title: Final Results of the Sunbelt Melanoma Trial: A Multi-Institutional Prospective Randomized Phase III Study Evaluating the Role of Adjuvant High-Dose Interferon Alfa-2b and Completion Lymph Node Dissection for Patients Staged by Sentinel Lymph Node Biopsy.
abstract: OBJECTIVE
  The 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.
  
  
  METHODS
  Patients 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).
  
  
  RESULTS
  In 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.
  
  
  CONCLUSIONS
  No 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.
authors: 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.
authors: Kelly M
authors: KM
authors: McMasters
authors: 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.
authors: Michael E
authors: ME
authors: Egger
authors: 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.
authors: Michael J
authors: MJ
authors: Edwards
authors: 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.
authors: Merrick I
authors: MI
authors: Ross
authors: 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.
authors: Douglas S
authors: DS
authors: Reintgen
authors: 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.
authors: R Dirk
authors: RD
authors: Noyes
authors: 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.
authors: Robert C G
authors: RC
authors: Martin
authors: 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.
authors: James S
authors: JS
authors: Goydos
authors: 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.
authors: Peter D
authors: PD
authors: Beitsch
authors: 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.
authors: Marshall M
authors: MM
authors: Urist
authors: 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.
authors: Stephan
authors: S
authors: Ariyan
authors: 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.
authors: Jeffrey J
authors: JJ
authors: Sussman
authors: 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.
authors: B Scott
authors: BS
authors: Davidson
authors: 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.
authors: Jeffrey E
authors: JE
authors: Gershenwald
authors: 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.
authors: Lee J
authors: LJ
authors: Hagendoorn
authors: 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.
authors: Arnold J
authors: AJ
authors: Stromberg
authors: 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.
authors: Charles R
authors: CR
authors: Scoggins
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D017024:Chemotherapy, Adjuvant; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007150:Immunohistochemistry; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D053208:Kaplan-Meier Estimate; D008197:Lymph Node Excision; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000008:administration & dosage; D020133:Reverse Transcriptase Polymerase Chain Reaction; D021701:Sentinel Lymph Node Biopsy; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery; D016896:Treatment Outcome; D057832:Watchful Waiting; D000096142:Cutaneous Malignant Melanoma
chemical_list: D000970:Antineoplastic Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins