IMAAGEN 研究：醋酸阿比特龙和泼尼松对非转移性去势抵抗性前列腺癌患者前列腺特异性抗原和影像学疾病进展的影响。
The IMAAGEN Study: Effect of Abiraterone Acetate and Prednisone on Prostate Specific Antigen and Radiographic Disease Progression in Patients with Nonmetastatic Castration Resistant Prostate Cancer.
机构信息
Helen Diller Family Comprehensive Cancer Center, University of California-San Francisco, San Francisco, California.
University of Colorado Cancer Center, Aurora, Colorado.
出版信息
J Urol. 2018 Aug;200(2):344-352. doi: 10.1016/j.juro.2018.03.125. Epub 2018 Apr 6.
PURPOSE
We evaluated the use of abiraterone acetate (1,000 mg) plus prednisone (5 mg) in patients with high risk, nonmetastatic, castration resistant prostate cancer.
MATERIALS AND METHODS
Patients considered at high risk for progression to metastatic disease (prostate specific antigen 10 ng/ml or greater, or prostate specific antigen doubling time 10 months or less) received abiraterone acetate plus prednisone daily in 28-day cycles. The primary study end point was the proportion of patients in whom a 50% or greater prostate specific antigen reduction was achieved during cycles 1 to 6. Secondary end points included time to prostate specific antigen progression, time to radiographic evidence of disease progression and safety.
RESULTS
Of the 131 enrolled patients 44 (34%) remained on treatment with a median followup of 40.0 months. Median age was 72 years (range 48 to 90). Of the patients 82.4% were white and 14.5% were black. Median screening prostate specific antigen was 11.9 ng/dl and median prostate specific antigen doubling time was 3.4 months. Prostate specific antigen was significantly reduced (p <0.0001) with a 50% or greater prostate specific antigen reduction in 86.9% of cases and a 90% or greater reduction in 59.8%. Median time to prostate specific antigen progression was 28.7 months (95% CI 21.2-38.2). Median time to radiographic evidence of disease progression was not reached but on sensitivity analysis in 15 patients it was estimated to be 41.4 months (95% CI 27.6-not estimable). Baseline testosterone 12.5 ng/dl or greater and a 90% or greater prostate specific antigen reduction at cycle 3 were associated with longer time to prostate specific antigen progression and radiographic evidence of disease progression. Outcomes in black patients were similar to those in other patients. Adverse events, grade 3 or greater adverse events and serious adverse events were reported in 96.2%, 61.1% and 43.5% of patients, respectively.
CONCLUSIONS
In patients with high risk, nonmetastatic, castration resistant prostate cancer treatment with abiraterone acetate plus prednisone demonstrated a significant 50% or greater prostate specific antigen reduction with encouraging results for the secondary end points, including the safety of 5 mg prednisone.
目的
我们评估了醋酸阿比特龙（1000 毫克）联合泼尼松（5 毫克）在高危、非转移性、去势抵抗性前列腺癌患者中的应用。
材料和方法
考虑有进展为转移性疾病风险（前列腺特异抗原 10ng/ml 或更高，或前列腺特异抗原倍增时间 10 个月或更短）的患者，接受醋酸阿比特龙联合泼尼松，每日 1 次，28 天为 1 个周期。主要研究终点为第 1 至 6 个周期中前列腺特异抗原降低 50%或更多的患者比例。次要终点包括前列腺特异抗原进展时间、影像学疾病进展时间和安全性。
结果
在 131 名入组患者中，44 名（34%）继续接受治疗，中位随访时间为 40.0 个月。中位年龄为 72 岁（范围 48 至 90 岁）。患者中 82.4%为白人，14.5%为黑人。筛查时中位前列腺特异抗原为 11.9ng/dl，中位前列腺特异抗原倍增时间为 3.4 个月。前列腺特异抗原显著降低（p<0.0001），86.9%的患者前列腺特异抗原降低 50%或更多，59.8%的患者降低 90%或更多。前列腺特异抗原进展时间的中位值为 28.7 个月（95%CI 21.2-38.2）。影像学疾病进展的中位时间尚未达到，但在 15 名患者的敏感性分析中估计为 41.4 个月（95%CI 27.6-不可估计）。基线睾酮 12.5ng/dl 或更高和第 3 周期前列腺特异抗原降低 90%或更高与前列腺特异抗原进展和影像学疾病进展时间延长相关。黑人患者的结局与其他患者相似。分别有 96.2%、61.1%和 43.5%的患者报告了不良事件、3 级或更高级别的不良事件和严重不良事件。
结论
在高危、非转移性、去势抵抗性前列腺癌患者中，醋酸阿比特龙联合泼尼松治疗显示前列腺特异抗原显著降低 50%或更多，次要终点结果令人鼓舞，包括 5mg 泼尼松的安全性。
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