Patient-reported outcomes in patients with relapsed or refractory follicular lymphoma treated with zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy: results from the ROSEWOOD trial
Creators: name: Trotman, Judith
name: Zinzani, Pier Luigi
name: Song, Yuqin
name: Delarue, Richard
name: Kim, Pil
name: Ivanova, Elena
name: Korde, Rasika
name: Mayer, Jiří
name: De Oliveira, Ana C.
name: Assouline, Sarit E.
name: Flowers, Christopher R.
name: Barnes, Gisoo
Publisher: name: Taylor & Francis
Year: 2024
Subjects: subject: Space Science
subject: Medicine
subject: Cell Biology
subject: Pharmacology
subject: Immunology
subject: FOS: Clinical medicine
subject: Cancer
subject: Science Policy
subject: Mental Health
subject: Infectious Diseases
subject: FOS: Health sciences

description: 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 <i>a</i> ≥ 5-point mean difference from baseline and between the ZO and O arms. 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. 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). Follicular lymphoma (or FL) is a common blood cancer where abnormal white blood cells form lumps in organs and glands in the body that normally help fight infection (lymph nodes). Zanubrutinib selectively blocks Bruton tyrosine kinase, which can prevent cancer cells growing and lead to their death. Obinutuzumab binds to a protein called CD20 on cancer cells, facilitating their removal using the body’s natural defense system. Previous results from the ROSEWOOD trial showed that zanubrutinib plus obinutuzumab had improved cancer-fighting effects versus obinutuzumab alone, with manageable side effects in patients whose cancer returned after treatment or when treatment had failed. This study examined how these two cancer treatments impacted the patients’ wellbeing and day-to-day functioning as reported directly by them (patient-reported outcomes). Researchers found that by week 48 of the trial, patients who received zanubrutinib plus obinutuzumab found it easier to manage daily activities (role functioning) and had fewer symptoms of feeling exhausted all the time (fatigue) and nausea/vomiting versus those who received obinutuzumab alone. Further analysis showed that the patients who received zanubrutinib plus obinutuzumab had noticeable improvements from the start of treatment in role functioning, pain, and fatigue versus patients receiving obinutuzumab alone at week 24 of the trial. In conclusion, this study showed that zanubrutinib plus obinutuzumab was associated with improved patient-reported outcomes versus obinutuzumab alone in patients with relapsed or refractory FL.