Eur J Cancer:瑞戈非尼联合纳武单抗治疗转移性结直肠癌

2022-05-17 Nebula MedSci原创

瑞戈非尼联合纳武单抗在转移性错配修复正常型结直肠癌患者中的耐受性良好

与错配修复缺陷型 (dMMR) 结直肠癌 (CRC) 相比,错配修复正常型 (pMMR) CRC 通常对抗 PD-1 免疫疗法无反应。近期临床前数据表明,瑞戈非尼(Regorafenib)或可增强抗 PD-1 免疫疗法的抗肿瘤活性。但是,瑞戈非尼联合纳武单抗在难治性转移性 pMMR 结直肠癌患者中的安全性和有效性尚未明确。

本研究旨在评估瑞戈非尼联合纳武单抗在转移性 pMMR CRC 患者中的安全性和有效性。

这是一项I/Ib期研究,采用标准的3+3设计加上最大耐受剂量 (MTD) 的剂量扩展。予以受试患者瑞戈非尼+纳武单抗治疗。主要终点是剂量限制性毒性(DLT)和最大耐受剂量。次要终点包括客观缓解率、安全性和总生存率(OS)。


治疗相关不良反应

共招募了52位患者,其中51位至少接受了一剂研究药物。3位患者经历了剂量限制性毒性(全是3级红疹)。最大耐受剂量定为瑞戈非尼 80 mg和纳武单抗 240 mg,每两周一次。最常见的3/4级治疗相关不良反应有高血压(16%)、红疹(10%)和贫血(6%)。


无进展生存率和总生存率

在40位可评估疗效的患者中,4位(10%)获得了部分缓解,包括一例未明确的缓解,21位(53%)患者病情保持稳定,疾病控制率为63%。中位无进展生存期和总生存期分别是4.3个月和11.1个月

综上所述,瑞戈非尼联合纳武单抗在转移性错配修复正常型结直肠癌患者中的耐受性良好,但抗癌活性有限。

 

原始出处:

Kim Richard D,Kovari Bence P,Martinez Maria et al. A phase I/Ib study of regorafenib and nivolumab in mismatch repair proficient advanced refractory colorectal cancer.[J] .Eur J Cancer, 2022, 169: 93-102. https://doi.org/10.1016/j.ejca.2022.03.026.

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