Completion dissection or observation for sentinel-node metastasis in melanoma

B. Faries; J. F. Thompson; A. J. Cochran; R. H. Andtbacka; N. Mozzillo; J. S. Zager; T. Jahkola; T. L. Bowles; A. Testori; P. D. Beitsch; H. J. Hoekstra; M. Moncrieff; C. Ingvar; M. W.J.M. Wouters; M. S. Sabel; E. A. Levine; D. Agnese; M. Henderson; R. Dummer; C. R. Rossi; R. I. Neves; S. D. Trocha; F. Wright; D. R. Byrd; M. Matter; E. Hsueh; A. MacKenzie-Ross; D. B. Johnson; P. Terheyden; A. C. Berger; T. L. Huston; J. D. Wayne; B. M. Smithers; H. B. Neuman; S. Schneebaum; J. E. Gershenwald; C. E. Ariyan; D. C. Desai; L. Jacobs; K. M. McMasters; A. Gesierich; P. Hersey; S. D. Bines; J. M. Kane; R. J. Barth; G. McKinnon; J. M. Farma; E. Schultz; S. Vidal-Sicart; R. A. Hoefer; J. M. Lewis; R. Scheri; M. C. Kelley; O. E. Nieweg; R. D. Noyes; D. S.B. Hoon; H. J. Wang; D. A. Elashoff; R. M. Elashoff

doi:10.1056/NEJMoa1613210

Completion dissection or observation for sentinel-node metastasis in melanoma

B. Faries, J. F. Thompson, A. J. Cochran, R. H. Andtbacka, N. Mozzillo, J. S. Zager, T. Jahkola, T. L. Bowles, A. Testori, P. D. Beitsch, H. J. Hoekstra, M. Moncrieff, C. Ingvar, M. W.J.M. Wouters, M. S. Sabel, E. A. Levine, D. Agnese, M. Henderson, R. Dummer, C. R. RossiR. I. Neves, S. D. Trocha, F. Wright, D. R. Byrd, M. Matter, E. Hsueh, A. MacKenzie-Ross, D. B. Johnson, P. Terheyden, A. C. Berger, T. L. Huston, J. D. Wayne, B. M. Smithers, H. B. Neuman, S. Schneebaum, J. E. Gershenwald, C. E. Ariyan, D. C. Desai, L. Jacobs, K. M. McMasters, A. Gesierich, P. Hersey, S. D. Bines, J. M. Kane, R. J. Barth, G. McKinnon, J. M. Farma, E. Schultz, S. Vidal-Sicart, R. A. Hoefer, J. M. Lewis, R. Scheri, M. C. Kelley, O. E. Nieweg, R. D. Noyes, D. S.B. Hoon, H. J. Wang, D. A. Elashoff, R. M. Elashoff

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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.

Original language	English (US)
Pages (from-to)	2211-2222
Number of pages	12
Journal	New England Journal of Medicine
Volume	376
Issue number	23
DOIs	https://doi.org/10.1056/NEJMoa1613210
State	Published - Jun 8 2017
Externally published	Yes

ASJC Scopus subject areas

General Medicine

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10.1056/NEJMoa1613210

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Faries, B., Thompson, J. F., Cochran, A. J., Andtbacka, R. H., Mozzillo, N., Zager, J. S., Jahkola, T., Bowles, T. L., Testori, A., Beitsch, P. D., Hoekstra, H. J., Moncrieff, M., Ingvar, C., Wouters, M. W. J. M., Sabel, M. S., Levine, E. A., Agnese, D., Henderson, M., Dummer, R., ... Elashoff, R. M. (2017). Completion dissection or observation for sentinel-node metastasis in melanoma. New England Journal of Medicine, 376(23), 2211-2222. https://doi.org/10.1056/NEJMoa1613210

Faries, B, Thompson, JF, Cochran, AJ, Andtbacka, RH, Mozzillo, N, Zager, JS, Jahkola, T, Bowles, TL, Testori, A, Beitsch, PD, Hoekstra, HJ, Moncrieff, M, Ingvar, C, Wouters, MWJM, Sabel, MS, Levine, EA, Agnese, D, Henderson, M, Dummer, R, Rossi, CR, Neves, RI, Trocha, SD, Wright, F, Byrd, DR, Matter, M, Hsueh, E, MacKenzie-Ross, A, Johnson, DB, Terheyden, P, Berger, AC, Huston, TL, Wayne, JD, Smithers, BM, Neuman, HB, Schneebaum, S, Gershenwald, JE, Ariyan, CE, Desai, DC, Jacobs, L, McMasters, KM, Gesierich, A, Hersey, P, Bines, SD, Kane, JM, Barth, RJ, McKinnon, G, Farma, JM, Schultz, E, Vidal-Sicart, S, Hoefer, RA, Lewis, JM, Scheri, R, Kelley, MC, Nieweg, OE, Noyes, RD, Hoon, DSB, Wang, HJ, Elashoff, DA & Elashoff, RM 2017, 'Completion dissection or observation for sentinel-node metastasis in melanoma', New England Journal of Medicine, vol. 376, no. 23, pp. 2211-2222. https://doi.org/10.1056/NEJMoa1613210

@article{bd75c73685014b66bf3f36d31b5f762f,

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, {A. J.} and Andtbacka, {R. H.} and N. Mozzillo and Zager, {J. S.} and T. 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 Rossi, {C. R.} and Neves, {R. I.} and Trocha, {S. D.} and F. Wright 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, {J. E.} and Ariyan, {C. E.} and Desai, {D. C.} and L. Jacobs 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 S. Vidal-Sicart and Hoefer, {R. A.} and Lewis, {J. M.} and R. Scheri and Kelley, {M. C.} and Nieweg, {O. E.} and Noyes, {R. D.} and Hoon, {D. S.B.} and Wang, {H. J.} and Elashoff, {D. A.} and Elashoff, {R. M.}",

note = "Publisher Copyright: {\textcopyright} 2017 Massachusetts Medical Society.",

year = "2017",

month = jun,

day = "8",

doi = "10.1056/NEJMoa1613210",

language = "English (US)",

volume = "376",

pages = "2211--2222",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "23",

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TY - JOUR

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

AU - Faries, B.

AU - Thompson, J. F.

AU - Cochran, A. J.

AU - Andtbacka, R. H.

AU - Mozzillo, N.

AU - Zager, J. S.

AU - Jahkola, T.

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, C. R.

AU - Neves, R. I.

AU - Trocha, S. D.

AU - Wright, 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, J. E.

AU - Ariyan, C. E.

AU - Desai, D. C.

AU - Jacobs, 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, S.

AU - Hoefer, R. A.

AU - Lewis, J. M.

AU - Scheri, R.

AU - Kelley, M. C.

AU - Nieweg, O. E.

AU - Noyes, R. D.

AU - Hoon, D. 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.

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U2 - 10.1056/NEJMoa1613210

DO - 10.1056/NEJMoa1613210

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VL - 376

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EP - 2222

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 23

ER -

Completion dissection or observation for sentinel-node metastasis in melanoma

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