Complete Lymph Node Dissection vs No Dissection in Patients With Sentinel Lymph Node Biopsy–Positive Melanoma
The Lancet Oncology
This German multicenter phase III trial compared outcomes for 483 patients with cutaneous melanoma and positive sentinel lymph node biopsy who were randomized for complete lymph node dissection (242 patients of whom 240 were eligible for inclusion) or observation (241 patients of whom 233 were eligible). Distant metastasis-free survival at 3 years was 74.9% and 77% for the observation and complete lymph node dissection groups, respectively. There were no serious adverse events reported. Adverse events reported in the complete lymph node dissection group included grade 3 events in 6% of patients and grade 4 events in 8% of patients. The grade 3 and 4 adverse events included lymphedema, infection, lymph fistula, seroma, and delayed wound healing.
Although this study closed early and was underpowered statistically, no survival difference was found between complete lymph node dissection and observation for patients with cutaneous melanoma and positive sentinel lymph node biopsy. While the lack of statistical power limits the conclusions that can be drawn, this study suggests that biopsy may not be recommended for these patients when lymph node micrometastases are 1 mm or less in diameter.
Almost three decades ago I had this and saw no evidence to promote further therapy. Now we have what appears to be a potentially active monoclonal antibody being investigate for what role it may play