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    Cancers. 2022 Feb 10. pii: cancers14040887. doi: 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 F1,  Flammia RS2,  Chung BI3,  Moschini M4,  Pradere B5,  Mari A6,  Soria F7,  Albisinni S8,  Krajewski W9,  Szydełko T10,  Laukhtina E11,  D'Andrea D12,  Gallioli A13,  Mertens LS14,  Maggi M15,  Sciarra A16,  Salciccia S17,  Ferro M18,  Scornajenghi CM19,  Asero V20,  Cattarino S21,  De Angelis M22,  Cacciamani GE23,  Autorino R24,  Pandolfo SD25,  Falagario UG26,  D'Altilia N27,  Mancini V28,  Chirico M29,  Cinelli F30,  Bettocchi C31,  Cormio L32,  Carrieri G33,  De Berardinis E34,  Busetto GM35,  On Behalf Of European Association Of Urology Eau-Young Academic Urologists Yau Urothelial Cancer Working Party
    Author information
    1Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I Hospital, "Sapienza" Rome University, 00185 Rome, Italy.
    2Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I Hospital, "Sapienza" Rome University, 00185 Rome, Italy.
    3Department of Urology, Stanford Medical Center, Stanford, CA 94305, USA.
    4Department of Urology, San Raffaele Hospital and Scientific Institute, 20132 Milan, Italy.
    5Department of Urology, Medical University of Vienna, 1090 Vienna, Austria.
    6Unit of Oncologic Minimally-Invasive Urology and Andrology, Department of Experimental and Clinical Medicine, Careggi Hospital, University of Florence, 50134 Florence, Italy.
    7Urology Division, Department of Surgical Sciences, University of Studies of Torino, 10126 Turin, Italy.
    8Urology Department, Erasme Hospital, Université Libre de Bruxelles, 1070 Brussels, Belgium.
    9Department of Urology and Oncological Urology, Wrocław Medical University, 50-556 Wrocław, Poland.
    10Department of Urology and Oncological Urology, Wrocław Medical University, 50-556 Wrocław, Poland.
    11Department of Urology, Medical University of Vienna, 1090 Vienna, Austria.
    12Department of Urology, Medical University of Vienna, 1090 Vienna, Austria.
    13Unit of Urology, Fundacio Puigvert, 08025 Barcelona, Spain.
    14Department of Urology, The Netherlands Cancer Institute, 1066 Amsterdam, The Netherlands.
    15Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I Hospital, "Sapienza" Rome University, 00185 Rome, Italy.
    16Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I Hospital, "Sapienza" Rome University, 00185 Rome, Italy.
    17Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I Hospital, "Sapienza" Rome University, 00185 Rome, Italy.
    18Division of Urology, European Institute of Oncology (IEO)-IRCCS, 20141 Milan, Italy.
    19Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I Hospital, "Sapienza" Rome University, 00185 Rome, Italy.
    20Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I Hospital, "Sapienza" Rome University, 00185 Rome, Italy.
    21Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I Hospital, "Sapienza" Rome University, 00185 Rome, Italy.
    22Department of Urology, San Raffaele Hospital and Scientific Institute, 20132 Milan, Italy.
    23USC Institute of Urology, University of Southern California, Los Angeles, CA 90089, USA.
    24Division of Urology, Department of Surgery, Virginia Commonwealth University, Richmond, VA 23284, USA.
    25Division of Urology, Department of Surgery, Virginia Commonwealth University, Richmond, VA 23284, USA.
    26Department of Neurosciences, Sciences of Reproduction, and Odontostomatology, Fderico II University, 80131 Naples, Italy.
    27Department of Urology and Renal Transplantation, Policlinico Riuniti di Foggia, University of Foggia, 71122 Foggia, Italy.
    28Department of Urology and Renal Transplantation, Policlinico Riuniti di Foggia, University of Foggia, 71122 Foggia, Italy.
    29Department of Urology and Renal Transplantation, Policlinico Riuniti di Foggia, University of Foggia, 71122 Foggia, Italy.
    30Department of Urology and Renal Transplantation, Policlinico Riuniti di Foggia, University of Foggia, 71122 Foggia, Italy.
    31Department of Urology and Renal Transplantation, Policlinico Riuniti di Foggia, University of Foggia, 71122 Foggia, Italy.
    32Department of Urology and Renal Transplantation, Policlinico Riuniti di Foggia, University of Foggia, 71122 Foggia, Italy.
    33Department of Urology and Renal Transplantation, Policlinico Riuniti di Foggia, University of Foggia, 71122 Foggia, Italy.
    34Department of Maternal-Infant and Urological Sciences, Policlinico Umberto I Hospital, "Sapienza" Rome University, 00185 Rome, Italy.
    35Department of Urology and Renal Transplantation, Policlinico Riuniti di Foggia, University of Foggia, 71122 Foggia, Italy.
    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 ( = 719, 84.4% on TICE; = 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%, = 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: BCG strain, BCG-RIVM, BCG-TICE, bladder cancer, cancer-specific survival, progression-free survival, re-TUR, recurrence-free survival

    Publikations ID: 35205635
    Quelle: öffnen
     
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