Clinical characteristics and treatment patterns of patients with muscle invasive bladder cancer: A real-world cohort study.
Authors: Gore John L. , Shih Vanessa , Kelkar Sneha , Chirikov Viktor , Donnowitz Kimberly , Dubow Stephanie , Young Christopher , Nimke David , Quicquaro Christina Marie , Willmon Candice , Pednekar Priti 
Published: February 2025

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Background:
Due to the evolving treatment landscape for muscle-invasive bladder cancer (MIBC), a better understanding of current treatment patterns among real-world patients is needed. This study reported demographic and clinical characteristics and examined the real-world treatment patterns of patients with MIBC in the US.
Methods:
This non-interventional, retrospective cohort study extracted data from the Inovalon Insights Payer-Sourced dataset, a claims database, from January 1, 2020–December 31, 2021. Patients aged ≥18 years with MIBC who were treated with cystectomy with or without neoadjuvant systemic treatment were followed from index date (first day of cystectomy or neoadjuvant systemic treatment) until the end of the study, loss of follow-up, diagnosis of metastasis, or end of enrollment in their medical or pharmacy health plan, whichever occurred first. Patients with metastasis from tumor types such as solid tumors, leukemia, lymphoma and, myeloma, with secondary malignancies, or participating in clinical trials by the index date were excluded. Results were reported for patients who received neoadjuvant and/or adjuvant treatment by therapy type.
Results:
Among 332 eligible patients, the mean (standard deviation [SD]) age was 64.3 (10.2) years, and 245 (73.8%) patients were male. Prior transurethral resection of a bladder tumor was reported for 236 (71.1%) patients. Common comorbidities were hypertension (198 [59.6%]), urinary tract infection (94 [28.3%]), diabetes without chronic complications (88 [26.5%]), and chronic pulmonary disease (80 [24.1%]). The mean (SD) age-adjusted Charlson Comorbidity Index was 6.3 (2.3). A total of 137 (41.3%) patients underwent cystectomy alone, while 195 (58.7%) patients received neoadjuvant systemic therapy followed by cystectomy. A total of 27 (8.1%) patients received both neoadjuvant and adjuvant therapies. In the 195 patients receiving neoadjuvant systemic therapies, 153 (78.5%) received chemotherapy with cisplatin; most commonly cisplatin + gemcitabine (76 [39.0%]) followed by cisplatin + doxorubicin + methotrexate + vinblastine (56 [28.7%]). Chemotherapy without cisplatin (41 [21.0%]) and immunotherapy (1 [0.5%]) were also given as neoadjuvant systemic therapies. Adjuvant therapies were received by 39 (11.7%) patients; of which, 20 (51.3%) received immunotherapy, 15 (38.5%) received chemotherapy with cisplatin, and 4 (10.3%) received chemotherapy without cisplatin. Cisplatin + gemcitabine (10 [25.6%]) and nivolumab monotherapy (10 [25.6%]) were the most common adjuvant treatments.
Conclusions:
Patients with MIBC had a substantial comorbidity burden. Many patients did not receive neoadjuvant or adjuvant treatment, indicating a persistent unmet need in this patient population for alternative therapeutic regimens. Further evaluation of treatment patterns is needed as the landscape evolves.