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

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


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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / administration & dosage*
  • Chemotherapy, Adjuvant
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Humans
  • Immunohistochemistry
  • Interferon alpha-2
  • Interferon-alpha / administration & dosage*
  • Kaplan-Meier Estimate
  • Lymph Node Excision*
  • Male
  • Melanoma / drug therapy*
  • Melanoma / pathology*
  • Melanoma / surgery
  • Middle Aged
  • Neoplasm Staging
  • Prospective Studies
  • Recombinant Proteins / administration & dosage
  • Reverse Transcriptase Polymerase Chain Reaction
  • Sentinel Lymph Node Biopsy*
  • Skin Neoplasms / drug therapy*
  • Skin Neoplasms / pathology*
  • Skin Neoplasms / surgery
  • Treatment Outcome
  • Watchful Waiting


  • Antineoplastic Agents
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins

Supplementary concepts

  • Melanoma, Cutaneous Malignant