Clin Cancer Res:法米替尼、卡瑞利珠单抗和nab-紫杉醇联合治疗晚期三阴性乳腺癌

2022-03-25 xiaozeng MedSci原创

法米替尼、卡瑞利珠单抗和nab-紫杉醇联合治疗晚期三阴性乳腺癌具有较好的疗效,且耐受性良好

卡瑞利珠单抗 (Camrelizumab) 是一种靶向程序性细胞死亡蛋白 1 (PD-1) 的单克隆抗体,联合nab-紫杉醇在难治性转移性免疫调节性三阴性乳腺癌 (TNBC) 中表现出了良好的抗肿瘤活性。法米替尼 (Famitinib) 是一种靶向VEGFR2、PDGFR 和 c-kit 的酪氨酸激酶抑制剂。

本研究旨在评估法米替尼、卡瑞利珠单抗和nab-紫杉醇联合治疗晚期免疫调节性三阴性乳腺癌的疗效和安全性。

研究流程

这是一项开放标签、单臂的II期研究,招募了既往未治疗过的晚期免疫调节性三阴性乳腺癌(CD8 IHC染色≥10%)患者,予以法米替尼(20 mg,口服,第1天至第28天)、卡瑞利珠单抗(200 mg,静滴,第1天和第15天)、nab-紫杉醇(100 mg/m2,第1天、第8天和第15天),28天为一疗程。主要终点是客观缓解率(ORR)。关键的次要终点包括无进展生存期(PFS)、总生存期(OS)、缓解持续时间(DOR)、安全性和探索性的生物标志物分析。

中位无进展生存期和总生存期

共招募了48位患者,均接受了研究治疗。中位随访了17.0个月后,证实的客观缓解率为81.3%,包括5例完全缓解和34例部分缓解中位无进展生存期是13.6个月,中位缓解持续时间是14.9个月。中位总生存期未达到。无治疗相关死亡报道。

不良反应

在30位进行了IHC检查的患者中,有13位(43.3%)为PD-L1阴性;PD-L1与较好的治疗反应相关。PKD1和KAT6A体细胞突变与治疗反应相关。

总而言之,该三联方案在既往未治疗过的晚期免疫调节性三阴性乳腺癌中有较好的疗效,且耐受性良好。此外,有一项对该研究结果进行验证的随机对照的临床试验正在进行中。

 

原始出处:

Li Chen; Yi-Zhou Jiang; Song-Yang Wu, et al. Famitinib with Camrelizumab and Nab-Paclitaxel for Advanced Immunomodulatory Triple-Negative Breast Cancer (FUTURE-C-Plus): An Open-Label, Single-Arm, Phase II Trial. Clin Cancer Res OF1–OF11. https://doi.org/10.1158/1078-0432.CCR-21-4313

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    2022-03-25 yangchou

    好文章,值得一读。

    0

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