Completion dissection or observation for sentinel-node metastasis in melanoma

TY - JOUR

T1 - Completion dissection or observation for sentinel-node metastasis in melanoma

AU - Faries, B.

AU - Thompson, J. F.

AU - Cochran, Alistair J.

AU - Andtbacka, R. H.

AU - Mozzillo, Nicola

AU - Zager, J. S.

AU - Jahkola, Tiina

AU - Bowles, T. L.

AU - Testori, A

AU - Beitsch, P. D.

AU - Hoekstra, H J

AU - Moncrieff, M.

AU - Ingvar, C.

AU - Wouters, M. W. J. M.

AU - Sabel, M. S.

AU - Levine, E. A.

AU - Agnese, D.

AU - Henderson, M

AU - Dummer, R.

AU - Rossi-Alvarez, C

AU - Neves, R. I.

AU - Trocha, S. D.

AU - Wright, Alan F

AU - Byrd, D. R.

AU - Matter, M.

AU - Hsueh, E.

AU - MacKenzie-Ross, A.

AU - Johnson, D. B.

AU - Terheyden, P.

AU - Berger, A. C.

AU - Huston, T. L.

AU - Wayne, J. D.

AU - Smithers, B. M.

AU - Neuman, H. B.

AU - Schneebaum, S.

AU - Gershenwald, Jeffrey E

AU - Ariyan, C. E.

AU - Desai, D. C.

AU - Jacobs, L. L.

AU - McMasters, K. M.

AU - Gesierich, A.

AU - Hersey, P

AU - Bines, S. D.

AU - Kane, J. M.

AU - Barth, R. J.

AU - McKinnon, G.

AU - Farma, J. M.

AU - Schultz, E.

AU - Vidal-Sicart, Sergi

AU - Hoefer, R. A.

AU - Lewis, Melanie J.

AU - Scheri, R.

AU - Kelley, M. C.

AU - Nieweg, Omgo E.

AU - Noyes, R. D.

AU - Hoon, Dave S. B.

AU - Wang, H. J.

AU - Elashoff, D. A.

AU - Elashoff, R. M.

PY - 2017/6/8

Y1 - 2017/6/8

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85020241826&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1613210

DO - 10.1056/NEJMoa1613210

M3 - Article

C2 - 28591523

AN - SCOPUS:85020241826

VL - 376

SP - 2211

EP - 2222

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 23

ER -