Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone.
Effects of lenalidomide and dexamethasone treatment duration on survival in patients with relapsed or refractory multiple myeloma treated with lenalidomide and dexamethasone.
复制标题
来那度胺和地塞米松治疗持续时间对接受来那度胺和地塞米松治疗的复发性或难治性多发性骨髓瘤患者生存的影响。
DOI：
10.3816/clml.2010.n.120
复制
发表时间：
2011
期刊：
影响因子：
--
通讯作者：
D. Weber
中科院分区：
文献类型：
--
作者：
J. San;M. Dimopoulos;E. Stadtmauer;S. Rajkumar;D. Siegel;M. Bravo;Marta Olesnyckyj;R. Knight;J. Zeldis;J. Harousseau;D. Weber
背景
在两项随机III期试验（MM-009和MM-010）中，与地塞米松单药治疗相比，来那度胺联合地塞米松治疗复发性/难治性多发性骨髓瘤患者的至疾病进展时间和总生存期（OS）显著延长。在这两项试验中，治疗均持续至疾病进展或出现不可接受的毒性。我们进行了亚组分析，以确定在达到≥部分缓解（PR）后继续治疗是否能改善生存率。
患者和方法
收集了212例接受来那度胺联合地塞米松治疗并达到≥PR的患者的数据。Kaplan-Meier生存估计值在继续治疗的患者与因不良事件、撤回同意或其他原因而停止治疗的患者之间进行比较。时间依赖性多变量回归分析用于确定继续来那度胺治疗的获益。
结果
共有174名患者接受持续治疗直至疾病进展或死亡，38名患者在没有进展的情况下停止治疗。继续治疗的患者中位OS有延长的趋势（50.9个月vs. 35.0个月; P= 0.0594）。当控制既往抗骨髓瘤治疗次数、β2-微球蛋白水平和Durie-Salmon分期时，（这对这些患者的生存率产生了不利影响），继续来那度胺治疗（HR，0.137; 95% CI，0.045-0.417; P=.0005）或每增加一个周期的来那度胺（HR，0.921; 95% CI，0.886-0.957; P<.0001）都与更长的生存期相关。
结论
当控制患者特征时，在达到≥PR后继续来那度胺治疗直至疾病进展与显著的生存优势相关。这些发现应在前瞻性设计的试验中得到证实。
BACKGROUND
In two randomized phase III trials (MM-009 and MM-010), lenalidomide plus dexamethasone significantly prolonged time to progression and overall survival (OS) in patients with relapsed/refractory multiple myeloma compared with dexamethasone alone. In both trials the treatment was continued until disease progression or unacceptable toxicity. We conducted a subanalysis to determine if continuing therapy after achieving≥partial response (PR) improved survival.
PATIENTS AND METHODS
Data were collected on 212 patients who were treated with lenalidomide plus dexamethasone and achieved≥PR. Kaplan-Meier survival estimates were compared between patients on continued treatment versus patients discontinuing therapy because of adverse events, withdrawal of consent, or other reasons. Time-dependent multivariate regression analyses were used to determine the benefit of continuing treatment with lenalidomide.
RESULTS
A total of 174 patients received continued treatment until disease progression or death, and 38 patients discontinued therapy without progression. There was a trend toward longer median OS in patients who continued therapy (50.9 months vs. 35.0 months; P=.0594). When controlling for the number of previous antimyeloma therapies, β2-microglobulin levels, and Durie-Salmon stage (which adversely affected survival in these patients), continued lenalidomide treatment (HR, 0.137; 95% CI, 0.045-0.417; P=.0005) or each additional cycle of lenalidomide (HR, 0.921; 95% CI, 0.886-0.957; P<.0001) were both associated with longer survival.
CONCLUSION
Continued lenalidomide treatment until disease progression after achievement of ≥PR is associated with a significant survival advantage when controlling for patient characteristics. These findings should be confirmed in a prospectively designed trial.