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• W4225710329 abstract "You have accessJournal of UrologyCME1 May 2022PD59-04 APPLICATION OF THE KEYNOTE-564 TRIAL RESULTS TO REAL LIFE POPULATION: WHICH PATIENTS WITH ADVANCED KIDNEY CANCER SHOULD RECEIVE ADJUVANT PEMBROLIZUMAB Giuseppe Fallara, Giuseppe Rosiello, Daniele Raggi, Laura Marandino, Greta Malena, Giuseppe Basile, Gianmarco Colandrea, Daniele Cignoli, Federico Belladelli, Giacomo Musso, Francesco Cei, Roberto Bertini, Alberto Briganti, Andrea Salonia, Francesco Montorsi, Alessandro Larcher, Andrea Necchi, and Umberto Capitanio Giuseppe FallaraGiuseppe Fallara More articles by this author , Giuseppe RosielloGiuseppe Rosiello More articles by this author , Daniele RaggiDaniele Raggi More articles by this author , Laura MarandinoLaura Marandino More articles by this author , Greta MalenaGreta Malena More articles by this author , Giuseppe BasileGiuseppe Basile More articles by this author , Gianmarco ColandreaGianmarco Colandrea More articles by this author , Daniele CignoliDaniele Cignoli More articles by this author , Federico BelladelliFederico Belladelli More articles by this author , Giacomo MussoGiacomo Musso More articles by this author , Francesco CeiFrancesco Cei More articles by this author , Roberto BertiniRoberto Bertini More articles by this author , Alberto BrigantiAlberto Briganti More articles by this author , Andrea SaloniaAndrea Salonia More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , Alessandro LarcherAlessandro Larcher More articles by this author , Andrea NecchiAndrea Necchi More articles by this author , and Umberto CapitanioUmberto Capitanio More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002644.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The KEYNOTE-564 has reported improved disease-free survival (DFS) for high-risk renal cell carcinoma (RCC) patients receiving adjuvant Pembrolizumab when compared with placebo. However, given toxicity, costs, and heterogeneity in survival outcomes, it is of utmost importance an accurate selection of those patients who may benefit from adjuvant Pembrolizumab. METHODS: From our institutional prospectively maintained database we identified 408 patients who met the KEYNOTE-564 inclusion criteria (pT2 with grade 4 and/or sarcomatoid differentiation, pT3-4, regional lymph-node metastasis (LNI) or stage M1 with NED and the following features: ECOG 0-1, no bone or brain metastases and no previous neoadjuvant therapies). Descriptive statistics compared our cohort to the placebo arm of the KEYNOTE-564 and Kaplan-Meier analyses were used to assess time to DFS. We then applied a regression tree method for censored data to generate a risk stratification tool to predict 12-months DFS. RESULTS: Relative to the trial population, in the real-life setting patients had worst ECOG (ECOG=1, 64 vs. 15%) and in 44% of cases had one or more comorbidity, despite similar age at baseline. Similarly, there were more pT4 (5.4 vs. 2.7%) and pN1 (15 vs 6.3%) cases. Median DFS was 29 months (95%CI 23-37) compared to median DFS not reached in the KEYNOTE-564. According to regression tree analysis, LNI and lympho-vascular invasion (LVI) identified patients at higher risk of 1-yr disease recurrence (1-yr DFS 21%); those with LNI and LVI- and those pN0/x and necrosis and LVI at pathological report were at intermediate risk (1-yr DFS 51%); those with pN0/x with necrosis but without LVI and those with pN0/X without necrosis were at low risk of recurrence (1-yr DFS 79%). Our study is limited by potential unmeasured confounders and by lack of validation. CONCLUSIONS: Patients eligible for adjuvant Pembrolizumab have significantly different baseline characteristics, pathological features, and early recurrence outcomes rates relative to the placebo arm of KEYNOTE-564. This implies the need to accurately identify patients who may benefit the most from the adjuvant regimen. Those with necrosis, LVI invasion and positive nodes appear those who might benefit the most from adjuvant treatment. Source of Funding: No © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e1019 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Giuseppe Fallara More articles by this author Giuseppe Rosiello More articles by this author Daniele Raggi More articles by this author Laura Marandino More articles by this author Greta Malena More articles by this author Giuseppe Basile More articles by this author Gianmarco Colandrea More articles by this author Daniele Cignoli More articles by this author Federico Belladelli More articles by this author Giacomo Musso More articles by this author Francesco Cei More articles by this author Roberto Bertini More articles by this author Alberto Briganti More articles by this author Andrea Salonia More articles by this author Francesco Montorsi More articles by this author Alessandro Larcher More articles by this author Andrea Necchi More articles by this author Umberto Capitanio More articles by this author Expand All Advertisement PDF DownloadLoading ..." @default.
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• W4225710329 title "PD59-04 APPLICATION OF THE KEYNOTE-564 TRIAL RESULTS TO REAL LIFE POPULATION: WHICH PATIENTS WITH ADVANCED KIDNEY CANCER SHOULD RECEIVE ADJUVANT PEMBROLIZUMAB" @default.
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