MP15-15 WHO ARE THE PATIENTS WHO BENEFIT THE MOST FROM EXTENDED PELVIC LYMPH NODE DISSECTION IN LOCALIZED PROSTATE CANCER? IDENTIFICATION OF THE OPTIMAL CANDIDATES TO BE INCLUDED IN A RANDOMIZED CONTROLLED TRIAL

Abstract

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy I (MP15)1 Sep 2021MP15-15 WHO ARE THE PATIENTS WHO BENEFIT THE MOST FROM EXTENDED PELVIC LYMPH NODE DISSECTION IN LOCALIZED PROSTATE CANCER? IDENTIFICATION OF THE OPTIMAL CANDIDATES TO BE INCLUDED IN A RANDOMIZED CONTROLLED TRIAL Giorgio Gandaglia, Giuseppe Rosiello, Simone Scuderi, Nicola Fossati, Armando Stabile, Andrea Necchi, Vito Cucchiara, Riccardo Leni, Donato Cannoletta, Andrea Gallina, Emanuele Zaffuto, Marco Moschini, Andrea Salonia, Federico Dehò, Francesco Montorsi, and Alberto Briganti Giorgio GandagliaGiorgio Gandaglia More articles by this author , Giuseppe RosielloGiuseppe Rosiello More articles by this author , Simone ScuderiSimone Scuderi More articles by this author , Nicola FossatiNicola Fossati More articles by this author , Armando StabileArmando Stabile More articles by this author , Andrea NecchiAndrea Necchi More articles by this author , Vito CucchiaraVito Cucchiara More articles by this author , Riccardo LeniRiccardo Leni More articles by this author , Donato CannolettaDonato Cannoletta More articles by this author , Andrea GallinaAndrea Gallina More articles by this author , Emanuele ZaffutoEmanuele Zaffuto More articles by this author , Marco MoschiniMarco Moschini More articles by this author , Andrea SaloniaAndrea Salonia More articles by this author , Federico DehòFederico Dehò More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001996.15AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: A Phase III RCT (NCT01812902) failed to show a benefit of limited vs extended pelvic lymph node dissection (ePLND) in intermediate and high-risk prostate cancer (PCa) patients undergoing RP. We aimed at assessing the generalizability of this trial and the outcomes of ePLND according to different selection criteria to identify the candidate for inclusion in a RCT METHODS: 3,421 PCa patients treated with RP and PLND were included. We identified men who fulfilled the NCT01812902 criteria for inclusion. Kaplan-Meier analyses assessed time to biochemical recurrence (BCR). An interaction test assessed whether the impact of the number of nodes removed on BCR-free survival varied according to the risk of lymph node invasion (LNI) according to different risk strata calculated with the Briganti nomogram RESULTS: The criteria proposed by the NCT01812902 trial would have resulted in 1,076 (72.7%) and 405 (27.3%) eligible intermediate- and high-risk patients. The number of nodes removed was 18 (vs. 17 in the ePLND group of the trial) and the rate of LNI was 15.6% (vs. 17%). If the 5% Briganti nomogram cut-off to select PLND candidates had been used, only 758 (51.2%) patients would have been included in the trial with a rate of LNI of 27.3% and a 55% 5-year BCR-free survival (n=171), lower than 67.5% (n=228) corresponding to intermediate and high risk patients. The impact of the PLND extent (i.e., number of nodes removed) on BCR varied according to the risk of LNI according to the Briganti nomogram (p=0.04 by interaction test). A more extensive PLND was associated with a decreased BCR if the risk of LNI was between 10-20% but not in men with a lower or higher risk (Figure). The use of this range of the estimated risk of LNI for patient selection would have resulted in only 258 (34%) eligible men CONCLUSIONS: The use of a 5% Briganti nomogram cut-off as eligibility criteria for a RCT would have resulted into the inclusion of only 50% of intermediate and high-risk patients. The NCT01812902 trial cannot be generalized to patients selected for PLND according to guidelines. A more extended PLND was beneficial in men with a 10-20% LNI risk, who should theoretically be considered for the inclusion in RCTs Source of Funding: © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e269-e269 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Giorgio Gandaglia More articles by this author Giuseppe Rosiello More articles by this author Simone Scuderi More articles by this author Nicola Fossati More articles by this author Armando Stabile More articles by this author Andrea Necchi More articles by this author Vito Cucchiara More articles by this author Riccardo Leni More articles by this author Donato Cannoletta More articles by this author Andrea Gallina More articles by this author Emanuele Zaffuto More articles by this author Marco Moschini More articles by this author Andrea Salonia More articles by this author Federico Dehò More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement Loading ...