Department of Urology, Federation of National Public Service Personnel Mutual Aid Associations Yokosuka Kyosai Hospital, Kanagawa, Japan.
Department of Urology, Independent Administrative Institution National Hospital Organization Sagamihara Hospital, Kanagawa, Japan.
Jpn J Clin Oncol. 2021 Apr 1;51(4):544-551. doi: 10.1093/jjco/hyaa225.
The aim was to evaluate the efficacy and safety of abiraterone acetate plus prednisolone in patients with chemotherapy-naïve early metastatic castration-resistant prostate cancer who failed first-line androgen deprivation therapy.
Patients with early metastatic castration-resistant prostate cancer with confirmed prostate-specific antigen progression within 1-year or prostate-specific antigen progression without having normal prostate-specific antigen level (<4.0 ng/mL) during first-line androgen deprivation therapy were enrolled and administered abiraterone acetate (1000 mg) plus prednisolone (10 mg). A minimum of 48 patients were required according to Simon's minimax design. The primary endpoint was prostate-specific antigen response rate (≥50% prostate-specific antigen decline by 12 weeks), secondary endpoints included prostate-specific antigen progression-free survival and overall survival. Safety parameters were also assessed.
For efficacy, 49/50 patients were evaluable. Median age was 73 (range: 55-86) years. The median duration of initial androgen deprivation therapy was 32.4 (range: 13.4-84.1) weeks and 48 patients experienced prostate-specific antigen progression within 1-year after initiation of androgen deprivation therapy. prostate-specific antigen response rate was 55.1% (95% confidence interval: 40.2%-69.3%), median prostate-specific antigen-progression-free survival was 24.1 weeks, and median overall survival was 102.9 weeks (95% confidence interval: 64.86 not estimable [NE]). Most common adverse event was nasopharyngitis (15/50 patients, 30.0%). The most common ≥grade 3 adverse event was alanine aminotransferase increased (6/50 patients, 12.0%).
Abiraterone acetate plus prednisolone demonstrated a high prostate-specific antigen response rate of 55.1%, suggesting tumor growth still depends on androgen synthesis in patients with early metastatic castration-resistant prostate cancer. However, prostate-specific antigen-progression-free survival was shorter than that reported in previous studies. Considering the benefit-risk profile, abiraterone acetate plus prednisolone would be a beneficial treatment option for patients with chemotherapy-naive metastatic prostate cancer who show early castration resistance.
评估醋酸阿比特龙联合泼尼松在一线雄激素剥夺治疗失败的化疗初治早期转移性去势抵抗性前列腺癌患者中的疗效和安全性。
入组患者为早期转移性去势抵抗性前列腺癌，在一线雄激素剥夺治疗期间，前列腺特异性抗原（PSA）确认进展（1 年内）或 PSA 进展而 PSA 水平未恢复正常（<4.0ng/mL）。患者接受醋酸阿比特龙（1000mg）联合泼尼松（10mg）治疗。根据 Simon 的最小最大设计，需要至少 48 例患者。主要终点为 PSA 缓解率（12 周时 PSA 下降≥50%），次要终点包括 PSA 无进展生存期和总生存期。还评估了安全性参数。
对于疗效，50 例患者中的 49 例可评估。中位年龄为 73 岁（范围：55-86 岁）。初始雄激素剥夺治疗的中位持续时间为 32.4 周（范围：13.4-84.1 周），48 例患者在开始雄激素剥夺治疗后 1 年内出现 PSA 进展。PSA 缓解率为 55.1%（95%置信区间：40.2%-69.3%），中位 PSA 无进展生存期为 24.1 周，中位总生存期为 102.9 周（95%置信区间：64.86 不可估计[NE]）。最常见的不良事件是鼻咽炎（50 例患者中有 15 例，30.0%）。最常见的≥3 级不良事件是丙氨酸氨基转移酶升高（50 例患者中有 6 例，12.0%）。
醋酸阿比特龙联合泼尼松治疗显示 PSA 缓解率高达 55.1%，表明在早期转移性去势抵抗性前列腺癌患者中，肿瘤生长仍依赖于雄激素合成。然而，PSA 无进展生存期短于既往研究报道。考虑到获益风险特征，醋酸阿比特龙联合泼尼松可能是化疗初治转移性前列腺癌患者早期去势抵抗的一种有益治疗选择。
