第二阶段研究人类anti-PDGFRalpha单克隆抗体(olaratumab IMC-3G3)以前治疗转移性胃肠道间质瘤患者。

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瓦格纳AJ, Kindler H, Gelderblom H, Schoffski P,鲍尔年代,霍恩P,科普HG, Lopez-Martin是的,此人M, Reichardt P,秦,Nippgen J, Ilaria RL,资助P

第二阶段研究人类anti-PDGFRalpha单克隆抗体(olaratumab IMC-3G3)以前治疗转移性胃肠道间质瘤患者。

28安杂志。2017年3月1;(3):541 - 546。doi: 10.1093 / annonc / mdw659。

PubMed ID

28426120 (在PubMed

]

文摘

背景:本研究评估肿瘤反应olaratumab (anti-PDGFRalpha单克隆抗体)在以前治疗的病人转移性胃肠道间质瘤(GIST)有或没有PDGFRalpha突变(组1和2,分别)。患者和方法:患者接受静脉注射olaratumab 20毫克/公斤每14天,直到疾病进展,死亡,或者难以忍受的毒性发生。结果测量是12周的肿瘤反应,无进展生存(PFS),总生存期(OS)和安全。结果:30例登记,21患者接受> / = 1剂olaratumab。可评价的人群(组1,n = 6;队列2 n = 14),没有完全缓解(CR)或部分反应观察(PR)。稳定的疾病(SD)是观察到在队列1和2 3例(50.0%)患者队列2中(14.3%)。进行性疾病(PD)在队列1中3例(50.0%),12例(85.7%)在队列2中。为期12周的临床受益率(CR + PR + SD) (90% CI)为50.0%(15.3 -84.7%)在队列1和14.3%(2.6 -38.5%)队列2中。SD持续了超过12周5例(组1,n = 3; cohort 2, n = 2). Median PFS (90% CI) was 32.1 (5.0-35.9) weeks in cohort 1 and 6.1 (5.7-6.3) weeks in cohort 2. Median OS was not reached in cohort 1 and was 24.9 (14.4-49.1) weeks in cohort 2. All patients in cohort 1 and 9 (64.3%) in cohort 2 experienced an olaratumab-related adverse event (AE), most commonly fatigue (38.1%), nausea (19.0%), and peripheral edema (14.3%). Two grade >/=3 olaratumab-related events were reported (cohort 1, syncope; cohort 2, hypertension). Conclusions: Olaratumab had an acceptable AE profile in patients with GIST. While there was no apparent effect on PFS in patients without PDGFRalpha mutations, patients with PDGFRalpha-mutant GIST (all with D842V mutations) treated with olaratumab had longer disease control compared with historical data for this genotype. ClinicalTrials.gov Identifier: NCT01316263.

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药物

Olaratumab