Feasibility of sentinel lymph node biopsy omission after integration of 18F-FDG dedicated lymph node PET in early breast cancer:a prospective phase Ⅱ trial

作者：Junjie Li; Jingyi Cheng; Guangyu Liu; Yifeng Hou; Genghong Di; Benglong Yang; Yizhou Jiang; Liang Huang; Feilin Qu; Sheng Chen; Yan Wang; Keda Yu; Zhimin Shao^*

来源：Cancer Biology & Medicine, 2022, 19(07): 1100-1108.

• Breast cancer
• sentinel lymph node biopsy
• 18F-fluorodeoxyglucose
• LymphPET
• negative predictive value

Objective:Sentinel lymph node biopsy(SLNB) is currently the standard of care in clinically node negative(cN0) breast cancer.The present study aimed to evaluate the negative predictive value(NPV) of 18F-FDG dedicated lymph node positron emission tomography(LymphPET) in cN0 patients.Methods:This was a prospective phase II trial divided into 2 stages(NCT04072653).In the first stage,cN0 patients underwent axillary LymphPET followed by SLNB.In the second stage,SLNB was omitted in patients with a negative preoperative axillary assessment after integration of LymphPET.Here,we report the results of the first stage.The primary outcome was the NPV of LymphPET to detect macrometastasis of lymph nodes(LN-macro).Results:A total of 189 patients with invasive breast cancer underwent LymphPET followed by surgery with definitive pathological reports.Forty patients had LN-macro,and 16 patients had only lymph node micrometastasis.Of the 131 patients with a negative LymphPET result,16 patients had LN-macro,and the NPV was 87.8%.After combined axillary imaging evaluation with ultrasound and LymphPET,100 patients were found to be both LymphPET and ultrasound negative,9 patients had LN-macro,and the NPV was 91%.Conclusions:LymphPET can be used to screen patients to potentially avoid SLNB,with an NPV> 90%.The second stage of the SOAPET trial is ongoing to confirm the safety of omission of SLNB according to preoperational axillary evaluation integrating LymphPET.

• 出版日期2022
• 单位复旦大学