Sentinel-node biopsy or nodal observation in melanoma
Date
2006
Authors
Morton, D.
Thompson, J.
Cochran, A.
Mozzillo, N.
Elashoff, R.
Essner, R.
Nieweg, O.
Roses, D.
Hoekstra, H.
Karakousis, C.
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Advisors
Journal Title
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Type:
Journal article
Citation
New England Journal of Medicine, 2006; 355(13):1307-1317
Statement of Responsibility
Donald L. Morton, M.D., John F. Thompson, M.D., Alistair J. Cochran, M.D., Nicola Mozzillo, M.D., Robert Elashoff, Ph.D., Richard Essner, M.D., Omgo E. Nieweg, M.D., Ph.D., Daniel F. Roses, M.D., Harald J. Hoekstra, M.D., Ph.D., Constantine P. Karakousis, Douglas S. Reintgen, M.D., Brendon J. Coventry, Edwin C. Glass, and He-Jing Wang,
Conference Name
Abstract
Background We evaluated the contribution of sentinel-node biopsy to outcomes in patients with newly diagnosed melanoma. Methods Patients with a primary cutaneous melanoma were randomly assigned to wide excision and postoperative observation of regional lymph nodes with lymphadenectomy if nodal relapse occurred, or to wide excision and sentinel-node biopsy with immediate lymphadenectomy if nodal micrometastases were detected on biopsy. Results Among 1269 patients with an intermediate-thickness primary melanoma, the mean (±SE) estimated 5-year disease-free survival rate for the population was 78.3±1.6% in the biopsy group and 73.1±2.1% in the observation group (hazard ratio for death, 0.74; 95% confidence interval [CI], 0.59 to 0.93; P = 0.009). Five-year melanoma-specific survival rates were similar in the two groups (87.1±1.3% and 86.6±1.6%, respectively). In the biopsy group, the presence of metastases in the sentinel node was the most important prognostic factor; the 5-year survival rate was 72.3±4.6% among patients with tumor-positive sentinel nodes and 90.2±1.3% among those with tumor- negative sentinel nodes (hazard ratio for death, 2.48; 95% CI, 1.54 to 3.98; P<0.001). The incidence of sentinel-node micrometastases was 16.0% (122 of 764 patients), and the rate of nodal relapse in the observation group was 15.6% (78 of 500 patients). The corresponding mean number of tumor-involved nodes was 1.4 in the biopsy group and 3.3 in the observation group (P<0.001), indicating disease progression during observation. Among patients with nodal metastases, the 5-year survival rate was higher among those who underwent immediate lymphadenectomy than among those in whom lymphadenectomy was delayed (72.3±4.6% vs. 52.4±5.9%; hazard ratio for death, 0.51; 95% CI, 0.32 to 0.81; P = 0.004). Conclusions The staging of intermediate-thickness (1.2 to 3.5 mm) primary melanomas according to the results of sentinel-node biopsy provides important prognostic information and identifies patients with nodal metastases whose survival can be prolonged by immediate lymphadenectomy. (ClinicalTrials.gov number, NCT00275496.)
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Copyright © 2006 Massachusetts Medical Society