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The American Society of Breast Surgeons.
Annals of Surgical Oncology

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The Sentinel Lymph Node Biopsy Using Indocyanine Green Fluorescence Plus Radioisotope Method Compared With the Radioisotope-Only Method for Breast Cancer Patients After Neoadjuvant Chemotherapy: A Prospective, Randomized, Open-Label, Single-Center Phase 2 Trial

So-Youn Jung MD, PhD, Jai Hong Han MD, Soo Jin Park MD, Eun-Gyeong Lee MD, Joohwa Kwak MD, Sun Hye Kim MD, Moo Hyun Lee MD, PhD, Eun Sook Lee MD, PhD, Han-Sung Kang MD, PhD, Keun Seok Lee MD, PhD, In Hae Park MD, PhD, Sung Hoon Sim MD, PhD, Hae Jeong Jeong MD, PhD, Youngmee Kwon MD, PhD, Dong-Eun Lee MS, Seok-Ki Kim MD, PhD, Seeyoun Lee MD, PhD
Breast Oncology
Volume 26, Issue 8 / August , 2019

Abstract

Background

This study aimed to compare the sentinel lymph node (SLN) identification rates for breast cancer patients after neoadjuvant chemotherapy (NAC) between the dual method (DM) of indocyanine green fluorescence (ICG-F) plus a radioisotope (RI) and RI alone.

Methods

This randomized study enrolled 130 patients who received NAC for breast cancer and 122 patients who received SLN biopsy (SLNB) using either DM (n = 58) or RI only (n = 64). The study compared the identification rate, number of SLNs, and detection time of SLNB.

Results

Among the 122 patients, 113 (92.6%) were clinically node-positive before NAC. The SLN identification rate was 98.3% in the DM group and 93.8% in the RI group (p = 0.14). The DM group and the RI group were similar in the average number of SLNs (2.2 ± 1.13 vs. 1.9 ± 1.33; p = 0.26) and the time to detection of the first SLN (8.7 ± 4.98 vs. 8.3 ± 4.31 min; p = 0.30). In the DM group, transcutaneous lymphatic drainage was visualized by fluorescence imaging for 65.5% (38 of 58) of the patients. The SLN identification rate was 94.7% using ICG-F and 93% using RI (p = 0.79). During and after the operation, no complications, including allergic reactions or skin necrosis, occurred.

Conclusions

This study is the first randomized trial to use ICG-F for SLNB in breast cancer patients after NAC. The DM including ICG-F could be a feasible and safe method for SLNB in initially node-positive breast cancer patients with NAC.

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