来自替拉布替尼I/II期研究的复发或难治性原发性中枢神经系统淋巴瘤患者的卡诺夫斯基体能状态和生活质量

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

作者信息

Arakawa Yoshiki, Narita Yoshitaka, Nagane Motoo, Mishima Kazuhiko, Terui Yasuhito, Yonezawa Hajime, Asai Katsunori, Fukuhara Noriko, Sugiyama Kazuhiko, Shinojima Naoki, Aoi Arata, Nishikawa Ryo

机构信息

Department of Neurosurgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.

Department of Neurosurgery and Neuro-Oncology, National Cancer Center Hospital, Tokyo, Japan.

出版信息

Neurooncol Adv. 2023 Sep 14;5(1):vdad109. doi: 10.1093/noajnl/vdad109. eCollection 2023 Jan-Dec.

DOI:10.1093/noajnl/vdad109

PMID:37744697

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10517093/

Abstract

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.

摘要

背景

替拉鲁替尼是一种第二代布鲁顿酪氨酸激酶抑制剂，基于在日本开展的I/II期研究，于2020年3月获批用于治疗复发或难治性原发性中枢神经系统淋巴瘤（r/r PCNSL）。我们之前报告了其总缓解率和安全性。基于超过1年的随访数据，我们描述了接受替拉鲁替尼治疗的r/r PCNSL患者的卡氏功能状态评分（KPS）和生活质量（QoL）。

方法

年龄≥20岁且KPS≥70的r/r PCNSL患者，在禁食条件下接受替拉鲁替尼治疗，每日一次，剂量为320、480或480 mg。使用欧洲癌症研究与治疗组织（EORTC）发布的问卷评估生活质量，即EORTC QLQ-C30、EORTC QLQ-BN20和欧洲五维健康量表3级（EQ-5D-3L），同时评估KPS。

结果

共纳入44例患者（平均年龄60岁[范围29 - 86岁]）。中位随访期为14.9个月（范围1.4 - 27.7个月）。患者基线时的中位KPS为80.0（范围70 - 100），治疗期间保持稳定。QLQ-C30中的总体健康状况/生活质量从基线到第3 - 17周期有显著改善，此后直到第23周期保持相对稳定。QLQ-C30部分的情绪功能和便秘也有改善。治疗期间，QLQ-C30和QLQ-BN20的其他项目、EQ-5D视觉模拟量表和EQ-5D指数保持稳定。