Completion dissection or observation for sentinel-node metastasis in melanoma

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@article{770bbf34e18f4407803a7a3c439a7090,
title = "Completion dissection or observation for sentinel-node metastasis in melanoma",
abstract = "BACKGROUND Sentinel-lymph-node biopsy is associated with increased melanoma-specific survival (i.e., survival until death from melanoma) among patients with node-positive intermediatethickness 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 melanomaspecific survival among 1934 patients with data that could be evaluated in an intention-Totreat 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 logrank 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<0.001 by the log-rank test); these results must be interpreted with caution. Nonsentinel-node metastases, identified in 11.5% of the patients in the dissection group, were a strong, independent prognostic factor for recurrence (hazard ratio, 1.78; P = 0.005). Lymphedema was observed in 24.1% of the patients in the dissection group and in 6.3% of those in the observation group. 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.",
author = "B. Faries and Thompson, {J. F.} and Cochran, {Alistair J.} and Andtbacka, {R. H.} and Nicola Mozzillo and Zager, {J. S.} and Tiina Jahkola and Bowles, {T. L.} and A Testori and Beitsch, {P. D.} and Hoekstra, {H J} and M. Moncrieff and C. Ingvar and Wouters, {M. W. J. M.} and Sabel, {M. S.} and Levine, {E. A.} and D. Agnese and M Henderson and R. Dummer and C Rossi-Alvarez and Neves, {R. I.} and Trocha, {S. D.} and Wright, {Alan F} and Byrd, {D. R.} and M. Matter and E. Hsueh and A. MacKenzie-Ross and Johnson, {D. B.} and P. Terheyden and Berger, {A. C.} and Huston, {T. L.} and Wayne, {J. D.} and Smithers, {B. M.} and Neuman, {H. B.} and S. Schneebaum and Gershenwald, {Jeffrey E} and Ariyan, {C. E.} and Desai, {D. C.} and Jacobs, {L. L.} and McMasters, {K. M.} and A. Gesierich and P Hersey and Bines, {S. D.} and Kane, {J. M.} and Barth, {R. J.} and G. McKinnon and Farma, {J. M.} and E. Schultz and Sergi Vidal-Sicart and Hoefer, {R. A.} and Lewis, {Melanie J.} and R. Scheri and Kelley, {M. C.} and Nieweg, {Omgo E.} and Noyes, {R. D.} and Hoon, {Dave S. B.} and Wang, {H. J.} and Elashoff, {D. A.} and Elashoff, {R. M.}",
year = "2017",
month = jun,
day = "8",
doi = "10.1056/NEJMoa1613210",
language = "English",
volume = "376",
pages = "2211--2222",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachusetts Medical Society",
number = "23",

}