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KMID : 1011820230640050466
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Investigative and Clinical Urology
2023 Volume.64 No. 5 p.466 ~ p.473
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A prospective, multicenter study on the clinical effectiveness of abiraterone in metastatic castration-resistant prostate cancer in Korea: Pre- vs. post-chemotherapy
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Jeong Seung-Hwan
Yeon Sang-Eun
Kim Su-Youn
Kwon Tae-Gyun
Jeon Seong-Soo
Choi Young-Deuk
Kwon Dong-Deuk
Chung Byung-Ha
Hong Sung-Hoo
Kim Byung-Hoon
Lee Hyo-Jin
Murali kannan Maruthamuthu
Choi Woo-Suk
Park Sung-Woo
Kang Taek-Won
Yun Seok-Joong
Cho Jin-Seon
Choi See-Min
Lee Na-Ri
Kwak Cheol
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Abstract
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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 post-chemotherapy 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.
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KEYWORD
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Abiraterone, Prostate cancer, Prostate-specific antigen, Real-world data
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