Limitations of SLNB as a Prognostic Indicator in Melanoma
NOW AVAILABLE: New Integrated Test Result (i31-ROR) for Precise and Personalized Risk of Recurrence Prediction. LEARN MORE
National guidelines recommend that the SLNB procedure be considered for patients with T1b tumors and above, as well as T1a tumors with high-risk features, based on an expected risk of SLN positivity exceeding 5%. This 5% risk threshold is based on the SLNB false negative rate observed in the Multicenter Selective Lymphadenectomy Trial (MSLT-I; Morton 2014), which showed that the SLNB procedure had no impact on survival. Use of this threshold results in an overall rate of SLNB positivity of approximately 12% (Ellis 2010; Bamboat 2014; Joyce 2017).
Thus, while providing prognostic information the SLNB procedure has significant limitations:
No survival benefit for SLNB surgical procedure and low sensitivity (two-thirds of melanoma deaths in SLN negative group) (Morton 2014)
Negative SLN result in approximately 88% of patients undergoing an SLNB surgical procedure
False negative rate of SLNB procedure reported to be 5-21%
Exposure to anesthesia risks and surgical complication rate of 11% (Moody 2016)
There is a clear need to identify patients with sufficiently low risk of a positive node who can safely avoid the SLNB procedure, as well as identify patients who may have a high risk of a positive node and should consider the SLNB procedure.