Efficacy and Safety of Mitoxantrone Hydrochloride Injection for Tracing Axillary Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial
BackgroundMitoxantrone 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...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-06-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2022.914057/full |
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| author | Dechuang Jiao Benlong Yang Benlong Yang Benlong Yang Jiajian Chen Jiajian Chen 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 Jiong Wu Jiong Wu |
| author_facet | Dechuang Jiao Benlong Yang Benlong Yang Benlong Yang Jiajian Chen Jiajian Chen 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 Jiong Wu Jiong Wu |
| author_sort | Dechuang Jiao |
| collection | DOAJ |
| description | BackgroundMitoxantrone 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).MethodsThe trial was conducted across seven 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%.ResultsSLN relative detection rate of MHI was 97.31% (362/372). Of the SLNs, 79.69% (871/1093) were co-detected by both tracers. Of the patients, 4.13% (16/387) had adverse events and recovered during the follow-up.ConclusionsMHI is a lymphatic tracer with comparable efficacy to radionuclides and can be used alone or in combination with radioactive substances for SLNB.Clinical Trial Registrationhttp://www.chinadrugtrials.org.cn, CTR20192435. |
| first_indexed | 2024-12-12T11:46:46Z |
| format | Article |
| id | doaj.art-94114c28f33a4619b25a526700cdc507 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-12-12T11:46:46Z |
| publishDate | 2022-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-94114c28f33a4619b25a526700cdc5072022-12-22T00:25:26ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2022-06-011210.3389/fonc.2022.914057914057Efficacy and Safety of Mitoxantrone Hydrochloride Injection for Tracing Axillary Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical TrialDechuang Jiao0Benlong Yang1Benlong Yang2Benlong Yang3Jiajian Chen4Jiajian Chen5Jiajian Chen6Chunjian Wang7Lidan Jin8Wenhe Zhao9Xueqiang Gao10Haibo Wang11Jun Li12Haidong Zhao13Di Wu14Zhimin Fan15Shujun Wang16Zhenzhen Liu17Yongsheng Wang18Jiong Wu19Jiong Wu20Jiong Wu21Department of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, ChinaDepartment of Oncology, Shanghai Medical College of Fudan University, Shanghai, ChinaDepartment of Collaborative Innovation Center for Cancer Medicine, Fudan University, Shanghai, ChinaDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, ChinaDepartment of Oncology, Shanghai Medical College of Fudan University, Shanghai, ChinaDepartment of Collaborative Innovation Center for Cancer Medicine, Fudan University, Shanghai, ChinaDepartment of Breast Surgery, Shandong Cancer Hospital Fudan University, Jinan, ChinaDepartment of Oncological Surgery, Affiliated Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, ChinaDepartment of Oncological Surgery, Affiliated Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, ChinaDepartment of Breast Surgery, The Affiliated Hospital of Qingdao University, Qingdao, ChinaDepartment of Breast Surgery, The Affiliated Hospital of Qingdao University, Qingdao, ChinaDepartment of Breast Surgery, Second Affiliated Hospital of Dalian Medical University, Dalian, ChinaDepartment of Breast Surgery, Second Affiliated Hospital of Dalian Medical University, Dalian, ChinaDepartment of Breast Surgery, The First Bethune Hospital of Jilin University, Changchun, ChinaDepartment of Breast Surgery, The First Bethune Hospital of Jilin University, Changchun, China0Department of Pharmaceutics, School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, ChinaDepartment of Breast Disease, Henan Breast Cancer Center, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Breast Surgery, Shandong Cancer Hospital Fudan University, Jinan, ChinaDepartment of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, ChinaDepartment of Oncology, Shanghai Medical College of Fudan University, Shanghai, ChinaDepartment of Collaborative Innovation Center for Cancer Medicine, Fudan University, Shanghai, ChinaBackgroundMitoxantrone 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).MethodsThe trial was conducted across seven 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%.ResultsSLN relative detection rate of MHI was 97.31% (362/372). Of the SLNs, 79.69% (871/1093) were co-detected by both tracers. Of the patients, 4.13% (16/387) had adverse events and recovered during the follow-up.ConclusionsMHI is a lymphatic tracer with comparable efficacy to radionuclides and can be used alone or in combination with radioactive substances for SLNB.Clinical Trial Registrationhttp://www.chinadrugtrials.org.cn, CTR20192435.https://www.frontiersin.org/articles/10.3389/fonc.2022.914057/fullbreast cancersentinel lymph node biopsymitoxantrone hydrochloride injection for tracingmastectomybreast-conserving surgeryradioactive tracers |
| spellingShingle | Dechuang Jiao Benlong Yang Benlong Yang Benlong Yang Jiajian Chen Jiajian Chen 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 Jiong Wu Jiong Wu Efficacy and Safety of Mitoxantrone Hydrochloride Injection for Tracing Axillary Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial Frontiers in Oncology breast cancer sentinel lymph node biopsy mitoxantrone hydrochloride injection for tracing mastectomy breast-conserving surgery radioactive tracers |
| title | Efficacy and Safety of Mitoxantrone Hydrochloride Injection for Tracing Axillary Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial |
| title_full | Efficacy and Safety of Mitoxantrone Hydrochloride Injection for Tracing Axillary Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial |
| title_fullStr | Efficacy and Safety of Mitoxantrone Hydrochloride Injection for Tracing Axillary Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial |
| title_full_unstemmed | Efficacy and Safety of Mitoxantrone Hydrochloride Injection for Tracing Axillary Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial |
| title_short | Efficacy and Safety of Mitoxantrone Hydrochloride Injection for Tracing Axillary Sentinel Nodes in Breast Cancer: A Self-Controlled Clinical Trial |
| title_sort | efficacy and safety of mitoxantrone hydrochloride injection for tracing axillary sentinel nodes in breast cancer a self controlled clinical trial |
| topic | breast cancer sentinel lymph node biopsy mitoxantrone hydrochloride injection for tracing mastectomy breast-conserving surgery radioactive tracers |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2022.914057/full |
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