Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma.
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Faries Mark B, Thompson John F, Cochran Alistair J, Andtbacka Robert H, Mozzillo Nicola, Zager Jonathan S, Jahkola Tiina, Bowles Tawnya L, Testori Alessandro, Beitsch Peter D, Hoekstra Harald J, Moncrieff Marc, Ingvar Christian, Wouters Michel W J M, Sabel Michael S, Levine Edward A, Agnese Doreen, Henderson Michael, Dummer Reinhard, Rossi Carlo R, Neves Rogerio I, Trocha Steven D, Wright Frances, Byrd David R, Matter Maurice, Hsueh Eddy, MacKenzie-Ross Alastair, Johnson Douglas B, Terheyden Patrick, Berger Adam C, Huston Tara L, Wayne Jeffrey D, Smithers B Mark, Neuman Heather B, Schneebaum Schlomo, Gershenwald Jeffrey E, Ariyan Charlotte E, Desai Darius C, Jacobs Lisa, McMasters Kelly M, Gesierich Anja, Hersey Peter, Bines Steven D, Kane John M, Barth Richard J, McKinnon Gregory, Farma Jeffrey M, Schultz Erwin, Vidal-Sicart Sergi, Hoefer Richard A, Lewis James M, Scheri Randall, Kelley Mark C, Nieweg Omgo E, Noyes R Dirk, Hoon Dave S B, Wang He-Jing, Elashoff David A, Elashoff Robert M
Аннотация
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 .).