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Karnofsky Performance Status and quality of life in patients with relapsed or refractory primary CNS lymphoma from a phase I/II study of tirabrutinib

BACKGROUND: Tirabrutinib, a second-generation inhibitor of Bruton’s tyrosine kinase, was approved in March 2020 for the treatment of relapsed or refractory primary central nervous system lymphoma (r/r PCNSL) based on phase I/II studies in Japan. We previously reported the overall response rate and s...

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Autores principales: Arakawa, Yoshiki, Narita, Yoshitaka, Nagane, Motoo, Mishima, Kazuhiko, Terui, Yasuhito, Yonezawa, Hajime, Asai, Katsunori, Fukuhara, Noriko, Sugiyama, Kazuhiko, Shinojima, Naoki, Aoi, Arata, Nishikawa, Ryo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10517093/
https://www.ncbi.nlm.nih.gov/pubmed/37744697
http://dx.doi.org/10.1093/noajnl/vdad109
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author Arakawa, Yoshiki
Narita, Yoshitaka
Nagane, Motoo
Mishima, Kazuhiko
Terui, Yasuhito
Yonezawa, Hajime
Asai, Katsunori
Fukuhara, Noriko
Sugiyama, Kazuhiko
Shinojima, Naoki
Aoi, Arata
Nishikawa, Ryo
author_facet Arakawa, Yoshiki
Narita, Yoshitaka
Nagane, Motoo
Mishima, Kazuhiko
Terui, Yasuhito
Yonezawa, Hajime
Asai, Katsunori
Fukuhara, Noriko
Sugiyama, Kazuhiko
Shinojima, Naoki
Aoi, Arata
Nishikawa, Ryo
author_sort Arakawa, Yoshiki
collection PubMed
description BACKGROUND: Tirabrutinib, a second-generation inhibitor of Bruton’s tyrosine kinase, was approved in March 2020 for the treatment of relapsed or refractory primary central nervous system lymphoma (r/r PCNSL) based on phase I/II studies in Japan. We previously reported the overall response rate and safety profile. We describe Karnofsky Performance Status (KPS) and the quality of life (QoL) in patients with r/r PCNSL receiving tirabrutinib based on more than 1-year follow-up data. METHODS: Patients with r/r PCNSL, age ≥20 years, and KPS ≥70 were treated with tirabrutinib once daily at a dose of 320, 480, or 480 mg under fasted conditions. QoL was assessed using questionnaires issued by the European Organization for Research and Treatment of Cancer (EORTC), namely EORTC QLQ-C30, EORTC QLQ-BN20, and EuroQol 5 dimensions 3-level (EQ-5D-3L) along with KPS. RESULTS: Forty-four patients (mean age, 60 years [range 29–86]) were enrolled. The median follow-up period was 14.9 months (range, 1.4–27.7). The median KPS of the patients at baseline was 80.0 (range, 70–100), and this remained constant during the treatment. The global health status/QoL in the QLQ-C30 showed significant improvements from baseline through cycles 3–17 and remained relatively constant thereafter until cycle 23. Improvements were also seen in emotional functioning and constipation in the QLQ-C30 segments. Other items of QLQ-C30 and QLQ-BN20, EQ-5D visual analog scales, and EQ-5D index were maintained during the treatment. CONCLUSIONS: Tirabrutinib generally maintains KPS and QoL scores with some improvements in specific QoL items in patients with r/r PCNSL.
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spelling pubmed-105170932023-09-24 Karnofsky Performance Status and quality of life in patients with relapsed or refractory primary CNS lymphoma from a phase I/II study of tirabrutinib Arakawa, Yoshiki Narita, Yoshitaka Nagane, Motoo Mishima, Kazuhiko Terui, Yasuhito Yonezawa, Hajime Asai, Katsunori Fukuhara, Noriko Sugiyama, Kazuhiko Shinojima, Naoki Aoi, Arata Nishikawa, Ryo Neurooncol Adv Clinical Investigations BACKGROUND: Tirabrutinib, a second-generation inhibitor of Bruton’s tyrosine kinase, was approved in March 2020 for the treatment of relapsed or refractory primary central nervous system lymphoma (r/r PCNSL) based on phase I/II studies in Japan. We previously reported the overall response rate and safety profile. We describe Karnofsky Performance Status (KPS) and the quality of life (QoL) in patients with r/r PCNSL receiving tirabrutinib based on more than 1-year follow-up data. METHODS: Patients with r/r PCNSL, age ≥20 years, and KPS ≥70 were treated with tirabrutinib once daily at a dose of 320, 480, or 480 mg under fasted conditions. QoL was assessed using questionnaires issued by the European Organization for Research and Treatment of Cancer (EORTC), namely EORTC QLQ-C30, EORTC QLQ-BN20, and EuroQol 5 dimensions 3-level (EQ-5D-3L) along with KPS. RESULTS: Forty-four patients (mean age, 60 years [range 29–86]) were enrolled. The median follow-up period was 14.9 months (range, 1.4–27.7). The median KPS of the patients at baseline was 80.0 (range, 70–100), and this remained constant during the treatment. The global health status/QoL in the QLQ-C30 showed significant improvements from baseline through cycles 3–17 and remained relatively constant thereafter until cycle 23. Improvements were also seen in emotional functioning and constipation in the QLQ-C30 segments. Other items of QLQ-C30 and QLQ-BN20, EQ-5D visual analog scales, and EQ-5D index were maintained during the treatment. CONCLUSIONS: Tirabrutinib generally maintains KPS and QoL scores with some improvements in specific QoL items in patients with r/r PCNSL. Oxford University Press 2023-09-14 /pmc/articles/PMC10517093/ /pubmed/37744697 http://dx.doi.org/10.1093/noajnl/vdad109 Text en © The Author(s) 2023. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Clinical Investigations
Arakawa, Yoshiki
Narita, Yoshitaka
Nagane, Motoo
Mishima, Kazuhiko
Terui, Yasuhito
Yonezawa, Hajime
Asai, Katsunori
Fukuhara, Noriko
Sugiyama, Kazuhiko
Shinojima, Naoki
Aoi, Arata
Nishikawa, Ryo
Karnofsky Performance Status and quality of life in patients with relapsed or refractory primary CNS lymphoma from a phase I/II study of tirabrutinib
title Karnofsky Performance Status and quality of life in patients with relapsed or refractory primary CNS lymphoma from a phase I/II study of tirabrutinib
title_full Karnofsky Performance Status and quality of life in patients with relapsed or refractory primary CNS lymphoma from a phase I/II study of tirabrutinib
title_fullStr Karnofsky Performance Status and quality of life in patients with relapsed or refractory primary CNS lymphoma from a phase I/II study of tirabrutinib
title_full_unstemmed Karnofsky Performance Status and quality of life in patients with relapsed or refractory primary CNS lymphoma from a phase I/II study of tirabrutinib
title_short Karnofsky Performance Status and quality of life in patients with relapsed or refractory primary CNS lymphoma from a phase I/II study of tirabrutinib
title_sort karnofsky performance status and quality of life in patients with relapsed or refractory primary cns lymphoma from a phase i/ii study of tirabrutinib
topic Clinical Investigations
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10517093/
https://www.ncbi.nlm.nih.gov/pubmed/37744697
http://dx.doi.org/10.1093/noajnl/vdad109
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