Department of Urology, Semmelweis University, Üllői út 78/B, Budapest, 1082, Hungary.
Department of Genitourinary Medical Oncology and Pharmacology, National Institute of Oncology, Budapest, Hungary.
Sci Rep. 2023 Oct 13;13(1):17378. doi: 10.1038/s41598-023-44103-9.
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)在转移性尿路上皮癌(mUC)中具有显著的抗肿瘤活性。由于其严格的入选标准,临床试验纳入了特定的患者群体,因此不一定代表真实世界的人群结果。在这项多中心、回顾性研究中,我们研究了真实世界的数据,以评估 pembrolizumab 和 atezolizumab 的有效性,并评估常规临床病理和实验室参数的预后价值。评估了接受 ICI(2017 年 1 月至 2021 年 12 月)的 mUC 患者的临床和随访数据。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 评分受损、存在内脏、肝脏或骨转移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 评分被证明对 OS、PFS 和 DCR 具有预后价值。总之,ICI 是广泛的 mUC 患者的有效治疗方法。我们的结果证实了众多风险因素的预后价值,并表明当将 CRP 添加到模型中时,Bellmunt 风险评分可以进一步提高。