Final Analysis of DeCOG-SLT Trial: No Survival Benefit for Complete Lymph Node Dissection in Patients With Melanoma With Positive Sentinel Node

Abstract

PURPOSE We have previously reported on the 3-year results of the phase III German Dermatologic Cooperative Oncology Group trial (DeCOG; ClinicalTrials.gov identifier: NCT02434107 ) comparing distant metastasis-free survival (DMFS), recurrence-free survival (RFS), and overall survival (OS) in patients with positive sentinel lymph-node biopsy who were randomly assigned to complete lymph node dissection (CLND) or observation. Here, we report the final analysis with 72 months of median follow up. PATIENTS AND METHODS The multicenter randomized phase III trial included patients with cutaneous melanoma of the trunk and extremities who were randomly assigned (1:1) to undergo CLND or observation. DMFS was analyzed as the primary end point, and RFS, OS, and recurrences in the regional lymph node basin were secondary end points. The analysis was by intention to treat. Disease and survival information were collected quarterly. RESULTS From January 2006 to December 2014, 5,547 patients were screened to identify 1,256 with metastases in the sentinel lymph node (SLN). Of these, 483 (39%) were included: 241 in the observation arm and 242 in the CLND arm. In the final analysis, median follow up was 72 months (interquartile range, 67-77 months). No significant treatment-related difference was seen in the 5-year DMFS between the observation and CLND arms (67.6% v 64.9%, respectively; hazard ratio [HR], 1.08; P = .87). The 5-year RFS and OS also showed no difference (HR, 1.01 and 0.99, respectively). Grade 3 and 4 adverse effects occurred in 32 patients (13%) in the CLND arm; lymphedema (n = 20) and delayed wound healing (n = 5) were most common and no serious adverse events were reported. CONCLUSION 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 CLND in SLN-positive patients is not superior to observation in terms of DMFS, RFS, or OS and support not recommending CLND in patients with SLN metastasis.

European consensus-based interdisciplinary guideline for melanoma. Part 2: Treatment – Update 2019

“…[34,35]. In the DeCOG study, 68% of patients in the observation arm and 65% in the CLND arm were free of distant metastases after 5 years of follow-up [38,39]. In the MSLT-II, 86% of the patients in both study groups (CLND or observation) were alive after 3 years [33].…”

A brief synopsis on scalp melanoma

“…B, Same patient as in Figure VI, the excisional defect following melanoma resection was reconstructed with scalp rotation flap and can be associated with formidable morbidity due to seroma formation, wound infection or lymphedema. 45…”

“…It carries significant morbidity, however, not all patients derive actual survival benefits from this undertaking. One logical explanation for this is that the positive SLNB may be the harbinger of a more widespread metastatic disease where lymph node dissection simply does not address the distant metastasis 1,3,[45][46][47]. 9 | METASTATIC EVALUATION AND THE "TNM" STAGING SYSTEM IN SCALP MELANOMA Scalp melanomas are known to be very aggressive and often have high mitotic rate.…”

Sentinel node tumor burden in prediction of prognosis in melanoma patients

“…However, with publications of the German Dermatologic Cooperative Oncology Group (DeCOG) trial [3] and Multicenter Selective Lymphadenectomy-2 trial (MSLT-2) [4], indications for CLND continue to evolve. The latest DeCOG trial results with 72 months follow-up have shown that CLND compared to observation in patients with positive SNB is not associated with increased overall survival [5]. MSLT-2 showed that CLND provides prognostic information as well as improved regional disease control [4], while final analysis of DeCOG-SLT trial concluded that a therapeutic benefit for CLND could not be demonstrated [5].…”

“…The latest DeCOG trial results with 72 months follow-up have shown that CLND compared to observation in patients with positive SNB is not associated with increased overall survival [5]. MSLT-2 showed that CLND provides prognostic information as well as improved regional disease control [4], while final analysis of DeCOG-SLT trial concluded that a therapeutic benefit for CLND could not be demonstrated [5]. However, there are differences in SNB protocols and clinicopathologic features of the patient cohorts between centres.…”