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Comparative Study
. 2021 Sep;39(9):3337-3344.
doi: 10.1007/s00345-021-03653-1. Epub 2021 Mar 13.

Association of patients' sex with treatment outcomes after intravesical bacillus Calmette-Guérin immunotherapy for T1G3/HG bladder cancer

David D'Andrea  1 , Francesco Soria  2 , Anne J Grotenhuis  3 , Eugene K Cha  4   5 , Nuria Malats  6 , Savino Di Stasi  7 , Steven Joniau  8 , Tommaso Cai  9 , Bas W G van Rhijn  10 , Jaques Irani  11 , Jeffrey Karnes  12 , John Varkarakis  13 , Jack Baniel  14 , Joan Palou  15 , Marek Babjuk  16 , Martin Spahn  17 , Peter Ardelt  18 , Renzo Colombo  19 , Vincenzo Serretta  20 , Guido Dalbagni  5 , Paolo Gontero  2 , Riccardo Bartoletti  21 , Stephane Larré  22 , Per-Uno Malmstrom  23 , Richard Sylvester  24 , Shahrokh F Shariat  25   4   5   26   27   28   29
Affiliations
Comparative Study

Association of patients' sex with treatment outcomes after intravesical bacillus Calmette-Guérin immunotherapy for T1G3/HG bladder cancer

David D'Andrea et al. World J Urol. 2021 Sep.

Abstract

Purpose: To investigate the association of patients' sex with recurrence and disease progression in patients treated with intravesical bacillus Calmette-Guérin (BCG) for T1G3/HG urinary bladder cancer (UBC).

Materials and methods: We analyzed the data of 2635 patients treated with adjuvant intravesical BCG for T1 UBC between 1984 and 2019. We accounted for missing data using multiple imputations and adjusted for covariate imbalance between males and females using inverse probability weighting (IPW). Crude and IPW-adjusted Cox regression analyses were used to estimate the hazard ratios (HR) with their 95% confidence intervals (CI) for the association of patients' sex with HG-recurrence and disease progression.

Results: A total of 2170 (82%) males and 465 (18%) females were available for analysis. Overall, 1090 (50%) males and 244 (52%) females experienced recurrence, and 391 (18%) males and 104 (22%) females experienced disease progression. On IPW-adjusted Cox regression analyses, female sex was associated with disease progression (HR 1.25, 95%CI 1.01-1.56, p = 0.04) but not with recurrence (HR 1.06, 95%CI 0.92-1.22, p = 0.41). A total of 1056 patients were treated with adequate BCG. In these patients, on IPW-adjusted Cox regression analyses, patients' sex was not associated with recurrence (HR 0.99, 95%CI 0.80-1.24, p = 0.96), HG-recurrence (HR 1.00, 95%CI 0.78-1.29, p = 0.99) or disease progression (HR 1.12, 95%CI 0.78-1.60, p = 0.55).

Conclusion: Our analysis generates the hypothesis of a differential response to BCG between males and females if not adequately treated. Further studies should focus on sex-based differences in innate and adaptive immune system and their association with BCG response.

Keywords: Age; BCG; Bladder cancer; Progression; Recurrence; Response.

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Conflict of interest statement

All authors declare that they have no conflict of interest for this manuscript.

Figures

Fig. 1
Fig. 1
Cumulative incidence curves for the association of patients’ sex with time to disease recurrence (a) and progression in 2635 patients treated with transurethral resection of the bladder (TURB) and adjuvant intravesical bacillus Calmette–Guérin (BCG) for T1G3/HG urinary bladder cancer
Fig. 2
Fig. 2
Cumulative incidence curves for the association of patients’ sex with time to disease recurrence (a) high-grade (HG) recurrence (b) and disease progression (c) in 1056 patients treated with transurethral resection of the bladder (TURB) and adequate adjuvant intravesical bacillus Calmette–Guérin (BCG) for T1G3/HG urinary bladder cancer
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