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-naïve 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.

Compared efficacy of adjuvant intravesical bcg-tice vs. bcg-rivm for high-risk non-muscle invasive bladder cancer (nmibc). a propensity score matched analysis / Del Giudice, F.; Flammia, R. S.; Chung, B. I.; Moschini, M.; Pradere, B.; Mari, A.; Soria, F.; Albisinni, S.; Krajewski, W.; Szydelko, T.; Laukhtina, E.; D'Andrea, D.; Gallioli, A.; Mertens, L. S.; Maggi, M.; Sciarra, A.; Salciccia, S.; Ferro, M.; Scornajenghi, C. M.; Asero, V.; Cattarino, S.; Angelis, M. D.; Cacciamani, G. E.; Autorino, R.; Pandolfo, S. D.; Falagario, U. G.; D'Altilia, N.; Mancini, V.; Chirico, M.; Cinelli, F.; Bettocchi, C.; Cormio, L.; Carrieri, G.; De Berardinis, E.; Busetto, G. M.. - In: CANCERS. - ISSN 2072-6694. - 14:4(2022), pp. 1-11. [10.3390/cancers14040887]

Compared efficacy of adjuvant intravesical bcg-tice vs. bcg-rivm for high-risk non-muscle invasive bladder cancer (nmibc). a propensity score matched analysis

Del Giudice F.
;
Flammia R. S.;Maggi M.;Sciarra A.;Salciccia S.;Scornajenghi C. M.;Asero V.;Cattarino S.;De Berardinis E.;
2022

Abstract

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-naïve 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.
2022
bcg strain; bcg-rivm; bcg-tice; bladder cancer; cancer-specific survival; progression-free survival; re-tur; recurrence-free survival
01 Pubblicazione su rivista::01a Articolo in rivista
Compared efficacy of adjuvant intravesical bcg-tice vs. bcg-rivm for high-risk non-muscle invasive bladder cancer (nmibc). a propensity score matched analysis / Del Giudice, F.; Flammia, R. S.; Chung, B. I.; Moschini, M.; Pradere, B.; Mari, A.; Soria, F.; Albisinni, S.; Krajewski, W.; Szydelko, T.; Laukhtina, E.; D'Andrea, D.; Gallioli, A.; Mertens, L. S.; Maggi, M.; Sciarra, A.; Salciccia, S.; Ferro, M.; Scornajenghi, C. M.; Asero, V.; Cattarino, S.; Angelis, M. D.; Cacciamani, G. E.; Autorino, R.; Pandolfo, S. D.; Falagario, U. G.; D'Altilia, N.; Mancini, V.; Chirico, M.; Cinelli, F.; Bettocchi, C.; Cormio, L.; Carrieri, G.; De Berardinis, E.; Busetto, G. M.. - In: CANCERS. - ISSN 2072-6694. - 14:4(2022), pp. 1-11. [10.3390/cancers14040887]
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