Final trial report of sentinel-node biopsy versus nodal observation in melanoma

D. 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, M. B. Faries

Research output: Contribution to journalArticlepeer-review

Abstract

Background: 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

Original languageEnglish
Pages (from-to)599-609
Number of pages11
JournalNew England Journal of Medicine
Volume370
Issue number7
DOIs
Publication statusPublished - 2014

ASJC Scopus subject areas

  • Medicine(all)

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