Real-world epidemiology and clinical outcomes of bladder cancer patients in Spain: BLARWE multicenter study.
Authors: Puente Javier , Sánchez-Camacho Alberto , Caballero Cristina , Gonzalo Victoria , Fernandez-Rodriguez Ricardo , Guerrero-Ramos Félix , Galvan Ruiz Saray , Fernández Parra Eva , Pujol Eduardo , Martinez Breijo Sara , Gomez De Liaño Lista Alfonso , Rodriguez-Vida Alejo , González Cordero Marta , Pinto Alvaro , Alvarez-Fernandez Carlos , Climent Duran Miguel A. , Baliera Ariela , Rubio-Briones Jose 
Published: February 2025

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Background:
Bladder cancer (BC) is one of the most prevalent oncologic diseases in the world, and its incidence in Spain is among the highest in Europe. The optimal management of patients with muscle-invasive bladder cancer (MIBC) and non-MIBC (NMIBC) remains challenging. Currently, there are clinical trials ongoing that have the potential to change the management of early BC and its standard of care. The aim of this study is to provide a comprehensive description of the epidemiology of BC in Spain, and to generate robust evidence on the clinical characteristics, treatment patterns and clinical outcomes of these patients in routine clinical practice.
Methods:
This multicenter observational study collected adult patients diagnosed with primary or recurrent BC between Jan 1, 2018, and Dec 31, 2018. Patients with histopathological confirmation were included from 16 participating sites, and real-world data was retrospectively collected from medical records. Three cohorts were included: Cohort 1: all cases of BC; cohort 2: high risk NMIBC patients; cohort 3: MIBC patients. The data from cohort 1 presented here includes the incidence of newly diagnosed BC (primary objective) and recurrent or progressive cases (secondary objective) at all stages (NMIBC, MIBC and mBC).
Results:
2071 patients were included, with the information available up to the data cutoff on Sep 13, 2024. The median age was 72 years and 84.9% of patients were male. 66,1% of patients were newly diagnosed, while 33.9% were recurrences/progressions. Most patients had NMIBC (80.8%), while the remaining patients had MIBC (16.5%) and mBC (2.7%), respectively. Patient characteristics at diagnosis according to type of BC are presented in the table. 2.8% of patients received their first treatment within a clinical trial after de novo or recurrent disease. Results from cohorts 2 and 3 are scheduled to be presented in the third quarter of 2025.
Conclusions:
This is the first study of this size to present real-world data on the incidence of all stages of BC (NMIBC, MIBC and mBC) including newly diagnosed/relapsed cases, in Spain. Most patients (4/5) had NMIBC and almost 2/3 were newly diagnosed. By 2025, the final results of the study are anticipated to provide robust evidence on the clinical characteristics, treatment patterns, and clinical outcomes of these patients in routine clinical practice.

Patient characteristics at index date (2018).

NMIBC
MIBC
mBC

Median age, years (range)

72.0 (20.0-102.0)
73.0 (37.0-101.0)
72.0 (46.0-95.0)

Age <=70, N (%)

763 (45.6)
144 (42.1)
23 (41.8)

Age >70, N (%)

910 (54.4)
198 (57.9)
32 (58.2)

Gender (Male), N (%)

1410 (84.3)
296(87.1)
49 (89.1)

New cases, N (%)

1072 (64.0)
264 (77.2)
33 (60.0)

Recurrences/progressions, N (%)

602 (36.0)
78 (22.8)
22 (40.0)

Enrolled in a clinical trial to receive first treatment after the index date N (%)

30 (1.8)
19 (5.6)
8 (14.5)