False Negative Rate: Spy-Elite assisted Sentinel Lymph Node Biopsy in Consecutive Cutaneous Melanoma Patients
Rafael A. Couto, MD, Brendan Alleyne, MD, Paul Durand, MD, Steven Rueda, MD, Gregory A. Lamaris, MD, Brian Gastman, MD.
Cleveland Clinic Foundation, Cleveland, OH, USA.
Despite the advances in the management of cutaneous melanoma, the false negative sentinel lymph node biopsy (SLNB) rate is still 5.2-22.0%. Indocyanine green SPY-Elite navigation for SLNB is a novel technique shown to be effective in this population. The aim of this study is to determine the false negative rate of SLNB using indocyanine green SPY-Elite navigation.
Consecutive cutaneous melanoma patients who underwent radioisotope and indocyanine green SPY-Elite SNLB by the senior author (B.G.) from
2011-2014 were prospectively studied. Patient inclusion criteria were: 1)
meeting the National Comprehensive Cancer Network criteria for SLNB and 2) a negative SLNB. The outcome variable was false negative SLNB (regional nodal recurrence in previously sampled negative SLN basin). Follow-up time was date of surgery to the date of last follow-up/death. Predictive variables included: age, sex, Breslow-thickness, mitotic-index/mm2, TNM-staging, and tumor and SLNB location.
The study comprised of 100 subjects, 56.0% males and 44.0% females. Tumor locations were: trunk(35.0%), upper extremity (25.0%), head/neck (23.0%), and lower extremity (17.0%). Most common SLNB location were the axilla(46.5%), followed by the groin(21.0%). Mean follow-up time was 18.9(±8.4) months. Mean Breslow-thickness and mitotic-index/mm2were 1.2(±0.8) cm and 2.0(±2.6), respectively. Ulceration was observed in 16.7% of patients. No false negative SNLB were observed. This technique exhibited a specificity and negative predictive value of 100%.
Indocyanine green SPY-Elite assisted SLNB exhibits high specificity and negative predictive value; it's an effective and reliable technique. This is an ongoing study with continuous patient enrollment.
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