Katja Weisel, Maria-Victoria Mateos, Ola Landgren, Xavier Leleu, Hang Quach, Lee Bennett, Mihaela Talpes, Istvan Majer, Sachin Patel, Saad Z Usmani
{"title":"卡非佐米、地塞米松和达拉单抗与卡非佐米和地塞米松治疗复发性/难治性多发性骨髓瘤患者的健康相关生活质量：CANDOR 3 期试验的患者报告结果分析。","authors":"Katja Weisel, Maria-Victoria Mateos, Ola Landgren, Xavier Leleu, Hang Quach, Lee Bennett, Mihaela Talpes, Istvan Majer, Sachin Patel, Saad Z Usmani","doi":"10.1016/j.clml.2025.02.005","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>In the phase 3 CANDOR trial (NCT03158688), daratumumab added to carfilzomib and dexamethasone (KdD) significantly prolonged progression-free survival relative to carfilzomib and dexamethasone (Kd) alone in previously treated patients with relapsed/refractory multiple myeloma (RRMM).</p><p><strong>Materials and methods: </strong>We present a post hoc analysis of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30-item module (EORTC QLQ-C30) and EORTC QLQ Myeloma 20-item module (EORTC QLQ-MY20) patient-reported outcome (PRO) measures from the CANDOR trial.</p><p><strong>Results: </strong>Median (range) duration of observation for PROs was 18.4 (0.9-50.0) months (KdD) and 10.3 (0.9-48.4) months (Kd). PRO compliance rates were high and similar between arms. Mean scores on the EORTC QLQ-C30 global health status (GHS)/quality-of-life (QOL) scale were numerically higher in the KdD than in the Kd arm and were generally sustained or trended toward improvement from baseline. Other EORTC QLQ-C30, EORTC QLQ-MY20, and EQ-5D visual analog scale (VAS) scores were generally similar between treatment arms and were stable over time, with some numerical trends favoring KdD. Risks of deterioration were similar for most scales; hazard ratios suggested improvement for KdD for EORTC QLQ-C30 social functioning, EORTC QLQ-MY20 disease symptoms, and EQ-5D VAS. Results were consistent for lenalidomide-exposed and lenalidomide-refractory subgroups. EORTC QLQ-C30 GHS/QOL scores trended toward improvement at some time points, and other scores remained generally stable when daratumumab was added to carfilzomib and dexamethasone.</p><p><strong>Conclusion: </strong>These results support the benefits of KdD for the RRMM population, including lenalidomide-exposed and lenalidomide-refractory patients.</p><p><strong>Clinical trial registration: </strong>NCT03158688.</p>","PeriodicalId":10348,"journal":{"name":"Clinical Lymphoma, Myeloma & Leukemia","volume":" ","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Health-Related Quality of Life in Patients With Relapsed/Refractory Multiple Myeloma Treated With Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone: An Analysis of Patient-Reported Outcomes From the Phase 3 CANDOR Trial.\",\"authors\":\"Katja Weisel, Maria-Victoria Mateos, Ola Landgren, Xavier Leleu, Hang Quach, Lee Bennett, Mihaela Talpes, Istvan Majer, Sachin Patel, Saad Z Usmani\",\"doi\":\"10.1016/j.clml.2025.02.005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>In the phase 3 CANDOR trial (NCT03158688), daratumumab added to carfilzomib and dexamethasone (KdD) significantly prolonged progression-free survival relative to carfilzomib and dexamethasone (Kd) alone in previously treated patients with relapsed/refractory multiple myeloma (RRMM).</p><p><strong>Materials and methods: </strong>We present a post hoc analysis of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30-item module (EORTC QLQ-C30) and EORTC QLQ Myeloma 20-item module (EORTC QLQ-MY20) patient-reported outcome (PRO) measures from the CANDOR trial.</p><p><strong>Results: </strong>Median (range) duration of observation for PROs was 18.4 (0.9-50.0) months (KdD) and 10.3 (0.9-48.4) months (Kd). PRO compliance rates were high and similar between arms. Mean scores on the EORTC QLQ-C30 global health status (GHS)/quality-of-life (QOL) scale were numerically higher in the KdD than in the Kd arm and were generally sustained or trended toward improvement from baseline. Other EORTC QLQ-C30, EORTC QLQ-MY20, and EQ-5D visual analog scale (VAS) scores were generally similar between treatment arms and were stable over time, with some numerical trends favoring KdD. Risks of deterioration were similar for most scales; hazard ratios suggested improvement for KdD for EORTC QLQ-C30 social functioning, EORTC QLQ-MY20 disease symptoms, and EQ-5D VAS. Results were consistent for lenalidomide-exposed and lenalidomide-refractory subgroups. 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Health-Related Quality of Life in Patients With Relapsed/Refractory Multiple Myeloma Treated With Carfilzomib, Dexamethasone, and Daratumumab Versus Carfilzomib and Dexamethasone: An Analysis of Patient-Reported Outcomes From the Phase 3 CANDOR Trial.
Background: In the phase 3 CANDOR trial (NCT03158688), daratumumab added to carfilzomib and dexamethasone (KdD) significantly prolonged progression-free survival relative to carfilzomib and dexamethasone (Kd) alone in previously treated patients with relapsed/refractory multiple myeloma (RRMM).
Materials and methods: We present a post hoc analysis of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30-item module (EORTC QLQ-C30) and EORTC QLQ Myeloma 20-item module (EORTC QLQ-MY20) patient-reported outcome (PRO) measures from the CANDOR trial.
Results: Median (range) duration of observation for PROs was 18.4 (0.9-50.0) months (KdD) and 10.3 (0.9-48.4) months (Kd). PRO compliance rates were high and similar between arms. Mean scores on the EORTC QLQ-C30 global health status (GHS)/quality-of-life (QOL) scale were numerically higher in the KdD than in the Kd arm and were generally sustained or trended toward improvement from baseline. Other EORTC QLQ-C30, EORTC QLQ-MY20, and EQ-5D visual analog scale (VAS) scores were generally similar between treatment arms and were stable over time, with some numerical trends favoring KdD. Risks of deterioration were similar for most scales; hazard ratios suggested improvement for KdD for EORTC QLQ-C30 social functioning, EORTC QLQ-MY20 disease symptoms, and EQ-5D VAS. Results were consistent for lenalidomide-exposed and lenalidomide-refractory subgroups. EORTC QLQ-C30 GHS/QOL scores trended toward improvement at some time points, and other scores remained generally stable when daratumumab was added to carfilzomib and dexamethasone.
Conclusion: These results support the benefits of KdD for the RRMM population, including lenalidomide-exposed and lenalidomide-refractory patients.
期刊介绍：
Clinical Lymphoma, Myeloma & Leukemia is a peer-reviewed monthly journal that publishes original articles describing various aspects of clinical and translational research of lymphoma, myeloma and leukemia. Clinical Lymphoma, Myeloma & Leukemia is devoted to articles on detection, diagnosis, prevention, and treatment of lymphoma, myeloma, leukemia and related disorders including macroglobulinemia, amyloidosis, and plasma-cell dyscrasias. The main emphasis is on recent scientific developments in all areas related to lymphoma, myeloma and leukemia. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.
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