Evaluation of the Clinical Utility of the ICG Fluorescence Method Compared with the Radioisotope Method for Sentinel Lymph Node Biopsy in Breast Cancer

Ann Surg Oncol. 2016 Jan;23(1):44-50. doi: 10.1245/s10434-015-4809-4. Epub 2015 Aug 15.

Abstract

Purpose: This study compared the clinical utility of indocyanine green (ICG) fluorescence and radioisotope (RI) for sentinel lymph node (SLN) detection in breast cancer.

Methods: Women with node-negative breast cancer underwent SLN biopsy using ICG fluorescence and RI. The primary end point was the sensitivity of ICG fluorescence compared with RI in the patients with tumor-positive SLNs. Secondary end points included detection rates for SLN, the additive effect of ICG fluorescence to RI, signature of positive SLNs according to tier, and adverse events related to ICG administration.

Results: A total of 847 women with clinical node-negative breast cancer underwent SLN biopsy, and 821 patients were included in the per-protocol analysis. SLN mapping was performed using ICG fluorescence and RI. The overall detection of SLNs using ICG fluorescence was identical to RI (97.2 vs. 97.0 %, P = 0.88), and the combination of both methods achieved a significant improvement compared with RI alone (99.8 vs. 97.0 %, P < 0.001). The detection rate for tumor-positive SLN was 93.3 % for ICG fluorescence and 90.0 % for RI, and the sensitivity of the ICG fluorescence method was 95.7 % (95 % CI 91.3-98.3, P = 0.11). The additional use of ICG significantly improved positive SLN detection for RI (97.2 vs. 90.0 %, P < 0.001). There were no serious adverse events related to hypersensitivity to ICG.

Conclusions: The ICG fluorescence method may be an acceptable alternative to SLN detection using RI in breast cancer.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Breast Neoplasms / diagnostic imaging*
  • Breast Neoplasms / pathology*
  • Breast Neoplasms / surgery
  • Coloring Agents*
  • Female
  • Fluorescence
  • Follow-Up Studies
  • Humans
  • Indocyanine Green*
  • Lymph Nodes / diagnostic imaging
  • Lymph Nodes / pathology
  • Lymph Nodes / surgery
  • Middle Aged
  • Neoplasm Invasiveness
  • Neoplasm Staging
  • Organotechnetium Compounds
  • Prognosis
  • Prospective Studies
  • Radionuclide Imaging
  • Radiopharmaceuticals*
  • Sentinel Lymph Node Biopsy*
  • Young Adult

Substances

  • Coloring Agents
  • Organotechnetium Compounds
  • Radiopharmaceuticals
  • Indocyanine Green