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

Andrew Davies, Peter Trask, Judit Demeter, Axel Florschütz, Mathias Hänel, Tomohiro Kinoshita, Ruth Pettengell, Hang Quach, Stephen Robinson, Shalal Sadullah, Juan Manuel Sancho, Miklos Udvardy, Mathias Witzens-Harig, Andrea Knapp, Wenxin Liu

Research output: Article

Abstract

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.

Original languageEnglish
JournalAnnals of Hematology
DOIs
Publication statusAccepted/In press - jan. 1 2020

ASJC Scopus subject areas

  • Hematology

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    Davies, A., Trask, P., Demeter, J., Florschütz, A., Hänel, M., Kinoshita, T., Pettengell, R., Quach, H., Robinson, S., Sadullah, S., Sancho, J. M., Udvardy, M., Witzens-Harig, M., Knapp, A., & Liu, W. (Accepted/In press). 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. https://doi.org/10.1007/s00277-020-04021-6