Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study

ABSTRACT 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 indocyani...

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Main 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
Format: Article
Language:English
Published: Wiley 2025-01-01
Series:Thoracic Cancer
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Online Access:https://doi.org/10.1111/1759-7714.15511
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author 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
author_facet 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
author_sort Miao Liu
collection DOAJ
description ABSTRACT 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. Trial Registration ClinicalTrials.gov (https://www.clinicaltrials.gov/), NCT02869815
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spelling doaj-art-fa58ee7c545d4c7da4d714c373a71c792025-01-30T22:40:34ZengWileyThoracic Cancer1759-77061759-77142025-01-01162n/an/a10.1111/1759-7714.15511Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort StudyMiao Liu0Yang Yang1Bin Hua2Rui Feng3Tianyu Xu4Mengyuan Wang5Xiaowei Qi6Yingming Cao7Bo Zhou8Fuzhong Tong9Peng Liu10Hongjun Liu11Lin Cheng12Houpu Yang13Fei Xie14Siyuan Wang15Chaobin Wang16Yuan Peng17Danhua Shen18Lei Chen19Jun Jiang20Shu Wang21Breast Disease Center Peking University People's Hospital Beijing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaDepartment of General Surgery Beijing Hospital Beijing ChinaDepartment of Breast Surgery Tianjin Central Hospital of Obstetrics and Gynecology Tian Jin ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaDepartment of Breast Surgery Chongqing University Three Gorges Hospital Chong Qing ChinaDepartment of Breast Surgery Southwest Hospital Chong Qing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaDepartment of Pathology Peking University People's Hospital Beijing ChinaDepartment of Radiology Peking University People's Hospital Beijing ChinaDepartment of Breast Surgery Southwest Hospital Chong Qing ChinaBreast Disease Center Peking University People's Hospital Beijing ChinaABSTRACT 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. Trial Registration ClinicalTrials.gov (https://www.clinicaltrials.gov/), NCT02869815https://doi.org/10.1111/1759-7714.15511breast cancerindocyanine green fluorescenceneoadjuvant chemotherapysentinel lymph node biopsy
spellingShingle 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
Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study
Thoracic Cancer
breast cancer
indocyanine green fluorescence
neoadjuvant chemotherapy
sentinel lymph node biopsy
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
title_full Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study
title_fullStr Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study
title_full_unstemmed Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study
title_short Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study
title_sort indocyanine green fluorescence plus blue dye for sentinel lymph node biopsy in patients undergoing neoadjuvant chemotherapy for breast cancer a multicenter prospective cohort study
topic breast cancer
indocyanine green fluorescence
neoadjuvant chemotherapy
sentinel lymph node biopsy
url https://doi.org/10.1111/1759-7714.15511
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