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.
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.
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.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.