1. A prospective, multicenter study on the clinical effectiveness of abiraterone in metastatic castration-resistant prostate cancer in Korea: Pre- vs. post-chemotherapy.
- Author
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Seung-hwan Jeong, Sang Eun Yeon, Su Youn Kim, Tae Gyun Kwon, Seong Soo Jeon, Young Deuk Choi, Dongdeuk Kwon, Byung Ha Chung, Sung-Hoo Hong, Byung Hoon Kim, Hyo Jin Lee, Sang Joon Shin, Woo Suk Choi, Sung Woo Park, Taek Won Kang, Seok Joong Yun, Jin Seon Cho, See Min Choi, Na-Ri Lee, and Cheol Kwak
- Subjects
CASTRATION-resistant prostate cancer ,DRUG side effects ,PROSTATE-specific antigen ,ABIRATERONE acetate ,PROGRESSION-free survival - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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