Mp53-18 Impact of Neoadjuvant Chemo-Immunotherapy on Intra and Post Operative Outcomes in Patients With Bladder Cancer Treated With Radical Cystectomy and Pelvic Lymph Node Dissection: Prospective Surgical Assessment From the Nure-Combo Trial

You have accessJournal of UrologyBladder Cancer: Invasive V (MP53)1 May 2024MP53-18 IMPACT OF NEOADJUVANT CHEMO-IMMUNOTHERAPY ON INTRA AND POST OPERATIVE OUTCOMES IN PATIENTS WITH BLADDER CANCER TREATED WITH RADICAL CYSTECTOMY AND PELVIC LYMPH NODE DISSECTION: PROSPECTIVE SURGICAL ASSESSMENT FROM THE NURE-COMBO TRIAL Chiara Re, Francesco Pellegrino, Mattia Longoni, Pietro Scilipoti, Giulio Avesani, Mario de Angelis, Chiara Mercinelli, Antonio Cigliola, Damiano Alfio Patanè, Daniele Raggi, Roberta Lucianò, Nazario Tenace, Renzo Colombo, Giorgio Gandaglia, Alberto Briganti, Francesco Montorsi, Andrea Necchi, and Marco Moschini Chiara ReChiara Re , Francesco PellegrinoFrancesco Pellegrino , Mattia LongoniMattia Longoni , Pietro ScilipotiPietro Scilipoti , Giulio AvesaniGiulio Avesani , Mario de AngelisMario de Angelis , Chiara MercinelliChiara Mercinelli , Antonio CigliolaAntonio Cigliola , Damiano Alfio PatanèDamiano Alfio Patanè , Daniele RaggiDaniele Raggi , Roberta LucianòRoberta Lucianò , Nazario TenaceNazario Tenace , Renzo ColomboRenzo Colombo , Giorgio GandagliaGiorgio Gandaglia , Alberto BrigantiAlberto Briganti , Francesco MontorsiFrancesco Montorsi , Andrea NecchiAndrea Necchi , and Marco MoschiniMarco Moschini View All Author Informationhttps://doi.org/10.1097/01.JU.0001008784.37684.bd.18AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Although an improvement in oncologic outcomes is evident, radical cystectomy (RC) is associated with a high rate of complications. Recent data suggest that RC in patients (pts) with muscle invasive bladder cancer (MIBC) treated with neoadjuvant anti PD-1 immunotherapy is surgically safe (PMID: 31911010). More advances have been established in the neoadjuvant trial setting with the combination of immuno+chemotherapy. We report intra and perioperative outcomes after RC+Pelvic Lymph Node Dissection (PLND) in pts with MIBC enrolled in a phase 2 trial of neoadjuvant Nivolumab (NIVO) + Nab-paclitaxel (ABX) (NCT04876313). METHODS: Eligible pts with MIBC who received 4 cycles of NIVO 360 mg Q3W+125 mg/m2 ABX on Day 1 and 8, Q3W were subsequently treated with open or robot-assisted RC (RARC) + PLND. After RC 13 cycles of 360 mg adjuvant NIVO 360 mg Q3W were administered. All patients had collected data about intra- and postoperative outcomes. Postoperative complications were graded according to the Clavien-Dindo system. Perioperative data were collected according to the European Association of Urology (EAU) Guidelines Panel recommendations on reporting and grading complications. The primary end point was to describe surgical outcomes after RC. The secondary endpoint was to compare perioperative outcomes of our cohort to 105 pts with MIBC who received 3 cycles of neoadjuvant Pembrolizumab (PEMBRO) 200 mg Q3W followed RC+PLND, inside the PURE01 trial (NCT02736266). RESULTS: 27 pts were enrolled from May 2022 to August 2023; 23 (85.2%) underwent RARC, 4 (14.8%) open RC, and 7 pts (26%) received an orthotopic neobladder. Median length of stay was 12 days. 19 (70%), 16 (59%), and 1 (3.7%) pts experienced any- grade complications, grade >2 complications, and readmission at 30 days, respectively. High- grade complications (defined as Clavien-Dindo >3a) were observed in 6 pts (22%). The most frequent complications were fever (n=12, 44%) and paralytic ileus (n=8, 30%). Despite the regular post operative course, one patient died 5 days after RC due to a heart failure. At multivariable analyses, no differences in complication and readmission rates at 30 days were observed between the two cohorts (all p>0.2). CONCLUSIONS: Our data represent the first prospective evidence supporting the surgical safety of RC+PLND in pts with MIBC who received neoadjuvant combination of chemo-immunotherapy with NIVO+ABX. Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e871 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Chiara Re More articles by this author Francesco Pellegrino More articles by this author Mattia Longoni More articles by this author Pietro Scilipoti More articles by this author Giulio Avesani More articles by this author Mario de Angelis More articles by this author Chiara Mercinelli More articles by this author Antonio Cigliola More articles by this author Damiano Alfio Patanè More articles by this author Daniele Raggi More articles by this author Roberta Lucianò More articles by this author Nazario Tenace More articles by this author Renzo Colombo More articles by this author Giorgio Gandaglia More articles by this author Alberto Briganti More articles by this author Francesco Montorsi More articles by this author Andrea Necchi More articles by this author Marco Moschini More articles by this author Expand All Advertisement PDF downloadLoading ...