Lessons learned: The safety and activity findings of abiraterone acetate plus prednisone treatment in black men with mCRPC were similar to results from previously conducted studies with largely white populations.Poor trial accrual continues to be a challenge in black men with mCRPC and further efforts are needed to address such underrepresentation.
Background: Self-identified black men have higher incidence and mortality from prostate cancer in the United States compared with white men but are dramatically underrepresented in clinical trials exploring novel therapies for metastatic castration-resistant prostate cancer (mCRPC).
Methods: Black men with mCRPC were treated with abiraterone acetate (AA), 1,000 mg daily, and prednisone (P), 5 mg twice daily. The primary objective was to determine antitumor activity (defined by a ≥30% decline in prostate-specific antigen [PSA] level) and to correlate germline polymorphisms in androgen metabolism genes with antitumor activity. Secondary objectives included determining safety, post-treatment changes in measurable disease, and time to disease progression.
Results: From April 2013 to March 2016, a total of 11 black men were enrolled and received AA plus P (AA+P); 7 of 10 evaluable patients were docetaxel naive. Post-treatment declines in PSA level of ≥30% were achieved in 90% of patients. The side effect profile was consistent with prior clinical trials exploring AA+P in mCRPC. Due to poor accrual, the study was closed prematurely with insufficient sample size for the planned pharmacogenetic analyses.
Conclusion: In this small prospective study terminated for poor accrual, the safety and activity of AA+P in black men with mCRPC was similar to that reported in prior studies exploring AA in largely white populations. Further efforts are needed to address underrepresentation of black men in mCRPC trials.
作者总结
经验
• 醋酸阿比特龙联合泼尼松治疗转移性去势抵抗性前列腺癌 (mCRPC) 黑人男性患者的安全性和有效性与既往主要在白人群体中开展的研究结果相似。
• mCRPC 临床试验中黑人男性患者入组不理想仍然是该人群研究的一大难题, 有必要进一步努力解决这一人群代表性不足的问题。
摘要
背景. 美国黑人男性前列腺癌的发病率和死亡率均高于白人男性, 但在转移性去势抵抗性前列腺癌 (mCRPC) 新治疗研发的临床试验中, 黑人男性的代表性却明显不足。
方法. 患有mCRPC的黑人男性接受醋酸阿比特龙 (AA) 1 000 mg每日1次和泼尼松 (P) 5 mg每日2次治疗。主要目的为确定该治疗方案的抗肿瘤活性[定义为前列腺特异性抗原 (PSA) 水平下降≥30%], 以及雄激素代谢基因生殖系多态性与抗肿瘤活性之间的相关性。次要目的包括确定安全性、可测量病灶在治疗后的改变, 以及至疾病进展时间。
结果. 从2013年4月至2016年3月, 研究共入组11例黑人男性接受AA+P治疗, 7/10例可评价患者未接受过多西他赛治疗。90%的患者治疗后PSA水平下降≥30%。副作用特征与既往研究AA+P治疗mCRPC的临床试验情况一致。研究因招募入组极不理想而提前关闭, 计划的药物遗传学分析样本量不足。
结论. 本项小型前瞻性研究因招募入组过慢而终止, AA+P在mCRPC黑人男性患者中的安全性和有效性与既往主要在白人男性中开展的AA研究相似。有必要进一步努力解决黑人男性在mCRPC临床试验中代表性不足的问题。The Oncologist 2016;21:1414–1415
Trial registration: ClinicalTrials.gov NCT01735396.
©AlphaMed Press; the data published online to support this summary is the property of the authors.