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Completion dissection or observation for sentinel-node metastasis in melanoma

Faries, B.; Thompson, J. F.; Cochran, Alistair J.; Andtbacka, R. H.; Mozzillo, Nicola; Zager, J. S.; Jahkola, Tiina; Bowles, T. L.; Testori, A and Beitsch, P. D., et al. (2017) In New England Journal of Medicine 376(23). p.2211-2222
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... (More)

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.

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New England Journal of Medicine
volume
376
issue
23
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12 pages
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Massachusetts Medical Society
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  • scopus:85020241826
ISSN
0028-4793
DOI
10.1056/NEJMoa1613210
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English
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yes
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770bbf34-e18f-4407-803a-7a3c439a7090
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2017-08-11 16:16:20
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2017-08-13 05:11:23
@article{770bbf34-e18f-4407-803a-7a3c439a7090,
  abstract     = {<p>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&lt;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.</p>},
  author       = {Faries, B. and Thompson, J. F. and Cochran, Alistair J. and Andtbacka, R. H. and Mozzillo, Nicola and Zager, J. S. and Jahkola, Tiina and Bowles, T. L. and Testori, A and Beitsch, P. D. and Hoekstra, H J and Moncrieff, M. and Ingvar, C. and Wouters, M. W. J. M. and Sabel, M. S. and Levine, E. A. and Agnese, D. and Henderson, M and Dummer, R. and Rossi-Alvarez, C and Neves, R. I. and Trocha, S. D. and Wright, Alan F and Byrd, D. R. and Matter, M. and Hsueh, E. and MacKenzie-Ross, A. and Johnson, D. B. and Terheyden, P. and Berger, A. C. and Huston, T. L. and Wayne, J. D. and Smithers, B. M. and Neuman, H. B. and Schneebaum, S. and Gershenwald, Jeffrey E and Ariyan, C. E. and Desai, D. C. and Jacobs, L. L. and McMasters, K. M. and Gesierich, A. and Hersey, P and Bines, S. D. and Kane, J. M. and Barth, R. J. and McKinnon, G. and Farma, J. M. and Schultz, E. and Vidal-Sicart, Sergi and Hoefer, R. A. and Lewis, Melanie J. and Scheri, R. 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.},
  issn         = {0028-4793},
  language     = {eng},
  month        = {06},
  number       = {23},
  pages        = {2211--2222},
  publisher    = {Massachusetts Medical Society},
  series       = {New England Journal of Medicine},
  title        = {Completion dissection or observation for sentinel-node metastasis in melanoma},
  url          = {http://dx.doi.org/10.1056/NEJMoa1613210},
  volume       = {376},
  year         = {2017},
}