As reported by Leiter et al in the Journal of Clinical Oncology, the final analysis of the German phase III DeCOG-SLT trial have shown no distant metastasis-free survival, recurrence-free survival, or overall survival benefit with complete lymph node dissection vs observation in patients with sentinel lymph node–positive melanoma after long-term follow-up. The current analysis confirms absence of benefit of complete lymph node dissection reported in the primary analysis at 3 years.
In the multicenter trial, 483 eligible patients with cutaneous melanoma of the trunk and extremities were randomly assigned between January 2006 and December 2014 to receive complete lymph node dissection (n = 242) or observation (n = 241). The primary endpoint was distant metastasis-free survival.
Five-Year Outcomes
Median follow-up for the current analysis was 72 months. The number of distant metastasis-free survival events increased from 109 to 164 events between the primary and current analysis.
KEY POINTS
- Complete lymph node dissection was not associated with improved distant metastasis-free, recurrence-free, or overall survival vs observation.
- At 5 years, distant metastasis-free survival was 64.9% in the complete lymph node dissection group vs 67.6% in the observation group.
At 5 years, distant metastasis-free survival was 64.9% in the complete lymph node dissection group vs 67.6% in the observation group (hazard ratio [HR] = 1.08, P = .65) recurrence-free survival was 59.9% vs 60.9% (HR = 1.01, P = .94), and overall survival was 72.3% vs 71.4% (HR = 0.99, P = .94). In a subgroup analysis of distant metastasis-free survival, no difference between groups was observed for sentinel lymph node micrometastases > 1.0 mm (HR = 1.12, P = .58) or ≤ 1.0 mm (HR = 0.98, P = .95).
Grade 3 or 4 adverse events occurred in 32 patients (13%) in the complete lymph node dissection arm, with lymphedema (n = 20) and delayed wound healing (n = 5) being the most common; no serious adverse events were reported.
The investigators concluded, “The final results of the German Dermatologic Cooperative Oncology Group trial with a median follow-up of 72 months showed higher event rates, but similar HRs compared with those at the 3-year analysis. These results confirm that immediate complete lymph node dissection in sentinel lymph node–positive patients is not superior to observation in terms of [distant metastasis–free, recurrence-free, or overall survival] and support not recommending complete lymph node dissection in patients with sentinel lymph node metastasis.”
Ulrike Leiter, MD, of the Center of Dermato-Oncology, Department of Dermatology, Eberhard-Karls-University, Tübingen, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was funded by German Cancer Aid. For full disclosures of the study authors, visit jco.ascopubs.org.
