The New England journal of medicine
Adult; Aged; Disease-Free Survival; Female; Humans; Intention to Treat Analysis; Lymph Node Excision; Lymph Nodes; Lymphatic Metastasis; Lymphedema; Male; Melanoma; Middle Aged; Neoplasm Staging; Postoperative Complications; Prognosis; Proportional Hazards Models; Sentinel Lymph Node; Sentinel Lymph Node Biopsy; Survival Analysis; Ultrasonography; Watchful Waiting; Young Adult
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 .).
Faries, Mark; 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). Articles, Abstracts, and Reports. 1334.