2016年2月18日訊 /生物谷BIOON/ --一項名為「Sunbelt Melanoma Trial」的臨床研究最終結果表明，根據目前的臨床診斷手段，對於大多數黑色素瘤癌症三期病人來說幹擾素治療並不會給他們帶來獲益。來自美國路易斯維爾大學的研究人員將相關研究結果在線發表在了國際學術期刊Journal of Clinical Oncology上。
這項開始於1997年的臨床研究共包含超過3600名臨床病人，這些病人的單個淋巴結中有少量的黑色素瘤，其中一部分病人接受高劑量的幹擾素治療，另外一部分病人只進行簡單的觀察。研究人員對參與研究的病人進行了長達10年的跟蹤調查以確定病人的無病生存率以及整體生存率。
1995年幹擾素通過美國FDA批准用於治療黑色素瘤，在檢測該藥物作用效果的臨床研究中，參與研究的病人都攜帶多個較大的可通過觸摸診斷的黑色素瘤轉移淋巴結，但隨著90年代前哨淋巴結活檢技術（SLN）的發展，醫生可以檢測到淋巴結中觸摸無法察覺到的微小腫瘤。
由於黑色素瘤出現在參與Sunbelt臨床研究的病人的淋巴結中，因此他們被診斷為癌症III期，但是由於淋巴結中的腫瘤較少，他們相比於SLN技術出現之前被診斷為癌症III期的病人來說出現癌症復發的風險也相對更低。文章作者McMasters指出，他們還對只能通過PCR技術在分子層面上進行診斷的癌症III期病人進行了臨床研究。
McMasters表示，他們進行這項臨床研究的目的在於研究幹擾素治療是否對低風險的癌症III期病人有效，但研究結果表明幹擾素治療似乎並沒有為這些病人帶來更多獲益，甚至沒有改善病人生存率的趨勢。由於幹擾素治療方法也帶有一定毒性，因此這項研究間接地為病人減輕了治療痛苦，同時節省了治療費用。基於這些發現，研究人員認為不適合推薦只在一個淋巴結中出現少量腫瘤的病人進行幹擾素治療。
基於目前的檢測手段，大部分癌症III期病人的淋巴結中都只有非常少量的腫瘤。因此雖然幹擾素是FDA審批通過的黑色素瘤輔助治療藥物，但是對於多數病人來說未來或許會有更好的治療選擇。對黑色素瘤的深入研究將進一步推動新藥物和治療方法的開發。（生物谷Bioon.com）
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doi: 10.1200/JCO.2015.63.3776
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
Kelly M. McMasters⇑, Michael E. Egger, Michael J. Edwards, Merrick I. Ross, Douglas S. Reintgen, R. Dirk Noyes, Robert C.G. Martin II, James S. Goydos, Peter D. Beitsch, Marshall M. Urist, Stephan Ariyan, Jeffrey J. Sussman, B. Scott Davidson, Jeffrey E. Gershenwald, Lee J. Hagendoorn, Arnold J. Stromberg and Charles R. Scoggins
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.