JCO:高剂量干扰素α-2b治疗黑色素瘤并不延长生存时间

2016-02-13 MedSci MedSci原创

 1996年是黑色素瘤治疗领域具有里程碑意义的一年。当年发布的群际黑色素瘤临床试验的结果表明黑色素瘤患者中的一些人群或许可以从淋巴结部分切除中获益。阳光地带黑色素瘤试验(Sunbelt Melanoma Trial)是一项前瞻性随机临床试验。该项试验评价了高剂量干扰素α-2b治疗(HDI)或者淋巴结完全切除(CLND)治疗由前哨淋巴结(SLN)活体组织切片分级的黑色素瘤患者。 

1996年是黑色素瘤治疗领域具有里程碑意义的一年。当年发布的群际黑色素瘤临床试验的结果表明黑色素瘤患者中的一些人群或许可以从淋巴结部分切除中获益。阳光地带黑色素瘤试验(Sunbelt Melanoma Trial)是一项前瞻性随机临床试验。该项试验评价了高剂量干扰素α-2b治疗(HDI)或者淋巴结完全切除(CLND)治疗由前哨淋巴结(SLN)活体组织切片分级的黑色素瘤患者。

受试者年龄均在18-70岁之间,且患有原发性皮肤黑色素瘤。黑色素瘤厚度超过1.0mm且经过了SLN活体组织切片检查。在方案A中,在SLN活检后患有肿瘤阳性淋巴结的患者经过CLND之间,被随机分为两组,分别接受观察或者HDI治疗。在方案B中,通过标准组织病理学和免疫组织化学检测的肿瘤阴性SLN患者经过反转录PCR进行分子层面的分级。反转录PCR确定的阳性患者被随机分成三组,分别接受观察或者CLND,或者是接受CLND+HDI。主要的终点是无疾病生存率(DFS)和总生存率(OS)。方案A的意向性分析表明,随机接受HDI或者观察的患者的DFS或者OS并没有显著性差异。方案B的意向性分析表明,总的DFS或者OS也没有显著性差异。疗效分析表明两种方案中的DFS或者OS都没有显著性差异。此项研究的中位随访时间为71个月。

此项研究结果表明,辅助HDI对于黑色素瘤患者并没有生存益处。

原始出处:
Kelly M. McMasters et al. Final Results of the Sunbelt Melanoma Trial: A Multi-Institutional Prospective Randomized PhaseIII Study Evaluating the Role of Adjuvant High-Dose Interferon Alfa-2b and Completion Lymph Node Dissection for Patients Staged by Sentinel Lymph Node Biopsy. JOURNAL OF CLINICAL ONCOLOGY. Published Ahead of Print on February 8, 2016 as 10.1200/JCO.2015.63.3776

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    2016-12-02 amy0550
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    2016-12-10 lidong40
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    2016-08-22 sunylz
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    2016-02-14 dhzzm

    希望有更多的循证支持

    0

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