Real-World Evidence, Evidera, Waltham, MA, USA.
Teradata UK Ltd, London, UK.
Cancer Epidemiol. 2019 Jun;60:121-127. doi: 10.1016/j.canep.2019.03.013. Epub 2019 Apr 4.
Metastatic urothelial carcinoma (mUC) treated with chemotherapy is associated with poor survival; however, as the field of immuno-oncology continues to evolve, new immunotherapies have recently become available. The current study aimed to assess real-world characteristics, treatment patterns, and overall survival (OS) of patients with mUC treated in the United States (US).
We conducted a retrospective, observational analysis of patients with mUC from the Flatiron Health longitudinal database from 2011 to 2017. Treatment patterns of patients who started systemic first-line therapy (1 L cohort) or second-line therapy following platinum-based first-line therapy (2 L cohort) were described using medication order and administration data. Kaplan-Meier analyses were used to assess OS from the start of first- and second-line therapy in the 1 L and 2 L cohorts, respectively.
A total of 1811 patients qualified for the 1 L cohort (median age [range], 72 [32-84] years); 476 met the criteria for the 2 L cohort (median age [range], 71 [40-84] years). The most common first- and second-line therapies were carboplatin + gemcitabine (n = 562 [34.6%]) and atezolizumab (n = 90 [13.1%]), respectively, in the 1 L cohort. Median OS was 12.7 months (95% confidence interval [CI] 11.8, 13.4) in the 1 L cohort and 8.3 months (95% CI 7.2, 8.9) in the 2 L cohort.
Consistent with clinical trial results, survival was poor in this real-world study in patients with mUC, indicating a continued unmet need. As immunotherapy becomes more commonplace in the treatment of mUC, future studies are needed to understand its real-world impact on survival.
接受化疗治疗的转移性尿路上皮癌（mUC）患者预后较差；然而，随着肿瘤免疫治疗领域的不断发展，新的免疫疗法最近已问世。本研究旨在评估美国 mUC 患者的真实世界特征、治疗模式和总生存期（OS）。
我们对 2011 年至 2017 年 Flatiron 健康纵向数据库中的 mUC 患者进行了回顾性、观察性分析。通过药物医嘱和管理数据描述了接受系统一线治疗（1L 队列）或铂类一线治疗后二线治疗（2L 队列）的患者的治疗模式。Kaplan-Meier 分析分别用于评估 1L 和 2L 队列中一线和二线治疗开始后的 OS。
共有 1811 例患者符合 1L 队列标准（中位年龄[范围]，72[32-84]岁）；476 例患者符合 2L 队列标准（中位年龄[范围]，71[40-84]岁）。1L 队列中最常见的一线和二线治疗分别为卡铂+吉西他滨（n=562[34.6%]）和阿特珠单抗（n=90[13.1%]）。1L 队列的中位 OS 为 12.7 个月（95%CI 11.8，13.4），2L 队列为 8.3 个月（95%CI 7.2，8.9）。
与临床试验结果一致，本真实世界研究中 mUC 患者的生存状况较差，表明存在未满足的需求。随着免疫疗法在 mUC 治疗中的应用越来越普遍，需要进一步研究以了解其对生存的实际影响。
