You have accessJournal of UrologyKidney Cancer: Advanced (including Drug Therapy) II (PD40)1 Sep 2021PD40-05 NEOADJUVANT IMMUNOTHERAPY IN PATIENTS WITH RENAL CELL CARCINOMA UNDERGOING NEPHRECTOMY Kyrollis Attalla, Maria Carlo, Sounak Gupta, Sujata Patil, Devon Coskey, Samuel Murray, Ritesh Kotecha, Jonathan Coleman, Robert Motzer, Yingbei Chen, Jeremy Durack, Paul Russo, A Ari Hakimi, and Martin Voss Kyrollis AttallaKyrollis Attalla More articles by this author , Maria CarloMaria Carlo More articles by this author , Sounak GuptaSounak Gupta More articles by this author , Sujata PatilSujata Patil More articles by this author , Devon CoskeyDevon Coskey More articles by this author , Samuel MurraySamuel Murray More articles by this author , Ritesh KotechaRitesh Kotecha More articles by this author , Jonathan ColemanJonathan Coleman More articles by this author , Robert MotzerRobert Motzer More articles by this author , Yingbei ChenYingbei Chen More articles by this author , Jeremy DurackJeremy Durack More articles by this author , Paul RussoPaul Russo More articles by this author , A Ari HakimiA Ari Hakimi More articles by this author , and Martin VossMartin Voss More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002050.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Immune checkpoint inhibitor (ICI) therapy improves survival in patients with advanced renal cell carcinoma (RCC), but has not been studied preoperatively in patients with localized RCC who may be at high risk of recurrence, or in patients with metastatic disease who are candidates for cytoreductive nephrectomy. We evaluate the safety and feasibility of neoadjuvant immunotherapy in patients with localized, high-risk RCC. METHODS: Single institution pilot study of neoadjuvant nivolumab in patients with localized, high-risk RCC undergoing nephrectomy. Patients were eligible if their risk of metastatic recurrence within the first 12 years was >20% by nomogram. Nivolumab was administered every 2 weeks for 4 treatments, with a follow-up renal MRI prior to nephrectomy. In addition, we retrospectively assessed a separate cohort of 21 patients with metastatic disease who received preoperative ICI off protocol. RESULTS: In the prospective study cohort, 18 patients (11 men; median age 60) with clear cell RCC were enrolled. All received at least 1 dose of nivolumab; 16/18 patients completed all doses. Two patients had nivolumab discontinued for immune-related adverse events, including grade 3 transaminitis (1) and grade 2 arthralgias (1). All patients had stable disease as the best response prior to surgery. 17/18 (94%) patients completed at least 3 doses and had nephrectomy without delay. 4 patients had surgical complications per Clavien-Dindo classification, including 2 patients with Grade IIIa chylous ascites after lymphadenectomy. The metastatic cohort included 20 patients with ccRCC and one with epithelioid AML. 15 patients received ipilimumab+nivolumab, 6 received single-agent PD-1 or PD-L1 inhibitors. 3 (14%) patients achieved a near or complete pathologic response, including a patient with epithelioid AML. No patient experienced a major intraoperative complication or 30- or 90-day mortality, and one patient was readmitted for pneumonia, metastatic bronchial occlusions requiring bronchoscopy and eventual intubation (Clavien 4a). 5 patients experienced grade 3 or 4 irAEs. CONCLUSIONS: In a pilot study of nivolumab prior to nephrectomy in patients with localized RCC, the approach appeared safe and feasible with no surgical delays and expected rate of immune related adverse events. A retrospective review of patients with metastatic disease who underwent cytoreductive nephrectomy after ICI showed favorable surgical outcomes, with an association of combination CTLA-4 and PD-1 inhibitor with higher grade irAE and pathologic complete responses. Source of Funding: This work was funded in part through the National Institute of Health (NIH)’s Cancer Therapy Evaluation Program (CTEP), and the NIH/NCI Cancer Center Support Grant P30 CA008748 © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e675-e676 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kyrollis Attalla More articles by this author Maria Carlo More articles by this author Sounak Gupta More articles by this author Sujata Patil More articles by this author Devon Coskey More articles by this author Samuel Murray More articles by this author Ritesh Kotecha More articles by this author Jonathan Coleman More articles by this author Robert Motzer More articles by this author Yingbei Chen More articles by this author Jeremy Durack More articles by this author Paul Russo More articles by this author A Ari Hakimi More articles by this author Martin Voss More articles by this author Expand All Advertisement Loading ...
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