多西他赛和阿比特龙治疗后进展的转移性去势抵抗性前列腺癌患者中恩扎鲁胺（MDV3100）的临床活性和耐受性。
Clinical activity and tolerability of enzalutamide (MDV3100) in patients with metastatic, castration-resistant prostate cancer who progress after docetaxel and abiraterone treatment.
机构信息
Department of Oncology, Tergooi Hospital, Blaricum, the Netherlands.
出版信息
Cancer. 2014 Apr 1;120(7):968-75. doi: 10.1002/cncr.28518. Epub 2013 Dec 30.
BACKGROUND
Enzalutamide (Enz) and abiraterone acetate (AA) are hormone treatments that have a proven survival advantage in patients with metastatic, castration-resistant prostate cancer who previously received docetaxel (Doc). Recently, limited activity of AA after Enz and of Enz after AA was demonstrated in small cohort studies. Here, the authors present the activity and tolerability of Enz in patients who previously received AA and Doc in the largest cohort to date.
METHODS
The efficacy and tolerability of Enz were investigated in men with progressive, metastatic, castrate-resistant prostate cancer who previously received Doc and AA. Toxicity, progression-free survival, time to prostate-specific antigen (PSA) progression, and overall survival were retrospectively evaluated.
RESULTS
Sixty-one patients were included in the analysis. The median age was 69 years (interquartile range [IQR], 64-74 years), 57 patients (93%) had an Eastern Cooperative Oncology Group performance status from 0 to 2, 48 patients (79%) had bone metastases, 33 patients (54%) had lymph node metastases, and 13 patients (21%) had visceral metastases. The median duration of Enz treatment was 14.9 weeks (IQR, 11.1-20.0 weeks), and 13 patients (21%) had a maximum PSA decline ≥50%. The median progression-free survival was 12.0 weeks (95% confidence interval [CI], 11.1-16.0 weeks), the median time to PSA progression was 17.4 weeks (95% CI, >16.0 weeks), and the median overall survival was 31.6 weeks (95% CI, >28.7 weeks). Enz was well tolerated, and fatigue and musculoskeletal pain were the most frequent grade ≥2 adverse events. The PSA response to Doc and AA did not predict the PSA response to Enz.
CONCLUSIONS
Enz has modest clinical activity in patients with metastatic, castrate-resistant prostate cancer who previously received Doc and AA. PSA response to Doc and AA does not predict for PSA response to ENz.
背景
恩扎鲁胺（Enz）和醋酸阿比特龙（AA）是激素治疗药物，在接受多西他赛（Doc）治疗的转移性去势抵抗性前列腺癌患者中具有已证实的生存优势。最近，在小队列研究中显示，Enz 之后使用 AA 和 AA 之后使用 Enz 的活性有限。在此，作者在迄今为止最大的队列中报告了先前接受 AA 和 Doc 治疗的患者使用 Enz 的活性和耐受性。
方法
对先前接受 Doc 和 AA 治疗的进展性、转移性、去势抵抗性前列腺癌男性患者进行 Enz 的疗效和耐受性研究。回顾性评估毒性、无进展生存期、前列腺特异性抗原（PSA）进展时间和总生存期。
结果
61 例患者纳入分析。中位年龄为 69 岁（四分位距 [IQR]，64-74 岁），57 例（93%）ECOG 表现状态为 0-2，48 例（79%）有骨转移，33 例（54%）有淋巴结转移，13 例（21%）有内脏转移。Enz 治疗的中位持续时间为 14.9 周（IQR，11.1-20.0 周），13 例（21%）的 PSA 下降最大≥50%。无进展生存期的中位值为 12.0 周（95%置信区间 [CI]，11.1-16.0 周），PSA 进展时间的中位值为 17.4 周（95%CI，>16.0 周），总生存期的中位值为 31.6 周（95%CI，>28.7 周）。Enz 耐受性良好，最常见的≥2 级不良事件为疲劳和肌肉骨骼疼痛。Doc 和 AA 的 PSA 反应并不能预测 Enz 的 PSA 反应。
结论
在先前接受 Doc 和 AA 治疗的转移性去势抵抗性前列腺癌患者中，Enz 具有适度的临床活性。Doc 和 AA 的 PSA 反应并不能预测 Enz 的 PSA 反应。
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