评估有资格接受avelumab 维持治疗的晚期尿路上皮癌患者的真实世界特征：一项多国回顾性病历审查。
Evaluating Real-World Characteristics of Patients With Advanced Urothelial Carcinoma Eligible for Avelumab Maintenance Therapy: A Multicountry Retrospective Medical Chart Review.
机构信息
Department of Medical Oncology, Dana-Farber Cancer Center and IMIM Research Lab, Harvard Medical School, Boston, MA.
Pfizer, New York, NY.
出版信息
Clin Genitourin Cancer. 2023 Aug;21(4):459-466. doi: 10.1016/j.clgc.2023.03.011. Epub 2023 Mar 31.
INTRODUCTION
Urothelial carcinoma (UC) is a malignancy of the urothelium that encompasses the renal pelvis, bladder, and urethra. Current treatment guidelines for advanced (ie, locally advanced or metastatic) UC recommend using avelumab maintenance therapy in patients with nonprogressive disease following first-line platinum-based chemotherapy. This study aimed to assess the representativeness of the patient population in the JAVELIN Bladder 100 (JB-100) trial, which examined the efficacy and safety of avelumab first-line maintenance, vs. real-world patients with advanced UC that had not progressed with first-line platinum-based chemotherapy treated between 2015 and 2018 by reviewing demographic and clinical characteristics.
PATIENTS AND METHODS
A medical chart review (MCR) study collected demographics and treatment characteristics for patients with advanced UC in the United States, the United Kingdom, and France. Data were analyzed descriptively for review with data collected from patients enrolled in JB-100.
RESULTS
Clinical characteristics were consistent between JB-100 and the MCR. Most patients were male, received 4 to 6 cycles of platinum-based chemotherapy, and had an Eastern Cooperative Oncology Group performance status of 0 or 1. All patients in the MCR had either stable disease or a response with platinum-based chemotherapy (∼75% achieved a complete or partial response). Fewer than half (42.5%) of all patients in the MCR received subsequent therapy.
CONCLUSION
Patient demographics, clinical characteristics, and treatment patterns from a MCR of patients with advanced UC that had not progressed following first-line platinum-based chemotherapy appeared similar to data from patients enrolled in JB-100. Future studies should examine whether real-world outcomes are consistent with findings from JB-100.
GOV IDENTIFIER
NCT02603432.
简介
尿路上皮癌（UC）是一种发生于尿路上皮的恶性肿瘤，包括肾盂、膀胱和尿道。对于局部晚期或转移性 UC 患者，目前的高级别（即局部晚期或转移性）治疗指南建议在一线铂类化疗后疾病无进展的情况下，采用avelumab 维持治疗。本研究旨在评估 JAVELIN Bladder 100（JB-100）试验中患者人群的代表性，该试验检查了一线维持用avelumab 的疗效和安全性，与 2015 年至 2018 年期间未接受一线基于铂类化疗治疗的进展性晚期 UC 患者的真实世界数据进行比较，这些患者接受了一线基于铂类化疗治疗且疾病未进展。
患者和方法
一项医疗记录回顾（MCR）研究收集了美国、英国和法国晚期 UC 患者的人口统计学和治疗特征。对数据进行了描述性分析，以便与 JB-100 患者的数据进行回顾。
结果
JB-100 与 MCR 的临床特征一致。大多数患者为男性，接受了 4 至 6 个周期的铂类化疗，且东部肿瘤协作组（ECOG）体能状态为 0 或 1。MCR 中的所有患者均对铂类化疗表现为疾病稳定或有反应（约 75%的患者达到完全或部分缓解）。不到一半（42.5%）的 MCR 患者接受了后续治疗。
结论
MCR 中未接受一线基于铂类化疗的进展性晚期 UC 患者的人口统计学、临床特征和治疗模式与 JB-100 患者的数据相似。未来的研究应检查真实世界的结果是否与 JB-100 的结果一致。
美国国立卫生研究院注册号
NCT02603432。
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