Department of Urology, Gifu University Graduate School of Medicine, Gifu, Japan.
Department of Urology, Ogaki Municipal Hospital, Ogaki, Japan.
Asia Pac J Clin Oncol. 2021 Jun;17(3):238-244. doi: 10.1111/ajco.13441. Epub 2020 Sep 24.
To date, the optimal sequencing of life-prolonging therapies for patients with metastatic castration-resistant prostate cancer (mCRPC) remains unclear owing to a lack of prospective trials. This study aimed to evaluate the efficacy and safety of cabazitaxel (CBZ) treatment and examine the prognostic factors for oncological outcomes in patients with mCRPC who received CBZ after docetaxel (DOC).
This multi-institutional retrospective study included 44 patients with mCRPC who received CBZ. All enrolled patients had histologically confirmed prostate cancer (PCa) with distant metastases and had received DOC before CBZ administration. The primary endpoint was the oncological outcomes, including the overall (OS) and progression-free survival (PFS). The secondary endpoints were adverse events due to CBZ and rates of ≥30% reduction in prostate-specific antigen (PSA) levels.
The median follow-up period was 9.2 months (range, 0.2-34 months). During this time, 34 patients (77%) died of PCa. The median OS and PFS were 12.2 (range, 0.2-34 months) and 1.4 months (range, 0.4-17 months), respectively. According to the PSA decline rate, patients who achieved a ≥30% reduction in PSA levels had significantly longer OS than those who showed a <30% reduction in PSA levels (P = 0.002). Regarding the number of cycles of CBZ, patients who received ≥4 cycles of CBZ showed significantly longer OS than those who received <4 cycles of CBZ (P < 0.001). Patients who had visceral metastasis showed significantly shorter OS than those without visceral metastasis (P = 0.012).
This study demonstrated that CBZ was effective and safe in Japanese local patients in a real-world setting. Patients with mCRPC who received ≥4 cycles of CBZ showed a ≥30% reduction in the serum PSA levels, and did not have visceral metastasis might achieve longer OS.
由于缺乏前瞻性试验，转移性去势抵抗性前列腺癌（mCRPC）患者的延长生命疗法的最佳序贯治疗仍不清楚。本研究旨在评估卡巴他赛（CBZ）治疗的疗效和安全性，并检查接受多西他赛后接受 CBZ 治疗的 mCRPC 患者的肿瘤学结果的预后因素。
这是一项多机构回顾性研究，纳入了 44 例接受 CBZ 治疗的 mCRPC 患者。所有入组患者均经组织学证实患有远处转移的前列腺癌（PCa），并在接受 CBZ 治疗前接受了多西他赛（DOC）治疗。主要终点是肿瘤学结果，包括总生存期（OS）和无进展生存期（PFS）。次要终点是由于 CBZ 引起的不良事件和前列腺特异性抗原（PSA）水平降低≥30%的发生率。
中位随访时间为 9.2 个月（范围，0.2-34 个月）。在此期间，34 例患者（77%）死于 PCa。中位 OS 和 PFS 分别为 12.2 个月（范围，0.2-34 个月）和 1.4 个月（范围，0.4-17 个月）。根据 PSA 下降率，PSA 水平降低≥30%的患者的 OS 明显长于 PSA 水平降低<30%的患者（P=0.002）。关于 CBZ 周期数，接受≥4 个周期 CBZ 治疗的患者的 OS 明显长于接受<4 个周期 CBZ 治疗的患者（P<0.001）。有内脏转移的患者的 OS 明显短于无内脏转移的患者（P=0.012）。
本研究表明，在真实环境中，CBZ 对日本当地患者是有效且安全的。接受≥4 个周期 CBZ 治疗且 PSA 水平降低≥30%、无内脏转移的 mCRPC 患者可能获得更长的 OS。
