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

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 po...

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Vydáno v:Journal of clinical oncology Ročník 37; číslo 32; s. 3000
Hlavní autoři: Leiter, Ulrike, Stadler, Rudolf, Mauch, Cornelia, Hohenberger, Werner, Brockmeyer, Norbert H, Berking, Carola, Sunderkötter, Cord, Kaatz, Martin, Schatton, Kerstin, Lehmann, Percy, Vogt, Thomas, Ulrich, Jens, Herbst, Rudolf, Gehring, Wolfgang, Simon, Jan-Christoph, Keim, Ulrike, Verver, Danielle, Martus, Peter, Garbe, Claus
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 10.11.2019
Témata:
Aged
Disease-Free Survival
Germany - epidemiology
Humans
Lymph Node Excision - methods
Lymph Node Excision - statistics & numerical data
Melanoma - mortality
Melanoma - pathology
Melanoma - surgery
Melanoma, Cutaneous Malignant
Middle Aged
Neoplasm Metastasis
Prospective Studies
Sentinel Lymph Node - pathology
Sentinel Lymph Node - surgery
Skin Neoplasms - mortality
Skin Neoplasms - pathology
Skin Neoplasms - surgery
Treatment Outcome
Germany
ISSN:1527-7755, 1527-7755
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Shrnutí: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. 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. 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% 64.9%, respectively; hazard ratio [HR], 1.08; = .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. 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.
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ISSN:1527-7755
1527-7755
DOI:10.1200/JCO.18.02306