Abstract P1-01-03: Comparison of sentinel lymph node biopsy guided by the multi-modal method of indocyanine green fluorescence, radioisotope and blue dye versus the radioisotope in breast cancer; A randomized phase II trial

Abstract

Abstract Background: Sentinel lymph node (SLN) biopsy is a standard surgery for axillary staging of early breast cancer. This study aimed to evaluate the identification rate and surgery time of SLN biopsy with the multi-modal method using the mixture of indocyanine green (ICG) fluorescence, RI and blue dye as a new method, in comparison with the RI, in clinically node negative breast cancer patients. Materials and methods: In this phase-II randomized study, 86 patients with clinically node negative breast cancer were randomized to receive periareolar injection of the mixture including ICG fluorescence, RI and blue dye or the only RI for SLN biopsy. We compared the identification rate, the number of SLN, and detections time of SLN biopsy between these two groups. Results: The mean age of the multimodal group and the only RI group was 48.2 years and 51.0 years (p = 0.12), respectively. There were no differences of histopathologic factors including tumor size, node positivity, hormone receptor positivity and HER2 positivity between two groups. Sentinel lymph nodes were identified in all patients of both groups (100% in the multimodal group vs 100% in the RI group). The average number of SLN in the mixture group was more than that of the RI group (3.4 ±1.37 vs 2.3 ± 1.04; p < 0.001). The time to excise the first SLN was similar in each group (6.5 ± 5.16 min vs 8.0 ± 4.35 min; p = 0.13). In multimodal group, percutaneous lymphatic drainage was visualized by fluorescent imaging in 90.7% (39 of 43 patients) and all of the first SLN were detected by both ICG fluorescent and RI. After operation, there was no complication including skin staining or necrosis. Conclusions: This study is the first randomize trial which compared the multimodal method using the mixture of ICG fluorescence, RI and blue dye and the conventional RI method for SLN biopsy. The multimodal method is an available method for SLN biopsy, which allows percutaneous visualization of lymphatic vessels and intraoperative lymph node detection. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-01-03.