Clin Cancer Res:卡瑞珠单抗+法米替尼在晚期肾癌中表现出有效且持久的抗肿瘤活性

2021-08-24 Nebula MedSci原创

卡瑞珠单抗联合法米替尼在晚期或转移性肾细胞癌患者中展现出有效且持久的抗肿瘤活性

阻断免疫检查点和血管生成是晚期或转移性肾细胞癌(RCC)的有效治疗策略。本文报告了一项开放标签的、多中心的、2 期篮子研究,卡瑞珠单抗(Camrelizumab)联合法米替尼(Famitinib)治疗晚期或转移性 RCC 的疗效和安全性。

在该研究中,受试患者接受卡瑞珠单抗(200 mg,静脉,1/3周)和法米替尼(20 mg,口服,1/日)治疗。主要终点是客观缓解率(ORR)。

总队列的无进展生存期

共招募了38位患者,包括13位(34.2%)初治的和25位(65.8%)既往治疗过的患者。从招募入组到截止日期的中位持续时间为16.5个月,23位患者获得了经证实的客观缓解,ORR为60.5%(95%CI 43.4-76.0),而且其中18位(78.3%)缓解者仍处于缓解中,Kaplan-Meier 估计的中位缓解持续时间仍未达到(范围 1.0+~14.8+个月)。中位无进展生存期(PFS)为14.6个月(95% CI 6.2-未达到)。

初治和既往治疗过的患者的无进展生存期

初治患者和既往治疗过的患者的ORR分别是84.6% (95% CI 54.6-98.1) 和 48.0% (95% CI 27.8-68.7),中位PFS分别是未达到和13.4个月(95% CI 4.1-未达到)。

部分治疗相关不良反应事件

最常见的3-4级治疗相关不良反应事件有蛋白尿(18.4%)、高血压(18.4%)、中性粒细胞计数降低(13.2%)、掌跖红斑感觉异常综合征(10.5%)和高甘油三酯血症(10.5%)。无治疗相关死亡,也无新的安全性问题。

总之,卡瑞珠单抗联合法米替尼在晚期或转移性肾细胞癌患者(无论是在初治还是既往治疗过)中展现出有效且持久的抗肿瘤活性

原始出处:

Qu Yuan-Yuan,Zhang Hai-Liang,Guo Hongqian et al. Camrelizumab plus famitinib in patients with advanced or metastatic renal cell carcinoma: data from an open-label, multicenter phase 2 basket study.[J] .Clin Cancer Res, 2021, https://doi.org/10.1158/1078-0432.CCR-21-1698

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