Treatment patterns, indicators of receiving systemic treatment, and clinical outcomes in metastatic urothelial carcinoma: A retrospective analysis of real-world data in Germany.
Authors: Niegisch Guenter , Grimm Marc-Oliver , Hardtstock Fraence , Krieger Julia , Starry Alexandra , Osowski Ulrike , Guenther Silke , Deiters Barthold , Maywald Ulf , Wilke Thomas , Kearney Mairead 
Published: March 2023

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Background: This study assessed real-world treatment (tx) and outcomes in patients with metastatic urothelial carcinoma (mUC) in Germany. Methods: Using 2 statutory health insurance (SHI) claims databases (SHI 1 and SHI 2; 2013-2020, ≈8 million insured), adults with an incident mUC diagnosis from 2015-2019 were identified. Those with other malignant tumors were excluded. Patients were observed for ≥12 mo after incident mUC diagnosis (index) or until death. Treated patients were delineated into 3 groups based on first-line (1L) tx received: platinum-based chemotherapy (PB CT), non–PB CT, and immunotherapy (IO). Patient characteristics were analyzed descriptively. Multivariable logistic regression was used to identify factors associated with receiving tx. Overall survival (OS) was calculated from 1L tx initiation by Kaplan-Meier estimation. Analyses were done separately for each database. Results: The study included 3,226 patients with mUC (male, 70.8%), with a mean (SD) follow-up of 13.8 mo (16.1). The mean (range) age was 73.8 y (23-99), and the mean (SD) Elixhauser Comorbidity score was 17.6 (11.4). Overall, 1,286 patients (39.9%) received tx in the first 12 mo post index; PB CT was the most common 1L tx (n=825, 64.2%), followed by non–PB CT (n=322, 25.0%) and IO (n=139, 10.8%). Over time, the number of patients receiving 1L tx increased (2015, 35.8%; 2019, 45.7%). Multiple factors were associated with a higher likelihood of receiving 1L tx: younger age (OR, 0.93), male sex (OR, 0.83), lower comorbidity score (OR, 0.97), previous UC-related interventions (OR, 1.65), and a more recent mUC diagnosis (OR, 1.11). In treated patients, the unadjusted median OS (interquartile range [IQR]) from index diagnosis was 13.7 mo (7-33) for SHI 1 and 13.8 mo (7-42) for SHI 2. In untreated patients, the median OS (IQR) from index diagnosis was 3.0 mo (1-11) for SHI 1 and 3.6 mo (1-18) for SHI 2. The median OS (IQR) after 1L tx initiation in PB CT–treated patients was 12.9 mo (6-33) for SHI 1 and 13.8 mo (7-49) for SHI 2; in non–PB CT–treated patients was 11.2 mo (4-36) for SHI 1 and 6.5 mo (3-15) for SHI 2; and in IO-treated patients was 4.11 mo (2-14) for SHI 1 and 8.19 mo (3 to not reached) for SHI 2. Conclusions: Our study describes real-world tx patterns/rates and clinical outcomes in patients with mUC in Germany, and highlights that the majority received no systemic tx within the first 12 mo, despite a positive trend in 1L tx rates over time. Treated patients were more likely to be younger, male, and have fewer comorbidities vs untreated patients. Systemic tx was associated with longer OS. Among treated patients, OS was longer in those receiving 1L PB CT vs other 1L tx. Future research should explore the unmet need in untreated patients to confirm alignment with updated tx guidelines and newer standards of care.