Siegel David, Weisel Katja, Zahlten-Kumeli Anita, Medhekar Rohan, Ding Bifeng, Leleu Xavier
John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.
Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Leuk Lymphoma. 2021 Dec;62(12):3002-3010. doi: 10.1080/10428194.2021.1941927. Epub 2021 Jun 26.
CANDOR (NCT03158688) compared carfilzomib, dexamethasone, and daratumumab (KdD) to carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM). A secondary objective of CANDOR was to evaluate health-related quality of life (HRQoL) scores using the Global Health Status (GHS)/Quality of Life (QoL) domain of the EORTC QLQ-C30. Scores were compared between KdD and Kd using a restricted maximum likelihood-based mixed effects model for repeated measures. GHS/QoL completion rates were >81% for both arms. Higher GHS/QoL scores were observed with KdD versus Kd from Cycle 7-26. The overall least squares mean estimate (95% CI) of the difference between treatment arms was 0.06 (-2.39 to 2.50; = 0.96). In an exploratory analysis, 55.5% in the KdD arm and 43.0% in the Kd arm improved ≥10 points in GHS/QoL score from baseline. HRQoL was maintained with KdD, consistent with superior clinical benefit observed with KdD versus Kd in patients with RRMM.
CANDOR(NCT03158688)研究在复发/难治性多发性骨髓瘤(RRMM)患者中,比较了卡非佐米、地塞米松和达雷妥尤单抗(KdD)与卡非佐米和地塞米松(Kd)的疗效。CANDOR的一个次要目标是使用欧洲癌症研究与治疗组织QLQ-C30量表的全球健康状况(GHS)/生活质量(QoL)领域来评估健康相关生活质量(HRQoL)评分。使用基于受限最大似然法的重复测量混合效应模型比较KdD组和Kd组的评分。两组的GHS/QoL完成率均>81%。从第7周期至第26周期,KdD组的GHS/QoL评分高于Kd组。治疗组之间差异的总体最小二乘均值估计(95%CI)为0.06(-2.39至2.50;P = 0.96)。在一项探索性分析中,KdD组55.5%的患者和Kd组43.0%的患者GHS/QoL评分较基线提高了≥10分。KdD维持了HRQoL,这与RRMM患者中KdD相对于Kd观察到的卓越临床获益一致。