Impact of enzalutamide and sequential flutamide and enzalutamide therapy for castration-resistant prostate cancer after bicalutamide-combined androgen blockade therapy onoverall survival: A follow-up study of randomized phase 2 trial (OCCU-CRPC study)
| Autor: | Taro Hase, Hiroyuki Iwata, Takashi Deguchi, Katsuki Iwamoto, Kazuya Morimoto, Takahisa Adachi, Satoshi Tamada, Minoru Kato, Tatsuya Nakatani, Taiyo Otoshi, Keiichi Ishii, Yoshinori Takegaki, Tetsuji Ohmachi, Koji Harimoto, Sayaka Yasuda, Tomohiro Kanamaru, Taro Iguchi, Koichiro Tashiro, Y. Machida, Shinji Yamamoto |
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| Rok vydání: | 2019 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Bicalutamide business.industry medicine.drug_class Follow up studies Castration resistant medicine.disease Androgen Flutamide Blockade Prostate cancer chemistry.chemical_compound chemistry Internal medicine medicine Enzalutamide business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 37:5042-5042 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2019.37.15_suppl.5042 |
| Popis: | 5042 Background: In Asia, bicalutamide-combined androgen blockade (CAB) is widely used to treat metastatic or locally advanced prostate cancer. Enzalutamide (ENZA) shows benefits in men with metastatic and nonmetastatic castration-resistant prostate cancer (CRPC), although flutamide (FLU) is still used as an alternative anti-androgen therapy after bicalutamide-CAB. Methods: The multicenter open-label phase 2 trial OCUU-CRPC (NCT02346578) randomized patients (1:1) with CRPC after bicalutamide-CAB to ENZA (160 mg/day) or FLU (375 mg/day). Patients were stratified according to distant metastases. The primary endpoint was the prostate-specific antigen (PSA) response rate (≥50% decrease) at 3 months. The endpoints of this follow-up observational study include PSA progression-free survival of ENZA therapy (PSA-PFS-ENZA), time to treatment failure of ENZA therapy (TTF-ENZA), and overall survival (OS). Results: In total, 103 patients were randomized to ENZA (n = 52) and FLU (n = 51). Overall, 67% had distant metastases and 10% had prior radical therapy. Twenty-five (48%) and 38 (75%) patients, respectively, discontinued their assigned treatment because of progressive disease or adverse events (AEs) and were treated by standard of care. Of the 38 patients that discontinued FLU, 34 (89%) received ENZA as subsequent therapy. The median follow-up time was 14 months (ENZA, interquartile range (IQR): 9.5-24.8) and 17.2 months (FLU, IQR: 9.8-24.9). PSA-PFS-ENZA was longer in patients not treated with FLU (hazard ratio (HR), 0.29; 95% confidence interval (CI), 0.14 to 0.63; p < 0.001), but there was no significant difference in TTF-ENZA (HR, 1.27; 95% CI, 0.73 to 2.19; p = 0.397)and OS (HR, 0.77; 95% CI, 0.31 to 1.89; p = 0.567) between the two groups. The AEs of ENZA were consistent with those observed in prior phase 3 trials. Conclusions: ENZA after bicalutamide-CAB resulted in greater PSA-PFS than sequential FLU and ENZA therapy. No differences were observed in TTF-ENZA and OS between ENZA after bicalutamide-CAB and sequential FLU and ENZA therapy. Clinical trial information: NCT02346578. [Table: see text] |
| Databáze: | OpenAIRE |
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