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

David D’Andrea, Francesco Soria, Anne J. Grotenhuis, Eugene K. Cha, Nuria Malats, Savino Di Stasi, Steven Joniau, Tommaso Cai, Bas W.G. van Rhijn, Jaques Irani, Jeffrey Karnes, John Varkarakis, Jack Baniel, Joan Palou, Marek Babjuk, Martin Spahn, Peter Ardelt, Renzo Colombo, Vincenzo Serretta, Guido DalbagniPaolo Gontero, Riccardo Bartoletti, Stephane Larré, Per Uno Malmstrom, Richard Sylvester, Shahrokh F. Shariat

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)3337-3344
Number of pages8
JournalWorld Journal of Urology
Issue number9
StatePublished - Sep 2021


  • Age
  • BCG
  • Bladder cancer
  • Progression
  • Recurrence
  • Response

ASJC Scopus subject areas

  • Urology


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