EFFICACY AND TOXICITY OF SUNITINIB IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WITH SEVERE RENAL IMPAIRMENT OR ON HAEMODIALYSIS
EFFICACY AND TOXICITY OF SUNITINIB IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WITH SEVERE RENAL IMPAIRMENT OR ON HAEMODIALYSIS
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舒尼替尼对患有严重肾损伤或进行血液透析的转移性肾细胞癌患者的疗效和毒性
DOI：
10.1111/j.1464-410x.2011.10179.x
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发表时间：
2011
影响因子：
4.5
通讯作者：
P. O’Donnell
中科院分区：
文献类型：
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作者：
P. O’Donnell
尽管事实上，自舒尼替尼首次被美国食品药品监督管理局（FDA）批准用于肾癌患者以来，已经过去了4年多，但仍然存在一个挥之不去的问题，也许是临床医生不愿意将其用于肾损害患者，可能是因为直到最近，人们对舒尼替尼在此类患者中的使用知之甚少。临床医生的担忧可能是自然的，因为所有导致舒尼替尼批准的研究都排除了严重肾损害的患者[1]，这使得这些患者可以说与临床医生实际看到的肾癌患者非常不同。例如，一项研究（以摘要形式报告）表明，在37%接受系统治疗的肾癌患者中发现肾损害（定义为肾小球滤过率<60 mL/min/1.73 m）[2]。此外，舒尼替尼的大型III期临床试验[3]显示，在转移性疾病中接受舒尼替尼治疗的患者中，约90%的患者既往接受过肾切除术，这样的人群本来就有更大的患肾功能不全的风险：一项对10000例以上肾癌患者行部分或全肾切除术的回顾性研究显示，这些患者中的70%最终发生不良肾脏并发症（因肾功能不全住院，需要肾脏科会诊、透析或肾移植）[4]。
Despite the fact that over 4 years have passed since sunitinib was first USA Food and Drug Administration (FDA)-approved for use in patients with renal cancer, there has remained a lingering question, and perhaps a reluctance on the part of clinicians, about its use in patients with renal impairment, probably because of the fact that until recently relatively little was known about sunitinib use in such patients. The concern on the part of clinicians is perhaps natural, given the fact that all of the studies which led to the approval of sunitinib excluded patients with significant renal impairment [1], making such patients arguably quite unlike the patients with renal cancer that clinicians are actually seeing in practice. For example, one study (reported in abstract form) suggests that renal impairment (defined as a glomerular filtration rate of <60 mL/min/1.73m) is found in 37% of systemically treated patients with renal cancer [2]. Furthermore, the large phase III trial of sunitinib [3] showed that ≈90% of patients receiving sunitinib in the metastatic setting had prior nephrectomies, and such a population is inherently at greater risk of having or developing renal insufficiency: a retrospective study of >10 000 patients undergoing partial or complete nephrectomy for renal cancer showed that ≈20% of those patients eventually develop adverse renal complications (hospitalization for renal insufficiency, need for nephrology consultation, dialysis, or renal transplantation) [4].