A Multicenter Study of 2-year Outcomes Following Hyperthermia Therapy with Mitomycin C in Treating Non-Muscle Invasive Bladder Cancer: HIVEC-E

• Published in: Bladder cancer 2022-01, Vol.8 (4), p.379-393
• Main Authors: Tan, Wei Phin, Plata Bello, Ana, Garcia Alvarez, Carlos, Guerrero-Ramos, Félix, González-Padilla, Daniel A., Nzeh, Cajetan, Manuel de la Morena, Jose, de Torres, Ignacio Gonzalez Valcarcel, Hendricksen, Kees, Díaz Goizueta, Francisco Javier, Del Álamo, Julio Fernandez, Chiancone, Francesco, Fedelini, Paolo, Poggio, Massimiliano, Porpiglia, Francesco, Gonzalo Rodríguez, Victoria C., Torres, Javier Montero, Wilby, Daniel, Robinson, Richard, Sousa-Escandón, Alejandro, Mata, Juan León, Pontones Moreno, Jose L., Molina, Francisco Delgados, Adriazola Semino, Miguel A., Stemberger, Andrew T., Escudero, Jesús Calleja, Redorta, Joan Palou, Tan, Wei Shen
• Format: Article
• Language: English
• Subjects: Research Report
• ISSN: 2352-3727; 2352-3727
• DOI: 10.3233/BLC-220026

INTRODUCTION: High grade, non-muscle invasive bladder cancer (NMIBC) is usually treated with intravesical Bacillus Calmette–Guérin. Chemohyperthermia therapy (CHT) may be a novel alternative therapy for the treatment of NMIBC. OBJECTIVE: To evaluate the recurrence-free survival (RFS) of patients treated with CHT using the Combat bladder recirculation system (BRS) for NMIBC. METHODS: This was a prospective multi-institutional study of 1,028 consecutive patients with NMIBC undergoing CHT between 2012 and 2020. A total of 835 patients were treated with CHT with Mitomycin C (MMC). Disease was confirmed on transurethral resection of bladder tumor (TURBT) prior to starting CHT. Follow-up included cystoscopy and subsequent TURBT if recurrence/progression was suspected. The primary endpoint was RFS. Secondary endpoints were progression-free survival (PFS) and adverse events from CHT. RESULTS AND LIMITATIONS: Median follow up was 22.4 months (Interquartile range (IQR): 12.8 –35.8). Median age was 70.4 years (IQR: 62.1 –78.6). A total of 557 (66.7%), 172 (20.6) and 74 (8.9%) of patients were classified to BCG naïve, BCG unresponsive and BCG failure, respectively. The RFS at 12 months and 24 months for BCG naïve was 87.6% (95% CI 85.0% - 90.4%) and 75.0% (95% CI 71.3% - 78.8%), respectively. The RFS at 12 months and 24 months for BCG unresponsive cohort was 78.1% (95% CI 72.0% - 84.7%) and 57.4% (95% CI 49.7% - 66.3%), respectively. The RFS at 24 months for the BCG unresponsive cohort for CIS with/without papillary disease and papillary only disease were 43.6% (95% CI 31.4% –60.4%) and 64.5% (95% CI 55.4% - 75.1%), respectively. Minor adverse events occurred in 216 (25.6%) patients and severe events occurred in 17 (2.0%) patients. CONCLUSIONS: CHT with MMC using the Combat BRS is effective in the medium term and has a favorable adverse event profile.