Mp53-07 Efficacy and Safety of the Combination of Cisplatin Plus Nab-Paclitaxel and Nivolumab With Radiotherapy After Maximal Tumor Resection in Non-Metastatic Muscle Invasive Bladder Cancer (Cnn-Bc Trial)

You have accessJournal of UrologyBladder Cancer: Invasive V (MP53)1 May 2024MP53-07 EFFICACY AND SAFETY OF THE COMBINATION OF CISPLATIN PLUS NAB-PACLITAXEL AND NIVOLUMAB WITH RADIOTHERAPY AFTER MAXIMAL TUMOR RESECTION IN NON-METASTATIC MUSCLE INVASIVE BLADDER CANCER (CNN-BC TRIAL) Marco Racioppi, Francesco Pio Bizzarri, Seyed Koosha Moosavi, Eros Scarciglia, Pierluigi Russo, Giuseppe Palermo, Ileana Sparagna, Anna Rita Allitto, Chiara Ciccarese, Luca Tagliaferri, Luca Boldrini, Maria Antonietta Gambacorta, Vincenzo Valentini, Giampaolo Tortora, and Roberto Iacovelli Marco RacioppiMarco Racioppi , Francesco Pio BizzarriFrancesco Pio Bizzarri , Seyed Koosha MoosaviSeyed Koosha Moosavi , Eros ScarcigliaEros Scarciglia , Pierluigi RussoPierluigi Russo , Giuseppe PalermoGiuseppe Palermo , Ileana SparagnaIleana Sparagna , Anna Rita AllittoAnna Rita Allitto , Chiara CiccareseChiara Ciccarese , Luca TagliaferriLuca Tagliaferri , Luca BoldriniLuca Boldrini , Maria Antonietta GambacortaMaria Antonietta Gambacorta , Vincenzo ValentiniVincenzo Valentini , Giampaolo TortoraGiampaolo Tortora , and Roberto IacovelliRoberto Iacovelli View All Author Informationhttps://doi.org/10.1097/01.JU.0001008784.37684.bd.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The therapeutic gold standard for muscle invasive bladder cancer (MIBC) is radical cystectomy (RC) preceded by neoadjuvant chemotherapy when appropriate. However, RC is a major surgery procedure with 13% rate of severe complication and a perioperative mortality rate of about 1.5 - 5 %. Trimodal therapy (TMT) is a "bladder sparing" option alternative to RC. TMT consists of complete transurethral bladder tumor resection (TURBT) followed by a combination of systemic chemotherapy and locoregional radiotherapy (RT), with the option of "salvage" cystectomy in case of local treatment failure. Immunotherapy with anti-PD1/PD-L1 monoclonal antibody significantly improves survival of metastatic BC patients, and it seems to potentiate the activity of RT without increased toxicity. Therefore, we investigate the role of a multimodal TMT strategy to increase the disease-free survival (DFS) and avoid or delay RC in non-metastatic MIBC pts. METHODS: CNN-BC trial (NCT05203913) is a phase 2, open-label, mono-institutional study evaluating the activity and safety of TMT with cisplatin, nab-paclitaxel and nivolumab as systemic therapy in non-metastatic MIBC pts. Eligible pts should have undergone complete TURBT with diagnosis of T2-T3 N0M0 urothelial carcinoma, and no evidence of lymph nodes or metastatic disease at FDG-PET within 6 weeks from the start of treatments. TMT consists of nivolumab (480 mg IV every 4 weeks for a total of 13 doses), weekly nab-paclitaxel (60mg/m2) plus cisplatin (20mg/m2) administered concurrently with RT (60Gy in 25 fractions over 5 weeks on original bladder tumor, plus a concomitant boost of 50Gy in 25 fractions on whole bladder and pelvic nodes). The primary endpoint is the 1-year DFS rate, defined as the rate of survival free of recurrence in pelvic nodes or bladder, or appearance of distant metastases. Secondary endpoints include: the rate of pts who require salvage cystectomy, the rate of locoregional complete response (CR) and of locoregional DFS, median DFS, safety, and quality of life. Exploratory biomarkers analysis will be performed. The trial is actively recruiting. RESULTS: On going. CONCLUSIONS: On going. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e865 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Marco Racioppi More articles by this author Francesco Pio Bizzarri More articles by this author Seyed Koosha Moosavi More articles by this author Eros Scarciglia More articles by this author Pierluigi Russo More articles by this author Giuseppe Palermo More articles by this author Ileana Sparagna More articles by this author Anna Rita Allitto More articles by this author Chiara Ciccarese More articles by this author Luca Tagliaferri More articles by this author Luca Boldrini More articles by this author Maria Antonietta Gambacorta More articles by this author Vincenzo Valentini More articles by this author Giampaolo Tortora More articles by this author Roberto Iacovelli More articles by this author Expand All Advertisement PDF downloadLoading ...