新英格兰：卡巴他赛与阿比特龙或恩杂鲁胺治疗转移性前列腺癌。前列腺癌是导致美国男性癌症死亡的第二大原因，在欧洲是癌症相关死亡的第三大原因。与雄激素信号靶向抑制剂（阿比特龙（abiraterone）和恩杂鲁胺enzalutamide））相比，卡巴他赛（cabazitaxel）对于转移性去势难治性前列腺癌的疗效和安全性尚不明确。

　　

　　医学专家和教授们的报告。近日，新英格兰杂志发表了一项研究，该研究按1:1的比例将以前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255名患者分为接受卡巴他赛（在25mg/m2体表面积剂量下，每3周静脉注射一次，每天加用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（每天1000毫克阿比特龙+泼尼松或160毫克恩扎鲁胺）。该研究得主要终点是基于影像学的无进展生存期。
　　

　　该研究发现经经过中位期为9.2个月的随访后，卡巴  他赛组129名患者中有95名(73.6%)出现了影像学进展或死亡，而在126名接受雄激素信号靶向抑制剂的患者中有101名出现了影像学进展或死亡(80.2%) (风险比0.54；95%置信区间[CI]，0.40-0.73；p<0.001)。卡巴他赛组的基于影像学的中位无进展生存期为8.0个月，雄激素信号靶向抑制剂组为3.7个月。卡巴他赛组的中位总生存期为13.6个月，雄激素信号靶向抑制剂组为11.0个月（死亡风险比0.64；95%置信区间，0.46-0.89；p=0.008）。卡巴他赛组的中位无进展生存期为4.4个月，雄激素信号靶向抑制剂组为2.7个月（进展或死亡的风险比，0.52；95%置信区间，0.40-0.68；p<0.001），前列腺特异性抗原反应分别为35.7%和13.5%（p<0.001），肿瘤反应分别为36.5%和11.5%（p=0.004）。不良反应事件发生率无统计学差异。该研究认为与阿比特龙或恩杂鲁胺相比，卡巴他赛治疗转移性前列腺癌显着改善了许多临床结果。a

　　

　　摘要全文
　　
　　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<0.001). The median imaging-based progression-free survival was 8.0 months with cabazitaxel and 3.7 months with the androgen-signaling–targeted inhibitor. The median overall survival was 13.6 months with cabazitaxel and 11.0 months with the androgen-signaling–targeted inhibitor (hazard ratio for death, 0.64; 95% CI, 0.46 to 0.89; P=0.008). The median progression-free survival was 4.4 months with cabazitaxel and 2.7 months with an androgen-signaling–targeted inhibitor (hazard ratio for progression or death, 0.52; 95% CI, 0.40 to 0.68; P<0.001), a prostate-specific antigen response occurred in 35.7% and 13.5% of the patients, respectively (P<0.001), and tumor response was noted in 36.5% and 11.5% (P=0.004). Adverse events of grade 3 or higher occurred in 56.3% of patients receiving cabazitaxel and in 52.4% of those receiving an androgen-signaling–targeted inhibitor. No new safety signals were observed.
　　
　　CONCLUSIONS
　　
　　Cabazitaxel significantly improved a number of clinical outcomes, as compared with the androgen-signaling–targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who had been previously treated with docetaxel and the alternative androgen-signaling–targeted agent (abiraterone or enzalutamide). (Funded by Sanofi; CARD ClinicalTrials.gov number, NCT02485691. opens in new tab.)
　　
　　参考文献
　　
　　De Wit R, De Bono J, Sternberg C N, et al. Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer[J]. New England Journal of Medicine, 2019, 381(26): 2506-2518.
　　
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