在再结晶的血浆Tagraxofusp树突细胞肿瘤。

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Pemmaraju N,莱恩AA,甜蜜的KL,斯坦,Vasu年代,布卢姆W, Rizzieri哒,王,Duvic M,斯隆JM,斯宾塞年代,示麦年代,布鲁克斯CL,巴尔斯J, Bergstein我,柳叶刀我,Kantarjian嗯,Konopleva M

在再结晶的血浆Tagraxofusp树突细胞肿瘤。

郑传经地中海J。2019年4月25日,380 (17):1628 - 1637。doi: 10.1056 / NEJMoa1815105。

PubMed ID

31018069 (在PubMed

]

文摘

背景:再结晶的血浆树突细胞肿瘤(BPDCN)是一个激进的血液癌症是由于改变了血浆树突细胞过多表达interleukin-3受体亚基α(IL3RA或CD123)。Tagraxofusp (sl - 401)是一个CD123-directed细胞毒素组成的人类interleukin-3融合截断白喉毒素。方法:在这个非盲、multicohort研究中,我们指定47未经处理或复发患者BPDCN接受静脉输液的tagraxofusp剂量的7杯或12杯每公斤体重1到5天每21天的周期。治疗直到疾病进展或不可接受的毒性作用。主要结果是相结合的完全缓解率和临床完全缓解的患者没有收到以前BPDCN治疗。第二个结果是响应时间。结果:47岁的患者,32接受tagraxofusp作为一线治疗和15收到以前的治疗。病人的平均年龄是70岁(范围,22到84)。在29日以前未经治疗的病人的剂量tagraxofusp 12杯每公斤,主要结果发生在21例(72%),和整体回应率为90%;这些患者中,45%接受了干细胞移植。 Survival rates at 18 and 24 months were 59% and 52%, respectively. Among the 15 previously treated patients, the response rate was 67%, and the median overall survival was 8.5 months. The most common adverse events were increased levels of alanine aminotransferase (64%) and aspartate aminotransferase (60%), hypoalbuminemia (55%), peripheral edema (51%), and thrombocytopenia (49%). Capillary leak syndrome was reported in 19% of the patients and was associated with one death in each of the dose subgroups. CONCLUSIONS: In adult patients with untreated or relapsed BPDCN, the use of tagraxofusp led to clinical responses. Serious adverse events included capillary leak syndrome; hepatic dysfunction and thrombocytopenia were common. (Funded by Stemline Therapeutics and the Leukemia and Lymphoma Society Therapy Acceleration Program; ClinicalTrials.gov number, NCT02113982.).

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Tagraxofusp