Department of Urology, Seoul National University Hospital, Seoul, Korea.
Medical Affairs, Janssen Korea Ltd, Seoul, Korea.
Investig Clin Urol. 2023 Sep;64(5):466-473. doi: 10.4111/icu.20230128.
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.
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.
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.
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.
对于转移性去势抵抗性前列腺癌（mCRPC），阿比特龙联合泼尼松（AAP）和化疗药物的合理治疗顺序尚未阐明。因此，本研究使用真实世界数据评估了 AAP 在化疗前和化疗后的有效性和安全性。
这是一项前瞻性、多中心、开放标签、观察性研究，纳入了 506 例 mCRPC 患者。患者根据化疗时机分为化疗前和化疗后组。比较了两组患者 AAP 的有效性和安全性；评估前列腺特异性抗原（PSA）应答、PSA 无进展生存期和影像学无进展生存期；并记录不良反应。
在纳入的患者中，319 例和 187 例分别属于化疗前和化疗后组。两组的风险分类相似。化疗前组 PSA 应答率为 61.8%，化疗后组为 39.0%（p<0.001）。化疗前组 PSA 进展时间（5.00 个月 vs. 2.93 个月，p=0.001）和影像学无进展生存期（11.84 个月 vs. 9.17 个月，p=0.002）显著长于化疗后组。化疗状态与 AAP 治疗期间的 PSA（风险比[HR] 1.39，95%置信区间[CI] 1.09-1.77）和影像学进展（HR 1.66，95% CI 1.18-2.33）相关。两组不良反应发生率相似。
在这项上市后监测中，AAP 使 mCRPC 患者受益，尤其是在化疗前使用时，PSA 应答率高，PSA 和影像学无进展生存期更长，且不良反应可耐受。
