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 ClinicalTrials.gov number, NCT00297895 .).
Recommended CitationFaries, Mark B.; Thompson, John F.; Cochran, Alistair J.; Andtbacka, Robert H.; Mozzillo, Nicola; Zager, Jonathan S.; Jahkola, Tiina; Bowles, Tawnya L.; Testori, Alessandro; Beitsch, Peter D.; Hoekstra, Harald J.; Moncrieff, Marc; Ingvar, Christian; Wouters, Michel W.J.M.; Sabel, Michael S.; Levine, Edward A.; Agnese, Doreen; Henderson, Michael; Dummer, Reinhard; Rossi, Carlo R.; Neves, Rogerio I.; Trocha, Steven D.; Wright, Frances; Byrd, David R.; Matter, Maurice; Hsueh, Eddy; MacKenzie-Ross, Alastair; Johnson, Douglas B.; Terheyden, Patrick; Berger, Adam C.; Huston, Tara L.; Wayne, Jeffrey D.; Smithers, B. Mark; Neuman, Heather B.; Schneebaum, Schlomo; Gershenwald, Jeffrey E.; Ariyan, Charlotte E.; Desai, Darius C.; Jacobs, Lisa; McMasters, Kelly M.; Gesierich, Anja; Hersey, Peter; Bines, Steven D.; Kane, John M.; Barth, Richard J.; McKinnon, Gregory; Farma, Jeffrey M.; Schultz, Erwin; Vidal-Sicart, Sergi; Hoefer, Richard A.; Lewis, James M; Scheri, Randall; Kelley, Mark C.; Nieweg, Omgo E.; Noyes, R. Dirk; Hoon, Dave S.B.; Wang, He-Jing; Elashoff, David A.; and Elashoff, Robert M., "Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma." (2017). Department of Surgery Faculty Papers. Paper 149.