Department of Oncology, Hematology and Respiratory Diseases, University of Modena and Reggio Emilia, Modena, Italy.
BJU Int. 2012 Sep;110(5):692-8. doi: 10.1111/j.1464-410X.2012.10946.x. Epub 2012 Feb 24.
What's known on the subject? and What does the study add? Sunitinib and sorafenib are orally administered multikinase inhibitors approved for the treatment of advanced RCC. The limited pharmacokinetics data on sunitinib and sorafenib suggest that haemodialysis does not significantly alter plasma concentrations. In this retrospective study we define the safety and efficacy of tyrosine kinase inhibitors in patients with metastatic RCC (mRCC) and end-stage renal disease requiring haemodialysis. Even though the retrospective nature of this survey and the relatively small sample size represent major limitations, these data indicate that treatment with sunitinib and sorafenib in this cohort of patients is feasible with no unexpected toxicity and good efficacy, results similar to those in the general population of patients with mRCC.
To investigate the safety and efficacy of tyrosine kinase inhibitors (TKIs) in patients with metastatic renal cell carcinoma (mRCC) and end-stage renal disease requiring haemodialysis (HD).
Between July 2006 and December 2010, 24 patients undergoing HD were treated with sunitinib and/or sorafenib for mRCC in 14 Italian institutions. We retrospectively reviewed the medical records of these patients to evaluate the administered doses of TKIs, treatment-related toxicities and the clinical response to therapy.
Sunitinib was administered at 50 mg daily for 4-6 weeks in six patients, 37.5 mg daily for 4-6 weeks in seven patients (one patient subsequently increased the dose to 50 mg daily), 25 mg daily for 4-6 weeks in two patients and 12.5 mg daily for 4-6 weeks in one patient. Among the eight patients treated with sorafenib, four patients received 800 mg daily (400 mg every 12 h), three patients 400 mg daily and one patient 200 mg daily with a continuous schedule. The estimated median progression-free and overall survival periods of this cohort of patients were 10.3 months and 22.6 months, respectively. With regard to tolerability and safety, no unexpected adverse events were registered and no grade 4 haematological or non-haematological toxicities were reported.
Sunitinib and sorafenib treatment is not contraindicated in patients with mRCC undergoing HD. The outcome of this patient population is similar to that observed in patients with normal renal function treated with TKIs. These results merit further confirmation by a larger prospective trial.
研究在需要血液透析的转移性肾细胞癌（mRCC）和终末期肾病患者中，使用酪氨酸激酶抑制剂（TKI）的安全性和疗效。
2006 年 7 月至 2010 年 12 月，14 家意大利机构的 24 名接受血液透析的患者接受了舒尼替尼和/或索拉非尼治疗 mRCC。我们回顾性地审查了这些患者的病历，以评估 TKI 的给药剂量、与治疗相关的毒性以及对治疗的临床反应。
6 名患者接受了 50mg 舒尼替尼每日治疗 4-6 周，7 名患者接受了 37.5mg 舒尼替尼每日治疗 4-6 周（其中 1 名患者随后增加剂量至 50mg 每日），2 名患者接受了 25mg 舒尼替尼每日治疗 4-6 周，1 名患者接受了 12.5mg 舒尼替尼每日治疗 4-6 周。8 名接受索拉非尼治疗的患者中，4 名患者接受了 800mg 每日治疗（400mg 每 12 小时），3 名患者接受了 400mg 每日治疗，1 名患者接受了 200mg 每日治疗。该患者队列的中位无进展生存期和总生存期分别为 10.3 个月和 22.6 个月。关于耐受性和安全性，未发现意外的不良事件，也未报告 4 级血液学或非血液学毒性。
舒尼替尼和索拉非尼治疗在接受血液透析的 mRCC 患者中并非禁忌。该患者人群的结果与接受 TKI 治疗的肾功能正常患者相似。这些结果需要更大的前瞻性试验进一步证实。
