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第三届医学研究委员会骨髓瘤病试验中的治疗对比。医学研究委员会成人白血病工作组。

Treatment comparisons in the third MRC myelomatosis trial. Medical Research Council's Working Party on Leukaemia in Adults.

出版信息

Br J Cancer. 1980 Dec;42(6):823-30. doi: 10.1038/bjc.1980.329.

Abstract

Results after an average follow-up of 3 years are presented on 485 patients in the 3rd MRC therapeutic trial in myelomatosis. The 353 non-azotaemic patients (199 now dead) were randomized between i.v. cyclophosphamide (CY) and oral melphalan with prednisone (M & P). THose treated with M & P fared slightly, but non-significantly, better. The 132 azotaemic patients (111 now dead) were randomized between i.v. CY and a 4-drug regimen, and both groups fared equally badly. Finally, after one year of the allocated treatment, 297 survivors (126 now dead) were randomized either to stop all treatment until evidence of relapse was obtained, or to continue treatment with azathioprine and vincristine, interrupted every 3 months for a course of the first-allocated treatment. The overall results suggested that maintenance therapy was beneficial, though the results were not statistically significant. Most of the difference was found among the few patients with unfavourable prognostic features who survived one year and were eligible for this randomization. In this, as in the two previous MRC trials, no striking differences have emerged between the therapeutic effects of different schedules of melphalan and/or CY. Consequently, a regimen of intermittent oral melphalan (with or without prednisone) seems satisfactory, because it is among the least toxic and most convenient. The 4th myeloma trial, now beginning, seeks to discover whether the addition of vincristine to the regimen can improve these results.

摘要

在骨髓瘤的第三次医学研究委员会(MRC)治疗试验中,对485例患者进行了平均3年的随访,并给出了结果。353例非氮血症患者(目前199例死亡)被随机分为静脉注射环磷酰胺(CY)组和口服美法仑加泼尼松(M&P)组。接受M&P治疗的患者情况稍好,但无显著差异。132例氮血症患者(目前111例死亡)被随机分为静脉注射CY组和四联疗法组,两组情况同样糟糕。最后,在分配治疗一年后,297例幸存者(目前126例死亡)被随机分为两组,一组在获得复发证据之前停止所有治疗,另一组继续用硫唑嘌呤和长春新碱治疗,每3个月中断一次,进行一个疗程的首次分配治疗。总体结果表明维持治疗有益,尽管结果无统计学意义。大多数差异存在于少数具有不良预后特征、存活一年且符合随机分组条件的患者中。与前两次MRC试验一样,美法仑和/或CY的不同给药方案的治疗效果之间没有显著差异。因此,间歇性口服美法仑(加或不加泼尼松)方案似乎令人满意,因为它毒性最小且最方便。正在进行的第四次骨髓瘤试验旨在探究在该方案中加入长春新碱是否能改善这些结果。

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