Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study.
Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study.
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DOI：
10.1186/s13045-018-0583-7
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发表时间：
2018-04-04
影响因子：
28.5
通讯作者：
Moreau P
中科院分区：
文献类型：
--
作者：
Dimopoulos M;Wang M;Maisnar V;Minarik J;Bensinger W;Mateos MV;Obreja M;Blaedel J;Moreau P
在ASPIRE中，与来那度胺和地塞米松(RD)相比，卡非佐米、来那度胺和地塞米松(KRD)显著改善了复发性多发性骨髓瘤患者的无进展生存期(PFS)和应答率。根据方案，患者接受最多18个周期的KRD，然后是RD到进展，因此KRD到进展的益处/风险概况尚未建立。这项随机后分析在18个月后评估了KRD与RD的疗效和安全性。评估KRD与RD随时间的累积完全缓解率(CR)或更好的缓解率以及18个月时的PFS危险比(HR)。根据细胞遗传学风险、既往的治疗路线和既往的Bortezomib治疗，也评估了PFS的HRs。用COX回归分析评价PFS的HRs。18个月时PFS的风险比(HR)为0.58，而整个ASPIRE研究的风险比(HR)为0.69。与RD相比，具有高风险细胞遗传学、≥ 1既往治疗路线和既往接触Bortezomib的患者从KRD中受益长达18个月。在预定义的亚组中，18个月时PFS的HRs低于整个研究中的HR值。在前18个月中，KRD和RD患者至少达到完全缓解(CR)的比例差异急剧增加，然后保持相对稳定。18个月的安全性与之前的研究结果一致。18个月时PFS HR的改善以及KRD在18个月周期中CR率的持续增加表明，继续接受卡菲佐米治疗可能是有好处的。临床试验.gov NCT01080391。注册日期为2010年3月2日。
In ASPIRE, carfilzomib, lenalidomide, and dexamethasone (KRd) significantly improved progression-free survival (PFS) and response rates versus lenalidomide and dexamethasone (Rd) in patients with relapsed multiple myeloma. Per protocol, patients received KRd for a maximum of 18 cycles followed by Rd to progression, so the benefit/risk profile of KRd to progression was not established. This post hoc analysis evaluated the efficacy and safety of KRd versus Rd at 18 months from randomization. Cumulative rates of complete response (CR) or better over time and PFS hazard ratio (HR) at 18 months were evaluated for KRd versus Rd. PFS HRs were also assessed according to cytogenetic risk, prior lines of therapy, and prior bortezomib treatment. Cox regression analysis was used to evaluate PFS HRs. The hazard ratio (HR) for PFS at 18 months was 0.58 versus 0.69 for the overall ASPIRE study. Patients with high-risk cytogenetics, ≥ 1 prior lines of therapy, and prior bortezomib exposure benefited from KRd up to 18 months versus Rd. The HRs for PFS at 18 months in the pre-defined subgroups were lower than those in the overall study. The difference in the proportion of KRd and Rd patients achieving at least a complete response (CR) increased dramatically over the first 18 months and then remained relatively constant. The safety profile at 18 months was consistent with previous findings. The improved PFS HR at 18 months and the continued increase in CR rates for KRd through 18 cycles suggest that there may be a benefit of continued carfilzomib treatment. Clinical trials.gov NCT01080391. Registered 2 March 2010.
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影响因子：
158.5
作者：
Lonial, Sagar;Dimopoulos, Meletios;Richardson, Paul
通讯作者：
Richardson, Paul
DOI：
10.1111/j.1365-2710.2009.01153.x
发表时间：
2011-02-01
影响因子：
2
作者：
Armoiry, X.;Fagnani, F.;Aulagner, G.
通讯作者：
Aulagner, G.
影响因子：
11.4
作者：
通讯作者：
--
影响因子：
20.3
作者：
Avet-Loiseau, Herve;Attal, Michel;Mathiot, Claire
通讯作者：
Mathiot, Claire
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.