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
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, similar to
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. identifier: NCT01332968.
