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Minerva Urologica e Nefrologica 2020 Aug 04

DOI: 10.23736/S0393-2249.20.03723-6

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

Enzalutamide in patients with castration-resistant prostate cancer: retrospective, multicenter, real life study

Mauro GACCI 1, Michele MARCHIONI 2, Piergustavo DE FRANCESCO 3, Clara NATOLI 4, Fabio CALABRÒ 5, Tania LOSANNO 5, Cito GIAMMARTIN 1, Sergio SERNI 1, Laura DONI 6, Cosimo DE NUNZIO 7, Michele DE TURSI 4, Maurizio VALERIANI 8, Silvana GIACINTI 9, Mario ALVAREZ-MAESTRO 10, Marcello SCARCIA 11, Giuseppe M. LUDOVICO 11, Gabriella DEL BENE 5, Giuseppe SIMONE 12, Mariaconsiglia FERRIERO 12, Gabriele TUDERTI 12, Pierluigi BOVE 13, 14, Anastasia LAUDISI 15, Giuseppe CARRIERI 16, Luigi CORMIO 16, Paolo VERZE 17, Roberto LA ROCCA 17, Mario FALSAPERLA 18, Viviana FRANTELLIZZI 19, Francesco GRECO 20, Marta DI NICOLA 2, Luigi SCHIPS 3, 21, Luca CINDOLO 3

1 Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, AOUC Careggi Hospital, Florence, Italy; 2 Department of Medical, Oral and Biotechnological Sciences, Laboratory of Biostatistics, University "G. d'Annunzio", Chieti, Italy; 3 Department of Urology, ASL Abruzzo2, Chieti, Italy; 4 Department of Medical, Oral and Biotechnological Sciences, Medical Oncology, "G. D'Annunzio" University, Chieti, Italy; 5 Medical Oncology “San Camillo” and “Forlanini” Hospital, Rome, Italy; 6 Medical Oncology AOUC Hospital, Florence, Italy; 7 Department of Urology, “Sant'Andrea” Hospital, “Sapienza University”, Rome, Italy; 8 Radiation Therapy Unit, “Sant'Andrea” Hospital, “Sapienza University”, Rome, Italy; 9 Oncology Unit, “Sant'Andrea” Hospital, “Sapienza University”, Rome , Italy; 10 Department of Urology, Hospital Universitario “La Paz”, Madrid, Spain; 11 Ente Ecclesiastico Ospedale "F. Miulli", Acquaviva delle Fonti, Bari, Italy; 12 “Regina Elena” National Cancer Institute, Department of Urology, Rome, Italy; 13 Department of Experimental Medicine and Surgery, Azienda Policlinico Tor Vergata, Rome, Italy; 14 UOC of Urology, San Carlo di Nancy Hospital, Rome, Italy; 15 UOSD of Medical Oncology, Azienda Policlinico Tor Vergata, Rome , Italy; 16 Department of Urology, University of Foggia, Foggia, Italy; 17 Department of Neurosciences, Sciences of Reproduction and Odontostomatology, Urology Unit, University of Naples "Federico II", Naples, Italy; 18 Department of Urology, Policlinico-Vittorio Emanuele, Catania, Italy; 19 Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy; 20 Department of Urology, Humanitas Gavazzeni, Bergamo, Italy; 21 Department of Medical, Oral and Biotechnological Sciences, Department of Urology, University "G. d'Annunzio" Chieti-Pescara, Chieti, Italy


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BACKGROUND: Metastatic castration-resistant prostate cancer (mCRPC) is the final stage of pCa history and represents a clinically relevant phenotype with an elevated burden of mortality. The aim of the present study is to evaluate the efficacy and safety of enzalutamide in a “real-life” setting in mCRPC patients.
METHODS: Data about all mCRPC patients treated with enzalutamide from September 2017 to September 2018 were collected. Demographics, comorbidities, clinical parameters, outcomes, toxicity, overall survival and progression free survival were analyzed.
RESULTS: Overall 158 patients were enrolled. Mean age was 75.8 (±8.7) years with a baseline median PSA of 16.5 (IQR 7.4-47.8) ng/mL. The median follow-up lasted 7.7 (IQR 4-14.1) months. Of all the 10.1% of patients reported grade 3-4 adverse events. 43.7% of patients experienced a progression. Overall the 6 and 12 months PFS rates were 69.5% (95% CI: 61.7-78.3%) and the 45.6% (95% CI: 36.5-57.1%); a median baseline PSA >16 ng/mL (HR:2.0, 95% CI: 1.2-3.3, p=0.005), the use of opioid (HR:3.1, 95% CI 1.9-5.0, p<0.001), a previous treatment (abiraterone, docetaxel or abiraterone + docetaxel) were significantly associated with higher rates of cancer progression. Conversely, a brief pain questionnaire of 0-1 (HR: 0.4, 95% CI: 0.2-0.7, p<0.001), a 12 weeks 50% PSA reduction (HR: 0.4, 95% CI: 0.2-0.8, p=0.006) and a longer time to mCRPC (HR: 0.4, 95% CI: 0.3-0.7, p=0.002) were related to lower cancer progression rates.
CONCLUSIONS: Our data shows an effective and safe profile of enzalutamide in a “realworld” perspective in patients with mcRPC.


KEY WORDS: Enzalutamide; mCRPC; Hormonal therapy; Antiandrogen

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