吲哚菁绿荧光联合蓝色染料用于接受新辅助化疗的乳腺癌患者前哨淋巴结活检：一项多中心前瞻性队列研究
Indocyanine Green Fluorescence Plus Blue Dye for Sentinel Lymph Node Biopsy in Patients Undergoing Neoadjuvant Chemotherapy for Breast Cancer: A Multicenter, Prospective Cohort Study.
作者信息
Liu Miao, Yang Yang, Hua Bin, Feng Rui, Xu Tianyu, Wang Mengyuan, Qi Xiaowei, Cao Yingming, Zhou Bo, Tong Fuzhong, Liu Peng, Liu Hongjun, Cheng Lin, Yang Houpu, Xie Fei, Wang Siyuan, Wang Chaobin, Peng Yuan, Shen Danhua, Chen Lei, Jiang Jun, Wang Shu
机构信息
Breast Disease Center, Peking University People's Hospital, Beijing, China.
Department of General Surgery, Beijing Hospital, Beijing, China.
出版信息
Thorac Cancer. 2025 Jan;16(2):e15511. doi: 10.1111/1759-7714.15511. Epub 2024 Dec 27.
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.
背景
对于初始cN1期乳腺癌患者，新辅助化疗（NAC）后使用放射性同位素示踪剂联合蓝色染料进行前哨淋巴结活检（SLNB）是金标准，但临床应用仍存在局限性。本研究旨在探讨双吲哚菁绿（ICG）和亚甲蓝示踪在初始cN1期乳腺癌患者完成NAC后行SLNB的诊断性能。
方法
本前瞻性、多中心队列研究连续纳入计划接受NAC治疗的经活检证实为cT0-3N1M0原发性浸润性乳腺癌的成年女性（20-80岁）。NAC完成后，使用ICG和亚甲蓝进行SLNB，随后进行腋窝淋巴结清扫。主要结局为检出率（DR）；次要结局包括假阴性率（FNR）以及与示踪剂使用相关的不良事件。
结果
共纳入156例患者；所有患者在NAC后均接受了SLNB。SLNB期间回收的淋巴结中位数为3个（范围：0-11个）。DR为97.4%（152/156；95%CI，93.6%-99.0%）。FNR为6.7%（4/60；95%CI，2.6%-15.9%）。阴性预测值为95.7%（88/92；95%CI，89.4%-98.3%）。在按ycN状态分层的亚组分析中，ycN0和ycN+亚组的FNR分别为4.0%（1/25；95%CI，0.7%-19.5%）和8.6%（3/35；95%CI，3.0%-22.4%）。未报告过敏反应。
结论
对于初始cN1期乳腺癌患者，ICG联合亚甲蓝进行SLNB可获得较高的DR和极低的FNR。
试验注册
ClinicalTrials.gov（https://www.CLINICALTRIALS.gov/），NCT02869815。
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