Introduction:

Female sex has been implicated both with higher stage at diagnosis, as well as a as a negative prognostic factor, amongst patients with non-muscle invasive bladder cancer (NMIBC). We present the clinical characteristics and natural history from a contemporary cohort of patients at a single tertiary care center treated with BCG for NMIBC in an effort to identify sex-specific differences associated with diagnosis, treatment and BCG response of NMIBC. 

Methods:

An IRB approved review of patients with NMIBC patients treated with at least induction BCG at our institution between 2000 and 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. Recurrence-free survival (RFS) and progression-free survival (PFS) were calculated as the number of months from the start of induction BCG to the event or death date. Overall survival (OS) was calculated as the number of months from induction BCG to death or last follow-up. The Kaplan-Meier product limit method was used to calculate the median survival endpoints. 

Results:

Of the 579 patients treated with BCG, 116 (20%) were female and 463 (80%) were male. Female patients were younger (median 66 vs. 69, p=0.048), had a lower BMI (median 27.4 vs. 28.9, p=0.008) and were more likely to have no smoking history (50.0% vs 27.1%, p<0.001). Tumor characteristics with respect to stage, size, multifocality, and presence of variant histology were similar between sexes. Recurrence-free, progression-free and overall survival rates demonstrated no significant difference between sexes (p=0.587, p=0.277, p=0.087, respectively). Analysis of only those patients receiving adequate BCG (defined as at least 5/6 doses of induction BCG and at least 2/3 doses of maintenance BCG per FDA definition) demonstrated no differences in BCG response rates between sexes. When female patients were further stratified by smoking status, there were also no differences in BCG response rates.  

Conclusion:

In our cohort of patients treated uniformly with BCG therapy, female sex was not associated with worse outcomes with regards to recurrence or progression. 
 
 

Funding: Wayne B Duddlesten Professorship in Cancer Research and Raymond and Maria Floyd Bladder Cancer Research Foundation Grant to AMK and NIH/NCI UT MD Anderson SPORE in Genitourinary Cancer (Bladder) (P50CA091846) to CPND