{Reference Type}: Journal Article
{Title}: A Multicenter Study of 2-year Outcomes Following Hyperthermia Therapy with Mitomycin C in Treating Non-Muscle Invasive Bladder Cancer: HIVEC-E.
{Author}: Tan WP;Plata Bello A;Garcia Alvarez C;Guerrero-Ramos F;González-Padilla DA;Nzeh C;Manuel de la Morena J;de Torres IGV;Hendricksen K;Díaz Goizueta FJ;Del Álamo JF;Chiancone F;Fedelini P;Poggio M;Porpiglia F;Gonzalo Rodríguez VC;Torres JM;Wilby D;Robinson R;Sousa-Escandón A;Mata JL;Pontones Moreno JL;Molina FD;Adriazola Semino MA;Stemberger AT;Escudero JC;Redorta JP;Tan WS;
{Journal}: Bladder Cancer
{Volume}: 8
{Issue}: 4
{Year}: 2022
{Factor}: 1.449
{DOI}: 10.3233/BLC-220026
{Abstract}: <B>BACKGROUND: </B>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.<BR><B>OBJECTIVE: </B>To evaluate the recurrence-free survival (RFS) of patients treated with CHT using the Combat bladder recirculation system (BRS) for NMIBC.<BR><B>METHODS: </B>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.<BR><B>CONCLUSIONS: </B>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.<BR><B>CONCLUSIONS: </B>CHT with MMC using the Combat BRS is effective in the medium term and has a favorable adverse event profile.