Santa Casa Medical School, São Paulo, Brazil.
Ankara University, Ankara, Turkey.
Br J Haematol. 2021 May;193(3):561-569. doi: 10.1111/bjh.17321. Epub 2021 Feb 8.
In the phase III CASTOR trial, daratumumab, bortezomib and dexamethasone (D-Vd) significantly extended progression-free survival compared with bortezomib and dexamethasone (Vd) alone in patients with relapsed/refractory multiple myeloma (RRMM). Here, we present patient-reported outcomes (PROs) from the CASTOR trial. PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) and the EuroQol 5-dimensional descriptive system questionnaire. Treatment effects through Cycle 8 were measured by a repeated measures mixed-effects model. After Cycle 8, PROs were only collected for patients in the D-Vd group who continued on daratumumab monotherapy. Compliance rates for PRO assessments were high and similar between treatment groups. Mean changes from baseline were generally similar between treatment groups for EORTC QLQ-C30 global health status (GHS), functioning and symptoms, and did not exceed 10 points for either treatment group. Subgroup analyses were consistent with the results observed in the overall population. There was no change in patients' health-related quality of life for the first eight cycles of therapy; thereafter, patients treated with daratumumab over the long-term reported improvements in GHS and pain. These results complement the significant clinical benefits observed with D-Vd in patients with RRMM and support its use in this patient population.
在 III 期 CASTOR 试验中,与硼替佐米和地塞米松(Vd)单药治疗相比,达雷妥尤单抗、硼替佐米和地塞米松(D-Vd)显著延长了复发/难治性多发性骨髓瘤(RRMM)患者的无进展生存期。在此,我们报告了 CASTOR 试验的患者报告结局(PRO)。使用欧洲癌症研究与治疗组织生活质量问卷核心 30 项(EORTC QLQ-C30)和欧洲五维健康量表问卷评估 PRO。通过重复测量混合效应模型测量第 8 周期的治疗效果。第 8 周期后,仅对继续接受达雷妥尤单抗单药治疗的 D-Vd 组患者收集 PRO。PRO 评估的依从率高,且两组之间相似。对于 EORTC QLQ-C30 全球健康状况(GHS)、功能和症状,治疗组之间的平均变化通常相似,且两种治疗均未超过 10 分。亚组分析与总体人群观察到的结果一致。在治疗的前 8 个周期,患者的健康相关生活质量没有变化;此后,长期接受达雷妥尤单抗治疗的患者报告 GHS 和疼痛有所改善。这些结果补充了 D-Vd 在 RRMM 患者中观察到的显著临床获益,并支持在该患者人群中使用。