Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma.
(Clinical Trial, Phase III;Journal Article;Multicenter Study)
BACKGROUND: Sentinel-lymph-node biopsy is associated with increased melanoma-specific survival (i.e., survival until death from melanoma) among patients with node-positive intermediate-thickness 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 melanoma-specific survival among 1934 patients with data that could be evaluated in an intention-to-treat 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 log-rank 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 .).
Faries, MB; 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, H-J; Elashoff, DA; Elashoff, RM
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