A Phase Ib Study of Lucitanib (AL3810) in a Cohort of Patients with Recurrent and Metastatic Nasopharyngeal Carcinoma.
A Phase Ib Study of Lucitanib (AL3810) in a Cohort of Patients with Recurrent and Metastatic Nasopharyngeal Carcinoma.
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Lucitanib (AL3810) 在复发性和转移性鼻咽癌患者队列中的 Ib 期研究
DOI：
10.1093/oncolo/oyab076
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发表时间：
2022-06-08
期刊：
影响因子：
5.8
通讯作者：
Zhang, Li
中科院分区：
文献类型：
--
作者：
Zhang, Yang;Luo, Fan;Ma, Yu-Xiang;Liu, Qian-Wen;Yang, Yun-Peng;Fang, Wen-Feng;Huang, Yan;Zhou, Ting;Li, Jin;Pan, Hong-Ming;Yang, Lei;Qin, Shu-Kui;Zhao, Hong-Yun;Zhang, Li
Lucitanib是FGFR 1 -3、VEGFR 1-3和PDGFR α/β的新型多靶点抑制剂。在这里，我们评估了Lucitanib在复发和转移性鼻咽癌（RM-NPC）中的安全性，耐受性和初步疗效。预先治疗的RM-NPC患者被随机分为两个治疗组：连续或间歇治疗。主要终点是安全性和耐受性。次要终点为客观缓解率（ORR）、疾病控制率（DCR）和无进展生存期（PFS）。连续治疗组100%的患者和间歇治疗组90%的患者至少发生1起治疗相关AE（TRAE）。连续治疗组5例患者（5/10，50%）发生≥3级相关TRAE。间歇组未发生TRAE等级>3的情况，连续组的ORR和DCR分别为20%和90%，间歇组分别为10%和60%。第一次评价时观察到所有反应。缓解持续时间超过1年，2例患者仍在接受治疗，持续缓解超过3年。Lucitanib在接受过大量预治疗的NPC患者中具有良好的临床活性和可耐受的安全性。对Lucitanib治疗有反应的患者通常会获得较长的DoR。Lucitanib目前正在II/III期研究中进行评估。NCT 03260179本文评价了Lucitanib在复发性和转移性鼻咽癌中的安全性、耐受性和初步疗效。
Lucitanib is a novel multi-target inhibitor of FGFR1-3, VEGFR 1-3, and PDGFR α/β. Here, we evaluated the safety, tolerability, and preliminary efficacy of lucitanib in recurrent and metastatic nasopharyngeal carcinoma (RM-NPC). Patients with pretreated RM-NPC were randomly divided into two treatment arms: continuous or intermittent treatment. The primary endpoint was safety and tolerability. Secondary endpoints were objective response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). One hundred percent of patients in the continuous arm and 90% of patients in the intermittent arm had at least one treatment-related AE (TRAE). Grade ≥3 related TRAEs occurred in 5 patients in the continuous arm (5/10, 50%). No TRAEs grade >3 occurred in the intermittent arm. The ORR and DCR of the continuous arm was 20% and 90%, and the intermittent arm was 10% and 60%, respectively. All responses were observed by the first evaluation. The duration of response was more than 1 year, with two patients still on treatment with sustained response at more than 3 years. Lucitanib has promising clinical activity and tolerable safety profile in heavily pretreated patients with NPC. Patients who responded to lucitanib treatment generally achieved a long DoR. Lucitanib is now being evaluated in phase II/III studies. NCT03260179 This article evaluates the safety, tolerability, and preliminary efficacy of lucitanib in recurrent and metastatic nasopharyngeal carcinoma.
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影响因子：
11.5
作者：
Wang, Wen-Yi;Twu, Chih-Wen;Lin, Jin-Ching
通讯作者：
Lin, Jin-Ching
影响因子：
11.5
作者：
Hui, Rina;Pearson, Alex;Curigliano, Giuseppe
通讯作者：
Curigliano, Giuseppe
影响因子：
11.5
作者：
Lim, Wan-Teck;Ng, Quan-Sing;Tan, Eng-Huat
通讯作者：
Tan, Eng-Huat
DOI：
10.6004/jnccn.2020.0031
发表时间：
2020-07-01
影响因子：
13.4
作者：
Pfister, David G.;Spencer, Sharon;Darlow, Susan D.
通讯作者：
Darlow, Susan D.
影响因子：
11.5
作者：
Andre, Fabrice;Bachelot, Thomas;Baselga, Jose
通讯作者：
Baselga, Jose