Indocyanine green use, detection and safety in patients with breast cancer undergoing sentinel lymph node biopsy: A French prospective observational study.

BACKGROUND

Sentinel lymph node (SLN) biopsy is the standard procedure for staging patients with early-stage breast cancer. Indocyanine green (ICG), a near-infrared fluorescent dye, has emerged as an alternative to other colorimetric and radioactive tracers for SLN mapping that has high sensitivity and is rarely allergenic.

METHODS

The Observational Assess SLN Infracyanine® (ICG) Surgery (OASIS) study was a prospective, multicenter, observational, single-arm study that enrolled 101 female patients with breast cancer undergoing SLN biopsy in metropolitan centers in France.

RESULTS

Mean (standard deviation) patient age was 62.5 (12.9) years and 75% were post-menopausal. Ninety-eight patients were evaluable. ICG was administered alone in 44 patients, in combination with 99mTc in 51 patients, and with methylene blue in 3 patients. Only one ICG injection was used for 57 patients, while 2-site and 4-site doses were required for 25 and 16 patients, respectively. All patients had ICG administered via the periareolar route. SLN mapping was performed using ICG in 96 patients (95%). At least 1 SLN was detected in 94 patients (95.9% [95% confidence interval: 90.0-98.4%]) and in 95/100 surgeries (95%). A median of 2 SLNs were detected per patient using ICG. The median (interquartile range) time from first injection to visualization of first SLN was 21 (15, 28) minutes. The detection rate appeared to be similar in obese/non-obese patients and across cancer stages. No adverse events or serious adverse events were reported.

CONCLUSION

ICG demonstrated real-world effectiveness for identifying SLNs in French patients undergoing surgery for early-stage breast cancer.