Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma

M.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, and R.M. Elashoff

 

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. (Funded by the National
Cancer Institute and others; MSLT-II ClinicalTrials.gov number, NCT00297895.)

 

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