McMasters Kelly M, Egger Michael E, Edwards Michael J, Ross Merrick I, Reintgen Douglas S, Noyes R Dirk, Martin Robert C G, Goydos James S, Beitsch Peter D, Urist Marshall M, Ariyan Stephan, Sussman Jeffrey J, Davidson B Scott, Gershenwald Jeffrey E, Hagendoorn Lee J, Stromberg Arnold J, Scoggins Charles R
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.
J Clin Oncol. 2016 Apr 1;34(10):1079-86. doi: 10.1200/JCO.2015.63.3776. Epub 2016 Feb 8.
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 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).
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.
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.
阳光地带黑色素瘤试验是一项前瞻性随机试验，旨在评估高剂量干扰素α-2b疗法（HDI）或根治性淋巴结清扫术（CLND）对经前哨淋巴结（SLN）活检分期的黑色素瘤患者的作用。
年龄在18至70岁之间、原发性皮肤黑色素瘤Breslow厚度≥1.0 mm且接受了SLN活检的患者符合入选标准。在方案A中，SLN活检后有单个肿瘤阳性淋巴结的患者接受CLND，并随机分配至观察组与HDI组。在方案B中，经标准组织病理学和免疫组化检查SLN为肿瘤阴性的患者，通过逆转录聚合酶链反应（RT-PCR）进行分子分期。RT-PCR检测呈阳性的患者被随机分配至观察组、CLND组或CLND+HDI组。主要终点为无病生存期（DFS）和总生存期（OS）。
在方案A的意向性分析中，随机分配至HDI组与观察组的患者在DFS（风险比，0.82；P = 0.45）或OS（风险比，1.10；P = 0.68）方面无显著差异。在方案B的意向性分析中，三个随机治疗组在总体DFS（P = 0.069）或OS（P = 0.77）方面无显著差异。同样，疗效分析（排除未接受分配治疗的患者）在方案A或方案B的DFS或OS方面未显示出显著差异。中位随访时间为71个月。
未发现单前哨淋巴结阳性患者辅助性HDI治疗能带来生存获益。在经传统病理学检查SLN为肿瘤阴性但经RT-PCR检测发现SLN中有黑色素瘤的患者中，CLND或CLND+HDI治疗未带来OS获益。
