Real-world treatment patterns and outcomes of patients with unresectable or metastatic urothelial carcinoma receiving systemic therapy in Japan

•A study in patients with unresectable or metastatic urothelial carcinoma (mUC).•Half of patients received cisplatin-based regimens as first-line therapy.•After 2017, 58.2% of patients received pembrolizumab as second-line therapy.•After 2017, 19.1% of patients received enfortumab vedotin as third-line therapy.•Overall survival of patients with mUC remains poor. 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