MP24-09 BALANCING EFFICACY AND TOXICITY OF DOCETAXEL IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER. RESULTS FROM A POOLED ANALYSIS OF THREE PROSPECTIVE RANDOMIZED TRIALS (2021)

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) II (MP24)1 Sep 2021MP24-09 BALANCING EFFICACY AND TOXICITY OF DOCETAXEL IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER. RESULTS FROM A POOLED ANALYSIS OF THREE PROSPECTIVE RANDOMIZED TRIALS Alberto Martini, Giuseppe Cirulli, Anish B. Parikh, John P. Sfakianos, Matthew D. Galsky, William K. Oh, Che-Kai Tsao, Giorgio Gandaglia, Nicola Fossati, Armando Stabile, Andrea Necchi, Vito Cucchiara, Francesco Pellegrino, Simone Scuderi, Pierre I. Karakiewicz, Francesco Montorsi, and Alberto Briganti Alberto MartiniAlberto Martini More articles by this author , Giuseppe CirulliGiuseppe Cirulli More articles by this author , Anish B. ParikhAnish B. Parikh More articles by this author , John P. SfakianosJohn P. Sfakianos More articles by this author , Matthew D. GalskyMatthew D. Galsky More articles by this author , William K. OhWilliam K. Oh More articles by this author , Che-Kai TsaoChe-Kai Tsao More articles by this author , Giorgio GandagliaGiorgio Gandaglia 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 , Francesco PellegrinoFrancesco Pellegrino More articles by this author , Simone ScuderiSimone Scuderi More articles by this author , Pierre I. KarakiewiczPierre I. Karakiewicz 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.0000000000002015.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Docetaxel is widely used in metastatic castration-resistant prostate cancer (mCRPC), however its optimal use remains unclear. Biomarkers and prediction models assessing efficacy and toxicity of Docetaxel may help optimize treatment selection. METHODS: Through Project Data Sphere, we accessed patient data from the control arms of three frontline mCRPC trials: ASCENT2, VENICE, and MAINSAIL. Treatment in each control arm consisted of Docetaxel 75mg/m2 every 21 days + prednisone 5mg twice/day. The primary outcome was occurrence of toxicity-related D discontinuation (TRDD). Reasons for Docetaxel discontinuation were recorded and extensive demographic and clinical data were considered in a competing risks regression (CRR) to develop a model to predict TRDD. Cumulative incidence (CI) of TRDD was estimated after accounting for the occurrence of competing events (death or progression). This model was used to build a risk calculator to predict TRDD, the output of which was used in a classification and regression tree (CART) to identify 3 risk groups. Overall survival (OS) for the pooled cohort and for each risk group was assessed via the Kaplan-Meier (KM) method. RESULTS: A total of 1568 pts were studied. Median follow-up was 12.1 mo. Median OS was 21 mos. CRR yielded the following significant factors that were included in the predictive model and risk calculator: age, ECOG performance status, AST, bilirubin, use of analgesics, and presence of diabetes and chronic kidney disease. Pooled CI of TRDD was 19% after accounting for competing events (death, 474 pts; progression, 59 pts) within 12 months of starting treatment. The CART analysis identified three risk groups: low (model-derived TRDD risk ≤24%), intermediate (25-64%), and high (≥65%) risk group. In each risk group, probability of TRDD during treatment was 14%, 58%, and 79%, and median OS was 24 months, 20 months, and 13 months, respectively (p<0.001). The KM survival curves for each group are shown in Fig. 1. CONCLUSIONS: For patients with mCRPC, our model can help clinicians balancing Docetaxel toxicity and efficacy. The three risk categories identified correlated with OS and this is particularly useful for an optimal shared decision-making process. Source of Funding: © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e415-e415 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Alberto Martini More articles by this author Giuseppe Cirulli More articles by this author Anish B. Parikh More articles by this author John P. Sfakianos More articles by this author Matthew D. Galsky More articles by this author William K. Oh More articles by this author Che-Kai Tsao More articles by this author Giorgio Gandaglia 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 Francesco Pellegrino More articles by this author Simone Scuderi More articles by this author Pierre I. Karakiewicz More articles by this author Francesco Montorsi More articles by this author Alberto Briganti More articles by this author Expand All Advertisement Loading ...