Mark B. Faries, Saint John's Health Center
John F. Thompson, University of California, Los Angeles
Alistair J. Cochran, University of California, Los Angeles
Robert H. Andtbacka, Huntsman Cancer Institute
Nicola Mozzillo, Saint John's Health Center
Jonathan S. Zager, Moffitt Cancer Center
Tiina Jahkola, Helsinki University Hospital
Tawnya L. Bowles, Intermountain Healthcare Cancer Services-Intermountain Medical Center
Alessandro Testori, Istituto Europeo di Oncologia
Peter D. Beitsch, Dallas Surgical GroupFollow
Harald J. Hoekstra, Universitair Medisch Centrum Groningen
Marc Moncrieff, Norfolk and Norwich University Hospital
Christian Ingvar, University Hospital Lund
Michel W.J.M. Wouters, Netherlands Cancer Institute
Michael S. Sabel, The University Of Michigan
Edward A. Levine, Wake Forest University; Duke University
Doreen Agnese, The Ohio State University
Michael Henderson, Peter MacCallum Cancer Centre
Reinhard Dummer, University of Zurich
Carlo R. Rossi, University of Padua
Rogerio I. Neves, Penn State Hershey Cancer Institute
Steven D. Trocha, Saint Louis University
Frances Wright, Tom Baker Cancer Centre
David R. Byrd, University of Washington
Maurice Matter, Centre Hospitalier Universitaire Vaudois
Eddy Hsueh, Tom Baker Cancer Centre
Alastair MacKenzie-Ross, Guy's and St. Thomas' NHS Foundation Trust
Douglas B. Johnson, University Hospital of Wörzburg
Patrick Terheyden, University Hospital Schleswig-Holstein
Adam C. Berger, Thomas Jefferson UniversityFollow
Tara L. Huston, Sunnybrook Research Institute
Jeffrey D. Wayne, Vanderbilt University, Nashville; University of Tennessee, Knoxville
B. Mark Smithers, Princess Alexandra Hospital
Heather B. Neuman, Fox Chase Cancer Center
Schlomo Schneebaum, Greenville Health System Cancer Center
Jeffrey E. Gershenwald, City Hospital of Nörnberg
Charlotte E. Ariyan, SUNY at Stony Brook Hospital Medical Center
Darius C. Desai, Philadelphia, and St. Luke's, University Health Network
Lisa Jacobs, Memorial Sloan Kettering Cancer Center
Kelly M. McMasters, Roswell Park Cancer Institute
Anja Gesierich, Northwestern University
Peter Hersey, University of Wisconsin-Madison
Steven D. Bines, Rush University Medical Center
John M. Kane, Tel Aviv Sourasky Medical Center
Richard J. Barth, Dartmouth-Hitchcock Medical Center
Gregory McKinnon, Johns Hopkins University School of Medicine
Jeffrey M. Farma, University of LouisvilleFollow
Erwin Schultz, Hospital Clinic Barcelona
Sergi Vidal-Sicart, Anderson Medical Center
Richard A. Hoefer, Dartmouth-Hitchcock Medical Center
James M Lewis, Sentara CarePlex Hospital
Randall Scheri, Newcastle Melanoma Unit
Mark C. Kelley, Istituto Nazionale Dei Tumori Napoli
Omgo E. Nieweg, University of Sydney
R. Dirk Noyes, Huntsman Cancer Institute
Dave S.B. Hoon, Saint John's Health CenterFollow
He-Jing Wang, University of California, Los Angeles
David A. Elashoff, University of California, Los Angeles
Robert M. Elashoff, University of California, Los Angeles

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This article has been peer reviewed. It is the author’s final published version in New England Journal of Medicine

Volume 376, Issue 23, June 2017, Pages 2211-2222.

The published version is available at DOI: 10.1056/NEJMoa1613210. Copyright © Massachusetts Medical Society.


BACKGROUND: Sentinel-lymph-node biopsy is associated with increased melanoma-specific survival (i.e., survival until death from melanoma) among patients with node-positive intermediate-thickness melanomas (1.2 to 3.5 mm). The value of completion lymph-node dissection for patients with sentinel-node metastases is not clear.

METHODS: In an international trial, we randomly assigned patients with sentinel-node metastases detected by means of standard pathological assessment or a multimarker molecular assay to immediate completion lymph-node dissection (dissection group) or nodal observation with ultrasonography (observation group). The primary end point was melanoma-specific survival. Secondary end points included disease-free survival and the cumulative rate of nonsentinel-node metastasis.

RESULTS: Immediate completion lymph-node dissection was not associated with increased melanoma-specific survival among 1934 patients with data that could be evaluated in an intention-to-treat analysis or among 1755 patients in the per-protocol analysis. In the per-protocol analysis, the mean (±SE) 3-year rate of melanoma-specific survival was similar in the dissection group and the observation group (86±1.3% and 86±1.2%, respectively; P=0.42 by the log-rank test) at a median follow-up of 43 months. The rate of disease-free survival was slightly higher in the dissection group than in the observation group (68±1.7% and 63±1.7%, respectively; P=0.05 by the log-rank test) at 3 years, based on an increased rate of disease control in the regional nodes at 3 years (92±1.0% vs. 77±1.5%; P

CONCLUSIONS: Immediate completion lymph-node dissection increased the rate of regional disease control and provided prognostic information but did not increase melanoma-specific survival among patients with melanoma and sentinel-node metastases. (Funded by the National Cancer Institute and others; MSLT-II number, NCT00297895 .).

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