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Previous Volume 355:1307-1317 September 28, 2006 Number 13 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Video Editorial by Balch, C. M. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article PubMed Citation

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 [ClinicalTrials.gov] .)

Source Information

From the Departments of Surgical Oncology (D.L.M., R. Essner) and Biostatistics (R. Elashoff, H.-J.W.), John Wayne Cancer Institute at Saint John's Health Center, Santa Monica, CA; the Sydney Melanoma Unit, Royal Prince Alfred Hospital, Camperdown, NSW, Australia (J.F.T.); the Department of Pathology and Laboratory Medicine, University of California at Los Angeles, Los Angeles (A.J.C.); the Department of Surgical Oncology, National Cancer Institute, Naples, Italy (N.M.); the Department of Biostatistics, University of California at Los Angeles, Los Angeles (R. Elashoff, H.-J.W.); the Department of Surgery, Netherlands Cancer Institute, Amsterdam (O.E.N.); the Department of Surgery, New York University School of Medicine, New York (D.F.R.); the Department of Surgical Oncology, University Medical Center Groningen and Groningen University, Groningen, the Netherlands (H.J.H.); the Department of Surgery, Millard Fillmore Hospital, Buffalo, NY (C.P.K.); the Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL (D.S.R.); the Department of Surgery, Royal Adelaide Hospital, Adelaide, SA, Australia (B.J.C.); and the Department of Nuclear Medicine, Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles (E.C.G.).

Address reprint requests to Dr. Morton at the John Wayne Cancer Institute at Saint John's Health Center, 2200 Santa Monica Blvd., Santa Monica, CA 90404, or at mortond{at}jwci.org.

Full Text of this Article

Related Letters:

Sentinel-Node Biopsy in Melanoma
Thomas J. M., A'Hern R. P., Grichnik J. M., Retsas S., Lipsker D., Kanzler M. H., Levitt L., Lin A., Morton D. L., Cochran A. J., Thompson J. F., Balch C. M., Cascinelli N.
Extract | Full Text | PDF  
N Engl J Med 2007; 356:418-421, Jan 25, 2007. Correspondence

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