AUTHOR=Jiao Dechuang , Yang Benlong , Chen Jiajian , Wang Chunjian , Jin Lidan , Zhao Wenhe , Gao Xueqiang , Wang Haibo , Li Jun , Zhao Haidong , Wu Di , Fan Zhimin , Wang Shujun , Liu Zhenzhen , Wang Yongsheng , Wu Jiong 

TITLE=Efficacy and Safety of Mitoxantrone Hydrochloride Injection for Tracing Axillary Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial

JOURNAL=Frontiers in Oncology

VOLUME=Volume 12 - 2022

YEAR=2022

URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.914057

DOI=10.3389/fonc.2022.914057

ISSN=2234-943X

ABSTRACT=Background: 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 MHI’s efficacy and safety in sentinel lymph node biopsy (SLNB).
Methods: The trial was conducted across 7 hospitals from December 2019 to December 2020. Patients with early-stage breast cancer received MHI and technetium-99m (99mTc) during the surgery. Sentinel node detection rates were compared between MHI and 99mTc to evaluate non-inferiority and concordance. Non-inferiority was valid if the lower limit of the 95% CI of sentinel node relative detection rate difference was ≥ -5%.
Results: SLN relative detection rate of MHI was 97.31% (362/372). Seventy nine point six nine percent（871 /1093）of the SLNs were co-detected by both tracers. Four point one three percent（16/387）of the patients had adverse events and recovered during the follow-up.
Conclusions: MHI is a lymphatic tracer with comparable efficacy to radionuclides and can be used alone or in combination with radioactive substances for SLNB.