• Kelly M McMasters, Michael E Egger, Michael J Edwards, Merrick I Ross, Douglas S Reintgen, R Dirk Noyes, Robert C G Martin, James S Goydos, Peter D Beitsch, Marshall M Urist, Stephan Ariyan, Jeffrey J Sussman, B Scott Davidson, Jeffrey E Gershenwald, Lee J Hagendoorn, Arnold J Stromberg, and Charles R Scoggins.
• Kelly M. McMasters, Michael E. Egger, Robert C.G. Martin II, and Charles R. Scoggins, University of Louisville, James Graham Brown Cancer Center; Arnold J. Stromberg, University of Kentucky; and Lee J. Hagendoorn, Advertek Louisville, KY; Michael J. Edwards and Jeffrey J. Sussman, University of Cincinnati, Cincinnati, OH; Merrick I. Ross and Jeffrey E. Gershenwald, University of Texas MD Anderson Cancer Center, Houston; Peter D. Beitsch, Dallas Surgical Group, Dallas, TX; Douglas S. Reintgen, University of South Florida School of Medicine, Tampa, FL; R. Dirk Noyes, LDS Hospital, Salt Lake City, UT; James S. Goydos, Rutgers Cancer Institute of New Jersey, Rutgers, The State University of New Jersey, New Brunswick, NJ; Marshall M. Urist, University of Alabama School of Medicine, Birmingham, AL; Stephan Ariyan, Yale University School of Medicine, New Haven, CT; and B. Scott Davidson, Northside Hospital Cancer Institute, Melanoma and Sarcoma Specialists of Georgia, Atlanta, GA. mcmasters@louisville.edu.
• J. Clin. Oncol. 2016 Apr 1; 34 (10): 1079-86.

PurposeThe Sunbelt Melanoma Trial is a prospective randomized trial evaluating the role of high-dose interferon alfa-2b therapy (HDI) or completion lymph node dissection (CLND) for patients with melanoma staged by sentinel lymph node (SLN) biopsy.Patients And MethodsPatients were eligible if they were age 18 to 70 years with primary cutaneous melanoma ≥ 1.0 mm Breslow thickness and underwent SLN biopsy. In Protocol A, patients with a single tumor-positive lymph node after SLN biopsy underwent CLND and were randomly assigned to observation versus HDI. In Protocol B, patients with tumor-negative SLN by standard histopathology and immunohistochemistry underwent molecular staging by reverse transcriptase polymerase chain reaction (RT-PCR). Patients positive by RT-PCR were randomly assigned to observation versus CLND versus CLND+HDI. Primary end points were disease-free survival (DFS) and overall survival (OS).ResultsIn the Protocol A intention-to-treat analysis, there were no significant differences in DFS (hazard ratio, 0.82; P = .45) or OS (hazard ratio, 1.10; P = .68) for patients randomly assigned to HDI versus observation. In the Protocol B intention-to-treat analysis, there were no significant differences in overall DFS (P = .069) or OS (P = .77) across the three randomized treatment arms. Similarly, efficacy analysis (excluding patients who did not receive the assigned treatment) did not demonstrate significant differences in DFS or OS in Protocol A or Protocol B. Median follow-up time was 71 months.ConclusionNo survival benefit for adjuvant HDI in patients with a single positive SLN was found. Among patients with tumor-negative SLN by conventional pathology but with melanoma detected in the SLN by RT-PCR, there was no OS benefit for CLND or CLND+HDI.© 2016 by American Society of Clinical Oncology.

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