Enzalutamide in patients with castration-resistant prostate cancer: retrospective, multicenter, real life study.
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Gacci Mauro, Marchioni Michele, DE Francesco Piergustavo, Natoli Clara, Calabrò Fabio, Losanno Tania, Gianmartin Cito, Serni Sergio, Doni Laura, DE Nunzio Cosimo, DE Tursi Michele, Valeriani Maurizio, Giacinti Silvana, Álvarez-Maestro Mario, Scarcia Marcello, Ludovico Giuseppe M, Del Bene Gabriella, Simone Giuseppe, Ferriero Mariaconsiglia, Tuderti Gabriele, Bove Pierluigi, Laudisi Anastasia, Carrieri Giuseppe, Cormio Luigi, Verze Paolo, LA Rocca Roberto, Falsaperla Mario, Frantellizzi Viviana, Greco Francesco, DI Nicola Marta, Schips Luigi, Cindolo Luca
Аннотация
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.