oncology, 2023, 33(2): 126-133. DOI： 10.19401/j.cnki.1007-3639.2023.02.005.

摘要

背景与目的：

国内外指南均推荐核素用作前哨淋巴结活检术（sentinel lymph node biopsy，SLNB）示踪剂，但多种原因导致该技术在国内未得到普及。示踪用盐酸米托蒽醌注射液（mitoxantrone hydrochloride injection for tracing，MHI）是一种新型乳腺癌前哨淋巴结（sentinel lymph node，SLN）示踪剂，其在乳腺癌SLNB中的效果尚未明确。本研究是一项大样本阳性对照临床试验，旨在评价MHI和核素在SLNB中的示踪差异。

方法：

试验纳入了2019年12月—2020年7家医院的早期乳腺癌患者。所有入组的早期乳腺癌患者均在手术前注射MHI和核素作为SLN示踪剂。分别统计MHI和核素的SLN检出数量和SLN检出率，分析两种示踪剂示踪效果的差异。

结果：

MHI的SLN检出率为96.9%（370/382），核素的SLN检出率为97.4%（372/382），两者检出率差异无统计学意义（

0.05）。两种示踪剂共同检测到362例（94.7%）受试者的SLN；16例（4.1%）发生可能与试验药物相关的不良事件。

结论：

本研究发现MHI示踪效果不劣于核素。且MHI的使用无需特殊仪器/设备辅助。

Abstract

Background and purpose:

Both domestic and foreign guidelines recommend the use of radionuclide as sentinel lymph node (SLN) biopsy (SLNB) tracer

however this technique has not been popularized in China for a variety of reasons. Mitoxantrone hydrochloride injection for tracing (MHI)

a new strategy to identify lymph nodes

has not been tested for axillary node staging in breast cancer. This multicenter

self-controlled

non-inferiority trial aimed to evaluate the differences between MHI and radionuclide in SLNB tracing.

Methods:

he trial was conducted across 7 hospitals from December 2019 to December 2020. Patients with early-stage breast cancer received MHI and radionuclide (technetium 99 labeled sulfur colloid

99m

Tc-Sc) as SLN tracers during the surgery. The number of SLNs detected and sentinel node detection rates of MHI and radionuclide were counted to evaluate differences in the tracing effects between the two tracers.

Results:

SLN detection rates of MHI and radionuclide were 96.9% (370/382) and 97.4% (372/382)

respectively

with no significant difference (

0.05). SLNs were co-detected by both tracers in 362 (94.7%) patients; 16 (4.1%) had adverse events possibly related to the trial drugs.

Conclusion:

In this study

it was found that the lymphatic tracing ability of MHI was not inferior to that of radionuclide. Meanwhile

the use of MHI does not require special instrument/equipment assistance.

关键词

Keywords

references

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