Long-term Efficacy and Safety of Enzalutamide Monotherapy in Hormone-naïve Prostate Cancer: 1- and 2-Year Open-label Follow-up Results

Tombal, Bertrand; Borre, Michael; Rathenborg, Per; Werbrouck, Patrick; Van Poppel, Hendrik; Heidenreich, Axel; Iversen, Peter; Braeckman, Johan; Heracek, Jiri; Baskin-Bey, Edwina; Ouatas, Taoufik; Perabo, Frank; Phung, De; Baron, Benoit; Hirmand, Mohammad; Smith, Matthew R

doi:10.1016/j.eururo.2015.01.027

Long-term Efficacy and Safety of Enzalutamide Monotherapy in Hormone-naïve Prostate Cancer: 1- and 2-Year Open-label Follow-up Results

Author:

Tombal, Bertrand

Borre, Michael ; Rathenborg, Per ; Werbrouck, Patrick ; Van Poppel, Hendrik ; Heidenreich, Axel ; Iversen, Peter ; Braeckman, Johan ; Heracek, Jiri ; Baskin-Bey, Edwina ; Ouatas, Taoufik ; Perabo, Frank ; Phung, De ; Baron, Benoit ; Hirmand, Mohammad ; Smith, Matthew R

Keywords:

Science & Technology, Life Sciences & Biomedicine, Urology & Nephrology, Androgen receptor, Enzalutamide, Hormone-naive prostate cancer, Prostate-specific antigen response, ANDROGEN-DEPRIVATION THERAPY, BONE-MINERAL DENSITY, III EXTENSION TRIAL, QUALITY-OF-LIFE, BICALUTAMIDE MONOTHERAPY, 1-ARM CROSSOVER, 150 MG, ANTIANDROGEN, CASTRATION, LEUPROLIDE, Hormone-naïve prostate cancer, Aged, Aged, 80 and over, Androgen Receptor Antagonists, Antineoplastic Agents, Hormonal, Benzamides, Chemotherapy, Adjuvant, Follow-Up Studies, Humans, Kallikreins, Longitudinal Studies, Male, Middle Aged, Neoplasm Recurrence, Local, Nitriles, Phenylthiohydantoin, Prostate-Specific Antigen, Prostatectomy, Prostatic Neoplasms, Treatment Outcome, 1103 Clinical Sciences, 3202 Clinical sciences

Abstract:

Enzalutamide is an androgen receptor inhibitor with a demonstrated overall survival benefit in metastatic castration-resistant prostate cancer. A phase 2 study of enzalutamide monotherapy in patients with hormone-naïve prostate cancer (HNPC) showed a high response rate for the prespecified primary endpoint (ie, prostate-specific antigen [PSA] response at week 25), regardless of metastases at baseline, and favorable tolerability.