Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma
Web of Science
AuthorDavies, A; Trask, P; Demeter, J; Florschuetz, A; Haenel, M; Kinoshita, T; Pettengell, R; Quach, H; Robinson, S; Sadullah, S; ...
Source TitleAnnals of Hematology
University of Melbourne Author/sQuach, Hang
AffiliationMedicine and Radiology
Document TypeJournal Article
CitationsDavies, A., Trask, P., Demeter, J., Florschuetz, A., Haenel, M., Kinoshita, T., Pettengell, R., Quach, H., Robinson, S., Sadullah, S., Sancho, J. -M., Udvardy, M., Witzens-Harig, M., Knapp, A. & Liu, W. (2020). Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. ANNALS OF HEMATOLOGY, 99 (12), pp.2837-2846. https://doi.org/10.1007/s00277-020-04021-6.
Access StatusOpen Access
Health-related quality of life was a secondary endpoint in the phase III GALLIUM study in previously untreated patients with follicular lymphoma who were treated with rituximab- or obinutuzumab-chemotherapy. Patients were randomized 1:1 to receive induction therapy with obinutuzumab- or rituximab-chemotherapy and maintenance in responders. Health-related quality of life was assessed using the Functional Assessment of Cancer Treatment-Lymphoma questionnaire, incorporating well-being and lymphoma-specific subscales. Assessments were performed at baseline, and during induction, maintenance, and follow-up (maximum 84 months). Clinically meaningful responses were defined by minimally important difference values. Of 1202 randomized patients (median follow-up 57.4 months), 557/601 (92.7%; obinutuzumab-chemotherapy) and 548/601 (91.2%; rituximab-chemotherapy) completed all Functional Assessment of Cancer Treatment-Lymphoma scales at baseline. Mean baseline health-related quality of life scores were similar between both arms, with all patients having some functional impairment and lymphoma symptoms. Over the course of treatment, mean health-related quality of life remained similar in both arms. Equal proportions of patients in both arms achieved minimally important difference by the Functional Assessment of Cancer Treatment-Lymphoma lymphoma-specific subscale and summary scales throughout induction, maintenance, and follow-up. On each summary scale, ~ 50% of patients in each arm achieved minimally important difference by maintenance month 2. In GALLIUM, similar improvements in health-related quality of life were seen with obinutuzumab- and rituximab-chemotherapy, suggesting that both treatments reduced lymphoma-related symptoms, and treatment-related side effects did not abrogate these improvements in well-being. ClinicalTrials.gov identifier: NCT01332968.
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