Universität zu Köln

Leiter, Ulrike ORCID: 0000-0002-8019-1577, Stadler, Rudolf, Mauch, Cornelia, Hohenberger, Werner, Brockmeyer, Norbert, Berking, Carola, Sunderkoetter, Cord, Kaatz, Martin, Schulte, Klaus-Werner, Lehmann, Percy, Vogt, Thomas, Ulrich, Jens, Herbst, Rudolf, Gehring, Wolfgang, Simon, Jan-Christoph, Keim, Ulrike, Martus, Peter and Garbe, Claus ORCID: 0000-0001-8530-780X (2016). 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., 17 (6). S. 757 - 768. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1474-5488

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Abstract

Background Complete lymph node dissection is recommended in patients with positive sentinel lymph node biopsy results. To date, the effect of complete lymph node dissection on prognosis is controversial. In the DeCOG-SLT trial, we assessed whether complete lymph node dissection resulted in increased survival compared with observation. Methods In this multicentre, randomised, phase 3 trial, we enrolled patients with cutaneous melanoma of the torso, arms, or legs from 41 German skin cancer centres. Patients with positive sentinel lymph node biopsy results were eligible. Patients were randomly assigned (1: 1) to undergo complete lymph node dissection or observation with permuted blocks of variable size and stratified by primary tumour thickness, ulceration of primary tumour, and intended adjuvant interferon therapy. Treatment assignment was not masked. The primary endpoint was distant metastasis-free survival and analysed by intention to treat. All patients in the intention-to-treat population of the complete lymph node dissection group were included in the safety analysis. This trial is registered with ClinicalTrials.gov, number NCT02434107. Follow-up is ongoing, but the trial no longer recruiting patients. Findings Between Jan 1, 2006, and Dec 1, 2014, 5547 patients were screened with sentinel lymph node biopsy and 1269 (23%) patients were positive for micrometastasis. Of these, 483 (39%) agreed to randomisation into the clinical trial; due to difficulties enrolling and a low event rate the trial closed early on Dec 1, 2014. 241 patients were randomly assigned to the observation group and 242 to the complete lymph node dissection group. Ten patients did not meet the inclusion criteria, so 233 patients were analysed in the observation group and 240 patients were analysed in the complete lymph node dissection group, as the intention-to-treat population. 311 (66%) patients (158 in the observation group and 153 in the dissection group) had sentinel lymph node metastases of 1 mm or less. Median follow-up was 35 months (IQR 20-54). Distant metastasis-free survival at 3 years was 77.0% (90% CI 71.9-82.1; 55 events) in the observation group and 74.9% (69.5-80.3; 54 events) in the complete lymph node dissection group. In the complete lymph node dissection group, grade 3 and 4 events occurred in 15 patients (6%) and 19 patients (8%) patients, respectively. Adverse events included lymph oedema (grade 3 in seven patients, grade 4 in 13 patients), lymph fistula (grade 3 in one patient, grade 4 in two patients), seroma (grade 3 in three patients, no grade 4), infection (grade 3 in three patients, no grade 4), and delayed wound healing (grade 3 in one patient, grade 4 in four patients); no serious adverse events were reported. Interpretation Although we did not achieve the required number of events, leading to the trial being underpowered, our results showed no difference in survival in patients treated with complete lymph node dissection compared with observation only. Consequently, complete lymph node dissection should not be recommended in patients with melanoma with lymph node micrometastases of at least a diameter of 1 mm or smaller.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Leiter, Ulrike UNSPECIFIED orcid.org/0000-0002-8019-1577 UNSPECIFIED Stadler, Rudolf UNSPECIFIED UNSPECIFIED UNSPECIFIED Mauch, Cornelia UNSPECIFIED UNSPECIFIED UNSPECIFIED Hohenberger, Werner UNSPECIFIED UNSPECIFIED UNSPECIFIED Brockmeyer, Norbert UNSPECIFIED UNSPECIFIED UNSPECIFIED Berking, Carola UNSPECIFIED UNSPECIFIED UNSPECIFIED Sunderkoetter, Cord UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaatz, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Schulte, Klaus-Werner UNSPECIFIED UNSPECIFIED UNSPECIFIED Lehmann, Percy UNSPECIFIED UNSPECIFIED UNSPECIFIED Vogt, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Ulrich, Jens UNSPECIFIED UNSPECIFIED UNSPECIFIED Herbst, Rudolf UNSPECIFIED UNSPECIFIED UNSPECIFIED Gehring, Wolfgang UNSPECIFIED UNSPECIFIED UNSPECIFIED Simon, Jan-Christoph UNSPECIFIED UNSPECIFIED UNSPECIFIED Keim, Ulrike UNSPECIFIED UNSPECIFIED UNSPECIFIED Martus, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Garbe, Claus UNSPECIFIED orcid.org/0000-0001-8530-780X UNSPECIFIED
URN:	urn:nbn:de:hbz:38-274663
DOI:	10.1016/S1470-2045(16)00141-8
Journal or Publication Title:	Lancet Oncol.
Volume:	17
Number:	6
Page Range:	S. 757 - 768
Date:	2016
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1474-5488
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language I MALIGNANT-MELANOMA; CUTANEOUS MELANOMA; AXILLARY DISSECTION; BREAST-CANCER; LYMPHADENECTOMY; MANAGEMENT; MORBIDITY; IMMEDIATE; EFFICACY; PROGNOSIS Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/27466