Zherebtsova V A, Vorobyev V I, Gemdzhian E G, Ulyanova M A, Chernikov M V, Ivanova V L, Vinogradova O Y, Ptushkin V V
Botkin City Clinical Hospital.
National Research Center for Hematology.
Ter Arkh. 2021 Jul 23;93(7):785-792. doi: 10.26442/00403660.2021.07.200956.
Carfilzomib, lenalidomide, and dexamethasone (KRd) have been approved for the treatment of relapsed and refractory multiple myeloma (RRMM) based on ASPIRE clinical trial.
Analysis of efficacy and safety of KRd in routine clinical practice.
The prospective analysis included patients with MM who received at least one line of previous therapy. The inclusion criteria were relapse/progression; refractoriness; lack of very good partial response (VGPR) and more after the first line of therapy. Since February 2016, we used KRd like in ASPIRE trial, since October 2019, carfilzomib has been used at a dose of 56 mg/m2 on days 1, 8 and 15. Autologous hematopoietic stem cell transplantation (autoHSCT), consolidation (KRd) and maintenance therapy (Rd) were regarded as one line of therapy.
We evaluated 77 patients with median age at the time of diagnosis is 55 (3072) years. For 56% (n=43) of patients KRd was applied as the second line (group 1), for 44% (n=34) as the third and more (group 2). In 23/43 patients from group 1, an early change in therapy was made due to insufficient effectiveness (after 24 courses of VCD or PAD). KRd served as a "bridge" to autoHSCT in 25 (32%) patients (21 of 25 in group 1). Another 7 patients underwent collection of autoHSC (all from group 1). The overall response rate (ORR) was 80.5%, with 33.8% complete response (CR) and 26% VGPR. ORR in group 1 was 98% versus 65.6% in group 2; 24-month overall survival (OS) was 70%, progression free survival (PFS) 49.8%. In group 1, 24-month OS was 85.6% versus 50.0% in group 2, 24-month PFS was 67.8% versus 25.5% (p=0.01).
Our analysis confirmed the high efficiency of KRd in the treatment of RRMM in real-life practice. Early correction of therapy with insufficient effectiveness of the first line made it possible to implement the strategy of high-dose consolidation and autoHSCT in a larger percentage of patients with MM.
基于ASPIRE临床试验，卡非佐米、来那度胺和地塞米松（KRd）已被批准用于治疗复发难治性多发性骨髓瘤（RRMM）。
分析KRd在常规临床实践中的疗效和安全性。
前瞻性分析纳入了接受过至少一线既往治疗的MM患者。纳入标准为复发/进展；难治性；一线治疗后缺乏非常好的部分缓解（VGPR）及以上疗效。自2016年2月起，我们按照ASPIRE试验使用KRd，自2019年10月起，卡非佐米在第1、8和15天的剂量为56mg/m²。自体造血干细胞移植（autoHSCT）、巩固治疗（KRd）和维持治疗（Rd）被视为一线治疗。
我们评估了77例患者，诊断时的中位年龄为55（30 - 72）岁。56%（n = 43）的患者将KRd作为二线治疗应用（第1组），44%（n = 34）作为三线及以上治疗应用（第2组）。在第1组的23/43例患者中，由于疗效不佳（在24个疗程的VCD或PAD治疗后）而进行了早期治疗调整。KRd在25例（32%）患者中作为autoHSCT的“桥梁”（第1组的25例中有21例）。另外7例患者进行了自体造血干细胞采集（均来自第1组）。总缓解率（ORR）为80.5%，完全缓解（CR）率为33.8%，VGPR率为26%。第1组的ORR为98%，而第2组为65.6%；24个月总生存率（OS）为70%，无进展生存期（PFS）为49.8%。在第1组中，24个月OS为85.6%，而第2组为50.0%，24个月PFS为67.8%，而第2组为25.5%（p = 0.01）。
我们的分析证实了KRd在现实生活实践中治疗RRMM的高效性。对一线治疗疗效不佳进行早期治疗调整，使得更大比例的MM患者能够实施大剂量巩固和autoHSCT策略。
