TY  - JOUR
AU  - Davies, A
AU  - Trask, P
AU  - Demeter, J
AU  - Florschuetz, A
AU  - Haenel, M
AU  - Kinoshita, T
AU  - Pettengell, R
AU  - Quach, H
AU  - Robinson, S
AU  - Sadullah, S
AU  - Sancho, J-M
AU  - Udvardy, M
AU  - Witzens-Harig, M
AU  - Knapp, A
AU  - Liu, W
Y2  - 2020/11/26
Y1  - 2020/04/20
SN  - 0939-5555
UR  - http://hdl.handle.net/11343/252044
AB  - 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.
LA  - English
PB  - SPRINGER
T1  - 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
DO  - 10.1007/s00277-020-04021-6
IS  - Annals of Hematology
VL  - 99
IS  - 12
SP  - 2837-2846
L1  - /bitstream/handle/11343/252044/s00277-020-04021-6.pdf?sequence=1&isAllowed=y
ER  -