卡巴他赛每两周治疗用于多西他赛治疗后转移性去势抵抗性前列腺癌（mCRPC）患者是安全的——Prosty II 试验的最终分析。
Biweekly Cabazitaxel Is a Safe Treatment Option for Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients After Docetaxel - A Final Analysis of the Prosty II Trial.
机构信息
Faculty of Medicine and Health Technology, University of Tampere and Center of Research, Development and Innovation, Tays Cancer Center, Tampere University Hospital, Tampere, Finland;
Department of Urology, Seinäjoki Central Hospital, Seinäjoki, Finland.
出版信息
Anticancer Res. 2020 Dec;40(12):6915-6921. doi: 10.21873/anticanres.14715. Epub 2020 Dec 7.
BACKGROUND/AIM: Our phase III trial showed that biweekly docetaxel (D) is better tolerated than triweekly D in metastatic castration-resistant prostate cancer (mCRPC). The safety of biweekly cabazitaxel (CBZ) post-docetaxel was studied in mCRPC.
PATIENTS AND METHODS
Altogether, 60 patients received CBZ 16 mg/m i.v. on day 1 and day 14 of a 4-week cycle. The mean serum PSA levels were 305 ng/ml, and the mean age 67 years. The primary endpoint was safety according to CTCAEv4.0.
RESULTS
A total of 255 4-week cycles of CBZ were administered. The most common grade 3/4 adverse events were neutropenia (16.7%), pain (13.3%), fatigue (10.0%), anemia (5.0%) and non-neutropenic infection (10.0%). PSA responses occurred in 10 patients (16.7%). Clinical benefit rate was 38.3% and median survival 10 months.
CONCLUSION
Biweekly CBZ is a well-tolerated treatment resulting in meaningful benefits for heavily pretreated mCRPC patients.
背景/目的：我们的 III 期临床试验表明，与每周三次的多西他赛（D）相比，每周两次的多西他赛（D）在转移性去势抵抗性前列腺癌（mCRPC）中更耐受。本研究旨在探讨多西他赛后每周两次卡巴他赛（CBZ）的安全性。
患者和方法
共 60 例 mCRPC 患者接受卡巴他赛 16 mg/m 静脉注射，每 14 天一次，4 周为一个周期。平均血清 PSA 水平为 305ng/ml，平均年龄为 67 岁。主要终点是根据 CTCAEv4.0 评估的安全性。
结果
共给予 255 个 4 周周期的卡巴他赛治疗。最常见的 3/4 级不良事件是中性粒细胞减少（16.7%）、疼痛（13.3%）、疲劳（10.0%）、贫血（5.0%）和非中性粒细胞减少性感染（10.0%）。10 例（16.7%）患者出现 PSA 反应。临床获益率为 38.3%，中位生存期为 10 个月。
结论
每周两次的卡巴他赛耐受性良好，可为大量预处理的 mCRPC 患者带来显著获益。
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