BACKGROUND Atezolizumab, a programmed-death ligand-1 (PD-L1) inhibitor, is a novel treatment option for patients with metastatic urothelial cancer (mUC). Clinical prognostic factors, survival outcomes, and the safety of patients with mUC treated with atezolizumab, in a real-world setting, were investigated. PATIENTS AND METHODS 62 patients with mUC, treated at the Institute of Oncology Ljubljana between May 8th 2018 and Dec 31st 2019, were included. Response rates and immune-related adverse events (irAE) were collected. Progression-free survival and overall survival times were assessed using the Kaplan-Meier method. The Cox proportional hazards model was applied to identify the factors affecting survival. RESULTS Of 62 patients, five (8.1%) have not yet been evaluated and 20 (32%) died prior to the first radiographic evaluation. We observed clinical benefit in 19 (33%), objective response in 12 (21%), and complete response in five (9%) patients. Median overall survival for the whole population was 6.8 (95% CI, 2.6-11.0), for platinum-naïve 8.7 (95% CI: 0.8-16.5), and for the platinum-treated group 6.8 (95% CI, 3.7-10) months. At the 5.8 (0.3-23.1) month median follow-up, the median duration of the response was not reached. IrAE occurred in 20 (32%) patients and seven (11%) of them discontinued the treatment. Multivariate analysis in platinum-treated patients showed that a treatment-free interval of more than six months was prognostic for overall survival (OS). CONCLUSIONS Responses to atezolizumab led to long disease remission in a subset of our patients. The median OS in our real-world population was compromised by a large percentage of patients with poor ECOG performance status (PS). A treatment-free interval from chemotherapy was associated with the longer survival of platinum-treated patients with mUC receiving further atezolizumab.

中文翻译：

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在现实世界的实践中，以铂类为基础的化疗控制疾病对转移性尿路上皮癌患者的生存具有预测意义。

背景 Atezolizumab 是一种程序性死亡配体-1 (PD-L1) 抑制剂，是转移性尿路上皮癌 (mUC) 患者的一种新型治疗选择。研究了在真实世界环境中接受阿特珠单抗治疗的 mUC 患者的临床预后因素、生存结果和安全性。患者与方法 2018 年 5 月 8 日至 2019 年 12 月 31 日期间在卢布尔雅那肿瘤研究所治疗​​的 62 名 mUC 患者被纳入研究。收集反应率和免疫相关不良事件（irAE）。使用 Kaplan-Meier 方法评估无进展生存期和总生存期。应用 Cox 比例风险模型来确定影响生存的因素。结果 62 名患者中，5 名 (8.1%) 尚未接受评估，20 名 (32%) 在第一次放射学评估之前死亡。我们观察到 19 名 (33%) 患者的临床获益、12 名 (21%) 患者的客观反应和 5 名 (9%) 患者的完全反应。整个人群的中位总生存期为 6.8 (95% CI, 2.6-11.0)，铂类初治组为 8.7 (95% CI: 0.8-16.5)，铂类治疗组为 6.8 (95% CI, 3.7-10) ) 个月。在 5.8 (0.3-23.1) 个月的中位随访中，未达到反应的中位持续时间。20 名 (32%) 患者发生 IrAE，其中 7 名 (11%) 停止治疗。铂类治疗患者的多变量分析表明，超过 6 个月的无治疗间隔是总生存期 (OS) 的预后因素。结论 对 atezolizumab 的反应导致我们的一部分患者的疾病长期缓解。大部分 ECOG 体能状态 (PS) 较差的患者影响了我们现实世界人群的中位 OS。化疗后的无治疗间隔与接受进一步 atezolizumab 的铂类治疗的 mUC 患者的较长生存期相关。