文章目录

多中心，单臂，2期试验

原文发布日期：2024-09-10

英文摘要：

摘要翻译：

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文章：

多中心，单臂，2期试验

a multicenter, single-arm, phase 2 trial

原文发布日期：2024-09-10

英文摘要：

Programmed death 1 blockade (tislelizumab) has been approved for metastatic urothelial carcinoma but not as part of neoadjuvant therapy for muscle-invasive bladder cancer (MIBC). In this multicenter single-arm trial (ChiCTR2000037670), 65 participants with cT2-4aN0M0 MIBC received neoadjuvant gemcitabine–cisplatin plus tislelizumab; 57 of them underwent radical cystectomy (RC). The primary endpoint of pathologic complete response (pCR) rate was 50.9% (29/57, 95% confidence interval (CI) 37.3–64.4%) and the pathologic downstaging (secondary endpoint) rate was 75.4% (43/57, 95% CI 62.2–85.9%) in participants undergoing RC. Genomic and transcriptomic analyses revealed three MIBC molecular subtypes (S): S1 (immune-desert) with activated cell-cycle pathway, S2 (immune-excluded) with activated transforming growth factor-β pathway and S3 (immune-inflamed) with upregulated interferon-α and interferon-γ response. Post hoc analysis showed pCR rates of 16% (3/19, S1), 77% (10/13, S2) and 80% (12/15, S3) (P = 0.006). In conclusion, neoadjuvant gemcitabine–cisplatin plus tislelizumab for MIBC was compatible with an enhanced pCR rate.

摘要翻译：

吉西利珠单抗用于转移性尿路上皮癌的阻断程序死亡1治疗已获批准，但未作为膀胱移行细胞癌（MIBC）新辅助治疗的一部分。在一项多中心单臂研究中（ChiCTR2000037670），65名cT2-4aN0M0 MIBC患者接受了吉西他滨-顺铂联合吉西利珠单抗的新辅助治疗，其中57人接受了 radical cystectomy。主要终点是 pathologic complete response (pCR) 率为 50.9%（29/57，95%置信区间（CI）37.3–64.4%），以及 pathologic downstaging（次要终点）率为 75.4%（43/57，95% CI 62.2–85.9%）。基因组和转录组分析揭示了三个 MIBC 分子亚型（S）：免疫沙漠型 S1 具有激活细胞周期通路；免疫排除型 S2 具有激活 transforming growth factor-β 路径；免疫炎症型 S3 表现为上调 interferon-α 和 interferon-γ应答。回顾性分析显示，pCR 率分别为 16%（3/19, S1），77%（10/13, S2）和 80%（12/15, S3）（P = 0.006）。结论：吉西他滨-顺铂联合吉西利珠单抗用于 MIBC 的新辅助治疗具有增强 pCR 率的兼容性。