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	Safety and pharmacokinetics of polatuzumab vedotin in Japanese patients with relapsed/refractory B-cell non-Hodgkin lymphoma: a phase 1 dose-escalation study
掲載誌名	正式名：Jpn J Clin Oncol ISSNコード：14653621
掲載区分	国外
巻・号・頁	51,70-77頁
著者・共著者	Kinoshita, T., Hatake, K., Yamamoto, K., Higuchi, Y., Murakami, S., Terui, Y., Yokoyama, M., Maruyama, D., Makita, S., Hida, Y., Saito, T., Tobinai, K.
発行年月	2021
概要	Patients received pola (1.0 or 1.8 mg/kg) intravenously every 21 days until disease progression or intolerance. Intra-patient dose escalation was prohibited. Tolerability was determined by the standard 3 + 3 rule. Blood sampling was performed to characterize pharmacokinetics. Four patients received pola 1.0 mg/kg; three received 1.8 mg/kg. Patients had follicular lymphoma (n = 4) or diffuse large B-cell lymphoma (n = 3), median age of 62 years, received a median of 3 prior therapies; six were female. Pola was well tolerated in both cohorts, with no dose-limiting toxicities observed. The most common adverse event was peripheral sensory neuropathy (n = 4). Grade 3 adverse events were cholecystitis and neutrophil count decreased (one each; both 1.0 mg/kg), and syncope and cataract (one each; both 1.8 mg/kg). The plasma half-life of antibody-conjugate monomethyl auristatin E was 4.43-7.98 days, and systemic exposure of unconjugated monomethyl auristatin E was limited in both cohorts.
DOI	10.1093/jjco/hyaa169
文献番号	33029633