Concord Repatriation General Hospital, University of Sydney, Concord, NSW, Australia.
IRCCS Azienda Ospedaliero-Universitaria di Bologna Istituto di Ematologia "Seràgnoli" and Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.
Curr Med Res Opin. 2024 Nov;40(11):1863-1871. doi: 10.1080/03007995.2024.2409837. Epub 2024 Oct 14.
We report patient-reported outcomes (PROs) measuring health-related quality of life (HRQoL) from the ROSEWOOD trial (NCT03332017), which demonstrated superior efficacy and a manageable safety profile with zanubrutinib plus obinutuzumab (ZO) versus obinutuzumab (O) in patients with heavily pretreated relapsed/refractory follicular lymphoma (R/R FL).
PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) and EQ-5D-5L questionnaires at baseline and subsequently every 12 weeks. All QLQ-C30 domains and EQ-5D-5L visual analog scale (VAS) scores were analyzed descriptively. At the key clinical timepoints (weeks 12 and 24), a mixed model for repeated measures (MMRM) analysis was used to evaluate the key PRO endpoints, including global health status, physical and role functioning, and symptoms of fatigue, pain, diarrhea, and nausea/vomiting. Clinically meaningful change was defined as ≥ 5-point mean difference from baseline and between the ZO and O arms.
Patients were randomized to ZO ( = 145) or O ( = 72). By week 48, descriptive analysis results indicated that patients in the ZO arm demonstrated improved outcomes in role functioning and fatigue and nausea/vomiting symptoms, compared with those in the O arm. Both groups experienced improvements in pain symptoms. EQ-5D-5L VAS scores showed no observable differences between treatment arms through week 48. MMRM analysis revealed that the global health status/quality of life of patients treated with ZO improved, as did fatigue, at week 12. At week 24, patients in the ZO arm experienced a clinically meaningful improvement in role functioning, pain, and fatigue.
In patients with R/R FL, ZO was associated with improved PROs compared with O. These findings suggest that zanubrutinib contributed clinically meaningful benefits to patient HRQoL when added to obinutuzumab.
The ROSEWOOD trial is registered on ClinicalTrials.gov (BGB-3111-212; ClinicalTrials.gov identifier: NCT03332017).
我们报告了 ROSEWOOD 试验（NCT03332017）中的患者报告结局（PROs），这些结局衡量了与健康相关的生活质量（HRQoL），结果显示，与奥滨尤妥珠单抗（O）相比，zanubrutinib 联合奥滨尤妥珠单抗（ZO）在既往大量治疗复发/难治滤泡性淋巴瘤（R/R FL）患者中具有更优的疗效和更可控的安全性。
使用欧洲癌症研究与治疗组织生存质量问卷核心 30 项（EORTC QLQ-C30）和 EQ-5D-5L 问卷在基线时和随后每 12 周评估 PROs。所有 EORTC QLQ-C30 领域和 EQ-5D-5L 视觉模拟量表（VAS）评分均进行描述性分析。在关键临床时间点（第 12 周和第 24 周），采用重复测量混合模型（MMRM）分析评估关键 PRO 终点，包括总体健康状况、身体和角色功能以及疲劳、疼痛、腹泻和恶心/呕吐症状。定义有临床意义的改善为与基线相比以及 ZO 和 O 臂之间的平均差异 ≥ 5 分。
患者被随机分配至 ZO（ = 145）或 O（ = 72）组。到第 48 周时，描述性分析结果表明，与 O 组相比，ZO 组患者的角色功能和疲劳以及恶心/呕吐症状得到改善。两组患者的疼痛症状均有所改善。在第 48 周时，EQ-5D-5L VAS 评分在治疗臂之间未观察到差异。MMRM 分析显示，在第 12 周时，接受 ZO 治疗的患者的总体健康状况/生活质量以及疲劳得到改善。在第 24 周时，ZO 组患者的角色功能、疼痛和疲劳均有临床意义的改善。
在 R/R FL 患者中，与 O 相比，ZO 与改善的 PROs 相关。这些发现表明，当 zanubrutinib 与奥滨尤妥珠单抗联合使用时，对患者的 HRQoL 有临床意义的获益。
ROSEWOOD 试验在 ClinicalTrials.gov 上注册（BGB-3111-212；ClinicalTrials.gov 标识符：NCT03332017）。
