Neuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.
Neuro Oncol. 2010 Aug;12(8):855-61. doi: 10.1093/neuonc/noq025. Epub 2010 Mar 3.
The objective of this phase II single-arm study was to evaluate the efficacy and safety of pazopanib, a multi-targeted tyrosine kinase inhibitor, against vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3, platelet-derived growth factor receptor-alpha and -beta, and c-Kit, in recurrent glioblastoma. Patients with < or =2 relapses and no prior anti-VEGF/VEGFR therapy were treated with pazopanib 800 mg daily on 4-week cycles without planned interruptions. Brain magnetic resonance imaging and clinical reassessment were made every 8 weeks. The primary endpoint was efficacy as measured by 6-month progression-free survival (PFS6). Thirty-five GBM patients with a median age of 53 years and median Karnofsky performance scale of 90 were accrued. Grade 3/4 toxicities included leukopenia (n = 1), lymphopenia (n = 2), thrombocytopenia (n = 1), ALT elevation (n = 3), AST elevation (n = 1), CNS hemorrhage (n = 1), fatigue (n = 1), and thrombotic/embolic events (n = 3); 8 patients required dose reduction. Two patients had a partial radiographic response by standard bidimensional measurements, whereas 9 patients (6 at the 8-week point and 3 only within the first month of treatment) had decreased contrast enhancement, vasogenic edema, and mass effect but <50% reduction in tumor. The median PFS was 12 weeks (95% confidence interval [CI]: 8-14 weeks) and only 1 patient had a PFS time > or =6 months (PFS6 = 3%). Thirty patients (86%) had died and median survival was 35 weeks (95% CI: 24-47 weeks). Pazopanib was reasonably well tolerated with a spectrum of toxicities similar to other anti-VEGF/VEGFR agents. Single-agent pazopanib did not prolong PFS in this patient population but showed in situ biological activity as demonstrated by radiographic responses. ClinicalTrials.gov identifier: NCT00459381.
这项 II 期单臂研究的目的是评估多靶点酪氨酸激酶抑制剂帕唑帕尼(针对血管内皮生长因子受体 [VEGFR]-1、-2 和 -3、血小板衍生生长因子受体-α和-β以及 c-Kit)在复发性胶质母细胞瘤中的疗效和安全性。<或=2 次复发且无既往抗 VEGF/VEGFR 治疗的患者接受帕唑帕尼 800mg 每日治疗,4 周为 1 个周期,无计划中断。每 8 周进行脑磁共振成像和临床评估。主要终点是 6 个月无进展生存期(PFS6)的疗效。共入组 35 例胶质母细胞瘤患者,中位年龄为 53 岁,卡氏功能状态评分为 90 分。3/4 级毒性包括白细胞减少症(n=1)、淋巴细胞减少症(n=2)、血小板减少症(n=1)、丙氨酸转氨酶升高(n=3)、天冬氨酸转氨酶升高(n=1)、中枢神经系统出血(n=1)、疲劳(n=1)和血栓栓塞事件(n=3);8 例患者需要减少剂量。2 例患者的标准二维测量有部分放射学反应,而 9 例患者(8 例在 8 周时,3 例仅在治疗的第一个月内)有对比增强减退、血管源性水肿和肿块效应,但肿瘤缩小<50%。中位无进展生存期为 12 周(95%置信区间 [CI]:8-14 周),仅有 1 例患者的无进展生存期>或=6 个月(PFS6=3%)。30 例患者(86%)死亡,中位生存期为 35 周(95%CI:24-47 周)。帕唑帕尼的耐受性良好,毒性谱与其他抗 VEGF/VEGFR 药物相似。在该患者人群中,单药帕唑帕尼未能延长无进展生存期,但显示出影像学反应所证明的原位生物学活性。临床试验注册号:NCT00459381。
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