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Bladder and Urothelial Cancer Treatments · Journal article
Bladder Cancer · August 10, 2026
Encouraging direction, but not yet definitive.
This retrospective multicenter cohort study reports that epirubicin-based HIVEC achieves 1-year intravesical and extravesical recurrence-free survival rates of 77.9% and 81.3% respectively in 65 BCG-failed NMIBC patients over a median 38-month follow-up. The evidence is limited by the lack of a control arm, modest sample size, and retrospective design, but suggests potential benefit for bladder-preserving management in inoperable or unwilling patients.
Multicenter retrospective cohort study. Patients with recurrent or persistent high-grade NMIBC after adequate BCG therapy (BCG failure) who underwent HIVEC because they were surgically inoperable or declined radical cystectomy.. Intervention: Epirubicin-based hyperthermic intravesical chemotherapy (HIVEC). n = 65. Multicenter (specific number of centers and countries not stated in abstract).
Intravesical recurrence occurred in 24 patients (36.9%) with 1-year intravesical RFS of 77.9% and 2-year RFS of 64.1% Extravesical recurrence occurred in 21 patients (32.3%) with 1-year extravesical RFS of 81.3% and 2-year RFS of 70.9% Higher number of prior recurrences significantly associated with extravesical recurrence (HR 1.31; 95% CI 1.03–1.67; p=0.027 in multivariate analysis)
Authors do not report overall survival, cancer-specific survival, or cystectomy-free survival; no safety or adverse event data provided
Clinicians managing BCG-failed NMIBC in patients unwilling or unfit for cystectomy may consider epirubicin-based HIVEC as a reasonable bladder-preserving alternative, though the evidence remains limited and prospective comparative data are needed to establish its role relative to other second-line options.
A sound but limited retrospective multicenter study of a bladder-preserving therapy in BCG-failed NMIBC, with meaningful recurrence-free survival rates but modest sample size and no comparator arm.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians managing BCG-failed NMIBC in patients unwilling or unfit for cystectomy may consider epirubicin-based HIVEC as a reasonable bladder-preserving alternative, though the evidence remains limited and prospective comparative data are needed to establish its role relative to other second-line options.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Background 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.
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