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ORIGINAL ARTICLE   

Minerva Urology and Nephrology 2021 August;73(4):489-97

DOI: 10.23736/S2724-6051.20.03723-6

Copyright © 2020 EDIZIONI MINERVA MEDICA

lingua: Inglese

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 GIANMARTIN 1, Sergio SERNI 1, Laura DONI 6, Cosimo DE NUNZIO 7, Michele DE TURSI 4, Maurizio VALERIANI 8, Silvana GIACINTI 9, Mario ÁLVAREZ-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, G. D’Annunzio University, Chieti, Chieti-Pescara, Italy; 3 Department of Urology, ASL Abruzzo2, Chieti, Italy; 4 Department of Medical, Oral and Biotechnological Sciences, Medical Oncology, G. D’Annunzio University, Chieti, Chieti-Pescara, Italy; 5 Department of Medical Oncology, San Camillo-Forlanini Hospital, Rome, Italy; 6 Department of Medical Oncology, Careggi University Hospital, Florence, Italy; 7 Department of Urology, Sant’Andrea Hospital, Sapienza University, Rome, Italy; 8 Unit of Radiation Therapy, Sant’Andrea Hospital, Sapienza University, Rome, Italy; 9 Unit of Oncology, Sant’Andrea Hospital, Sapienza University, Rome, Italy; 10 Department of Urology, La Paz University Hospital, Madrid, Spain; 11 F. Miulli Hospital, Acquaviva delle Fonti, Bari, Italy; 12 Department of Urology, Regina Elena National Cancer Institute, Rome, Italy; 13 Department of Experimental Medicine and Surgery, Tor Vergata Polyclinic, Rome, Italy; 14 Unit of Urology, San Carlo di Nancy Hospital, Rome, Italy; 15 UOSD of Medical Oncology, Tor Vergata Polyclinic, Rome, Italy; 16 Department of Urology, University of Foggia, Foggia, Italy; 17 Unit of Urology, Department of Neurosciences, Sciences of Reproduction and Odontostomatology, Federico II University, Naples, Italy; 18 Department of Urology, Vittorio Emanuele Polyclinic, Catania, Italy; 19 Department of Molecular Medicine, Sapienza University, Rome, Italy; 20 Department of Urology, Humanitas Gavazzeni Hospital, Bergamo, Italy; 21 Department of Medical, Oral and Biotechnological Sciences, Department of Urology, G. D’Annunzio University, Chieti, Chieti-Pescara, Italy



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 was 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 “real world” perspective in patients with mcRPC.


KEY WORDS: Prostatic neoplasms; Androgens; Drug therapy

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