Clinical trials revealed significant antitumor activity for immune checkpoint inhibitors (ICI) in metastatic urothelial carcinoma (mUC). Due to their strict eligibility criteria, clinical trials include selected patient cohorts, and thus do not necessarily represent real-world population outcomes. In this multicentric, retrospective study, we investigated real-world data to assess the effectiveness of pembrolizumab and atezolizumab and to evaluate the prognostic value of routinely available clinicopathological and laboratory parameters. Clinical and follow-up data from mUC patients who received ICIs (01/2017-12/2021) were evaluated. Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and duration of response (DOR) were used as endpoints. Patients’ (n = 210, n = 76 atezolizumab and 134 pembrolizumab) median OS and PFS were 13.6 and 5.9 months, respectively. Impaired ECOG-PS, the presence of visceral, liver or bone metastases, and hemoglobin levels were independently associated with poor OS and DCR. Furthermore, Bellmunt risk factors and the enhanced Bellmunt-CRP score were shown to be prognostic for OS, PFS and DCR. In conclusion, ICIs are effective treatments for a broad range of mUC patients. Our results confirmed the prognostic value of numerous risk factors and showed that Bellmunt risk scores can further be improved when adding CRP to the model.

临床试验显示免疫检查点抑制剂 (ICI) 对转移性尿路上皮癌 (mUC) 具有显着的抗肿瘤活性。由于其严格的资格标准，临床试验包括选定的患者队列，因此不一定代表现实世界的人群结果。在这项多中心回顾性研究中，我们调查了真实世界数据，以评估派姆单抗和阿替利珠单抗的有效性，并评估常规可用的临床病理学和实验室参数的预后价值。对接受 ICI（01/2017-12/2021）的 mUC 患者的临床和随访数据进行了评估。总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）、疾病控制率（DCR）和缓解持续时间（DOR）作为终点。患者（n = 210、n = 76 atezolizumab 和 134 pembrolizumab）的中位 OS 和 PFS 分别为 13.6 个月和 5.9 个月。ECOG-PS 受损、内脏、肝脏或骨转移的存在以及血红蛋白水平与 OS 和 DCR 不良独立相关。此外，Bellmunt 风险因素和增强的 Bellmunt-CRP 评分被证明可以预测 OS、PFS 和 DCR。总之，ICIs 对于广泛的 mUC 患者来说是有效的治疗方法。我们的结果证实了众多风险因素的预后价值，并表明在模型中添加 CRP 时可以进一步改善 Bellmunt 风险评分。