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桓兴医讯Nivolumab治疗转移性肾细胞癌:一项随机2期临床试验结果
文章来源:北京市朝阳区桓兴肿瘤医院 点击数: 发布时间:2014-12-09 08:55
《临床肿瘤杂志》2014年12月1日在线先发
Nivolumab治疗转移性肾细胞癌:一项随机2期临床试验结果
目的:
Nivolumab是一种全人源化免疫球蛋白G4程序化死亡1(PD-1)免疫抑制剂的检查点抗体,该抗体可恢复T细胞的免疫活性。本2期临床试验评估了nivolumab在治疗转移性肾细胞癌患者(mRCC)方面的抗肿瘤活性、剂量反应关系及其安全性。
患者及方法:
将以前接受过针对血管内皮生长因子通路治疗的转移性肾透明细胞癌患者被随机 (盲率1:1:1的比例) 分配成3组:分别接受nivolumab 0.3 mg/kg、2 mg/kg、或10 mg/kgQ3w静脉注射一次。主要目的是通过无进展生存(PFS) 作为评估剂量反应关系;次要研究终点包括客观缓解率(ORR)、总生存期(OS)和其安全性。
结果:
共有168例患者随机接受nivolumab观察, 其中0.3 mg/kg组(n = 60)、2 mg/kg组(n = 54)、10 mg/kg(n = 54)。118例患者既往结果不止一个系统治疗方案。三种不同剂量的中位PFS分别为2.7、4.0和4.2个月(P = .9);ORR为20%、22%,、和 20%;中位OS为18.2月、(80% CI, 16.2 -24.0月 )、25.5月 (80% CI, 19.8-28.8月)和 24.7 个月(80% CI, 15.3 -26.0月)。最常见的治疗相关不良反应是疲劳(三剂量分别为24%、22%及35%)。其中有19例(11%)发生了3-4度治疗相关不良反应。
结论:
通过三种剂量在mRCC研究结果显示了Nivolumab具有抗肿瘤活性及可控药物安全性。通过PFS观察未发现有剂量反应关系。这些在mRCC中支持研究的疗效和安全性结果会设置在3期试验中研究。
北京桓兴肿瘤医院 桓兴医讯编译组 远丽芳
2014年12月9日 星期四
Published online before print December 1, 2014, doi:10.1200/JCO.2014.59.0703JCO December 1, 2014JCO.2014.59.0703 Nivolumab for Metastatic Renal Cell Carcinoma: Results of a Randomized Phase II Trial
Purpose Nivolumab is a fully human immunoglobulin G4 programmed death–1 immune checkpoint inhibitor antibody that restores T-cell immune activity. This phase II trial assessed the antitumor activity, dose-response relationship, and safety of nivolumab in patients with metastatic renal cell carcinoma (mRCC).
Patients and Methods Patients with clear-cell mRCC previously treated with agents targeting the vascular endothelial growth factor pathway were randomly assigned (blinded ratio of 1:1:1) to nivolumab 0.3, 2, or 10 mg/kg intravenously once every 3 weeks. The primary objective was to evaluate the dose-response relationship as measured by progression-free survival (PFS); secondary end points included objective response rate (ORR), overall survival (OS), and safety.
Results A total of 168 patients were randomly assigned to the nivolumab 0.3- (n = 60), 2- (n = 54), and 10-mg/kg (n = 54) cohorts. One hundred eighteen patients (70%) had received more than one prior systemic regimen. Median PFS was 2.7, 4.0, and 4.2 months, respectively (P = .9). Respective ORRs were 20%, 22%, and 20%. Median OS was 18.2 months (80% CI, 16.2 to 24.0 months), 25.5 months (80% CI, 19.8 to 28.8 months), and 24.7 months (80% CI, 15.3 to 26.0 months), respectively. The most common treatment-related adverse event (AE) was fatigue (24%, 22%, and 35%, respectively). Nineteen patients (11%) experienced grade 3 to 4 treatment-related AEs.
Conclusion Nivolumab demonstrated antitumor activity with a manageable safety profile across the three doses studied in mRCC. No dose-response relationship was detected as measured by PFS. These efficacy and safety results in mRCC support study in the phase III setting.
http://jco.ascopubs.org/content/early/2014/12/01/JCO.2014.59.0703.abstract

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