This study hypothesizes that WLE plus SLN will not significantly change the 2-year recurrence-free survival (RFS) rate compared to WLE alone for elderly patients, and that de-escalated management will result in superior patient-reported outcomes (PRO). The goal of this study is to obtain clinical outcomes data, both RFS and PRO, on older patients who undergo SOC (WLE and SLN biopsy when indicated) vs. de-escalated surgical management [WLE only, without SLN biopsy, with nodal basin surveillance (US or CT, per institutional/physician preference)] of early-stage primary melanoma. A less aggressive treatment approach may spare patients more extensive surgery, more frequent follow up visits, and may result in less frequent utilization of adjuvant therapy, which may be of limited benefit in older/more frail patients with competing causes of mortality. As SLN metastases are less common in the elderly, and this population has competing causes of mortality, we may be over aggressively managing older melanoma patients. The concern becomes that a positive SLN may go undetected in patients randomized to de-escalated care with WLE only, and thus the patient may be under staged (presumed stage I-II when they in fact have occult stage III disease). It is important to note that for patients with clinically occult SLN metastases, 5-year MSS ranges from 93%-32% at 5 years11. In patients who have moderate to severe comorbidities that are likely to interfere with life expectancy within that time frame, or in patients age ≧85, more aggressive measurements may not provide long-term benefit.

Adjuvant immunotherapy with anti-PD1 is approved by the FDA for resected stage IIB/IIC melanoma on the basis of improved RFS13. Thus, patients with stage IIB and higher resected melanoma are now candidates for adjuvant anti-PD1. However, while generally well tolerated, adjuvant immunotherapy is associated with ~15% severe immune related adverse events (IRAEs), for an approximately 50% reduction in recurrence risk. In the clinic, conversations are frequently had with the elderly patient population about whether to pursue SLN and/or adjuvant therapy, though prospective data to address this question are sorely lacking. It is important to note that the goal of this trial is to determine whether SLN biopsy impacts RFS and PRO. This trial does not mandate whether or not physicians utilize adjuvant therapy, which is an option in the current treatment landscape regardless of nodal status (approved for stage IIB-IIID). Data on whether adjuvant therapy is utilized will be captured, and the trial has adequate power to detect differences in RFS and PRO regardless of adjuvant therapy use, as outlined in the statistics section.