Please use this identifier to cite or link to this item: https://hdl.handle.net/2440/93373
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dc.contributor.authorMorton, D.-
dc.contributor.authorThompson, J.-
dc.contributor.authorCochran, A.-
dc.contributor.authorMozzillo, N.-
dc.contributor.authorNieweg, O.-
dc.contributor.authorRoses, D.-
dc.contributor.authorHoekstra, H.-
dc.contributor.authorKarakousis, C.-
dc.contributor.authorPuleo, C.-
dc.contributor.authorCoventry, B.-
dc.contributor.authorKashani-Sabet, M.-
dc.contributor.authorSmithers, B.-
dc.contributor.authorPaul, E.-
dc.contributor.authorKraybill, W.-
dc.contributor.authorMcKinnon, J.-
dc.contributor.authorWang, H.-
dc.contributor.authorElashoff, R.-
dc.contributor.authorFaries, M.-
dc.date.issued2014-
dc.identifier.citationNew England Journal of Medicine, 2014; 370(7):599-609-
dc.identifier.issn0028-4793-
dc.identifier.issn1533-4406-
dc.identifier.urihttp://hdl.handle.net/2440/93373-
dc.description.abstractBACKGROUND: Sentinel-node biopsy, a minimally invasive procedure for regional melanoma staging, was evaluated in a phase 3 trial. METHODS: We evaluated outcomes in 2001 patients with primary cutaneous melanomas randomly assigned to undergo wide excision and nodal observation, with lymphadenectomy for nodal relapse (observation group), or wide excision and sentinel-node biopsy, with immediate lymphadenectomy for nodal metastases detected on biopsy (biopsy group). Results No significant treatment-related difference in the 10-year melanoma-specific survival rate was seen in the overall study population (20.8% with and 79.2% without nodal metastases). Mean (± SE) 10-year disease-free survival rates were significantly improved in the biopsy group, as compared with the observation group, among patients with intermediate-thickness melanomas, defined as 1.20 to 3.50 mm (71.3 ± 1.8% vs. 64.7 ± 2.3%; hazard ratio for recurrence or metastasis, 0.76; P=0.01), and those with thick melanomas, defined as >3.50 mm (50.7 ± 4.0% vs. 40.5 ± 4.7%; hazard ratio, 0.70; P=0.03). Among patients with intermediate-thickness melanomas, the 10-year melanoma-specific survival rate was 62.1 ± 4.8% among those with metastasis versus 85.1 ± 1.5% for those without metastasis (hazard ratio for death from melanoma, 3.09; P<0.001); among patients with thick melanomas, the respective rates were 48.0 ± 7.0% and 64.6 ± 4.9% (hazard ratio, 1.75; P=0.03). Biopsy-based management improved the 10-year rate of distant disease-free survival (hazard ratio for distant metastasis, 0.62; P=0.02) and the 10-year rate of melanoma-specific survival (hazard ratio for death from melanoma, 0.56; P=0.006) for patients with intermediate-thickness melanomas and nodal metastases. Accelerated-failure-time latent-subgroup analysis was performed to account for the fact that nodal status was initially known only in the biopsy group, and a significant treatment benefit persisted. CONCLUSIONS: Biopsy-based staging of intermediate-thickness or thick primary melanomas provides important prognostic information and identifies patients with nodal metastases who may benefit from immediate complete lymphadenectomy. Biopsy-based management prolongs disease-free survival for all patients and prolongs distant disease-free survival and melanoma-specific survival for patients with nodal metastases from intermediate-thickness melanomas. (Funded by the National Cancer Institute, National Institutes of Health, and the Australia and New Zealand Melanoma Trials Group; ClinicalTrials.gov number, NCT00275496.).-
dc.description.statementofresponsibilityD.L. Morton, J.F. Thompson, A.J. Cochran, N. Mozzillo, O.E. Nieweg, D.F. Roses, H.J. Hoekstra, C.P. Karakousis, C.A. Puleo, B.J. Coventry, M. Kashani-Sabet, B.M. Smithers, E. Paul, W.G. Kraybill, J.G. McKinnon, H.-J. Wang, R. Elashoff, and M.B. Faries, for the MSLT Group-
dc.language.isoen-
dc.publisherMassachusetts Medical Society-
dc.rights©2014 Massachusetts Medical Society-
dc.source.urihttp://dx.doi.org/10.1056/nejmoa1310460-
dc.subjectHumans-
dc.titleFinal trial report of sentinel-node biopsy versus nodal observation in melanoma-
dc.typeJournal article-
dc.identifier.doi10.1056/NEJMoa1310460-
pubs.publication-statusPublished-
dc.identifier.orcidCoventry, B. [0000-0002-3596-7735]-
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