Yasuoka Shotaro, Minegishi Toshihiko, Kojima Shingo, Okuyama Kotoba, Fukasawa Toshiki, Akahane Mizuho, Uenaka Hidetoshi, Ito Yuichiro, Miyake Makito
Medical Affairs, MSD K.K., Tokyo, Japan.
Medical Affairs, MSD K.K., Tokyo, Japan.
Urol Oncol. 2025 May;43(5):329.e1-329.e8. doi: 10.1016/j.urolonc.2024.09.020. Epub 2024 Oct 15.
Cisplatin-based chemotherapy has traditionally been the standard treatment for unresectable or metastatic urothelial carcinoma (mUC). Recently, the longstanding paradigm has changed with the emergence of immune checkpoint inhibitors and antibody-drug conjugates, such as pembrolizumab and enfortumab vedotin (EV). This longitudinal descriptive study aimed to identify real-world treatment patterns and assess the outcomes of patients with mUC between 2010 and 2023.
Patients with mUC who received first-line systemic therapy were identified from a Japanese electronic medical records database. A Sankey diagram was used to present the proportion of patients who transitioned to second- and third-line therapies. Kaplan-Meier survival analysis was used to estimate the time to next treatment (TTNT) and overall survival (OS).
A total of 794 patients were included in this study. The median age of the patients was 73.0 years, and 72.9% were male. The most common primary tumor site was the bladder (59.7%). First-line therapy comprised cisplatin-based regimens in 52.0% of the patients (11.8% at standard doses, 32.4% at reduced doses, and 7.8% at unknown doses), carboplatin-based regimens in 32.1%, and other regimens in 15.9%. Among the patients enrolled after 2017, following the approval of pembrolizumab for mUC progressing after chemotherapy in Japan, 58.2% received pembrolizumab as second-line therapy, and 19.1% received EV monotherapy as third-line therapy. The median OS for the total population was 24.1 months, with patients enrolled between 2010 and 2016 having a shorter OS (21.1 months) than those enrolled between 2017 and 2022 (24.9 months). For patients with eGFRs of ≥60 and <60 mL/min/1.73 m, the median OS was 24.1 and 23.8 months, respectively.
Platinum-based regimens, including reduced-dose cisplatin and carboplatin, remain the predominant first-line systemic therapies. Since 2017, pembrolizumab and EV have become widespread choices for second-line and subsequent treatments, gradually surpassing the previously prevalent platinum-based regimens. The introduction of these novel therapies might have prolonged the OS of patients with mUC. A plain language summary is available in this article.
传统上，以顺铂为基础的化疗一直是不可切除或转移性尿路上皮癌（mUC）的标准治疗方法。最近，随着免疫检查点抑制剂和抗体药物偶联物（如帕博利珠单抗和恩扎妥昔单抗（EV））的出现，这一长期以来的模式发生了变化。这项纵向描述性研究旨在确定真实世界中的治疗模式，并评估2010年至2023年间mUC患者的治疗结果。
从日本电子病历数据库中识别接受一线全身治疗的mUC患者。使用桑基图展示过渡到二线和三线治疗的患者比例。采用Kaplan-Meier生存分析来估计下次治疗时间（TTNT）和总生存期（OS）。
本研究共纳入794例患者。患者的中位年龄为73.0岁，72.9%为男性。最常见的原发肿瘤部位是膀胱（59.7%）。一线治疗中，52.0%的患者采用以顺铂为基础的方案（标准剂量占11.8%，低剂量占32.4%，剂量未知占7.8%），32.1%采用以卡铂为基础的方案，15.9%采用其他方案。在2017年后入组的患者中，自帕博利珠单抗在日本被批准用于化疗后进展的mUC以来，58.2%的患者接受帕博利珠单抗作为二线治疗，19.1%的患者接受EV单药治疗作为三线治疗。总体人群的中位OS为24.1个月，2010年至2016年入组的患者OS较短（21.1个月），而2017年至2022年入组的患者OS较长（24.9个月）。对于估算肾小球滤过率（eGFR）≥60和<60 mL/min/1.73 m²的患者，中位OS分别为24.1个月和23.8个月。
包括低剂量顺铂和卡铂在内的铂类方案仍然是主要的一线全身治疗方法。自2017年以来，帕博利珠单抗和EV已成为二线及后续治疗的广泛选择，逐渐超过了先前普遍使用的铂类方案。这些新型疗法的引入可能延长了mUC患者的OS。本文提供了通俗易懂的总结。
