Supplementary appendix

Transcription

1 Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Leiter U, Stadler R, Mauch C, et al, for the German Dermatologic Cooperative Oncology Group (DeCOG). 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; published online May 5.

2 Supplementary material: Table 1: Patient characteristics of included vs. non-included patients. Included patients N = 473 Non-included patients N = 786 Gender male % % female % % Age at Diagnosis Median (IQR) 56 (45.0; 66.5) 62 (48.0; 70.0) <41 yrs % % yrs % % yrs % % yrs % % >70 yrs % % Body site trunk % % upper extremity % % lower extremity % % head and neck % others % Tumour thickness Median (IQR) 2.4 mm (1.6; 4.0) 2.4 mm (1.5; 4.0) 1.0 mm mm mm > 4.0 mm Ulceration present absent % % % % % % % % % % % % SN per patient > 3 n.a. Histological criteria H&E positive Immunhisto. pos. (S100, HMB45, Melan A) not specified Size of metastases SLNB single cells / <0,5 mm 0,5-1,00 mm 1,01-2,00 mm 2,01-5,00 mm 5, mm % % % % % % % % % % % 7 1.5% % % % 0 0% % % % % % % % % others % % Data are number of patients (%) unless otherwise indicated. Comparing both groups significant differences (p<0.05) were identified for age at diagnosis (p<0.001), number of SLN per patient (p<0.001), size of metastasis (p<0.001). 1

3 Table 2: Centers involved in the recruitment Centre Principal investigator Dept. of Dermatology, University of Tuebingen Dept. of Dermatology, Medical Hospital of Kassel Dept. of Dermatology, Medical Hospital of Erfurt Dept. of Dermatology, University of Cologne Dept. of Dermatology, University of Saarland Dept. of Dermatology, University of Berlin (Charité) Dept. of Dermatology, Gera and University of Jena Dept. of Surgery, University of Erlangen Dept. of Dermatology, University of Dresden Dept. of Dermatology, University of Magdeburg and Dept. of Dermatology, Medical Hospital of Quedlinburg Dept. of Dermatology, University of Duesseldorf Dept. of Dermatology, University of Leipzig Dept. of Dermatology, Medical Hospital of Minden Dept. of Dermatology, Medical Hospital of Cottbus Dept. of Dermatology, Medical Hospital of Karlsruhe Dept. of Dermatology, University of Regensburg Dept. of Dermatology, University of Muenster Dept. of Dermatology, University of Wuerzburg Dept. of Dermatology, Medical Hospital of Unna Dept. of Dermatology, University of Mainz Dept. of Dermatology, Ludwig-Maximilians University of Munich Dept. of Dermatology, University of Frankfurt/Main Dept. of Dermatology, Medical Hospital of Oldenburg Dept. of Dermatology, University of Luebeck Dept. of Dermatology, Medical Hospital of Berlin- Neukölln Dept. of Dermatology, University of Bochum Dept. of Dermatology, Medical Hospital of Dessau Dept. of Dermatology, University of Essen Dept. of Dermatology, Medical Hospital of Wuppertal Claus Garbe, MD Rainer Rompel, MD Rudolf Herbst, MD Cornelia Mauch, MD Thomas Vogt, MD Thorsten Zuberbier, MD Martin Kaatz, MD Werner Hohenberger, MD Stefan Beissert, MD Jens Ulrich, MD Klaus-Werner Schulte, MD Jan-Christoph Simon, MD Rudolf Stadler, MD Dieter Bachter, MD Wolfgang Gehring, MD Michael Landthaler, MD Cord Sunderkötter, MD Matthias Göbeler, MD Hans-Joachim Böhmer, MD Stephan Grabbe, MD Carola Berking, MD Roland Kaufmann, MD Erhard Hölzle, MD Detlef Zillikens, MD Peter Kohl, MD Norbert Brockmeyer, MD Christos Zouboulis, MD Dirk Schadendorf, MD Percy Lehmann, MD 2

4 Dept. of Dermatology, University of Heidelberg Dept. of Dermatology, Medical Hospital of Dresden- Friedrichstadt Dept. of Dermatology, University of Goettingen Dept. of Dermatology, Medical Hospital of Ludwigshafen Dept. of Dermatology, University of Mannheim Dept. of Dermatology, Medical Hospital of Detmold Dept. of Dermatology, Medical Hospital St. Georg, Hamburg Dept. of Dermatology, Medical Hospital of Darmstadt Dept. of Dermatology, University of Bonn Dept. of Dermatology, University of Marburg Dept. of Dermatology, Technical University of Munich Dept. of Dermatology, Medical Hospital of Zwickau Alexander Enk, MD Uwe Wollina, MD Michael Schön, MD Edgar Dippel, MD Jochen Utikal, MD Stefan Nestoris, MD Christian Sander, MD Maurizio Podda, MD Thomas Bieber, MD Michael Hertl, MD Johannes Ring, MD Dirk Mechtel, MD 3

5 Figure: Regional lymph node metastasis free survival in the further course of the disease: Arm A (observation, blue line) and arm B (CLND, red line) 4