Judith Trotman, Pier Luigi Zinzani, Yuqin Song, Richard Delarue, Pil Kim, Elena Ivanova, Rasika Korde, Jiří Mayer, Ana C De Oliveira, Sarit E Assouline, Christopher R Flowers, Gisoo Barnes
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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 <i>a</i> ≥ 5-point mean difference from baseline and between the ZO and O arms.</p><p><strong>Results: </strong>Patients were randomized to ZO (<i>n</i> = 145) or O (<i>n</i> = 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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>The ROSEWOOD trial is registered on ClinicalTrials.gov (BGB-3111-212; ClinicalTrials.gov identifier: NCT03332017).</p>","PeriodicalId":2,"journal":{"name":"ACS Applied Bio Materials","volume":null,"pages":null},"PeriodicalIF":4.6000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Patient-reported outcomes in patients with relapsed or refractory follicular lymphoma treated with zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy: results from the ROSEWOOD trial.\",\"authors\":\"Judith Trotman, Pier Luigi Zinzani, Yuqin Song, Richard Delarue, Pil Kim, Elena Ivanova, Rasika Korde, Jiří Mayer, Ana C De Oliveira, Sarit E Assouline, Christopher R Flowers, Gisoo Barnes\",\"doi\":\"10.1080/03007995.2024.2409837\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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).</p><p><strong>Methods: </strong>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 <i>a</i> ≥ 5-point mean difference from baseline and between the ZO and O arms.</p><p><strong>Results: </strong>Patients were randomized to ZO (<i>n</i> = 145) or O (<i>n</i> = 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. 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引用次数: 0
摘要
目的：我们报告了ROSEWOOD试验（NCT03332017）中测量健康相关生活质量（HRQoL）的患者报告结果（PROs），该试验证明扎鲁替尼加奥比妥珠单抗（ZO）与奥比妥珠单抗（O）相比，在重度预处理复发/难治性滤泡性淋巴瘤（R/R FL）患者中具有更优越的疗效和可控的安全性：在基线时使用欧洲癌症研究和治疗组织生活质量问卷-核心30（EORTC QLQ-C30）和EQ-5D-5L问卷评估PROs，随后每12周评估一次。对所有 QLQ-C30 领域和 EQ-5D-5L 视觉模拟量表 (VAS) 分数进行描述性分析。在关键的临床时间点（第 12 周和第 24 周），采用重复测量混合模型 (MMRM) 分析来评估关键的 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。有临床意义的变化是指与基线相比，ZO组和O组之间的平均差异≥5分：患者被随机分配到 ZO 组（145 人）或 O 组（72 人）。到第 48 周时，描述性分析结果显示，与 O 组相比，ZO 组患者的角色功能、疲劳和恶心/呕吐症状均有所改善。两组患者的疼痛症状均有所改善。EQ-5D-5L VAS评分显示，治疗组之间在第48周之前没有明显差异。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/生活质量有所改善，疲劳感也有所改善。第24周时，ZO治疗组的患者在角色功能、疼痛和疲劳方面有了有临床意义的改善：这些研究结果表明，在奥比妥珠单抗的基础上，扎鲁替尼对患者的 HRQoL 有临床意义。
Patient-reported outcomes in patients with relapsed or refractory follicular lymphoma treated with zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy: results from the ROSEWOOD trial.
Objective: 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).
Methods: 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 a ≥ 5-point mean difference from baseline and between the ZO and O arms.
Results: Patients were randomized to ZO (n = 145) or O (n = 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.
Conclusions: 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.
Trial registration: The ROSEWOOD trial is registered on ClinicalTrials.gov (BGB-3111-212; ClinicalTrials.gov identifier: NCT03332017).
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