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达雷妥尤单抗、来那度胺、硼替佐米及地塞米松联合治疗新诊断的适合移植的多发性骨髓瘤患者的健康相关生活质量:GRIFFIN研究的患者报告结局

Health-related quality of life in transplant-eligible patients with newly diagnosed multiple myeloma treated with daratumumab, lenalidomide, bortezomib, and dexamethasone: Patient-reported outcomes from GRIFFIN.

作者信息

Silbermann Rebecca, Laubach Jacob, Kaufman Jonathan L, Sborov Douglas W, Reeves Brandi, Rodriguez Cesar, Chari Ajai, Costa Luciano J, Anderson Larry D, Nathwani Nitya, Shah Nina, Bumma Naresh, Holstein Sarah A, Costello Caitlin, Jakubowiak Andrzej, Orlowski Robert Z, Shain Kenneth H, Cowan Andrew J, Gries Katharine S, Pei Huiling, Cortoos Annelore, Patel Sharmila, Lin Thomas S, Voorhees Peter M, Usmani Saad Z, Richardson Paul G

机构信息

Division of Hematology/Medical Oncology, Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.

Department of Medical Oncology, Dana-Farber/Partners Cancer Care, Boston, Massachusetts, USA.

出版信息

Am J Hematol. 2024 Jul;99(7):1257-1268. doi: 10.1002/ajh.27326. Epub 2024 Apr 15.

Abstract

In the phase 2 GRIFFIN trial (ClinicalTrials.gov identifier: NCT02874742), daratumumab added to lenalidomide, bortezomib, and dexamethasone (D-RVd) improved depth of response and progression-free survival (PFS) versus lenalidomide, bortezomib, and dexamethasone (RVd) alone in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM). Here, we present patient-reported outcomes (PROs) collected using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30-item (QLQ-C30), EORTC Quality of Life Questionnaire Multiple Myeloma Module 20-item (QLQ-MY20), and EuroQol 5-Dimension 5-Level (EQ-5D-5L) tools on day 1 of cycles 1, 2, and 3; on day 21 of cycle 4 (end of induction therapy); on day 1 of cycle 5; on day 21 of cycle 6 (end of posttransplant consolidation therapy); and at months 6, 12, 18, and 24 of maintenance therapy. Meaningful improvements from baseline were seen in most of the PRO scales with both treatments after consolidation and were sustained for at least 2 years of maintenance treatment. Large reductions from baseline (~20 points) were especially observed in pain symptoms for both treatment groups, although these were numerically higher for patients receiving D-RVd during the majority of the time points. In addition, improvements in key scales, such as global health status, fatigue symptoms, and physical functioning, were also seen with both D-RVd and RVd. These improvements in health-related quality of life contribute to the totality of evidence supporting the improvement in clinical outcomes such as response rates and PFS with D-RVd in induction, consolidation, and maintenance therapy in TE patients with NDMM.

摘要

在2期GRIFFIN试验(ClinicalTrials.gov标识符:NCT02874742)中,对于新诊断的多发性骨髓瘤(NDMM)且适合移植(TE)的患者,与单独使用来那度胺、硼替佐米和地塞米松(RVd)相比,在来那度胺、硼替佐米和地塞米松(RVd)基础上加用达雷妥尤单抗(D-RVd)可改善缓解深度和无进展生存期(PFS)。在此,我们展示了使用欧洲癌症研究与治疗组织(EORTC)生活质量问卷核心30项(QLQ-C30)、EORTC生活质量问卷多发性骨髓瘤模块20项(QLQ-MY20)以及欧洲五维健康量表(EQ-5D-5L)工具,在第1、2和3周期的第1天;第4周期的第21天(诱导治疗结束时);第5周期的第1天;第6周期的第21天(移植后巩固治疗结束时);以及维持治疗的第6、12、18和24个月收集的患者报告结局(PRO)。巩固治疗后,两种治疗方法在大多数PRO量表上均出现了有意义的自基线改善,且在至少2年的维持治疗中得以维持。两个治疗组的疼痛症状均出现了自基线的大幅降低(约20分),尽管在大多数时间点接受D-RVd治疗的患者在数值上更高。此外,D-RVd和RVd在关键量表上也有改善,如总体健康状况、疲劳症状和身体功能。这些健康相关生活质量的改善有助于全面证明支持在TE-NDMM患者的诱导、巩固和维持治疗中使用D-RVd可改善缓解率和PFS等临床结局。

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