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J Clin Oncol. 2016 Apr 1;34(10):1079-86. doi: 10.1200/JCO.2015.63.3776. Epub 2016 Feb 8.

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.

Author information

1
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.
2
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.

Abstract

PURPOSE:

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.

PATIENTS AND 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.

CONCLUSION:

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.

PMID:
26858331
PMCID:
PMC5321066
DOI:
10.1200/JCO.2015.63.3776
[Indexed for MEDLINE]
Free PMC Article

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