Sentinel-Node Biopsy or Nodal Observation in Melanoma
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, M.D., Ph.D., Douglas S. Reintgen, M.D., Brendon J. Coventry, M.D., Edwin C. Glass, M.D., He-Jing Wang, M.D., for the MSLT Group
Background We evaluated the contribution of sentinel-node biopsyto outcomes in patients with newly diagnosed melanoma.
Methods Patients with a primary cutaneous melanoma were randomlyassigned to wide excision and postoperative observation of regionallymph nodes with lymphadenectomy if nodal relapse occurred,or to wide excision and sentinel-node biopsy with immediatelymphadenectomy if nodal micrometastases were detected on biopsy.
Results Among 1269 patients with an intermediate-thickness primarymelanoma, the mean (±SE) estimated 5-year disease-freesurvival rate for the population was 78.3±1.6% in thebiopsy group and 73.1±2.1% in the observation group (hazardratio for death, 0.74; 95% confidence interval [CI], 0.59 to0.93; P=0.009). Five-year melanoma-specific survival rates weresimilar in the two groups (87.1±1.3% and 86.6±1.6%,respectively). In the biopsy group, the presence of metastasesin the sentinel node was the most important prognostic factor;the 5-year survival rate was 72.3±4.6% among patientswith tumor-positive sentinel nodes and 90.2±1.3% amongthose 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-nodemicrometastases was 16.0% (122 of 764 patients), and the rateof nodal relapse in the observation group was 15.6% (78 of 500patients). The corresponding mean number of tumor-involved nodeswas 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 ratewas higher among those who underwent immediate lymphadenectomythan 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 3.5mm) primary melanomas according to the results of sentinel-nodebiopsy provides important prognostic information and identifiespatients with nodal metastases whose survival can be prolongedby 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.
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.
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N Engl J Med 2007;
356:418-421, Jan 25, 2007.
Correspondence
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A correction has been published: N Engl J Med 2006;355(18):1944.
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