Department of Oncology, Military Institute of Medicine, Warsaw, Poland.
University Hospital of Lord's Transfiguration, Poznan, Poland.
Clin Genitourin Cancer. 2019 Jun;17(3):e556-e564. doi: 10.1016/j.clgc.2019.02.002. Epub 2019 Feb 20.
Cabozantinib is an approved treatment for metastatic renal cell carcinoma (mRCC). This report presents an analysis of the safety profile and efficacy of cabozantinib in an unselected population from Poland.
Patients with mRCC, who had been treated with at least 1 previous agent targeting the vascular endothelial growth factor pathway, were eligible to receive cabozantinib at a once-daily dose of 60 mg orally, according to the Managed Access Program (MAP). Data were collected in 4 Polish centers. Patients who had received ≥ 1 dose of cabozantinib were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0.
A total of 115 patients were enrolled between October 2016 and March 2018, including 50% with bone metastases, 10% with brain metastases and 4.3% with non-clear-cell RCC; 76% had received ≥ 2 lines of therapy. The median time of follow-up was 12.6 months (95% confidence interval [CI], 11.5-14.1 months). The most common grade 3 and 4 AEs were fatigue (23%), hand-foot syndrome (12%), and diarrhea (10%). Only 4% of patients discontinued treatment owing to AEs, and there were no treatment-related deaths. Partial response was observed in 19% of patients, whereas 56% had stable disease. The median progression-free survival was 12.5 months (95% CI, 9.2-14.2 months), with a 12-month overall survival rate of 70.4% (95% CI, 60.2%-78.5%).
Cabozantinib demonstrated acceptable tolerability and activity in a large unselected population of patients with mRCC under clinical conditions.
卡博替尼是一种已被批准用于转移性肾细胞癌（mRCC）的治疗药物。本报告分析了卡博替尼在波兰未经选择人群中的安全性概况和疗效。
符合条件的患者为接受过至少一种针对血管内皮生长因子途径的药物治疗的 mRCC 患者，可根据管理准入计划（MAP）接受卡博替尼治疗，每日一次，剂量为 60mg 口服。数据在波兰的 4 个中心收集。接受了至少 1 剂卡博替尼治疗的患者使用通用不良事件术语标准（CTCAE）v.4.0 监测不良事件（AE）。
共有 115 名患者于 2016 年 10 月至 2018 年 3 月入组，其中 50%有骨转移，10%有脑转移，4.3%是非透明细胞 RCC；76%接受了≥2线治疗。中位随访时间为 12.6 个月（95%置信区间，11.5-14.1 个月）。最常见的 3 级和 4 级 AE 为乏力（23%）、手足综合征（12%）和腹泻（10%）。仅有 4%的患者因 AE 而停止治疗，且无治疗相关死亡。19%的患者观察到部分缓解，56%的患者疾病稳定。中位无进展生存期为 12.5 个月（95%置信区间，9.2-14.2 个月），12 个月总生存率为 70.4%（95%置信区间，60.2%-78.5%）。
卡博替尼在临床情况下，在未经选择的大量 mRCC 患者中表现出可接受的耐受性和疗效。
