Hospital Universitario 12 de Octubre, Madrid, Spain.
Expert Opin Drug Saf. 2013 Jul;12(4):455-63. doi: 10.1517/14740338.2013.781581. Epub 2013 Mar 20.
To examine real-world safety and treatment patterns of angiogenesis inhibitors for advanced renal cell carcinoma (aRCC) using observational data from two Spanish hospitals.
A retrospective medical record review was performed for 93 patients with a histological diagnosis of aRCC who received sunitinib, sorafenib, bevacizumab or temsirolimus as first-line angiogenesis inhibitor therapy, between January 2005 and September 2010 at two Spanish hospitals. Data were collected on adverse events (AEs), dosing to calculate relative dose intensity (RDI), treatment modifications and reasons for modifications.
Sixty patients received sunitinib, 23 received sorafenib, 6 received bevacizumab, 1 received temsirolimus and 3 received a bevacizumab-temsirolimus combination. 91.7 and 100.0% of patients receiving sunitinib and sorafenib, respectively, experienced ≥ 1 AE; 40.0% and 43.5% had ≥ 1 grade 3/4 AE. Mean RDI for sunitinib and sorafenib were 0.866 (standard deviation (std) = 0.903) and 0.798 (std = 2.154), respectively. Among patients receiving sunitinib, 15.0% discontinued treatment, 43.3% had an interruption and 33.3% had a reduction due to AEs. For sorafenib, these rates were 4.3, 56.5 and 34.8%, respectively.
High rates of AEs were observed which resulted in high rates of treatment interruptions and dose reductions. These results suggest the need for additional treatment options for aRCC with improved tolerability.
利用来自西班牙两家医院的观察性数据，研究晚期肾细胞癌（aRCC）血管生成抑制剂的真实世界安全性和治疗模式。
对 2005 年 1 月至 2010 年 9 月期间在西班牙两家医院接受舒尼替尼、索拉非尼、贝伐珠单抗或替西罗莫司一线血管生成抑制剂治疗的 93 例组织学诊断为 aRCC 的患者进行回顾性病历审查。收集了不良事件（AE）、剂量以计算相对剂量强度（RDI）、治疗修改和修改原因的数据。
60 例患者接受舒尼替尼治疗，23 例接受索拉非尼治疗，6 例接受贝伐珠单抗治疗，1 例接受替西罗莫司治疗，3 例接受贝伐珠单抗替西罗莫司联合治疗。分别有 91.7%和 100.0%接受舒尼替尼和索拉非尼的患者发生了≥1 次 AE；40.0%和 43.5%发生了≥1 次 3/4 级 AE。舒尼替尼和索拉非尼的平均 RDI 分别为 0.866（标准差（std）=0.903）和 0.798（std=2.154）。接受舒尼替尼治疗的患者中，15.0%停止治疗，43.3%中断治疗，33.3%因 AE 减少剂量。索拉非尼的这些比例分别为 4.3%、56.5%和 34.8%。
观察到高发生率的 AE，导致治疗中断和剂量减少的发生率很高。这些结果表明，需要为 aRCC 提供具有更好耐受性的额外治疗选择。
