Van Praet Charles, Rottey Sylvie, Van Hende Fransien, Pelgrims Gino, Demey Wim, Van Aelst Filip, Wynendaele Wim, Gil Thierry, Schatteman Peter, Filleul Bertrand, Schallier Dennis, Machiels Jean-Pascal, Schrijvers Dirk, Everaert Els, D'Hondt Lionel, Werbrouck Patrick, Vermeij Joanna, Mebis Jeroen, Clausse Marylene, Rasschaert Marika, Van Erps Joanna, Verheezen Jolanda, Van Haverbeke Jan, Goeminne Jean-Charles, Lumen Nicolaas
Department of Urology, Ghent University Hospital, Ghent, Belgium.
Department of Medical Oncology, Ghent University Hospital, Ghent, Belgium.
Urol Oncol. 2016 Jun;34(6):254.e7-254.e13. doi: 10.1016/j.urolonc.2015.12.017. Epub 2016 Feb 2.
Abiraterone acetate (AA) is licensed for treating metastatic castration-resistant prostate cancer (mCRPC). Real-world data on oncological outcome after AA are scarce. The current study assesses efficacy and safety of AA in mCRPC patients previously treated with docetaxel who started treatment during the Belgian compassionate use program (January 2011-July 2012).
Records from 368 patients with mCRPC from 23 different Belgian hospitals who started AA 1000mg per day with 10mg prednisone or equivalent were retrospectively reviewed (September 2013-December 2014). Prostate-specific antigen (PSA) response (decrease≥50%), time to PSA progression (increase>50% over PSA nadir in case of PSA response/>25% in absence of PSA response), time to radiographic progression (on bone scans or for soft tissue lesions using Response Evaluation Criteria In Solid Tumors 1.1), overall survival and adverse event rate (Common Terminology Criteria for Adverse Events v4.03) were analyzed. Kaplan-Meier statistics were applied.
Overall, 92 patients (25%) had an Eastern Cooperative Oncology Group performance status≥2. Median age was 73 years, median PSA was 103ng/dl. PSA response was observed in 131 patients (37.4%). Median time to PSA and radiographic progression was 4.1 months (95% CI: 3.6-4.6) and 5.8 months (5.3-6.4), respectively. Median overall survival was 15.1 months (13.6-16.6). Most common grade 3 to 4 adverse events were anemia (13.9%), hypokalemia (7.3%), fatigue (6.8%), and pain (6.3%). Median duration of AA treatment was 5.3 months (interquartile range: 2.8-10.3). The main study limitation is its retrospective design.
These real-world data on post-docetaxel AA efficacy are in line with the COU-AA-301 trial. Importantly, incidence of severe anemia and hypokalemia is up to 50% higher than reported in previous studies.
醋酸阿比特龙（AA）已获许可用于治疗转移性去势抵抗性前列腺癌（mCRPC）。关于AA治疗后肿瘤学结局的真实世界数据匮乏。本研究评估了AA在多西他赛治疗后的mCRPC患者中的疗效和安全性，这些患者在比利时同情用药项目期间（2011年1月至2012年7月）开始接受治疗。
回顾性分析了来自比利时23家不同医院的368例mCRPC患者的记录，这些患者开始每日服用1000mg AA并联合10mg泼尼松或等效药物（2013年9月至2014年12月）。分析前列腺特异性抗原（PSA）反应（降低≥50%）、PSA进展时间（在有PSA反应的情况下，相对于PSA最低点增加>50%/在无PSA反应的情况下增加>25%）、影像学进展时间（根据实体瘤疗效评价标准1.1进行骨扫描或软组织病变评估）、总生存期和不良事件发生率（采用不良事件通用术语标准v4.03）。应用Kaplan-Meier统计方法。
总体而言，92例患者（25%）东部肿瘤协作组体能状态≥2。中位年龄为73岁，中位PSA为103ng/dl。131例患者（37.4%）观察到PSA反应。PSA进展和影像学进展的中位时间分别为4.1个月（95%CI：3.6 - 4.6）和5.8个月（5.3 - 6.4）。中位总生存期为15.1个月（13.6 - 16.6）。最常见的3 - 4级不良事件为贫血（13.9%）、低钾血症（7.3%）、疲劳（6.8%）和疼痛（6.3%）。AA治疗的中位持续时间为5.3个月（四分位间距：2.8 - 10.3）。主要研究局限性在于其回顾性设计。
这些关于多西他赛后AA疗效的真实世界数据与COU - AA - 301试验结果一致。重要的是，严重贫血和低钾血症的发生率比先前研究报告的高出多达50%。
