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

M van der Meulen; K Bakunina; M Nijland; M C Minnema; G Cull; W B C Stevens; J W Baars; K D Mason; A Beeker; M Beijert; M J B Taphoorn; M J van den Bent; S Issa; J K Doorduijn; J E C Bromberg; L Dirven

doi:10.1016/j.annonc.2020.04.014

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

Ann Oncol. 2020 Aug;31(8):1046-1055. doi: 10.1016/j.annonc.2020.04.014. Epub 2020 May 3.

Authors

M van der Meulen¹, K Bakunina², M Nijland³, M C Minnema⁴, G Cull⁵, W B C Stevens⁶, J W Baars⁷, K D Mason⁸, A Beeker⁹, M Beijert¹⁰, M J B Taphoorn¹¹, M J van den Bent¹², S Issa¹³, J K Doorduijn¹⁴, J E C Bromberg¹², L Dirven¹¹

Affiliations

¹ Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center, Rotterdam, The Netherlands. Electronic address: m.vandermeulen.2@erasmusmc.nl.
² HOVON Data Center, Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
³ Department of Hematology, University Medical Center Groningen, Groningen, The Netherlands.
⁴ Department of Hematology, University Medical Center Utrecht, Utrecht, The Netherlands.
⁵ Haematology Department, Sir Charles Gairdner Hospital and PathWest Laboratory Medicine, Nedlands, Australia; University of Western Australia, Crawley, Australia.
⁶ Department of Hematology, Radboud University Medical Center, Nijmegen, The Netherlands.
⁷ Department of Hemato-Oncology, Antoni van Leeuwenhoek Hospital/Dutch Cancer Institute, Amsterdam, The Netherlands.
⁸ Department of Hematology, Royal Melbourne Hospital, Melbourne, Australia.
⁹ Department of Hematology, Spaarne Gasthuis, Haarlem, The Netherlands.
¹⁰ Department of Radiotherapy, University Medical Center Groningen, Groningen, The Netherlands.
¹¹ Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands; Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.
¹² Department of Neuro-Oncology, Erasmus MC Cancer Institute, Brain Tumor Center, University Medical Center, Rotterdam, The Netherlands.
¹³ Department of Hematology, Middlemore Hospital, Auckland, New Zealand.
¹⁴ Department of Hematology, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, The Netherlands.

PMID: 32371123
DOI: 10.1016/j.annonc.2020.04.014

Abstract

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.

Keywords: health-related quality of life; primary central nervous system lymphoma; radiation; rituximab.

Publication types

Clinical Trial, Phase III
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Central Nervous System
Central Nervous System Neoplasms* / drug therapy
Health Status
Humans
Quality of Life*
Rituximab
Surveys and Questionnaires

Substances

Rituximab