Eligible patients with muscle-invasive bladder cancer (MIBC) typically receive cisplatin-based chemotherapy before radical cystectomy, although approximately 50% will have disease relapse within 3 years. Now, newly published data from the phase III NIAGARA trial simultaneously presented at the ESMO Congress 2024 demonstrate that adding perioperative durvalumab to neoadjuvant chemotherapy improves outcomes in this setting.

A total of 1,063 patients were randomly allocated (1:1) to receive neoadjuvant gemcitabine–cisplatin followed by radical cystectomy with or without neoadjuvant and adjuvant durvalumab (durvalumab and control group, respectively). Pathological complete response (pCR) and event-free survival (EFS) were the co-primary end points.

符合条件的肌层浸润性膀胱癌 （MIBC） 患者通常在根治性膀胱切除术前接受基于顺铂的化疗，但大约 50% 的患者会在 3 年内复发。现在，在 2024 年 ESMO 年会上同时提交的 III 期 NIAGARA 试验的新发表数据表明，在新辅助化疗中加入围手术期 durvalumab 可改善这种情况的预后。

共有 1,063 名患者被随机分配 （1：1） 接受新辅助吉西他滨-顺铂，然后进行根治性膀胱切除术，联合或不联合新辅助 durvalumab 和辅助 durvalumab （分别为 durvalumab 和对照组）。病理完全缓解 （pCR） 和无事件生存期 （EFS） 是共同的主要终点。