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Efficacy and safety of abiraterone acetate plus prednisolone in patients with early metastatic castration-resistant prostate cancer who failed first-line androgen-deprivation therapy: a single-arm, phase 4 study.

醋酸阿比特龙联合泼尼松龙治疗一线雄激素剥夺治疗失败的早期转移性去势抵抗性前列腺癌患者的疗效和安全性: 一项单组4期研究。

  • 影响因子:2.04
  • DOI:10.1093/jjco/hyaa225
  • 作者列表:"Kobayashi K","Okuno N","Arai G","Nakatsu H","Maniwa A","Kamiya N","Satoh T","Kikukawa H","Nasu Y","Uemura H","Nakashima T","Mikami K","Iinuma M","Tanabe K","Furukawa J","Kobayashi H
  • 发表时间:2021-04-01
Abstract

AIM: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. METHODS: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. RESULTS: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%). CONCLUSIONS: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.

摘要

目的: 评价醋酸阿比特龙联合泼尼松龙治疗一线雄激素阻断治疗失败的早期转移性去势抵抗性前列腺癌患者的疗效和安全性。 方法: 在一线雄激素剥夺治疗期间,患有早期转移性去势抵抗性前列腺癌的患者在1年内确认前列腺特异性抗原进展或前列腺特异性抗原进展而无正常前列腺特异性抗原水平 (<4.0 ng/mL),入选并施用醋酸阿比特龙 (1000 mg)。加泼尼松龙 (10 mg)。根据Simon的minimax设计,至少需要48名患者。主要终点为前列腺特异性抗原应答率 (至12周时前列腺特异性抗原下降 ≥ 50%),次要终点包括前列腺特异性抗原无进展生存期和总生存期.还评估了安全性参数。 结果: 对于疗效,49/50例患者可评价。中位年龄为73 (范围: 55-86) 岁。初始雄激素剥夺治疗的中位持续时间为32.4 (范围: 13.4-84.1) 周,48例患者在开始雄激素剥夺治疗后1年内出现前列腺特异性抗原进展。前列腺特异性抗原缓解率为55.1% (95% 置信区间: 40.2%-69.3%),中位前列腺特异性抗原无进展生存期为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 (15/50例患者,30.0%)。最常见的 ≥ 3级不良事件是丙氨酸氨基转移酶升高 (6/50例患者,12.0%)。 结论: 醋酸阿比特龙联合泼尼松龙治疗早期转移性去势抵抗性前列腺癌患者的前列腺特异性抗原应答率高达55.1%,提示肿瘤生长仍然依赖雄激素合成。然而,前列腺特异性抗原无进展生存期短于以前的研究报道。考虑到获益-风险特征,醋酸阿比特龙联合泼尼松龙对于早期去势抵抗的未经化疗的转移性前列腺癌患者将是一种有益的治疗选择.

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影响因子:2.68
发表时间:2021-02-01
DOI:10.1080/14656566.2020.1814255
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DOI:10.1007/s11033-021-06299-9
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