Enzalutamide versus Abiraterone Plus Prednisolone for Nonmetastatic Castration-Resistant Prostate Cancer: A Sub-Analysis from the ENABLE Study for PCa

Author:

Mita Koji1ORCID,Izumi Kouji2,Goriki Akihiro13ORCID,Tasaka Ryo13,Hatayama Tomoya13,Shima Takashi4,Kato Yuki25ORCID,Kamiyama Manabu6,Inoue Shogo37,Tanaka Nobumichi8,Hoshi Seiji9ORCID,Okamura Takehiko10,Yoshio Yuko11,Enokida Hideki12,Chikazawa Ippei13,Kawai Noriyasu14ORCID,Hashimoto Kohei15,Fukagai Takashi16,Shigehara Kazuyoshi217,Takahara Shizuko1819,Kadono Yoshifumi2ORCID,Mizokami Atsushi2ORCID

Affiliation:

1. Department of Urology, Hiroshima City North Medical Center Asa Citizens Hospital, 1-2-1 Kameyama-Minami, Asakita-ku, Hiroshima 731-0293, Japan

2. Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, 13-1 Takaramachi, Kanazawa 920-8641, Japan

3. Department of Urology, Hiroshima University Graduate School of Biomedical Sciences, 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan

4. Department of Urology, Toyama Prefectural Central Hospital, 2-2-78 Nishinagae, Toyama 930-8550, Japan

5. Department of Urology, Fukui-Ken Saiseikai Hospital, 7-1 Wadanakacho-Funabashi, Fukui 918-8503, Japan

6. Department of Urology, University of Yamanashi, 1110 Shimokato, Chuo 409-3898, Japan

7. Department of Urology, Shobara Red Cross Hospital, 2-7-10 Nishihonmachi, Shobara 727-0013, Japan

8. Department of Urology, Nara Medical University, 840 Shijocho, Kashihara 634-8521, Japan

9. Department of Urology, Fukushima Medical University, 1 Hikarigaoka, Fukushima 960-1295, Japan

10. Department of Urology, Anjo Kosei Hospital, 28 Anjocho-Higashihirokute, Anjo 446-8602, Japan

11. Nephro-Urologic Surgery and Andrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu 514-8507, Japan

12. Department of Urology, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan

13. Department of Urology, Kanazawa Medical University, 1-1 Uchinadamachi-Daigaku, Kahoku 920-0293, Japan

14. Department of Nephro-urology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8602, Japan

15. Department of Urology, School of Medicine, Sapporo Medical University, 16-291 Minami-1-Jo-Nishi, Sapporo 060-8543, Japan

16. Department of Urology, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan

17. Department of Urology, Ishikawa Prefectural Central Hospital, 2-1 Kuratsukihigashi, Kanazawa 920-8530, Japan

18. Innovative Clinical Research Center, Kanazawa University, 13-1 Takaramachi, Kanazawa 920-8641, Japan

19. Medical Research Support Center, University of Fukui Hospital, 23-3 Shimoaizuki, Matsuoka Eiheiji-cho Yoshida-gun, Fukui 910-1193, Japan

Abstract

Enzalutamide (ENZ) and abiraterone plus prednisolone (ABI) can improve the survival of patients with castration-resistant prostate cancer (CRPC). However, the agent that is more effective against nonmetastatic CRPC remains unclear. To evaluate the agent that can be used as the first-line treatment for CRPC, an investigator-initiated, multicenter, randomized controlled trial (ENABLE Study for PCa) including both metastatic and nonmetastatic CRPC was conducted in Japan. The prostate-specific antigen (PSA) response rate, overall survival, some essential survival endpoints, and safety of patients with nonmetastatic CRPC were also analyzed. In this subanalysis, 15 and 26 patients in the ENZ and ABI arms, respectively, presented with nonmetastatic CRPC. There was no significant difference in terms of the PSA response rate between the ENZ and ABI arms (80% and 64%, respectively; p = 0.3048). The overall survival did not significantly differ between the two arms (HR: 0.68; 95% CI: 0.22–2.14, p = 0.5260). No significant differences were observed in terms of radiographic progression-free survival and cancer-specific survival between the ENZ and ABI arms (HR: 0.81; 95% CI: 0.35–1.84; p = 0.6056 and HR: 0.72; 95% CI: 0.19–2.73; p = 0.6443, respectively). Only four and six patients in the ENZ and ABI arms, respectively, had ≥grade 3 adverse events. ABI and ENZ had similar efficacy and safety profiles in patients with nonmetastatic CRPC.

Funder

Japanese Foundation for Multidisciplinary Treatment of Cancer

Publisher

MDPI AG

Subject

Cancer Research,Oncology

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