Intra- and extravesical recurrence after epirubicin-based hyperthermic intravesical chemotherapy (HIVEC) in patients with NMIBC and BCG failure: A multicenter retrospective Observational Study
Nicolas Arnold, Julien Blanc, Ilaria Lucca, Mihai Dorin Vartolomei, Laila Schneidewind, Nicola Giudici, Raphael Röthlisberger, George N. Thalmann, Bernhard Kiss, Beat RothBackground
Guidelines recommend intravesical Bacillus Calmette-Guérin (BCG) as adjuvant therapy for intermediate- and high-risk non-muscle-invasive bladder cancer after transurethral resection. In the event of BCG failure, hyperthermic intravesical chemotherapy (HIVEC) represents a treatment alternative to patients who are surgically inoperable, or decline radical cystectomy.
Objective
The aim of this study was to evaluate oncological outcomes in patients receiving epirubicin-based HIVEC as a second-line therapeutic approach.
Methods
Retrospective inclusion of patients from our prospectively maintained, multicenter HIVEC database, who underwent HIVEC due to recurrent or persistent high-grade NMIBC following adequate BCG therapy (BCG failure) between November 2016 and December 2024. Survival was evaluated using Kaplan–Meier analysis and log-rank testing. Associations between clinicopathological factors and oncological outcomes were assessed using Cox regression analysis.
Results
Sixty-five patients were included. Median follow-up was 38 months (IQR 21–55). Twenty-four patients (36.9%) experienced intravesical recurrence with a median intravesical recurrence-free survival (RFS) of 24 months (IQR 9-45) and 1-/2-year intravesical RFS rates of 77.9% and 64.1%, respectively. Extravesical recurrence was observed in 21 patients (32.3%) with a median extravesical RFS of 22 months (IQR 7-43) and 1-/2-year extravesical RFS rates of 81.3% and 70.9%, respectively. Higher number of recurrences prior to HIVEC were significantly associated with extravesical recurrence in univariate (HR 2.23; 95% CI 1.23-3.87; p=0.019) and multivariate analysis (HR 1.31; 95% CI 1.03-1.67; p=0.027).
Conclusions
Although limited by the relatively small sample size, Epirubicin-based HIVEC demonstrated promising oncological outcomes indicating its potential value as bladder-preserving treatment option after BCG failure. Prospective controlled studies are warranted to further assess the role of epirubicin-based HIVEC in this setting.