Publication details

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

TROTMAN Judith ZINZANI Pier Luigi SONG Yuqin DELARUE Richard KIM Pil IVANOVA Elena KORDE Rasika MAYER Jiří DE OLIVEIRA Ana C ASSOULINE Sarit E FLOWERS Christopher R BARNES Gisoo

Year of publication 2024
Type Article in Periodical
Magazine / Source Current medical research and opinion
MU Faculty or unit

Faculty of Medicine

Citation
Web https://www.tandfonline.com/doi/full/10.1080/03007995.2024.2409837
Doi http://dx.doi.org/10.1080/03007995.2024.2409837
Keywords Follicular lymphoma; health-related quality of life; obinutuzumab; patient-reported outcome measures; relapsed or refractory; ROSEWOOD; zanubrutinib
Description ObjectiveWe 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).MethodsPROs 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.ResultsPatients 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.ConclusionsIn 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 registrationThe ROSEWOOD trial is registered on ClinicalTrials.gov (BGB-3111-212; ClinicalTrials.gov identifier: NCT03332017).

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