5b903b49d4b9e39678adafc64bbcec45 277686.pdf 7254af7c29e32f02db058d170a6d2ab66221f225 277686.pdf 62980c33d26480d77d7e7fcd0fc012c9c56d5091ae22ed20f787a457ad20050e 277686.pdf Title: Compared Efficacy of Adjuvant Intravesical BCG-TICE vs. BCG-RIVM for High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC): A Propensity Score Matched Analysis Subject: 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. Keywords: bladder cancer; re-TUR; BCG strain; BCG-TICE; BCG-RIVM; recurrence-free survival; progression-free survival; cancer-specific survival Author: Francesco Del Giudice, Rocco Simone Flammia, Benjamin I. Chung, Marco Moschini, Benjamin Pradere, Andrea Mari, Francesco Soria, Simone Albisinni, Wojciech Krajewski, Tomasz Szydełko, Ekaterina Laukhtina, David D’Andrea, Andrea Gallioli, Laura S. Mertens, Martina Maggi, Alessandro Sciarra, Stefano Salciccia, Matteo Ferro, Carlo Maria Scornajenghi, Vincenzo Asero, Susanna Cattarino, Mario De Angelis, Giovanni E. Cacciamani, Riccardo Autorino, Savio Domenico Pandolfo, Ugo Giovanni Falagario, Nicola D’Altilia, Vito Mancini, Marco Chirico, Francesco Cinelli, Carlo Bettocchi, Luigi Cormio, Giuseppe Carrieri, Ettore De Berardinis, Gian Maria Busetto and on behalf of European Association of Urology (EAU)—Young Academic Urologists (YAU) Urothelial Cancer Working Party Creator: LaTeX with hyperref Producer: pdfTeX-1.40.21 CreationDate: Tue Feb 15 10:39:51 2022 CET ModDate: Tue Feb 15 10:55:54 2022 CET Tagged: no UserProperties: no Suspects: no Form: none JavaScript: no Pages: 11 Encrypted: no Page size: 595.276 x 841.89 pts (A4) Page rot: 0 File size: 1437342 bytes Optimized: no PDF version: 1.7 name type encoding emb sub uni object ID ------------------------------------ ----------------- ---------------- --- --- --- --------- OPZDHV+VnURWPalladioL Type 1 Custom yes yes no 10 0 PBIDCS+URWPalladioL-Bold Type 1 Custom yes yes no 15 0 IZQPVD+URWPalladioL-Roma Type 1 Custom yes yes no 20 0 KDQJRO+URWPalladioL-Ital Type 1 Custom yes yes no 24 0 MCBCCI+SourceSansRoman-Regular Type 1C Custom yes yes no 32 0 MCBCCM+SourceSansRoman.613wght Type 1C Custom yes yes no 36 0 MCBCCO+SourceSansRoman-Bold Type 1C Custom yes yes no 40 0 LCJEVJ+TimesNewRomanPS-BoldItalicMT Type 1C WinAnsi yes yes no 53 0 VSPIKV+CMSY10 Type 1 Builtin yes yes no 75 0 QLBIEB+URWPalladioL-BoldItal Type 1 Custom yes yes no 88 0 Jhove (Rel. 1.22.1, 2019-04-17) Date: 2023-07-18 02:34:01 CEST RepresentationInformation: 277686.pdf ReportingModule: PDF-hul, Rel. 1.12.1 (2019-04-17) LastModified: 2023-07-17 15:01:36 CEST Size: 1437342 Format: PDF Version: 1.7 Status: Well-Formed and valid SignatureMatches: PDF-hul MIMEtype: application/pdf PDFMetadata: Objects: 226 FreeObjects: 1 IncrementalUpdates: 0 DocumentCatalog: PageLayout: SinglePage PageMode: UseNone Outlines: Item: Title: Introduction Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@44c8afef Item: Title: Patients and Methods Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7b69c6ba Children: Item: Title: Eligibility CRITERIA Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@46daef40 Item: Title: BCG Protocol, Treatment Schedule, and Strains Administered Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@12f41634 Item: Title: Statistical Analysis Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@13c27452 Item: Title: Results Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@262b2c86 Children: Item: Title: Recurrence-Free Survival (RFS) Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@371a67ec Item: Title: Progression-Free Survival (PFS) Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@5ed828d Item: Title: Cancer-Specific Survival (CSS) Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@50d0686 Item: Title: Discussion Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@7a3d45bd Item: Title: Conclusions Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@1e7c7811 Item: Title: References Destination: edu.harvard.hul.ois.jhove.module.pdf.PdfSimpleObject@77ec78b9 Info: Title: Compared Efficacy of Adjuvant Intravesical BCG-TICE vs. BCG-RIVM for High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC): A Propensity Score Matched Analysis Author: Francesco Del Giudice, Rocco Simone Flammia, Benjamin I. Chung, Marco Moschini, Benjamin Pradere, Andrea Mari, Francesco Soria, Simone Albisinni, Wojciech Krajewski, Tomasz Szydełko, Ekaterina Laukhtina, David D’Andrea, Andrea Gallioli, Laura S. Mertens, Martina Maggi, Alessandro Sciarra, Stefano Salciccia, Matteo Ferro, Carlo Maria Scornajenghi, Vincenzo Asero, Susanna Cattarino, Mario De Angelis, Giovanni E. Cacciamani, Riccardo Autorino, Savio Domenico Pandolfo, Ugo Giovanni Falagario, Nicola D’Altilia, Vito Mancini, Marco Chirico, Francesco Cinelli, Carlo Bettocchi, Luigi Cormio, Giuseppe Carrieri, Ettore De Berardinis, Gian Maria Busetto and on behalf of European Association of Urology (EAU) Young Academic Urologists (YAU) Urothelial Cancer Working Party Subject: 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. 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