Interferon-α treatment in multiple myeloma:: Meta-analysis of 30 randomised trials among 3948 patients
Interferon-α treatment in multiple myeloma:: Meta-analysis of 30 randomised trials among 3948 patients
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DOI：
10.1023/a:1026548226770
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发表时间：
2000-11-01
影响因子：
50.5
通讯作者：
Ludwig, H
中科院分区：
文献类型：
--
作者：
Fritz, E;Ludwig, H
背景资料：经过20年的干扰素（IFN）治疗骨髓瘤患者和许多随机临床试验，没有明确的证据证明其益处。所有可用的相关发表的数据测试IFN和对照组之间的差异，在一个大的患者群体，并解决了问题的成本效益。患者和方法：荟萃分析进行了17个试验中，2333例患者接受IFN-化疗诱导治疗或化疗单独和13个试验中，1615例IFN维持治疗或不治疗。应答率和公布的Kaplan-Meier无复发和总生存曲线的参数进行了analysed.Results：IFN组患者在所有研究参数中均显示出明显更好的结果：IFN-化疗诱导治疗产生了6.6%的高反应率无复发生存期延长4.8个月（P <0.01），总生存期延长3.1个月（P <0.01）。干扰素维持治疗使无复发生存期和总生存期分别延长4.4个月（P <0.01）和7.0个月（P <0.01）。所有IFN试验的荟萃分析结果显示，IFN相关的无复发生存期和总生存期分别增加了4.6个月和3.7个月。早在IFN治疗开始后6个月和12个月，IFN试验组的累积无复发率和总生存率始终显著较高。IFN药物费用为一年的生存增益，确定从AUC的最佳拟合Gompertz函数的IFN和控制生存曲线，估计为42，482.28美元的诱导治疗和18，968.16美元的维持treatment.Conclusions：显著上级的结果是一致的IFN试验组发表的数据的荟萃分析。这些结果与对个体患者数据同时进行的荟萃分析一致，但更容易获得。考虑到我们的所有结果，即，IFN治疗多发性骨髓瘤患者的临床结果的持续显著改善（尽管有限）及其可接受的成本效益似乎值得考虑。
Background: After two decades of interferon (IFN) treatment in myeloma patients and many randomised clinical trials, no definite proof of its benefits exists. This meta-analysis of all available relevant published data tests the differences between IFN and control arms in a large patient population and addresses the issue of cost-effectiveness.Patients and methods: Meta-analysis was performed on 17 trials among 2333 patients who received IFN-chemotherapy induction treatment or chemotherapy alone and on 13 trials among 1615 patients on IFN maintenance therapy or without treatment. Response rates and parameters of published Kaplan-Meier relapse-free and overall survival curves were analysed.Results: Patients in IFN arms showed significantly better results in all investigated parameters: IFN-chemotherapy induction treatment yielded 6.6% higher response rates (2P < 0.002) as well as 4.8-month and 3.1-month prolongations of relapse-free (P < 0.01) and overall survival (P < 0.01), respectively. Interferon maintenance therapy lead to 4.4-month (P < 0.01) and 7.0-month (P < 0.01) prolongations of relapse-free and overall survival, respectively. Meta-analysis of all IFN trials combined resulted in 4.6-month and 3.7-month IFN-related gains in relapse-free and overall survival, respectively. As early as 6 and 12 months after the start of IFN treatment, percentages of cumulative relapse-free and overall survival were always significantly higher in IFN trial arms. IFN drug expenses for a one-year survival gain, as determined from AUCs of best-fitted Gompertz functions of IFN and control survival curves, were estimated to be US$42,482.28 for induction therapy and US$18,968.16 for maintenance treatment.Conclusions: Significantly superior outcomes were consistently found in IFN trial arms by meta-analysis of published data. These results are in accordance with a concomittantly conducted meta-analysis on individual patient data but were much easier to accrue. Taking all our results into account, i.e., the consistently significant, although limited, improvement of clinical outcomes and its acceptable cost-effectiveness, IFN treatment of patients with multiple myeloma seems worthwhile to be considered.