A Multicenter Study of 2-year Outcomes Following Hyperthermia Therapy with Mitomycin C in Treating Non-Muscle Invasive Bladder Cancer: HIVEC-E
Por:
Tan, WP, Bello, AP, Alvarez, CG, Guerrero-Ramos, F, Gonzalez-Padilla, DA, Nzeh, C, De la Morena, JM, De Torres, IGV, Hendricksen, K, Goizueta, FJD, Del Alamo, JF, Chiancone, F, Fedelini, P, Poggio, M, Porpiglia, F, Rodriguez, VCG, Torres, JM, Wilby, D, Robinson, R, Sousa-Escandon, A, Mata, JL, Moreno, JLP, Molina, FD, Semino, MAA, Stemberger, AT, Escudero, JC, Redorta, JP, Tan, WS
Publicada:
1 ene 2022
Resumen:
INTRODUCTION: High grade, non-muscle invasive bladder cancer (NMIBC) is usually treated with intravesical Bacillus Calmette-Gu ' erin. 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/progressionwas suspected. The primary endpointwas 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 naive, BCG unresponsive and BCG failure, respectively. The RFS at 12 months and 24 months for BCG naive 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.
Filiaciones:
Tan, WP:
NYU Langone Hlth, Dept Urol, 222 E 41st St,12th Floor, New York, NY 10017 USA
Bello, AP:
Univ Hosp Canary Isl, Dept Urol, Tenerife, Spain
Alvarez, CG:
Univ Hosp Canary Isl, Dept Urol, Tenerife, Spain
Guerrero-Ramos, F:
Hosp Univ 12 Octubre, Dept Urol, Madrid, Spain
Gonzalez-Padilla, DA:
Hosp Univ 12 Octubre, Dept Urol, Madrid, Spain
Nzeh, C:
St Barbara Hosp, Gladbeck, Germany
De la Morena, JM:
Hosp Univ Infanta Sofia, Madrid, Spain
De Torres, IGV:
Hosp Univ Infanta Sofia, Madrid, Spain
Hendricksen, K:
Netherlands Canc Inst, Dept Urol, Amsterdam, Netherlands
Goizueta, FJD:
Hosp Univ Torrejon, Dept Urol, Madrid, Spain
Del Alamo, JF:
Hosp Univ Torrejon, Dept Urol, Madrid, Spain
Chiancone, F:
AORN A Cardarelli, Dept Urol, Naples, Italy
Fedelini, P:
AORN A Cardarelli, Dept Urol, Naples, Italy
Poggio, M:
San Luigi Hosp Orbassano, Turin, Italy
Porpiglia, F:
San Luigi Hosp Orbassano, Turin, Italy
Rodriguez, VCG:
Hosp Univ Burgos, Burgos, Spain
Torres, JM:
Hosp Univ Burgos, Burgos, Spain
Wilby, D:
Queen Alexandra Hosp, Dept Urol, Portsmouth, Hants, England
Robinson, R:
Queen Alexandra Hosp, Dept Urol, Portsmouth, Hants, England
Sousa-Escandon, A:
Comarcal Hosp Monforte, Lugo, Spain
Mata, JL:
Comarcal Hosp Monforte, Lugo, Spain
Moreno, JLP:
Hosp Univ La Fe, Valencia, Spain
Molina, FD:
Hosp Univ La Fe, Valencia, Spain
Semino, MAA:
Hosp Gen Rio Carrion, Valencia, Spain
Stemberger, AT:
Rowan Sch Med, Camden, NJ USA
Escudero, JC:
Hosp Clin Valladolid, Dept Urol, Valladolid, Spain
Redorta, JP:
Autonomous Univ Barcelona, Dept Urol, Fundacio Puigvert, Barcelona, Spain
Tan, WS:
UCL, Div Surg & Intervent Sci, London, England
Univ Coll London Hosp, Dept Urooncol, London, England
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