Ruiz-Bañobre J, Molina-Díaz A, Fernández-Calvo O, Fernández-Núñez N, Medina-Colmenero A, Santomé L, Lázaro-Quintela M, Mateos-González M, García-Cid N, López-López R, Vázquez S, Anido-Herranz U
Medical Oncology Department, University Clinical Hospital of Santiago de Compostela, University of Santiago de Compostela (USC), Santiago de Compostela, Spain; Translational Medical Oncology Group (Oncomet), Health Research Institute of Santiago (IDIS), University Clinical Hospital of Santiago de Compostela, University of Santiago de Compostela (USC), CIBERONC, Santiago de Compostela, Spain.
Medical Oncology Department, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.
ESMO Open. 2021 Apr;6(2):100090. doi: 10.1016/j.esmoop.2021.100090. Epub 2021 Mar 16.
Few studies have investigated the safety and efficacy of anti-PD-(L)1 antibodies in metastatic urothelial carcinoma (mUC) in daily clinical practice. Knowledge about the influence of baseline clinical and analytical factors on therapy outcomes is scarce.
We conducted a multicenter retrospective study involving 119 previously treated or untreated mUC patients under anti-PD-(L)1 therapy in a real-world scenario. The objectives of this study were to confirm the safety and efficacy of anti-PD-(L)1 monotherapy and to identify pretreatment factors influencing therapy outcomes. In addition, an independent prognostic model for overall survival (OS) was developed and internally validated.
Median OS was 7.8 months [95% confidence interval (CI), 5.4-10.4], median progression-free survival (PFS) was 2.80 months (95% CI, 2.4-3.4), disease control rate (DCR) was 40% (95% CI, 31-49), and overall response rate (ORR) was 24% (95% CI, 15-31). Presence of peritoneal metastases was associated with poor OS [hazard ratio (HR) = 2.40, 95% CI, 1.08-5.33; P = 0.03]. Use of proton-pump inhibitors (PPI) was associated with poor OS (HR = 1.83, 95% CI, 1.11-3.02; P = 0.02) and PFS (HR = 1.94, 95% CI, 1.22-3.09; P = 0.005), and lower DCR (OR = 0.38, 95% CI, 0.17-0.89; P = 0.03) and ORR (OR = 0.18, 95% CI, 0.02-1.60; P = 0.002). The three risk category prognostic model developed included Eastern Cooperative Oncology Group performance status, PPI use, albumin level, presence of liver metastases, and presence of peritoneal metastases variables and was associated with higher risk of death (HR = 3.00, 95% CI, 1.97-4.56; P = 0.0001).
This study confirms anti-PD-(L)1 monotherapy as a safe and effective treatment option in daily clinical practice for mUC patients. It also describes the presence of peritoneal metastases as an independent prognostic factor for OS and underlines the association between PPI use and worse therapeutic outcomes. Finally, it proposes a new easy-to-use risk-assessment model for OS prediction.
在日常临床实践中，很少有研究调查抗程序性死亡受体-1（PD-1）/程序性死亡配体-1（PD-L1）抗体治疗转移性尿路上皮癌（mUC）的安全性和疗效。关于基线临床和分析因素对治疗结果影响的了解很少。
我们进行了一项多中心回顾性研究，纳入了119例在真实临床场景中接受抗PD-（L）1治疗的既往接受过治疗或未接受过治疗的mUC患者。本研究的目的是确认抗PD-（L）1单药治疗的安全性和疗效，并确定影响治疗结果的预处理因素。此外，还开发了一个用于总生存期（OS）的独立预后模型并进行了内部验证。
中位OS为7.8个月[95%置信区间（CI），5.4 - 10.4]，中位无进展生存期（PFS）为2.80个月（95%CI，2.4 - 3.4），疾病控制率（DCR）为40%（95%CI，31 - 49），总缓解率（ORR）为24%（95%CI，15 - 31）。存在腹膜转移与较差的OS相关[风险比（HR）= 2.40，95%CI，1.08 - 5.33；P = 0.03]。使用质子泵抑制剂（PPI）与较差的OS（HR = 1.83，95%CI，1.11 - 3.02；P = 0.02）和PFS（HR = 1.94，95%CI，1.22 - 3.09；P = 0.005）相关，且DCR较低（OR = 0.38，95%CI，0.17 - 0.89；P = 0.03）和ORR较低（OR = 0.18，95%CI，0.02 - 1.60；P = 0.002）。所开发的三风险类别预后模型包括东部肿瘤协作组体能状态、PPI使用、白蛋白水平、肝转移的存在以及腹膜转移的存在等变量，并且与较高的死亡风险相关（HR = 3.00，95%CI，1.97 - 4.56；P = 0.0001）。
本研究证实抗PD-（L）1单药治疗是mUC患者日常临床实践中一种安全有效的治疗选择。它还将腹膜转移的存在描述为OS的独立预后因素，并强调了PPI使用与较差治疗结果之间的关联。最后，它提出了一种新的易于使用的OS预测风险评估模型。
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