Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma: A Phase III Randomized Controlled Trial of Health-Related Quality of Life and Symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group
Adjuvant Therapy With Pegylated Interferon Alfa-2b Versus Observation in Resected Stage III Melanoma: A Phase III Randomized Controlled Trial of Health-Related Quality of Life and Symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group
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DOI：
10.1200/jco.2008.20.2069
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发表时间：
2009-06-20
影响因子：
45.3
通讯作者：
Eggermont, Alexander
中科院分区：
文献类型：
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作者：
Bottomley, Andrew;Coens, Corneel;Eggermont, Alexander
目的以干扰素（IFN）为基础的辅助治疗黑色素瘤伴随着明显的副作用，因此有必要对患者的健康相关生活质量（HRQOL）进行评价。我们的试验检查了辅助聚乙二醇化IFN-α-2b对HRQOL的影响方法总共1,256名III期黑色素瘤患者在完全淋巴结切除术后被随机分配接受观察（n = 629）或PEG-IFN-α-2b（n = 627）：诱导6 g/kg/周，持续8周，然后维持3 g/kg/周，预期总持续时间为5年。欧洲组织的研究和治疗癌症的生活质量问卷C30被用来评估HRQOL.ResultsAt 3.8年的中位数随访，为主要终点，无复发生存期（RFS），风险降低了18%（风险率= 0.82; P = .01），在PEG-IFN-α-2b臂相比，观察。与观察组相比，PEG-IFN-α-2b治疗组发生了显著且有临床意义的差异，显示第3个月（-11.6分; 99% CI，-8.2至-15.0）和第2年（-10.5分; 99% CI，-6.6至-14.4）时总体HRQOL降低。当比较两组时，许多其他量表显示出统计学上的显著差异。从临床的角度来看，重要的差异被发现为五个尺度：两个功能尺度（社会和角色功能）和三个症状尺度（食欲不振，疲劳和呼吸困难），与PEG-IFN-α-2b手臂最imported.ConclusionPEG-IFN-α-2b导致RFS的显着和持续改善。当患者接受PEG-IFN-α-2b治疗时，对总体HRQOL和选定症状有预期的负面影响。J Clin Oncol 27：2916-2923. (C)2009年美国临床肿瘤学会
PurposeInterferon (IFN) -based adjuvant therapy in melanoma is associated with significant side effects, which necessitates evaluation of health-related quality of life (HRQOL). Our trial examined the HRQOL effects of adjuvant pegylated IFN-alpha-2b (PEG-IFN-alpha-2b) versus observation in patients with stage III melanoma.MethodsA total of 1,256 patients with stage III melanoma were randomly assigned after full lymphadenectomy to receive either observation (n = 629) or PEG-IFN-alpha-2b (n = 627): induction 6 g/kg/wk for 8 weeks then maintenance 3 g/kg/wk for an intended total duration of 5 years. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 was used to assess HRQOL.ResultsAt 3.8 years of median follow-up, for the primary end point, recurrence-free survival (RFS), risk was reduced by 18% (hazard rate = 0.82; P = .01) in the PEG-IFN-alpha-2b arm compared with observation. Significant and clinically meaningful differences occurred with the PEG-IFN-alpha-2b treatment arm compared with the observation group, showing decreased global HRQOL at month 3 (-11.6 points; 99% CI, -8.2 to -15.0) and year 2 (-10.5 points; 99% CI, -6.6 to -14.4). Many of the other scales showed statistically significant differences between scores when comparing the two arms. From a clinical point of view, important differences were found for five scales: two functioning scales (social and role functioning) and three symptom scales (appetite loss, fatigue, and dyspnea), with the PEG-IFN-alpha-2b arm being most impaired.ConclusionPEG-IFN-alpha-2b leads to a significant and sustained improvement in RFS. There is an expected negative effect on global HRQOL and selected symptoms when patients undergo PEG-IFN-alpha-2b treatment. J Clin Oncol 27: 2916-2923. (C) 2009 by American Society of Clinical Oncology