Miao Liu, Yang Yang, Bin Hua, Rui Feng, Tianyu Xu, Mengyuan Wang, Xiaowei Qi, Yingming Cao, Bo Zhou, Fuzhong Tong, Peng Liu, Hongjun Liu, Lin Cheng, Houpu Yang, Fei Xie, Siyuan Wang, Chaobin Wang, Yuan Peng, Danhua Shen, Lei Chen, Jun Jiang, Shu Wang
{"title":"吲哚菁绿荧光加蓝色染料在乳腺癌新辅助化疗患者前哨淋巴结活检中的应用：一项多中心、前瞻性队列研究","authors":"Miao Liu, Yang Yang, Bin Hua, Rui Feng, Tianyu Xu, Mengyuan Wang, Xiaowei Qi, Yingming Cao, Bo Zhou, Fuzhong Tong, Peng Liu, Hongjun Liu, Lin Cheng, Houpu Yang, Fei Xie, Siyuan Wang, Chaobin Wang, Yuan Peng, Danhua Shen, Lei Chen, Jun Jiang, Shu Wang","doi":"10.1111/1759-7714.15511","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Sentinel lymph node biopsy (SLNB) using radioisotope tracer plus blue dye is the gold standard after neoadjuvant chemotherapy (NAC) in initially cN1 breast cancer patients, but clinical use still has limitations. This study aims to examine diagnostic performance of dual indocyanine green (ICG) and methylene blue tracing for SLNB in patients who have completed NAC for breast cancer with initially cN1 disease.</p><p><strong>Methods: </strong>Adult women (20-80 years of age) scheduled to undergo NAC for biopsy-proven cT0-3N1M0 primary invasive breast cancer were consecutively enrolled in this prospective, multicenter, cohort study. Upon the completion of NAC, SLNB was conducted using ICG and methylene blue, followed by axillary lymph node dissection. The primary outcome was the detection rate (DR); secondary outcomes included the false-negative rate (FNR) and adverse events associated with the use of tracers.</p><p><strong>Results: </strong>A total of 156 patients were enrolled; all underwent SLNB after NAC. The median number of lymph nodes retrieved during SLNB was 3 (range: 0-11). The DR was 97.4% (152/156; 95% CI, 93.6%-99.0%). The FNR was 6.7% (4/60; 95% CI, 2.6%-15.9%). Negative predictive value was 95.7% (88/92; 95% CI, 89.4%-98.3%). In the subgroup analysis stratified by ycN status, FNR was 4.0% (1/25; 95% CI, 0.7%-19.5%) and 8.6% (3/35; 95% CI, 3.0%-22.4%) in the ycN0 and ycN+ subgroups, respectively. No allergic reaction was reported.</p><p><strong>Conclusions: </strong>SLNB with ICG plus methylene blue achieved a high DR and a very low FNR in breast cancer patients with initially cN1 disease.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (https://www.</p><p><strong>Clinicaltrials: </strong>gov/), NCT02869815.</p>","PeriodicalId":23338,"journal":{"name":"Thoracic Cancer","volume":" ","pages":"e15511"},"PeriodicalIF":2.3000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11735736/pdf/","citationCount":"0","resultStr":"{\"title\":\"Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study.\",\"authors\":\"Miao Liu, Yang Yang, Bin Hua, Rui Feng, Tianyu Xu, Mengyuan Wang, Xiaowei Qi, Yingming Cao, Bo Zhou, Fuzhong Tong, Peng Liu, Hongjun Liu, Lin Cheng, Houpu Yang, Fei Xie, Siyuan Wang, Chaobin Wang, Yuan Peng, Danhua Shen, Lei Chen, Jun Jiang, Shu Wang\",\"doi\":\"10.1111/1759-7714.15511\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Sentinel lymph node biopsy (SLNB) using radioisotope tracer plus blue dye is the gold standard after neoadjuvant chemotherapy (NAC) in initially cN1 breast cancer patients, but clinical use still has limitations. This study aims to examine diagnostic performance of dual indocyanine green (ICG) and methylene blue tracing for SLNB in patients who have completed NAC for breast cancer with initially cN1 disease.</p><p><strong>Methods: </strong>Adult women (20-80 years of age) scheduled to undergo NAC for biopsy-proven cT0-3N1M0 primary invasive breast cancer were consecutively enrolled in this prospective, multicenter, cohort study. Upon the completion of NAC, SLNB was conducted using ICG and methylene blue, followed by axillary lymph node dissection. The primary outcome was the detection rate (DR); secondary outcomes included the false-negative rate (FNR) and adverse events associated with the use of tracers.</p><p><strong>Results: </strong>A total of 156 patients were enrolled; all underwent SLNB after NAC. The median number of lymph nodes retrieved during SLNB was 3 (range: 0-11). The DR was 97.4% (152/156; 95% CI, 93.6%-99.0%). The FNR was 6.7% (4/60; 95% CI, 2.6%-15.9%). Negative predictive value was 95.7% (88/92; 95% CI, 89.4%-98.3%). In the subgroup analysis stratified by ycN status, FNR was 4.0% (1/25; 95% CI, 0.7%-19.5%) and 8.6% (3/35; 95% CI, 3.0%-22.4%) in the ycN0 and ycN+ subgroups, respectively. No allergic reaction was reported.</p><p><strong>Conclusions: </strong>SLNB with ICG plus methylene blue achieved a high DR and a very low FNR in breast cancer patients with initially cN1 disease.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (https://www.</p><p><strong>Clinicaltrials: </strong>gov/), NCT02869815.</p>\",\"PeriodicalId\":23338,\"journal\":{\"name\":\"Thoracic Cancer\",\"volume\":\" \",\"pages\":\"e15511\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11735736/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Thoracic Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/1759-7714.15511\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/12/27 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Thoracic Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/1759-7714.15511","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/12/27 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study.
Background: Sentinel lymph node biopsy (SLNB) using radioisotope tracer plus blue dye is the gold standard after neoadjuvant chemotherapy (NAC) in initially cN1 breast cancer patients, but clinical use still has limitations. This study aims to examine diagnostic performance of dual indocyanine green (ICG) and methylene blue tracing for SLNB in patients who have completed NAC for breast cancer with initially cN1 disease.
Methods: Adult women (20-80 years of age) scheduled to undergo NAC for biopsy-proven cT0-3N1M0 primary invasive breast cancer were consecutively enrolled in this prospective, multicenter, cohort study. Upon the completion of NAC, SLNB was conducted using ICG and methylene blue, followed by axillary lymph node dissection. The primary outcome was the detection rate (DR); secondary outcomes included the false-negative rate (FNR) and adverse events associated with the use of tracers.
Results: A total of 156 patients were enrolled; all underwent SLNB after NAC. The median number of lymph nodes retrieved during SLNB was 3 (range: 0-11). The DR was 97.4% (152/156; 95% CI, 93.6%-99.0%). The FNR was 6.7% (4/60; 95% CI, 2.6%-15.9%). Negative predictive value was 95.7% (88/92; 95% CI, 89.4%-98.3%). In the subgroup analysis stratified by ycN status, FNR was 4.0% (1/25; 95% CI, 0.7%-19.5%) and 8.6% (3/35; 95% CI, 3.0%-22.4%) in the ycN0 and ycN+ subgroups, respectively. No allergic reaction was reported.
Conclusions: SLNB with ICG plus methylene blue achieved a high DR and a very low FNR in breast cancer patients with initially cN1 disease.
期刊介绍：
Thoracic Cancer aims to facilitate international collaboration and exchange of comprehensive and cutting-edge information on basic, translational, and applied clinical research in lung cancer, esophageal cancer, mediastinal cancer, breast cancer and other thoracic malignancies. Prevention, treatment and research relevant to Asia-Pacific is a focus area, but submissions from all regions are welcomed. The editors encourage contributions relevant to prevention, general thoracic surgery, medical oncology, radiology, radiation medicine, pathology, basic cancer research, as well as epidemiological and translational studies in thoracic cancer. Thoracic Cancer is the official publication of the Chinese Society of Lung Cancer, International Chinese Society of Thoracic Surgery and is endorsed by the Korean Association for the Study of Lung Cancer and the Hong Kong Cancer Therapy Society.
The Journal publishes a range of article types including: Editorials, Invited Reviews, Mini Reviews, Original Articles, Clinical Guidelines, Technological Notes, Imaging in thoracic cancer, Meeting Reports, Case Reports, Letters to the Editor, Commentaries, and Brief Reports.
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