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
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