TY - JOUR
T1 - Final Results of the Sunbelt Melanoma trial
T2 - 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
AU - McMasters, Kelly M.
AU - Egger, Michael E.
AU - Edwards, Michael J.
AU - Ross, Merrick I.
AU - Reintgen, Douglas S.
AU - Noyes, R. Dirk
AU - Martin, Robert C.G.
AU - Goydos, James S.
AU - Beitsch, Peter D.
AU - Urist, Marshall M.
AU - Ariyan, Stephan
AU - Sussman, Jeffrey J.
AU - Davidson, B. Scott
AU - Gershenwald, Jeffrey E.
AU - Hagendoorn, Lee J.
AU - Stromberg, Arnold J.
AU - Scoggins, Charles R.
N1 - Publisher Copyright:
© 2016 by American Society of Clinical Oncology.
PY - 2016/4/1
Y1 - 2016/4/1
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.2015.63.3776
DO - 10.1200/JCO.2015.63.3776
M3 - Article
C2 - 26858331
AN - SCOPUS:84962285552
VL - 34
SP - 1079
EP - 1086
IS - 10
ER -