Abstract
Purpose
Female sex has been implicated with higher stage at diagnosis and as a negative prognostic factor amongst patients with non-muscle invasive bladder cancer (NMIBC). Whether this holds true with contemporary management paradigms is unknown. We analyzed a cohort of patients treated with adequate bacillus Calmette–Guerin (BCG) for NMIBC in an effort to identify sex-specific influence on BCG response.
Methods
An IRB-approved review of patients with NMIBC treated at our institution with at least ‘adequate BCG’, as defined by the US FDA and EAU, from 2000 to 2018 was performed. Patients were then stratified by sex and response to BCG. Non-parametric tests were used to summarize the data overall and by groups. The Kaplan–Meier product limit method was used to calculate median survival endpoints.
Results
Of the 541 patients treated with adequate BCG, 111 (20.5%) were female and 430 (79.5%) were male. Female patients were younger (median 66 vs. 69, p = 0.071), had a lower BMI (median 27.3 vs. 28.8, p = 0.010) and were more likely to have no smoking history (49.5% vs. 27.0%, p < 0.001). Tumor characteristics with respect to stage, size, multifocality, presence of carcinoma in situ, and presence of variant histology were similar between sexes. While rates of recurrence were higher in females than in males this, was not statistically significant (44.1% vs. 34.7%, p = 0.064) and Kaplan–Meier estimates of recurrence-free, progression-free and overall survival demonstrated no significant difference between sexes (p = 0.409, p = 0.253, p = 0.171, respectively).
Conclusion
In a contemporary cohort of patients with NMIBC treated with adequate BCG, female sex was not associated with adverse oncologic outcomes.
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Funding
This research was supported by the Wayne B. Duddlesten Professorship in Cancer Research, the Raymond and Maria Floyd Bladder Cancer Research Foundation Grant to AMK and NIH/NCI UTMD Anderson SPORE in Genitourinary Cancer (Bladder) (P50CA091846) to CPND and the Cancer Center Support Grant (NCI Grant P30 CA016672).
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KKB: project development, data analysis, manuscript writing; PJH: project development, manuscript writing; NB, JM: data collection or management; GMN-G: data analysis; NN, CPD: manuscript editing; AMK: project development, data analysis, manuscript editing.
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KK Bree: Stratify genomics—consultant; CP Dinney: National Cancer Institutes research funding, University of East Finland Faculty of Health Sciences (UEFHS) research funding, grant and personal fees from FKD Therapies, creator of intellectual property owned by UT/MDACC related to the use of genetic alterations as a predictive biomarker for response to Nadofaragene firadenovac. AM Kamat: personal fees and other from Merck, personal fees from Abbott Molecular, personal fees from Arquer, personal fees from ArTara, personal fees from Asieris, personal fees and other from Photocure, personal fees from Astra Zeneca, personal fees from BioClin Therapeutics, personal fees and other from BMS, personal fees from Cepheid, personal fees from Cold Genesys, other from FKD Industries, personal fees from Eisai, personal fees from Engene, Inc., personal fees from Ferring, personal fees from FerGene, personal fees from Imagin, personal fees from Janssen, personal fees from MDxHealth, personal fees from Medac, personal fees from Pfizer, personal fees from Roviant, personal fees from Sessen Bio, personal fees from ProTara, personal fees from Nucleix, personal fees from Seattle Genetics, grants from CEC Oncology, personal fees from Theralase, personal fees from TMC Innovation, personal fees from US Biotest, other from Adolor, other from Heat Biologics, patent for CyPRIT-Cytokine Panel for Response to Intravesical Immunotherapy pending.
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This study had been approved by the competent ethics committee (2017–02257) and all applicable institutional and governmental regulations concerning the ethical use of the data were followed. All data were encrypted and kept confidential.
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Bree, K.K., Hensley, P.J., Brooks, N. et al. Impact of sex on response to BCG in non-muscle invasive bladder cancer patients: a contemporary review from a tertiary care center. World J Urol 39, 4143–4149 (2021). https://doi.org/10.1007/s00345-021-03755-w
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DOI: https://doi.org/10.1007/s00345-021-03755-w