Department of Urology, Toho University Sakura Medical Center, Chiba, Japan.
Medical Oncology Department, 12 de Octubre University Hospital, Madrid, Spain.
Jpn J Clin Oncol. 2021 Aug 1;51(8):1287-1297. doi: 10.1093/jjco/hyab028.
In the CARD study (NCT02485691), cabazitaxel significantly improved clinical outcomes versus abiraterone or enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel and the alternative androgen-signalling-targeted inhibitor. However, some patients received docetaxel or the prior alternative androgen-signalling-targeted inhibitor in the metastatic hormone-sensitive (mHSPC) setting. Therefore, the CARD results cannot be directly translated to a Japanese population.
Patients (N = 255) received cabazitaxel (25 mg/m2 IV Q3W, prednisone, G-CSF) versus abiraterone (1000 mg PO, prednisone) or enzalutamide (160 mg PO) after prior docetaxel and progression ≤12 months on the alternative androgen-signalling-targeted inhibitor. Patients who received combination therapy for mHSPC were excluded (n = 33) as docetaxel is not approved in this setting in Japan.
A total of 222 patients (median age 70 years) were included in this subanalysis. Median number of cycles was higher for cabazitaxel versus androgen-signalling-targeted inhibitors (7 versus 4). Clinical outcomes favoured cabazitaxel over abiraterone or enzalutamide including, radiographic progression-free survival (rPFS; median 8.2 versus 3.4 months; P < 0.0001), overall survival (OS; 13.9 versus 11.8 months; P = 0.0102), PFS (4.4 versus 2.7 months; P < 0.0001), confirmed prostate-specific antigen response (37.0 versus 14.4%; P = 0.0006) and objective tumour response (38.9 versus 11.4%; P = 0.0036). For cabazitaxel versus androgen-signalling-targeted inhibitor, grade ≥ 3 adverse events occurred in 55% versus 44% of patients, with adverse events leading to death on study in 2.7% versus 5.7%.
Cabazitaxel significantly improved outcomes including rPFS and OS versus abiraterone or enzalutamide and are reflective of the Japanese patient population. Cabazitaxel should be considered the preferred treatment option over abiraterone or enzalutamide in this setting.
在 CARD 研究(NCT02485691)中,与阿比特龙或恩扎鲁胺相比,转移性去势抵抗性前列腺癌患者在接受多西他赛和替代雄激素信号靶向抑制剂治疗后,卡巴他赛显著改善了临床结局。然而,一些患者在转移性激素敏感(mHSPC)环境中接受了多西他赛或之前的替代雄激素信号靶向抑制剂治疗。因此,CARD 结果不能直接转化为日本人群。
患者(N=255)在接受多西他赛和进展后,接受卡巴他赛(25mg/m2 IV Q3W,泼尼松,G-CSF)与阿比特龙(1000mg PO,泼尼松)或恩扎鲁胺(160mg PO)治疗。(n=33)排除接受 mHSPC 联合治疗的患者,因为在日本,多西他赛在该环境中未获批准。
本亚分析共纳入 222 例患者(中位年龄 70 岁)。卡巴他赛的中位周期数高于雄激素信号靶向抑制剂(7 个周期对 4 个周期)。卡巴他赛在放射学无进展生存期(rPFS;中位 8.2 对 3.4 个月;P<0.0001)、总生存期(OS;13.9 对 11.8 个月;P=0.0102)、无进展生存期(PFS;4.4 对 2.7 个月;P<0.0001)、确认的前列腺特异性抗原反应(37.0%对 14.4%;P=0.0006)和客观肿瘤反应(38.9%对 11.4%;P=0.0036)方面均优于阿比特龙或恩扎鲁胺。卡巴他赛与雄激素信号靶向抑制剂相比,≥3 级不良事件发生率为 55%对 44%,研究中因不良事件导致死亡的发生率为 2.7%对 5.7%。
与阿比特龙或恩扎鲁胺相比,卡巴他赛显著改善了 rPFS 和 OS 等结局,反映了日本患者人群的情况。在这种情况下,卡巴他赛应被视为优于阿比特龙或恩扎鲁胺的首选治疗方案。