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
Davies, A. (Cancer Research UK Centre)
Trask, P. (Genentech Inc.)
Demeter, J. (Semmelweis University)
Florschütz, A. (Städtisches Klinikum Dessau)
Hänel, M. (Klinikum Chemnitz gGmbH)
Kinoshita, T. (Aichi Cancer Center Hospital)
Pettengell, R. (St George's University)
Quach, H. (St Vincent's Hospital (Sydney))
Robinson, S. (Bristol Haematology and Oncology Centre)
Sadullah, S. (James Paget Hospital)
Sancho, Juan-Manuel (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Udvardy, M. (Medical and Health Science Centre. University of Debrecen)
Witzens-Harig, M. (Uniklinik Heidelberg)
Knapp, A. (F. Hoffmann-La Roche Ltd)
Liu, W. (F. Hoffmann-La Roche Ltd)
Universitat Autònoma de Barcelona

Date:	2020
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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Follicular lymphoma ; Indolent non-Hodgkin lymphoma ; Obinutuzumab ; Quality of life ; Rituximab
Published in:	Annals of Hematology, Vol. 99 Núm. 12 (december 2020) , p. 2837-2846, ISSN 1432-0584

DOI: 10.1007/s00277-020-04021-6
PMID: 32314038

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP) > Josep Carreras Leukaemia Research Institute
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