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

Abstract

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.

• Authors: Mauro Gacci, Michele Marchioni, Piergustavo DE Francesco, Clara Natoli, Fabio Calabrò, Tania Losanno, Cito Gianmartin, Sergio Serni, Laura Doni, Cosimo DE Nunzio, Michele DE Tursi, Maurizio Valeriani, Silvana Giacinti, Mario Álvarez-Maestro, Marcello Scarcia, Giuseppe M Ludovico, Gabriella Del Bene, Giuseppe Simone, Mariaconsiglia Ferriero, Gabriele Tuderti, Pierluigi Bove, Anastasia Laudisi, Giuseppe Carrieri, Luigi Cormio, Paolo Verze, Roberto LA Rocca, Mario Falsaperla, Viviana Frantellizzi, Francesco Greco, Marta DI Nicola, Luigi Schips, Luca Cindolo
• Journal: Minerva urology and nephrology (Minerva Urol Nephrol) Vol. 73 Issue 4 Pg. 489-497 (08 2021) ISSN: 2724-6442 [Electronic] Italy
• PMID: 32748613 (Publication Type: Journal Article, Multicenter Study)

Chemical References

• Benzamides
• Nitriles
• Phenylthiohydantoin
• enzalutamide

Topics

• Aged
• Benzamides
• Humans
• Male
• Nitriles
• Phenylthiohydantoin (adverse effects)
• Prostatic Neoplasms, Castration-Resistant (drug therapy)
• Retrospective Studies
• Treatment Outcome