The important Sunbelt melanoma trial was published in May 2008 in Journal of Clinical Oncology.
This trial attempted to see whether patients with a single positive sentinel lymph node biopsy and then complete lymph node resection benefited from interferon. - They did not.
Also, selected SLNB histology negative patients who were RT/PCR positive underwent complete node dissection with or without interferon. They were not helped either by the nodal surgery or the interferon.
J Clin Oncol 26: 2008 (May 20 suppl; abstr 9003)
Authors:
K. M. McMasters, M. I. Ross, D. S. Reintgen, M. J. Edwards, R. D. Noyes, M. Urist, J. Sussman, J. Goydos, P. Beitsch, R. C. Martin, C. R. Scoggins
Background:
The Sunbelt Melanoma Trial is a multicenter prospective randomized prospective trial to evaluate the role of high-dose interferon alfa-2b (IFN) or completion lymph node dissection (CLND) in patients with melanoma staged by sentinel lymph node (SLN) biopsy.
Methods:
Eligible patients aged 18 to 70 years with primary melanoma >1.0 mm Breslow thickness underwent SLN biopsy. In Protocol A, patients with a single tumor-positive lymph node after SLN biopsy and CLND were randomized to observation vs. high dose IFN (20 MU/m2/d i.v. x 4 wks followed by 10 MU/m2 s.q. TIW x 48 wks). In Protocol B, patients with tumor-negative SLN by standard histopathology and immunohistochemistry underwent molecular staging of the SLN by reverse transcriptase polymerase chain reaction (RT-PCR) to detect melanoma- specific mRNA (tyrosinase, MART 1, MAGE 3, gp100); patients with RT-PCR-positive SLN were randomized to observation vs. CLND vs. CLND + IFN (20 MU/m2/d i.v. x 4 wks only). Randomization was stratified for Breslow thickness and ulceration. Disease-free survival (DFS) and overall survival (OS) were the primary endpoints. Intention-to-treat and efficacy analyses were performed by Kaplan-Meier analyses and Cox Proportional Hazards Models. The final analysis was approved by the Data Safety and Monitoring Committee.
Results:
Patients were enrolled between 6/24/1997 and 10/31/2003. Median follow-up was 64 months. In the Protocol A intention-to-treat analysis, there were no significant differences in DFS (HR 0.82, 95% CI: 0.47-1.40, p=0.46) or OS (HR 1.07, CI: 0.65-1.78, p=0.79) for patients randomized to IFN (N=112) vs. observation (N=106). In Protocol B there were no significant differences in DFS or OS among patients randomized to CLND (N=192, DFS: HR 0.72, CI 0.42-1.23, p=0.23; OS: HR 0.94, CI 0.55-1.59, p=0.81) or CLND + IFN (N=184; DFS: HR 0.90, CI 0.54-1.50, p=0.69; OS: HR 0.96, CI 0.56-1.63, p=0.88) vs. observation (N=180). Similarly, efficacy analysis (excluding patients who did not receive the assigned treatment) did not demonstrate significant differences in DFS or OS.
Conclusions:
This study failed to demonstrate a benefit for adjuvant high-dose IFN for patients with a single positive SLN. Among patients with melanoma cells detected in the SLN by RT-PCR analysis, there was no significant benefit to CLND or CLND + IFN.