Clin Cancer Res:立体定向放疗和原位病毒基因疗法可增强免疫检查点阻滞对转移性三阴乳腺癌的疗效

2022-09-09 MedSci原创 MedSci原创

立体定向放疗和原位病毒基因疗法可增强免疫检查点阻滞对转移性三阴乳腺癌的疗效

三阴性乳腺癌 (TNBC) 是一种侵袭性的、难以治疗的疾病。局部晚期不可切除或转移性TNBC (mTNBC) 的中位总生存期 (OS) 为8-13个月。与其他类型乳腺癌相比,TNBC有更高的PD-L1表达水平,使得免疫检查点封闭(ICB)成为了一种潜在的有吸引力的治疗方法。

这项单臂、开放标签的2期试验,目的是评估通过立体定向放疗(SBRT)和腺病毒介导的单纯疱疹病毒胸苷激酶表达(ADV/HSV-tk)联合valacyclovir基因治疗增强单剂免疫检查点阻滞的效果。

在该试验中,mTNBC患者接受ADV/HSV-tk瘤内注射,然后采用SBRT对注射肿瘤部位进行放射,最后予以派姆单抗。主要终点是临床获益率(CBR;完全缓解率[CR],部分缓解率[PR],或疾病稳定[SD]≥24周)。次要终点包括治疗持续时间(DoT)、总生存期(OS)和安全性。探索性终点包括对治疗的免疫反应。


有无应答缓解患者的总生存率

共招募了28位患者,全部接受了研究治疗。在6位患者中观察到了CBR(21.4%),包括两例完全缓解、1例部分缓解和3例疾病稳定。有临床获益的患者获得持续缓解,中位DoT是9.6个月,中位OS是14.7个月。总人群的中位OS是6.6个月。

该联合方案的耐受性良好。与时间流式细胞术 (CyTOF) 和成像质细胞术 (IMC) 相关的研究显示,有反应者的CD8 T细胞显著增加,无反应者的髓系细胞显著增加。

总之,从该联合方案中获得临床收益的转移性三阴乳腺癌患者的中位总生存期延长了两倍以上。该疗法的耐受性良好。早期检测到CD8 T细胞和髓系细胞的增多可提示是否有临床获益。

原始出处:

Kai Sun, Yitian Xu, Licheng Zhang, et al. A Phase 2 Trial of Enhancing Immune Checkpoint Blockade by Stereotactic Radiation and In Situ Virus Gene Therapy in Metastatic Triple-Negative Breast Cancer. Clin Cancer Res 2022; https://doi.org/10.1158/1078-0432.CCR-22-0622

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    2022-11-28 liao1632
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