Contemporary outcomes of bladder carcinoma in situ treated with an adequate BCG immunotherapy.

To assess whether bacillus Calmette-Guérin (BCG) responsiveness after initiation of an adequate BCG treatment (at least five of six instillations of induction and at least two of three instillations of maintenance) impacts oncological outcomes in patients with CIS of the bladder treated with BCG immunotherapy.

Data were available for 193 patients with bladder CIS with or without associated cTa/cT1 disease who received an adequate BCG treatment between 2008 and 2015. Bladder biopsies were performed at 6 months and patients were then stratified as either BCG responsive (negative biopsies) or BCG unresponsive (positive biopsies). Inverse probability weighting (IPW)-adjusted Kaplan-Meier and IPW-adjusted Cox regression were performed to compare progression-free survival (PFS), radical cystectomy-free survival (RCFS), overall survival OS, and cancer-specific survival (CSS) in the two groups.

Comparing the BCG-responsive and BCG-unresponsive groups, IPW-adjusted Kaplan-Meier analysis revealed, respectively, a PFS of 9 months (IQR 5-15) vs 48.5 months (IQR 28-77) (p=0.001), an RCFS of 11 months (IQR 9-15) vs 49 months (IQR 24-76) (p<0.001), and a CSS of 25 months (IQR 13-60) vs 109 months (IQR 78-307) (p=0.004). On IPW-adjusted Cox regression analysis, BCG-unresponsive patients had a worse PFS (HR 3.40, 95% CI 1.59-7.27), RCFS (HR 3.52, 95% CI 1.77-7), and CSS (HR 4.42, 95% CI 1.95-10.01). We found no significant differences for OS.

Using an IPW method we found that lack of response after initiation of an adequate BCG treatment has prognostic implications beyond identification of complete response in patients with CIS. BCG-unresponsive patients, satisfying the novel definition of BCG unresponsive, showed a poor PFS, RCFS, and CSS. In this setting, the patients should be counseled regarding radical cystectomy as a first option or enrolled in a clinical trial if they refuse radical cystectomy or are unfit for surgery.

BJU international. 2021 Aug 10 [Epub ahead of print]

José Daniel Subiela, Óscar Rodríguez Faba, Júlia Aumatell, Julio Calderón, Asier Mercadé, Josep Balañà, Cristina Esquinas, Ferran Algaba, Alberto Breda, Joan Palou

Urooncology Unit, Department of Urology, Universitat Autònoma de Barcelona, Department of Surgery, Fundació Puigvert, Barcelona, Spain., Statistics Unit, Departament of Urology, Universitat Autònoma de Barcelona, Department of Surgery, Fundació Puigvert, Barcelona, Spain., Departament of Pathology, Universitat Autònoma de Barcelona, Department of Surgery, Fundació Puigvert, Barcelona, Spain.

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