LBA01-08 INTERIM ANALYSIS OF PADRES (PRIOR AXITINIB AS A DETERMINANT OF OUTCOME OF RENAL SURGERY NCT03438708) CLINICAL TRIAL

Abstract

You have accessJournal of UrologyCME1 May 2022LBA01-08 INTERIM ANALYSIS OF PADRES (PRIOR AXITINIB AS A DETERMINANT OF OUTCOME OF RENAL SURGERY NCT03438708) CLINICAL TRIAL Kevin Hakimi, Steven Campbell, Mimi Nguyen, Nityam Rathi, Luke Wang, Brian Rini, Moshe Ornstein, Rana McKay, and Ithaar Derweesh Kevin HakimiKevin Hakimi More articles by this author , Steven CampbellSteven Campbell More articles by this author , Mimi NguyenMimi Nguyen More articles by this author , Nityam RathiNityam Rathi More articles by this author , Luke WangLuke Wang More articles by this author , Brian RiniBrian Rini More articles by this author , Moshe OrnsteinMoshe Ornstein More articles by this author , Rana McKayRana McKay More articles by this author , and Ithaar DerweeshIthaar Derweesh More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002669.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In renal cell carcinoma (RCC), partial nephrectomy (PN) is imperatively indicated for individuals with solitary kidney, chronic kidney disease, or bilateral tumors. Neoadjuvant Tyrosine Kinase Inhibitor therapy can potentially cytoreduce renal tumors and may therefore permit PN in circumstances not otherwise feasible. We report interim analysis of the PADRES (Prior Axitinib as a Determinant of Outcome of Renal Surgery NCT03438708). METHODS: This was a single arm phase II clinical trial of neoadjuvant axitinib in patients with complex renal mass (RENAL nephrometry score 10-12 and cT1b-cT3M0) biopsy-proven clear cell RCC with strong indications for partial nephrectomy (PN), and in whom radical nephrectomy may result in dialysis dependence. Axitinib 5 mg was administered orally twice daily for 8 weeks prior to surgery. Primary outcome was reduction in longest tumor diameter based on imaging criteria; secondary outcomes included tumor response (RECIST), change in RENAL score, feasibility of PN, change in estimated glomerular filtration rate (∆eGFR), post-surgical complications, and survival outcomes. RESULTS: 27 patients consented for study of which 26 proceeded with protocol (median age 69 years; median follow-up 12 months). Prior to therapy, 19 (73.1%) patients had ≥ clinical T3a staged tumors. Post therapy, 17 (65.4%) patients had ≥T3a staged tumors, and 8/26 (31%) of patients were downstaged on imaging. Axitinib resulted in reductions in median tumor size (19%, 7.7 vs. 6.3 cm, p <0.001 and RENAL score (11 vs. 10, p <0.001); 21/26 (80.9%) had partial response, and 5/26 (19.2%) had stable disease by RECIST criteria. PN was performed in 20/26 (76.9%) with median ischemia time of 34 minutes and with 25/26 (96.8%) achieving negative margins. All radical nephrectomy patients had at ≥T3a tumors on final pathology. Five (19.2%) had Clavien III-IV post-surgical complications. At last follow up, median ∆eGFR was 4.5 mL/min/1.73m2, 1/26 (3.8%) died due to progression, and 2/26 (7.7%) had recurrence. CONCLUSIONS: In this interim analysis, neoadjuvant Axitnib resulted in significant reductions in tumor size and complexity, enabling partial nephrectomy in a cohort of highly complex renal masses, and with acceptable safety and functional preservation. Accrual is ongoing to reach a target of 50. Source of Funding: Pfizer © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e1038 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kevin Hakimi More articles by this author Steven Campbell More articles by this author Mimi Nguyen More articles by this author Nityam Rathi More articles by this author Luke Wang More articles by this author Brian Rini More articles by this author Moshe Ornstein More articles by this author Rana McKay More articles by this author Ithaar Derweesh More articles by this author Expand All Advertisement PDF DownloadLoading ...