新英格兰:卡巴他赛与阿比特龙或<a href="https://www.jnang11.com/dugs/enzalutamide” target=”_blank” >恩杂鲁胺医治肿瘤转移前列腺肿瘤。前列腺肿瘤是造成英国男士癌病身亡的第二大缘故,在欧洲地区是癌病有关身亡的第三大缘故。与雄激素数据信号靶向抑制剂(阿比特龙(abiraterone)和恩杂鲁胺enzalutamide))对比,卡巴他赛(cabazitaxel)针对肿瘤转移阉割不易治前列腺肿瘤的功效和安全系数尚不确立。
医生专家和老师们的汇报。近日,新英格兰杂志发表了一项科学研究,该科学研究按1:1的占比将之前接纳过多西他赛和雄激素数据信号靶向抑制剂(
阿比特龙或恩杂鲁胺)的255名病人分成接纳卡巴他赛(在25mg/m2体表面积使用量下,每3周静脉输液一次,每日再加泼尼松和粒细胞集落刺激性因素)或别的雄激素数据信号靶向抑制剂(每日1000mg阿比特龙 泼尼松或160mg恩扎鲁胺)。该科学研究得关键终点站是根据影像诊断的无进度存活期。
该研究发现经历经负相关期是9.两个月的随诊后,卡巴 他赛组129名病人中有95名(73.6%)发生了影像诊断进度或身亡,而在126名接纳雄激素数据信号靶向抑制剂的病人中有101名发生了影像诊断进度或身亡(80.2%) (风险比0.54;95%可信区间[CI],0.40-0.73;p<0.001)。卡巴他赛组的根据影像诊断的负相关无进度存活期为8.0个月,雄激素数据信号靶向抑制剂组为3.七个月。卡巴他赛组的负相关总存活期为13.6个月,雄激素数据信号靶向抑制剂组为11.0个月(身亡风险比0.64;95%可信区间,0.46-0.89;p=0.008)。卡巴他赛组的负相关无进度存活期为4.4个月,雄激素数据信号靶向抑制剂组为2.七个月(进度或身亡的风险比,0.52;95%可信区间,0.40-0.68;p<0.001),男性前列腺非特异抗原体反映各自为35.7%和13.5%(p<0.001),恶性肿瘤反映各自为36.5%和11.5%(p=0.004)。副作用事情发病率无统计学差异。该科学研究觉得与阿比特龙或恩杂鲁胺对比,卡巴他赛医治肿瘤转移前列腺肿瘤显着改进了很多临床医学結果。a
引言全篇
BACKGROUND
The efficacy and safety of cabazitaxel, as compared with an androgen-signaling�Ctargeted 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�Ctargeted 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�Ctargeted 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�Ctargeted 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�Ctargeted inhibitor. The median overall survival was 13.6 months with cabazitaxel and 11.0 months with the androgen-signaling�Ctargeted 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�Ctargeted 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�Ctargeted inhibitor. No new safety signals were observed.
CONCLUSIONS
Cabazitaxel significantly improved a number of clinical outcomes, as compared with the androgen-signaling�Ctargeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who had been previously treated with docetaxel and the alternative androgen-signaling�Ctargeted agent (abiraterone or enzalutamide). (Funded by Sanofi; CARD ClinicalTrials.gov number, NCT02485691. opens in new tab.)
论文参考文献
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.