Belch A, Shelley W, Bergsagel D, Wilson K, Klimo P, White D, Willan A
University of Alberta, Edmonton, Canada.
Br J Cancer. 1988 Jan;57(1):94-9. doi: 10.1038/bjc.1988.17.
In order to assess the role of maintenance melphalan and prednisone (MP) in responding multiple myeloma patients, 185 eligible patients who responded to initial MP with stabilization for at least 4 months were randomized to either stop treatment and resume therapy at relapse or to continue MP until relapse. Time to first relapse was significantly shorter in the no maintenance group (P = 0.0011), however 57% of the no maintenance patients had a second response when MP was restarted and others had minor improvement. The time to final progression on MP, which reflects the duration of disease control by MP, was therefore longer for the no maintenance group (median = 39 months) compared to the maintenance group (median = 31 months) although the observed difference was not statistically significant (P = 0.086). Median survival from start of MP in the maintenance group (46 months) was also not significantly different than the no maintenance group (51 months) (P = 0.587). Multifactor analysis of the randomized patients demonstrated shorter total remission duration and shorter survival in patients who had an initially rapid response to therapy or a lesser reduction in serum M-protein concentration.
为了评估美法仑和泼尼松（MP）维持治疗在多发性骨髓瘤缓解患者中的作用，185例对初始MP治疗有反应且病情稳定至少4个月的合格患者被随机分为两组，一组在复发时停止治疗并重新开始治疗，另一组继续MP治疗直至复发。无维持治疗组的首次复发时间显著缩短（P = 0.0011），然而，57%的无维持治疗患者在重新开始MP治疗时有第二次缓解，其他患者有轻微改善。无维持治疗组MP治疗至最终进展的时间（反映MP控制疾病的持续时间）为39个月，比维持治疗组（中位数 = 31个月）长，尽管观察到的差异无统计学意义（P = 0.086）。维持治疗组从开始MP治疗起的中位生存期为46个月，与无维持治疗组（51个月）相比也无显著差异（P = 0.587）。对随机分组患者的多因素分析表明，初始治疗反应迅速或血清M蛋白浓度降低较少的患者，其总缓解期较短，生存期也较短。
