Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer
Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer
复制标题
DOI：
10.1056/nejmoa1911206
复制
发表时间：
2019-12-26
影响因子：
158.5
通讯作者：
Castellano, Daniel
中科院分区：
文献类型：
--
作者：
de Wit, Ronald;de Bono, Johann;Castellano, Daniel
一项涉及接受多西他赛和激素治疗后疾病进展的转移性前列腺癌患者的随机试验表明，卡巴他赛在延长基于影像学的无进展生存期、总生存期和 PSA 反应方面优于雄激素信号靶向药物。之前接受过多西他赛治疗，并在接受替代抑制剂（阿比特龙或恩杂鲁胺）期间 12 个月内病情进展尚不清楚。方法 我们以 1:1 的比例将既往接受过多西他赛和雄激素信号靶向抑制剂（阿比特龙或恩杂鲁胺）的患者随机分配至接受卡巴他赛（剂量为每平方米体表面积 25 mg，每 3 周静脉注射一次，加上每日泼尼松和粒细胞集落刺激因子）或其他雄激素信号靶向抑制剂（1000 mg 或 1000 mg）。每日阿比特龙加泼尼松或每日 160 毫克恩杂鲁胺）。主要终点是基于影像学的无进展生存期。评估了生存、反应和安全性的次要终点。结果共有 255 名患者接受了随机分组。中位随访 9.2 个月后，卡巴他赛组 129 名患者中有 95 名 (73.6%) 报告基于影像学的进展或死亡，而接受雄激素信号靶向抑制剂组 126 名患者中有 101 名 (80.2%) 报告出现基于影像学的进展或死亡（风险比，0.54；95% 置信区间 [CI]，0.40 至 0.73；P
A randomized trial involving patients with metastatic prostate cancer whose disease progressed after receipt of docetaxel and hormonal therapy showed that cabazitaxel was superior to an androgen-signaling-targeted agent in extending imaging-based progression-free survival, overall survival, and PSA response.Background The efficacy and safety of cabazitaxel, as compared with an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who were previously treated with docetaxel and had progression within 12 months while receiving the alternative inhibitor (abiraterone or enzalutamide) are unclear. Methods We randomly assigned, in a 1:1 ratio, patients who had previously received docetaxel and an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide) to receive cabazitaxel (at a dose of 25 mg per square meter of body-surface area intravenously every 3 weeks, plus prednisone daily and granulocyte colony-stimulating factor) or the other androgen-signaling-targeted inhibitor (either 1000 mg of abiraterone plus prednisone daily or 160 mg of enzalutamide daily). The primary end point was imaging-based progression-free survival. Secondary end points of survival, response, and safety were assessed. Results A total of 255 patients underwent randomization. After a median follow-up of 9.2 months, imaging-based progression or death was reported in 95 of 129 patients (73.6%) in the cabazitaxel group, as compared with 101 of 126 patients (80.2%) in the group that received an androgen-signaling-targeted inhibitor (hazard ratio, 0.54; 95% confidence interval [CI], 0.40 to 0.73; P