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 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, ~ 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.
Follicular lymphoma, Indolent non-Hodgkin lymphoma, Obinutuzumab, Quality of life, Rituximab
2837-2846
Davies, Andrew
0fe6a40a-10d1-4ade-a7e6-d1dceb2470af
Trask, Peter
c4764158-85cb-42a2-96ab-b0323ae11d1b
Demeter, Judit
2ee96336-c74d-44ec-8bcc-1cd57df4ba1e
Florschütz, Axel
20858aab-9925-4126-8093-95b87270b5d3
Hänel, Mathias
c3388636-c89a-46b4-88c1-d326e76209b8
Kinoshita, Tomohiro
9a96c96d-d301-449c-8585-c164e3e985f9
Pettengell, Ruth
28ecc9df-584b-4a52-b6e6-c8e9228d421b
Quach, Hang
c43cacaf-af9c-4403-91df-7901417d606a
Robinson, Stephen
a786ba7c-e3ff-442f-8757-56054e130bee
Sadullah, Shalal
5ba487dd-e52a-4fb7-8ac4-eef61f84b9d6
Sancho, Juan-Manuel
75af152b-a08c-4233-ae21-8af1d594fd80
Udvardy, Miklos
2fa1a1b3-2792-4770-91d7-bb74c90bf303
Witzens-Harig, Mathias
d39b2e6f-f0b5-49f1-8a73-76e0fdc50520
Knapp, Andrea
c201c779-4c66-42eb-8619-352c4aee960c
Liu, Wenxin
7cfad0d1-d53f-4bef-a156-e10f326f4476
December 2020
Davies, Andrew
0fe6a40a-10d1-4ade-a7e6-d1dceb2470af
Trask, Peter
c4764158-85cb-42a2-96ab-b0323ae11d1b
Demeter, Judit
2ee96336-c74d-44ec-8bcc-1cd57df4ba1e
Florschütz, Axel
20858aab-9925-4126-8093-95b87270b5d3
Hänel, Mathias
c3388636-c89a-46b4-88c1-d326e76209b8
Kinoshita, Tomohiro
9a96c96d-d301-449c-8585-c164e3e985f9
Pettengell, Ruth
28ecc9df-584b-4a52-b6e6-c8e9228d421b
Quach, Hang
c43cacaf-af9c-4403-91df-7901417d606a
Robinson, Stephen
a786ba7c-e3ff-442f-8757-56054e130bee
Sadullah, Shalal
5ba487dd-e52a-4fb7-8ac4-eef61f84b9d6
Sancho, Juan-Manuel
75af152b-a08c-4233-ae21-8af1d594fd80
Udvardy, Miklos
2fa1a1b3-2792-4770-91d7-bb74c90bf303
Witzens-Harig, Mathias
d39b2e6f-f0b5-49f1-8a73-76e0fdc50520
Knapp, Andrea
c201c779-4c66-42eb-8619-352c4aee960c
Liu, Wenxin
7cfad0d1-d53f-4bef-a156-e10f326f4476
Davies, Andrew, Trask, Peter, Demeter, Judit, Florschütz, Axel, Hänel, Mathias, Kinoshita, Tomohiro, Pettengell, Ruth, Quach, Hang, Robinson, Stephen, Sadullah, Shalal, Sancho, Juan-Manuel, Udvardy, Miklos, Witzens-Harig, Mathias, Knapp, Andrea and Liu, Wenxin
(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), .
(doi:10.1007/s00277-020-04021-6).
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.
Text
GALLIUM PRO Ann Hematol Davies 27 March 20 clean
- Accepted Manuscript
Text
Davies 2020 Article Health-related Quality Of Life
- Version of Record
Text
Davies_et_al-2020-Annals_of_Hematology
Restricted to Repository staff only
Request a copy
More information
Accepted/In Press date: 2 April 2020
e-pub ahead of print date: 20 April 2020
Published date: December 2020
Additional Information:
Funding Information:
GALLIUM was sponsored by the F. Hoffmann-La Roche Ltd. Third-party medical writing assistance, under the direction of Andrew Davies, was provided by the Russell Craddock and Louise Profit of Gardiner-Caldwell Communications, and was funded by the F. Hoffmann-La Roche Ltd.
Publisher Copyright:
© 2020, The Author(s).
Keywords:
Follicular lymphoma, Indolent non-Hodgkin lymphoma, Obinutuzumab, Quality of life, Rituximab
Identifiers
Local EPrints ID: 439734
URI: http://eprints.soton.ac.uk/id/eprint/439734
ISSN: 0939-5555
PURE UUID: eb8a76a6-b1a1-42e0-a1ac-faa4c371ed93
Catalogue record
Date deposited: 30 Apr 2020 16:35
Last modified: 17 Mar 2024 03:14
Export record
Altmetrics
Contributors
Author:
Peter Trask
Author:
Judit Demeter
Author:
Axel Florschütz
Author:
Mathias Hänel
Author:
Tomohiro Kinoshita
Author:
Ruth Pettengell
Author:
Hang Quach
Author:
Stephen Robinson
Author:
Shalal Sadullah
Author:
Juan-Manuel Sancho
Author:
Miklos Udvardy
Author:
Mathias Witzens-Harig
Author:
Andrea Knapp
Author:
Wenxin Liu
Download statistics
Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.
View more statistics
