Academic Unit of Medical Oncology, IRCCS San Martino Polyclinic Hospital.
Department of Internal Medicine and Medical Specialties (DIMI), School of Medicine, University of Genoa, Genoa.
Anticancer Drugs. 2019 Sep;30(8):854-858. doi: 10.1097/CAD.0000000000000805.
The phase III PROSELICA trial showed that cabazitaxel 20 mg/m (C20) was not inferior and better tolerated compared to cabazitaxel 25 mg/m (C25) in patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed during or after docetaxel. Here, we report on a real-world retrospective analysis concerning the safety and the activity of C20 schedule in patients with mCRPC treated at our Institution. We identified 35 patients with mCRPC who received C20 as baseline dose treatment because they were frail or experienced serious toxicities to previous treatments. Adverse events assessment was performed at each visit during the treatment. Progression-free survival (PFS) and overall survival (OS) curves were obtained using the Kaplan-Meyer product-limit estimator. Median age was 71 years. All patients received a previous treatment with docetaxel; 19 patients (54%) received one additional line of therapy and 9 (26%) two or more. Patients received a median of 4 cycles (range: 2-10). Only one patient experienced grade 3 neutropenia (3%), two patients grade 3 anemia (6%), and one patient grade 3 fatigue (3%); three patients were treated with prophylactic Granulocyte colony-stimulating factor (9%). The most frequent adverse events of all grades were: anemia (39%), fatigue (33%), and diarrhea (15%). Median PFS was 3.7 months [95% confidence interval (CI): 3.31-4.09]; median OS was 10.3 months (95% CI: 4.63-15.97). Our real-world analysis confirms that C20 is a feasible option for elderly and heavily pretreated patients with mCRPC, showing activity and good tolerability.
III 期 PROSELICA 试验表明，在转移性去势抵抗性前列腺癌（mCRPC）患者中，与卡巴他赛 25mg/m（C25）相比，卡巴他赛 20mg/m（C20）并不劣效且耐受性更好，这些患者在接受多西他赛治疗期间或之后进展。在此，我们报告了一项真实世界的回顾性分析，该分析涉及在我们机构接受治疗的 mCRPC 患者中 C20 方案的安全性和疗效。我们确定了 35 名 mCRPC 患者，他们因虚弱或先前治疗的严重毒性而接受 C20 作为基础剂量治疗。在治疗期间的每次就诊时都进行了不良事件评估。使用 Kaplan-Meier 乘积限估计器获得无进展生存期（PFS）和总生存期（OS）曲线。中位年龄为 71 岁。所有患者均接受过多西他赛的先前治疗；19 名患者（54%）接受了一线以上的治疗，9 名患者（26%）接受了二线或更多的治疗。患者接受了中位数为 4 个周期（范围：2-10）的治疗。只有 1 名患者出现 3 级中性粒细胞减少症（3%）、2 名患者出现 3 级贫血（6%）和 1 名患者出现 3 级疲劳（3%）；3 名患者接受了预防性粒细胞集落刺激因子（G-CSF）治疗（9%）。所有级别中最常见的不良反应是：贫血（39%）、疲劳（33%）和腹泻（15%）。中位 PFS 为 3.7 个月[95%置信区间（CI）：3.31-4.09]；中位 OS 为 10.3 个月（95%CI：4.63-15.97）。我们的真实世界分析证实，C20 是一种可行的选择，适用于老年和大量预处理的 mCRPC 患者，显示出疗效和良好的耐受性。
