Daratumumab-lenalidomide-dexamethasone vs standard-of-care regimens: Efficacy in transplant-ineligible untreated myeloma.
Daratumumab-lenalidomide-dexamethasone vs standard-of-care regimens: Efficacy in transplant-ineligible untreated myeloma.
复制标题
DOI：
10.1002/ajh.25963
复制
发表时间：
2020-12
影响因子：
12.8
通讯作者：
Facon T
中科院分区：
文献类型：
--
作者：
Durie BGM;Kumar SK;Usmani SZ;Nonyane BAS;Ammann EM;Lam A;Kobos R;Maiese EM;Facon T
Daratumumab联合来那度胺-地塞米松(D-RD)最近获得FDA批准，用于治疗新诊断的多发性骨髓瘤(NDMM)的移植不合格患者。目前的Pegasus研究比较了MAIA试验中接受D-RD治疗的患者和来自Flatiron Health电子健康记录衍生身份数据库的接受普通标准护理方案治疗的患者的无进展存活率(PFS)，该数据库有美国主要在社区肿瘤学实践中接受治疗的患者的数据。来自两个数据源的个体水平的患者数据被用于进行锚定的间接治疗比较(ITC)，D-RD与波特佐米-来那度胺-地塞米松(VRD)和波特佐米-地塞米松(VD)进行锚定的间接治疗比较；来那度胺-地塞米松(RD)是ITC的共同锚。分别使用反映PFS在MAIA(D-RD与RD)和熨斗健康(VRD与RD；Vd与RD)之间的直接比较的危险比(HR)来制定D-RD与VRD和VD的ITC。在应用MAIA纳入/排除标准和倾向-分数加权后，熨斗健康患者在测量的基线特征上与MAIA试验人群相似。基于MAIA内的直接比较，与RD相比，D-RD治疗的进展或死亡风险显著降低(HR 0.54；95%CI 0.42，0.71)。根据ITCs，D-RD的进展或死亡风险显著低于VRD(HR 0.68；95%CI 0.48，0.98)和VD(HR 0.48；95%CI 0.33，0.69)。在缺乏比较D-RD与VRD或VD的面对面试验的情况下，目前的ITC可能有助于为不符合移植条件的NDMM患者提供治疗选择的信息。
Daratumumab in combination with lenalidomide‐dexamethasone (D‐Rd) recently received FDA approval for the treatment of transplant‐ineligible patients with newly diagnosed multiple myeloma (NDMM). The present PEGASUS study compared progression‐free survival (PFS) in patients treated with D‐Rd in the MAIA trial and patients treated with common standard‐of‐care regimens from the Flatiron Health electronic health record‐derived deidentified database, which has data from patients treated primarily at community‐based oncology practices in the United States. Individual‐level patient data from both data sources were used to perform an anchored indirect treatment comparison (ITC) of D‐Rd to bortezomib‐lenalidomide‐dexamethasone (VRd) and bortezomib‐dexamethasone (Vd); lenalidomide‐dexamethasone (Rd) was the common anchor for the ITC. Hazard ratios (HRs) reflecting direct comparisons of PFS within MAIA (D‐Rd vs Rd) and Flatiron Health (VRd vs Rd; Vd vs Rd) were used to make ITCs for D‐Rd vs VRd and Vd, respectively. After application of MAIA inclusion/exclusion criteria and propensity‐score weighting, the Flatiron Health patients resembled the MAIA trial population on measured baseline characteristics. Based on the direct comparison within MAIA, treatment with D‐Rd was associated with a significantly lower risk of progression or death compared to Rd (HR 0.54; 95% CI 0.42, 0.71). Based on the ITCs, D‐Rd was associated with a significantly lower risk of progression or death compared to VRd (HR 0.68; 95% CI 0.48, 0.98) and Vd (HR 0.48; 95% CI 0.33, 0.69). In the absence of head‐to‐head trials comparing D‐Rd to VRd or Vd, the present ITC may help inform treatment selection in transplant‐ineligible patients with NDMM.
登录
查看更多内容
DOI：
10.1161/circoutcomes.113.000359
发表时间：
2013-09-01
期刊：
Circulation. Cardiovascular quality and outcomes
影响因子：
--
作者：
Brookhart MA;Wyss R;Layton JB;Stürmer T
通讯作者：
Stürmer T
影响因子：
12.8
作者：
Durie, Brian G. M.;Hoering, Antje;Barlogie, Bart
通讯作者：
Barlogie, Bart
影响因子：
11.4
作者：
Durie, B. G. M.;Harousseau, J-L;Rajkumar, S. V.
通讯作者：
Rajkumar, S. V.
影响因子：
4.5
作者：
Signorovitch, James E.;Sikirica, Vanja;Wu, Eric Q.
通讯作者：
Wu, Eric Q.
影响因子：
10.1
作者：
Blommestein, Hedwig M.;van Beurden-Tan, Chrissy H. Y.;Zweegman, Sonja
通讯作者：
Zweegman, Sonja