Abstract
Abstract Purpose This study aimed to evaluated the identification rate and operation time of sentinel lymph node biopsy (SLNB) by a multimodal fluorescent-radioactive system (MFS) using a mixture of indocyanine green (ICG), radioisotope (RI) compared with the RI alone in advanced breast cancer patients with neoadjuvant therapy. Methods In this phase II randomized study, we enrolled 65 patients with advanced breast cancer with neoadjuvant therapy. Then, they received SLNB with either MFS or RI. We compared the identification rate, operation time of SLNB and number of sentinel lymph nodes. We also evaluated the safety. We analyzed the data of 65 patients for interim analysis. Results The mean age of the MFS group and RI group was 51.7 and 45.9 years (p=0.024), respectively. There were no differences in histopathological characteristics, including tumor size, node positivity, and hormone receptor status between two groups. The radiologic study showed the clinically complete response in axillary lymph nodes after neoadjuvant therapy. In MFS group, sentinel lymph nodes (SLNs) were identified in 30 patients and we could not identify the SLNs in one patient. In RI group, we identified the SLNs in 33 patients and also could not identify them in one patient. (p=0.947). The average numbers of SLNs in the MFS and RI group were similar. (2.32±1.10 vs. 2.18 ± 1.57, respectively; p=0.668) The operation time of SLNB was similar in the each group (11.65 ± 6.49 vs. 9.47 ± 6.26, respectively, p= 0.174) There were no complication, including allergic reactions, skin staining or necrosis. Conclusions This study is the randomized trial that compared MFS using ICG and RI and the conventional RI method for SLNB in the advanced breast cancer with neoadjuvant therapy. The multimodal fluorescent-radioactive system is a feasible and safe method for SLNB for the breast cancer patients with neoadjuvant therapy. We will evaluate the 130 patients for final analysis. Citation Format: Lee S, Jung S-Y, Kim S-K, Lee ES, Lee MH, Park SJ, Kang H-S, Lee KS, Park IH, Sim SH, Kim Y, Kwon Y, Joo J, Kang SH. Clinical application of multimodal fluorescent-radioactive system in advanced breast cancer patients with neoadjuvant therapy; interim analysis for 65 patients [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-01-15.
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