テルイ ヤスヒト
TERUI Yasuhito
照井 康仁 所属 埼玉医科大学 医学部 血液内科 職種 教授 |
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論文種別 | 学術雑誌(原著) |
言語種別 | 英語 |
査読の有無 | 査読あり |
表題 | Phase I/II study of tirabrutinib, a second-generation Bruton's tyrosine kinase inhibitor, in relapsed/refractory primary central nervous system lymphoma |
掲載誌名 | 正式名:Neuro Oncol ISSNコード:15235866 |
掲載区分 | 国外 |
巻・号・頁 | 23,122-133頁 |
著者・共著者 | Narita, Y., Nagane, M., Mishima, K., Terui, Y., Arakawa, Y., Yonezawa, H., Asai, K., Fukuhara, N., Sugiyama, K., Shinojima, N., Kitagawa, J., Aoi, A., Nishikawa, R. |
発行年月 | 2021 |
概要 | Patients with relapsed/refractory PCNSL, Karnofsky performance status ≥70, and normal end-organ function received tirabrutinib 320 and 480 mg once daily (q.d.) in phase I to evaluate dose-limiting toxicity (DLT) within 28 days using a 3 + 3 dose escalation design and with 480 mg q.d. under fasted conditions in phase II.|Forty-four patients were enrolled; 20, 7, and 17 received tirabrutinib at 320, 480, and 480 mg under fasted conditions, respectively. No DLTs were observed, and the maximum tolerated dose was not reached at 480 mg. Common grade ≥3 adverse events (AEs) were neutropenia (9.1%), lymphopenia, leukopenia, and erythema multiforme (6.8% each). One patient with 480 mg q.d. had grade 5 AEs (pneumocystis jirovecii pneumonia and interstitial lung disease). Independent review committee assessed overall response rate (ORR) at 64%: 60% with 5 CR/CRu at 320 mg, 100% with 4 CR/CRu at 480 mg, and 53% with 6 CR/CRu at 480 mg under fasted conditions. |
DOI | 10.1093/neuonc/noaa145 |
文献番号 | 32583848 |