Enzalutamide in Japanese patients with chemotherapy-naïve, metastatic castration-resistant prostate cancer: A post-hoc analysis of the placebo-controlled PREVAIL trial
| Autor: | Hank Mansbach, Ad Theeuwes, Masahiro Nozawa, Tomasz M. Beer, Junji Yonese, Takeshi Ueda, Takashi Fukagai, Tomomi Kamba, Go Kimura, Kazuo Nishimura, Bertrand Tombal |
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| Rok vydání: | 2015 |
| Předmět: |
Oncology
Male medicine.medical_specialty Urology medicine.medical_treatment 030232 urology & nephrology Antineoplastic Agents Placebo Disease-Free Survival Androgen deprivation therapy 03 medical and health sciences chemistry.chemical_compound Prostate cancer 0302 clinical medicine Double-Blind Method Japan Internal medicine Nitriles Phenylthiohydantoin medicine Enzalutamide Humans Adverse effect Chemotherapy business.industry Hazard ratio medicine.disease Discontinuation Surgery Prostatic Neoplasms Castration-Resistant Treatment Outcome chemistry 030220 oncology & carcinogenesis Benzamides business |
| Zdroj: | International journal of urology : official journal of the Japanese Urological Association. 23(5) |
| ISSN: | 1442-2042 |
| Popis: | Objectives To evaluate the treatment effects, safety and pharmacokinetics of enzalutamide in Japanese patients. Methods This was a post-hoc analysis of the phase 3, double-blind, placebo-controlled PREVAIL trial. Asymptomatic or mildly symptomatic chemotherapy-naive patients with metastatic castration-resistant prostate cancer progressing on androgen deprivation therapy were randomized one-to-one to 160 mg/day oral enzalutamide or placebo until discontinuation on radiographic progression or skeletal-related event and initiation of subsequent antineoplastic therapy. Coprimary end-points were centrally assessed radiographic progression-free survival and overall survival. Secondary end-points were investigator-assessed radiographic progression-free survival, time to initiation of chemotherapy, time to prostate-specific antigen progression, prostate-specific antigen response (≥50% decline) and time to skeletal-related event. Results Of 1717 patients, 61 were enrolled in Japan (enzalutamide, n = 28; placebo, n = 33); hazard ratios (95% confidence interval) of 0.30 for centrally assessed radiographic progression-free survival (0.03–2.95), 0.59 for overall survival (0.20–1.8), 0.46 for time to chemotherapy (0.22–0.96) and 0.36 for time to prostate-specific antigen progression (0.17–0.75) showed the treatment benefit of enzalutamide over the placebo. Prostate-specific antigen responses were observed in 60.7% of enzalutamide-treated men versus 21.2% of placebo-treated men. Plasma concentrations of enzalutamide were higher in Japanese patients: the geometric mean ratio of Japanese/non-Japanese patients was 1.126 (90% confidence interval 1.018–1.245) at 13 weeks. Treatment-related adverse events grade ≥3 occurred in 3.6% of enzalutamide- and 6.1% of placebo-treated Japanese patients. Conclusion Treatment effects and safety in Japanese patients were generally consistent with the overall results from PREVAIL. |
| Databáze: | OpenAIRE |
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