SES AUA 2022: Gender Disparities in the Clinical Trials and Real-World Utilization of Systemic Therapy in the Management of Urothelial Carcinoma

( The 2022 Southeastern Section of the AUA’s annual meeting included a bladder cancer session and Dr. Nick Batra discussing gender disparities in the clinical trials and real-world utilization of systemic therapy in the management of urothelial carcinoma. Urothelial carcinoma of the bladder is more common in men than women by a 3:1 ratio. However, women have an increased risk of (i) muscle invasive bladder cancer, (ii) disease recurrence, (iii) disease progression, and (iv) cancer-specific mortality, as well as a decrease in overall survival. The objective of this study was to determine if gender disparities exist within the clinical trials utilized to guide recommendations from the National Comprehensive Cancer Network (NCCN) for the use of systemic therapy in the management of urothelial carcinoma, as well as assess the relationship between gender and systemic therapy administration in the management of urothelial carcinoma in the United States.

 This study used version 1 of the 2021 NCCN guidelines for urothelial carcinoma and all systemic therapy clinical trials cited were reviewed. Gender proportions were determined for each trial and compared with corresponding proportions in the general US population of patients with urothelial carcinoma between 1999 and 2018 using the National Cancer Database (NCDB) program. Dr. Batra and colleagues identified 58,031 adult patients diagnosed with Stage II-IV urothelial carcinoma between 1999-2018 treated with systemic therapy within this administrative database. Univariable and multivariable analysis was used to determine predictors of systemic therapy.

 Overall, there were 31 trials, including 10,158 patients. The majority of trials were phase 2 trials (45%), however phase 3 trials made up the majority of patients (57%). The results found that women make up 30.5% of US patients with urothelial carcinoma in an administrative database, while accounting for only 20% of patients in NCCN-cited systemic therapy trials:


SES AUA 22 - Batra 


Of the trials referenced in the NCCN guideline, significant gender disparity was based on trial randomization, phase, inclusion of upper tract disease, and type of systemic therapy (chemotherapy versus immunotherapy). When evaluating the NCDB, women had lower odds (versus men) of receiving systemic therapy (OR 0.93, 95% CI 0.89-0.96; p < 0.001) on multivariable analysis.


Dr. Batra concluded his presentation discussing gender disparities within the clinical trials utilized to guide recommendations from the NCCN for the use of systemic therapy for urothelial carcinoma with the following take-home messages:

  • Women appear to be under-represented in clinical trials that guide national recommendations and are less like to receive systemic therapy for urothelial carcinoma in a national database
  • Further investigation into factors that lead to lower trial recruitment/enrollment and use of systemic therapy amongst women is warranted


Presented By: Nick Batra, MD, Department of Urology, University of Florida, Gainesville, FL
Co-Authors: Hiro Miyagi1, Shahab Bozorgmehri2, Jonathan Chatzkel3, Brian Ramnaraign3, Kathryn Hitchcock4, Bob Zlotecki4, Wayne Brisbane1, Padraic O'Malley1, Paul Crispen1
Affiliations: 1Dept of Urology, University of Florida, 2Dept of Nephrology, University of Florida, 3Dept of Medicine, University of Florida, 4Dept of Radiation Oncology, University of Florida


Written By: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 86th Annual Meeting of the Southeastern Section of the American Urological Association, San Juan, PR, Mar 16 – 19, 2022