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, multicenter, dose-escalation study of avadomide in adult Japanese patients with advanced malignancies
掲載誌名	正式名：Cancer Sci ISSNコード：13497006
掲載区分	国外
巻・号・頁	112,331-338頁
著者・共著者	Hatake, K., Chou, T., Doi, T., Terui, Y., Kato, H., Hirose, T., Seo, S., Pourdehnad, M., Ogaki, Y., Fujimoto, H., Hagner, P. R., Yamamoto, K.
発行年月	2021
概要	This phase I multicenter study evaluated avadomide in Japanese patients with advanced solid tumors or NHL. Fourteen patients with NHL and one with a solid tumor (esophageal carcinoma), were enrolled in four dose-escalation cohorts using a 3 + 3 design. Primary endpoints included safety, DLT, maximum-tolerated dose and/or recommended phase II dose (RP2D), and pharmacokinetics. Secondary endpoints included ORR and duration of response. One patient with NHL experienced DLT, which included face edema, pharyngeal edema, and tumor flare that led to a dose reduction. Eleven patients had grade ≥3 treatment-emergent adverse events, most frequently decreased neutrophil count (33%) and decreased lymphocyte count (20%). The ORR in patients with NHL (n = 13) was 54%, including four complete and three partial responses.
DOI	10.1111/cas.14704
文献番号	33075165