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Bending the Curve Trial by Trial
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DeCOG-SLT

Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma

Phase 3N = 483NCT02434107

Population
Patients with cutaneous melanoma of the torso, arms or legs and a positive sentinel lymph node biopsy; the intention-to-treat population was 473 patients (233 observation, 240 dissection) after 10 patients who did not meet the inclusion criteria were excluded.
Design
Multicentre, randomised, phase 3 trial at 41 German skin cancer centres, 1:1 randomisation to complete lymph node dissection or observation (stratified by primary tumour thickness, ulceration and intended adjuvant interferon); treatment assignment not masked. Of 5547 patients screened with sentinel lymph node biopsy, 1269 were positive and 483 agreed to randomisation. The trial closed early on 1 December 2014 because of enrolment difficulties and a low event rate; its authors describe it as underpowered.
Primary endpoint
DMFS
Arms
  • Complete lymph node dissection (control, n = 242): Complete lymph node dissection after a positive sentinel lymph node biopsy
  • Observation (experimental, n = 241): Observation after a positive sentinel lymph node biopsy
People
Leiter U, senior author Garbe C, German Dermatologic Cooperative Oncology Group (DeCOG)
Δ 36-month DMFS+2.1 points
Show the numbers
Results reported for DeCOG-SLT
EndpointAnalysisObservationComplete lymph node dissectionEffect
DMFSITT population (473 analysed: 233 observation, 240 dissection)primarymedian follow-up 35 monthsLeiter 201677% at 3 y74.9% at 3 yIntervals published are 90% CIs, not 95% CIs: 71.9 to 82.1 (observation, 55 events) and 69.5 to 80.3 (dissection, 54 events). Median follow-up interquartile range 20 to 54 months. The trial did not reach the required number of events.
Results reported for DeCOG-SLT
EndpointAnalysisObservationComplete lymph node dissectionEffect
DMFSITT population (473 analysed: 233 observation, 240 dissection)primarymedian follow-up 35 monthsLeiter 201677% at 3 y74.9% at 3 yIntervals published are 90% CIs, not 95% CIs: 71.9 to 82.1 (observation, 55 events) and 69.5 to 80.3 (dissection, 54 events). Median follow-up interquartile range 20 to 54 months. The trial did not reach the required number of events.
Primary publication: Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer N, Berking C, et al. Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2016;17(6):757-767. PubMedDOI

Appears in

Sources

  1. Leiter U, Stadler R, Mauch C, Hohenberger W, Brockmeyer N, Berking C, et al. Complete lymph node dissection versus no dissection in patients with sentinel lymph node biopsy positive melanoma (DeCOG-SLT): a multicentre, randomised, phase 3 trial. Lancet Oncol. 2016;17(6):757-767.

    PubMedDOI