Compared Efficacy of Adjuvant Intravesical BCG-TICE vs. BCG-RIVM for High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC): A Propensity Score Matched Analysis
Por:
Del Giudice, F, Flammia, RS, Chung, BJMI, Moschini, M, Pradere, B, Mari, A, Soria, F, Albisinni, S, Krajewski, W, Szydelko, T, Laukhtina, E, D'Andrea, D, Gallioli, A, Mertens, LS, Maggi, M, Sciarra, A, Salciccia, S, Ferro, M, Scornajenghi, CM, Asero, V, Cattarino, S, De Angelis, M, Cacciamani, GE, Autorino, R, Pandolfo, SD, Falagario, UG, D'Altilia, N, Mancini, V, Chirico, M, Cinelli, F, Bettocchi, C, Cormio, L, Carrieri, G, De Berardinis, E, Busetto, GM
Publicada:
1 feb 2022
Resumen:
Simple Summary Intravesical immunotherapy with bacillus Calmette-Guerin (BCG) is the standard therapy for high-risk non-muscle invasive bladder cancer. Different BCG strains are currently available and the superiority of any BCG strain over another could not be demonstrated yet. We compared the efficacy of two BCG strains: RIVM and TICE, respectively. In this propensity-score matched cohort study, we showed no particular survival benefit of TICE vs RIVM in the case of high-risk disease. Nevertheless, stratifying our data for re-staging procedures and for those who received BCG maintenance, we identified BCG TICE to improve RFS independently. Herein, we corroborated the importance of performing a routine secondary resection followed by an adequate maintenance course of BCG. Future larger prospective randomized head-to-head trials are needed to further elucidate this important topic, especially in this era of BCG shortage. Background: Intravesical immunotherapy with bacillus Calmette-Guerin (BCG) is the standard therapy for high-risk non-muscle invasive bladder cancer (NMIBC). The superiority of any BCG strain over another could not be demonstrated yet. Methods: Patients with NMIBCs underwent adjuvant induction +/- maintenance schedule of intravesical immunotherapy with either BCG TICE or RIVM at two high-volume tertiary institutions. Only BCG-naive patients and those treated with the same strain over the course of follow-up were included. One-to-one (1:1) propensity score matching (PSM) between the two cohorts was utilized to adjust for baseline demographic and tumor characteristics imbalances. Kaplan-Meier estimates and multivariable Cox regression models according to high-risk NMIBC prognostic factors were implemented to address survival differences between the strains. Sub-group analysis modeling of the influence of routine secondary resection (re-TUR) in the setting of the sole maintenance adjuvant schedule for the two strains was further performed. Results: 852 Ta-T1 NMIBCs (n = 719, 84.4% on TICE; n = 133, 15.6% on RIVM) with a median of 53 (24-77) months of follow-up were reviewed. After PSM, no differences at 5-years RFS, PFS, and CSS at both Kaplan-Meier and Cox regression analyses were detected for the whole cohort. In the sub-group setting of full adherence to European/American Urology Guidelines (EAU/NCCN), BCG TICE demonstrated longer 5-years RFS compared to RIVM (68% vs. 43%, p = 0.008; HR: 0.45 95% CI 0.25-0.81). Conclusion: When routinely performing re-TUR followed by a maintenance BCG schedule, TICE was superior to RIVM for RFS outcomes. However, no significant differences were detected for PFS and CSS, respectively.
Filiaciones:
Del Giudice, F:
Sapienza Rome Univ, Policlin Umberto I Hosp, Dept Maternal Infant & Urol Sci, I-00185 Rome, Italy
Stanford Med Ctr, Dept Urol, Stanford, CA 94305 USA
Flammia, RS:
Sapienza Rome Univ, Policlin Umberto I Hosp, Dept Maternal Infant & Urol Sci, I-00185 Rome, Italy
Chung, BJMI:
Stanford Med Ctr, Dept Urol, Stanford, CA 94305 USA
Moschini, M:
San Raffaele Hosp & Sci Inst, Dept Urol, I-20132 Milan, Italy
Pradere, B:
Med Univ Vienna, Dept Urol, A-1090 Vienna, Austria
Mari, A:
Univ Florence, Careggi Hosp, Dept Expt & Clin Med, Unit Oncol Minimally Invas Urol & Androl, I-50134 Florence, Italy
Soria, F:
Univ Torino, Dept Surg Sci, Urol Div, I-10126 Turin, Italy
Albisinni, S:
Univ Libre Bruxelles, Erasme Hosp, Urol Dept, B-1070 Brussels, Belgium
Krajewski, W:
Wroclaw Med Univ, Dept Urol & Oncol Urol, PL-50556 Wroclaw, Poland
Szydelko, T:
Wroclaw Med Univ, Dept Urol & Oncol Urol, PL-50556 Wroclaw, Poland
Laukhtina, E:
Med Univ Vienna, Dept Urol, A-1090 Vienna, Austria
Sechenov Univ, Inst Urol & Reprod Hlth, Moscow 19435, Russia
D'Andrea, D:
Med Univ Vienna, Dept Urol, A-1090 Vienna, Austria
Gallioli, A:
Fundacio Puigvert, Unit Urol, Barcelona 08025, Spain
Mertens, LS:
Netherlands Canc Inst, Dept Urol, NL-1066 Amsterdam, Netherlands
Maggi, M:
Sapienza Rome Univ, Policlin Umberto I Hosp, Dept Maternal Infant & Urol Sci, I-00185 Rome, Italy
Sciarra, A:
Sapienza Rome Univ, Policlin Umberto I Hosp, Dept Maternal Infant & Urol Sci, I-00185 Rome, Italy
Salciccia, S:
Sapienza Rome Univ, Policlin Umberto I Hosp, Dept Maternal Infant & Urol Sci, I-00185 Rome, Italy
Ferro, M:
European Inst Oncol IEO IRCCS, Div Urol, I-20141 Milan, Italy
Scornajenghi, CM:
Sapienza Rome Univ, Policlin Umberto I Hosp, Dept Maternal Infant & Urol Sci, I-00185 Rome, Italy
Asero, V:
Sapienza Rome Univ, Policlin Umberto I Hosp, Dept Maternal Infant & Urol Sci, I-00185 Rome, Italy
Cattarino, S:
Sapienza Rome Univ, Policlin Umberto I Hosp, Dept Maternal Infant & Urol Sci, I-00185 Rome, Italy
De Angelis, M:
San Raffaele Hosp & Sci Inst, Dept Urol, I-20132 Milan, Italy
Cacciamani, GE:
Univ Southern Calif, USC Inst Urol, Los Angeles, CA 90089 USA
Autorino, R:
Virginia Commonwealth Univ, Dept Surg, Div Urol, Richmond, VA 23284 USA
Pandolfo, SD:
Fderico II Univ, Dept Neurosci Sci Reprod & Odontostomatol, I-80131 Naples, Italy
Virginia Commonwealth Univ, Dept Surg, Div Urol, Richmond, VA 23284 USA
Falagario, UG:
Fderico II Univ, Dept Neurosci Sci Reprod & Odontostomatol, I-80131 Naples, Italy
D'Altilia, N:
Univ Foggia, Dept Urol & Renal Transplantat, Policlin Riuniti Foggia, I-71122 Foggia, Italy
Mancini, V:
Univ Foggia, Dept Urol & Renal Transplantat, Policlin Riuniti Foggia, I-71122 Foggia, Italy
Chirico, M:
Univ Foggia, Dept Urol & Renal Transplantat, Policlin Riuniti Foggia, I-71122 Foggia, Italy
Cinelli, F:
Univ Foggia, Dept Urol & Renal Transplantat, Policlin Riuniti Foggia, I-71122 Foggia, Italy
Bettocchi, C:
Univ Foggia, Dept Urol & Renal Transplantat, Policlin Riuniti Foggia, I-71122 Foggia, Italy
Cormio, L:
Univ Foggia, Dept Urol & Renal Transplantat, Policlin Riuniti Foggia, I-71122 Foggia, Italy
Carrieri, G:
Univ Foggia, Dept Urol & Renal Transplantat, Policlin Riuniti Foggia, I-71122 Foggia, Italy
De Berardinis, E:
Sapienza Rome Univ, Policlin Umberto I Hosp, Dept Maternal Infant & Urol Sci, I-00185 Rome, Italy
Busetto, GM:
Univ Foggia, Dept Urol & Renal Transplantat, Policlin Riuniti Foggia, I-71122 Foggia, Italy
gold, Green Published
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