Morgans Alicia K, Sonpavde Guru P, Shih Vanessa, Wright Phoebe, Hepp Zsolt, Willmon Candice L, Chang Nancy N, Mucha Lisa, Naga Sai Sriteja Boppudi, Powles Thomas
Dana-Farber Cancer Institute, Boston, MA.
AdventHealth Cancer Institute, Orlando, FL.
Clin Genitourin Cancer. 2025 Feb;23(1):102270. doi: 10.1016/j.clgc.2024.102270. Epub 2024 Nov 15.
1L PBC has historically been recommended for patients with la/mUC. Maintenance avelumab is recommended for patients without disease progression following 1L PBC. Real-world data on the proportion of patients eligible for maintenance avelumab are limited, and outcomes among patients ineligible for maintenance avelumab are uncertain. This study assessed the proportion of patients with la/mUC initiating 1L PBC who were maintenance-avelumab eligible and real-world outcomes following 1L PBC by maintenance-avelumab eligibility.
A retrospective, observational study was conducted using a longitudinal electronic health record-derived database comprising de-identified patient-level structured and unstructured data including adults with Ia/mUC who received ≥1 dose of 1L PBC (April 2020-January 2022). The proportion of patients eligible for maintenance avelumab (real-world stable disease, partial response, or complete response following 1L PBC) was estimated and median overall survival (mOS) assessed for maintenance avelumab-eligible and -ineligible patients.
Of 336 patients with Ia/mUC treated with 1L PBC (55.4% received cisplatin-based treatment 44.6% carboplatin-based treatment); 181 (54%) were maintenance-avelumab eligible; and 138 (41%) maintenance-avelumab ineligible (17 [5%] were nonevaluable). Of 181 maintenance-avelumab-eligible patients, 67 (37.0%; 19.9% of all 1L PBC-treated patients) received maintenance avelumab. mOS (95% CI) among all 1L PBC-treated patients was 15.0 (12.2-19.6) months and among maintenance-avelumab-ineligible patients was 8.0 (6.7-10.3) months; whereas among maintenance-avelumab-eligible patients (including 37% who received maintenance avelumab), mOS was 27.6 (23.4-not reached) months.
In this study, approximately half of 1L PBC-treated patients were maintenance-avelumab eligible, and one-fifth received it. Real-world OS remains short for the overall 1L PBC-treated population. These results support the use of treatment-guideline preferred 1L treatment options that demonstrate survival benefit for all patients with la/mUC, and are available to patients irrespective of their eligibility for cisplatin, or response to PBC.
一线铂类化疗(1L PBC)历来被推荐用于晚期/转移性尿路上皮癌(la/mUC)患者。对于接受1L PBC治疗后无疾病进展的患者,推荐使用阿维鲁单抗进行维持治疗。关于符合阿维鲁单抗维持治疗条件的患者比例的真实世界数据有限,而不符合阿维鲁单抗维持治疗条件的患者的结局尚不确定。本研究评估了启动1L PBC治疗的la/mUC患者中符合阿维鲁单抗维持治疗条件的比例,以及根据阿维鲁单抗维持治疗条件划分的1L PBC治疗后的真实世界结局。
使用一个纵向电子健康记录衍生数据库进行了一项回顾性观察研究,该数据库包含去识别化的患者层面结构化和非结构化数据,包括接受≥1剂1L PBC治疗(2020年4月至2022年1月)的成年la/mUC患者。估计了符合阿维鲁单抗维持治疗条件(1L PBC治疗后真实世界疾病稳定、部分缓解或完全缓解)的患者比例,并评估了符合和不符合阿维鲁单抗维持治疗条件的患者的中位总生存期(mOS)。
336例接受1L PBC治疗的la/mUC患者中(55.4%接受基于顺铂的治疗,44.6%接受基于卡铂的治疗);181例(54%)符合阿维鲁单抗维持治疗条件;138例(41%)不符合阿维鲁单抗维持治疗条件(17例[5%]无法评估)。在181例符合阿维鲁单抗维持治疗条件的患者中,67例(37.0%;占所有接受1L PBC治疗患者的19.9%)接受了阿维鲁单抗维持治疗。所有接受1L PBC治疗的患者的mOS(95%CI)为15.0(12.2 - 19.6)个月,不符合阿维鲁单抗维持治疗条件的患者为8.0(6.7 - 10.3)个月;而在符合阿维鲁单抗维持治疗条件的患者中(包括37%接受阿维鲁单抗维持治疗的患者),mOS为27.6(23.4 - 未达到)个月。
在本研究中,约一半接受1L PBC治疗的患者符合阿维鲁单抗维持治疗条件,五分之一的患者接受了该治疗。对于接受1L PBC治疗的总体人群,真实世界的总生存期仍然较短。这些结果支持使用治疗指南推荐的一线治疗方案,这些方案对所有la/mUC患者均显示出生存获益,且无论患者是否符合顺铂治疗条件或对PBC的反应如何均可使用。