Investig Clin Urol.  2023 Sep;64(5):466-473. 10.4111/icu.20230128.

A prospective, multicenter study on the clinical effectiveness of abiraterone in metastatic castration-resistant prostate cancer in Korea: Pre- vs. post-chemotherapy

• Jeong Sh
• Yeon SE
• Kim SY
• Kwon TG
• Jeon SS
• Choi YD
• Kwon D
• Chung BH
• Hong SH
• Kim BH
• Lee HJ
• Shin SJ
• Choi WS
• Park SW
• Kang TW
• Yun SJ
• Cho JS
• Choi SM
• Lee NR
• Kwak C

• KMID: 2545564
• DOI: http://doi.org/10.4111/icu.20230128

Abstract

Purpose
The proper treatment sequence for administering abiraterone acetate plus prednisolone (AAP) and chemotherapeutic agents has not yet been elucidated for metastatic castration-resistant prostate cancer (mCRPC). Hence, this study evaluated the effectiveness and safety of AAP in pre- and post-chemotherapy settings using real-world data.
Materials and Methods
This prospective, multicenter, open-label, observational study included 506 patients with mCRPC. Patients were classified according to the timing of chemotherapy into pre- and post-chemotherapy groups. The effectiveness and safety of AAP were compared between the groups; the prostate-specific antigen (PSA) response, PSA progression-free survival, and radiologic progression-free survival were assessed; and adverse drug reactions were recorded.
Results
Among the included patients, 319 and 187 belonged to the pre- and post-chemotherapy groups, respectively. Risk classification was similar between the two groups. The PSA response was 61.8% in the pre-chemotherapy group and 39.0% in the postchemotherapy group (p<0.001). The median time to PSA progression (5.00 vs. 2.93 mo, p=0.001) and radiologic progression-free survival (11.84 vs. 9.17 mo, p=0.002) were significantly longer in the pre-chemotherapy group. Chemotherapy status was associated with PSA (hazard ratio [HR] 1.39, 95% confidence interval [CI] 1.09–1.77) and radiologic progression (HR 1.66, 95% CI 1.18–2.33) during AAP treatment. Adverse drug reactions were reported at similar frequencies in both groups.
Conclusions
In this postmarketing surveillance, AAP benefited patients with mCRPC, especially in settings before chemotherapy was administered, resulting in a high PSA response and longer PSA and radiologic progression-free survival with tolerable adverse drug reactions.

Keyword

Abiraterone; Prostate cancer; Prostate-specific antigen; Real-world data