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Tytuł:
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Health-related quality of life after chemotherapy with or without rituximab in primary central nervous system lymphoma patients: results from a randomised phase III study.
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Autorzy:
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van der Meulen M; Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center, Rotterdam, The Netherlands. Electronic address: .
Bakunina K; HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Nijland M; Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.
Minnema MC; Department of Hematology, University Medical Center Utrecht, Utrecht, The Netherlands.
Cull G; Haematology Department, Sir Charles Gairdner Hospital and PathWest Laboratory Medicine, Nedlands, Australia; University of Western Australia, Crawley, Australia.
Stevens WBC; Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.
Baars JW; Department of Hemato-Oncology, Antoni van Leeuwenhoek Hospital/Dutch Cancer Institute, Amsterdam, The Netherlands.
Mason KD; Department of Hematology, Royal Melbourne Hospital, Melbourne, Australia.
Beeker A; Department of Hematology, Spaarne Gasthuis, Haarlem, The Netherlands.
Beijert M; Department of Radiotherapy, University Medical Center Groningen, Groningen, The Netherlands.
Taphoorn MJB; Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.
van den Bent MJ; Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center, Rotterdam, The Netherlands.
Issa S; Department of Hematology, Middlemore Hospital, Auckland, New Zealand.
Doorduijn JK; Department of Hematology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Bromberg JEC; Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center, Rotterdam, The Netherlands.
Dirven L; Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.
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Źródło:
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Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2020 Aug; Vol. 31 (8), pp. 1046-1055. Date of Electronic Publication: 2020 May 03.
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Typ publikacji:
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Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: 2020- : London : Elsevier
Original Publication: Dordrecht ; Boston : Kluwer Academic Publishers, c1990-
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MeSH Terms:
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Central Nervous System Neoplasms*/drug therapy
Quality of Life*
Central Nervous System ; Health Status ; Humans ; Rituximab ; Surveys and Questionnaires
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Contributed Indexing:
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Keywords: health-related quality of life; primary central nervous system lymphoma; radiation; rituximab
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Substance Nomenclature:
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4F4X42SYQ6 (Rituximab)
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Entry Date(s):
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Date Created: 20200507 Date Completed: 20210106 Latest Revision: 20220531
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Update Code:
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20240105
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DOI:
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10.1016/j.annonc.2020.04.014
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PMID:
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32371123
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Background: The impact of rituximab on health-related quality of life (HRQoL) in primary central nervous system lymphoma patients is not well known. We determined the impact of rituximab added to standard high-dose methotrexate-based treatment on HRQoL in patients in a large randomised trial.
Patients and Methods: Patients from a large phase III trial (HOVON 105/ALLG NHL 24), randomly assigned to receive standard chemotherapy with or without rituximab and followed by 30 Gy whole brain radiotherapy (WBRT) in patients ≤60 years, completed the EORTC QLQ-C30 and QLQ-BN20 questionnaires before and during treatment, and up to 24 months of follow-up or progression. Differences between treatment arms over time in global health status, role functioning, social functioning, fatigue, and motor dysfunction were assessed. Differences ≥10 points were deemed clinically relevant. The effect of WBRT on HRQoL was analysed in irradiated patients.
Results: A total of 160/175 patients eligible for the HRQoL study completed at least one questionnaire and were included. Over time, scores improved statistically significantly and were clinically relevant in both arms. Between arms, there were no differences on any scale (range: -3.8 to +4.0). Scores on all scales were improved to a clinically relevant extent at 12 and 24 months compared with baseline in both arms, except for fatigue and motor dysfunction at 12 months (-7.4 and -8.8, respectively). In irradiated patients (n = 59), scores in all preselected scales, except motor dysfunction, remained stable up to 24 months compared with shortly after WBRT, overall mean difference ranging between 0.02 and 4.570.
Conclusion: Compared with baseline, treatment resulted in improved HRQoL scores. The addition of rituximab to standard chemotherapy did not impact HRQoL over time. WBRT did not result in deterioration of HRQoL in the first 2 years.
Competing Interests: Disclosure The authors have declared no conflicts of interest.
(Copyright © 2020 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.)
Comment in: Ann Oncol. 2020 Aug;31(8):976-977. (PMID: 32485295)
