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联合化疗与美法仑加泼尼松治疗多发性骨髓瘤的比较:来自27项随机试验的6633例患者的概述。骨髓瘤试验协作组

Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group.

出版信息

J Clin Oncol. 1998 Dec;16(12):3832-42. doi: 10.1200/JCO.1998.16.12.3832.

DOI:10.1200/JCO.1998.16.12.3832
PMID:9850028
Abstract

PURPOSE

To compare combination chemotherapy (CCT) versus melphalan plus prednisone (MP) as treatment for multiple myeloma.

PATIENTS AND METHODS

In a collaborative worldwide overview of randomized trials of CCT versus MP, individual patient data on 4,930 patients from 20 trials were analyzed, with the addition of published data on a further 1,703 patients from seven trials. The main outcome measure was mortality, with response and recurrence rates being subsidiary end points.

RESULTS

Taking all of the trials together, response rates were significantly higher with CCT than with MP (60.0% v 53.2%; P < .00001, two-tailed). There was no evidence of any difference in mortality between CCT and MP, with a nonsignificant 1.5% reduction in death rate in favor of CCT (P = .6, two-tailed). There is heterogeneity of design between the trials, but subgroup analyses by type of CCT or by dose-intensities of CCT, of melphalan, or of prednisone did not identify any particular forms of therapy that were either clearly beneficial or clearly adverse. Similarly, analysis of the presentation features of the patients did not find any categories in which CCT differed significantly from MP in its effects on mortality; in particular, there was no evidence that poor-risk patients benefited more from CCT.

CONCLUSION

This overview found no difference, either overall or within any subgroup, in mortality between CCT and MP. In terms of survival, these therapeutic options, as tested in the trials considered, are approximately equivalent.

摘要

目的

比较联合化疗(CCT)与美法仑加泼尼松(MP)治疗多发性骨髓瘤的效果。

患者与方法

在一项关于CCT与MP的随机试验的全球合作综述中,分析了来自20项试验的4930例患者的个体数据,并补充了来自7项试验的另外1703例患者的已发表数据。主要结局指标是死亡率,缓解率和复发率为次要终点。

结果

综合所有试验来看,CCT组的缓解率显著高于MP组(60.0%对53.2%;P<0.00001,双侧)。没有证据表明CCT与MP在死亡率上存在差异,CCT组死亡率有1.5%的降低但无统计学意义(P=0.6,双侧)。试验之间存在设计异质性,但按CCT类型或CCT、美法仑或泼尼松的剂量强度进行亚组分析,未发现任何明显有益或明显有害的特定治疗形式。同样,对患者表现特征的分析也未发现CCT在死亡率影响方面与MP有显著差异的任何类别;特别是,没有证据表明高危患者从CCT中获益更多。

结论

本综述发现,CCT与MP在总体死亡率或任何亚组内均无差异。就生存而言,在这些试验中所测试的这些治疗选择大致相当。

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