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二期试验

原文发布日期：2024-02-14

英文摘要：

摘要翻译：

原文链接：

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二期试验

a phase Ib trial

原文发布日期：2024-02-14

英文摘要：

We report the results of 24 women, 50% (N = 12) with hormone receptor-positive breast cancer and 50% (N = 12) with advanced triple-negative breast cancer, treated with entinostat + nivolumab + ipilimumab from the dose escalation (N = 6) and expansion cohort (N = 18) of ETCTN-9844 (NCT02453620). The primary endpoint was safety. Secondary endpoints were overall response rate, clinical benefit rate, progression-free survival and change in tumor CD8:FoxP3 ratio. There were no dose-limiting toxicities. Among evaluable participants (N = 20), the overall response rate was 25% (N = 5), with 40% (N = 4) in triple-negative breast cancer and 10% (N = 1) in hormone receptor-positive breast cancer. The clinical benefit rate was 40% (N = 8), and progression-free survival at 6 months was 50%. Exploratory analyses revealed that changes in myeloid cells may contribute to responses; however, no correlation was noted between changes in CD8:FoxP3 ratio, PD-L1 status and tumor mutational burden and response. These findings support further investigation of this treatment in a phase II trial.

摘要翻译：

我们报告了24名受试者的结果，其中50%（N=12）患有激素受体阳性乳腺癌，50%（N=12）患有进展性三阴性乳腺癌。这些患者接受的是艾尼索坦+尼单表糖蛋白1号+伊维昔单抗的治疗方案，来自ETCTN-9844试验中的剂量递增阶段（N=6）和扩展组（N=18）。主要终点是安全事件，次要终点包括总响应率、临床疗效率、无进展生存期以及肿瘤中CD8:FoxP3比例的变化。在可评估的参与者（N=20）中，总响应率为25%（N=5），其中三阴性乳腺癌患者中有40%（N=4）反应，激素受体阳性乳腺癌患者中有10%（N=1）。临床疗效率为40%（N=8），6个月的无进展生存期为50%。探索性分析表明，白细胞的变化可能与反应有关；然而，CD8:FoxP3比例、PD-L1状态和肿瘤基因突变负担与反应之间的相关性没有发现。这些结果支持进一步在二期试验中对此治疗进行研究。