Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul, Korea.
Chemotherapy. 2010;56(6):485-91. doi: 10.1159/000321033. Epub 2010 Nov 24.
Understanding the effect of adverse events from commonly used agents such as sunitinib in hemodialyzed renal cell carcinoma (RCC) patients is important in clinical practice. Despite its clinical relevance, little information has been provided on the safety and toxicity profile of sunitinib when administered in hemodialyzed patients with RCC.
Six patients undergoing hemodialysis were treated with sunitinib for metastatic RCC between February 2007 and May 2009. We retrospectively reviewed the medical records of these patients and examined the administered dose of sunitinib, treatment-related toxicity, and the clinical response to therapy.
The initial dose of sunitinib was 25 mg (cases 1 and 5), 37.5 mg (cases 2 and 3), and 50 mg (cases 4 and 6), respectively. Toxicities greater than grade 3 were observed in cases 3 and 6, and subsequently the dose was reduced in case 6. No patient had to stop sunitinib due to toxicities. Among the 6 patients, 3 (cases 2, 3, and 5) had disease progression after 1, 2, and 2 cycles of sunitinib, respectively. Three patients (cases 1, 4, and 6) had stable disease after 12, 5, and 4 cycles of treatment, respectively, and 2 of them (cases 4 and 6) were still on sunitinib 8 and 7 months, respectively, after the start of treatment.
The toxicity of and response to sunitinib in dialyzed patients seem to be comparable to those in patients with normal renal function. However, due to the limitations of this study, i.e. a small number of participants and lack of pharmacokinetic data, prospective clinical trials with pharmacokinetic studies in a larger cohort of patients are required.
了解索坦等常用药物在血液透析的肾细胞癌（RCC）患者中的不良反应影响在临床实践中非常重要。尽管其具有临床相关性，但对于接受血液透析的 RCC 患者使用索坦的安全性和毒性特征，提供的信息很少。
2007 年 2 月至 2009 年 5 月，我们对 6 名接受血液透析的转移性 RCC 患者使用索坦进行治疗。我们回顾性地审查了这些患者的病历，并检查了索坦的给药剂量、与治疗相关的毒性以及对治疗的临床反应。
索坦的初始剂量分别为 25mg（病例 1 和 5）、37.5mg（病例 2 和 3）和 50mg（病例 4 和 6）。病例 3 和 6 出现大于 3 级的毒性，随后病例 6 减少了剂量。没有患者因毒性而停止使用索坦。在 6 名患者中，3 名（病例 2、3 和 5）在使用索坦 1、2 和 2 个周期后分别出现疾病进展。3 名患者（病例 1、4 和 6）在接受治疗 12、5 和 4 个周期后分别出现稳定疾病，其中 2 名（病例 4 和 6）在治疗开始后分别仍在接受索坦治疗 8 个月和 7 个月。
在血液透析患者中，索坦的毒性和反应似乎与肾功能正常的患者相当。然而，由于本研究的局限性，即参与者人数较少且缺乏药代动力学数据，需要在更大的患者队列中进行具有药代动力学研究的前瞻性临床试验。
