Abstract:
The aim of this study is to share real-life data on the increase in creatinine due to CDK 4/6 inhibitor treatment and patients diagnosed with HR+/HER2-MBC and treated with ribociclib or palbociclib combined with ET were included in the study. While creatinine increase was observed in 17.9% (n = 19) of the 106 patients in the study population, 8.5% (n = 9) had Grade 1, 8.5% (n = 8) had Grade 2, and % 0.9 (n = 1) had Grade 3 creatinine elevation. The increase in creatinine occurred in 25% (n = 12) of ribociclib users and 12.1% (n = 7) of palbociclib users. No patient required a dose reduction or discontinuation of treatment due to elevated creatinine. Of the patients with high creatinine levels, 36.8% (n = 7) were over 65 years of age. Those with multiple comorbidities, blood urea nitrogen (BUN) >13.5 mg/dl, creatinine >0.66 mg/dl, BUN/creatinine ratio >19.95, glomerular filtration rate (GFR) >96.05 ml/min, and uric acid >4.69mg/dl. It was observed that the increase in the creatinine level was statistically significant (p <0.001). In conclusion, this study revealed that the increase in the serum creatinine secondary to ribociclib and palbociclib treatments is associated with kidney function tests and the number of concomitant diseases. Key Words: CDK 4/6 inhibitor, Creatinine elevation, Palbociclib, Ribociclib.
摘要:
这项研究的目的是分享有关CDK4/6抑制剂治疗引起的肌酐增加的真实数据,并将诊断为HR/HER2-MBC并接受ribociclib或palbociclib联合ET治疗的患者纳入研究。虽然在研究人群中106名患者中有17.9%(n=19)的肌酐增加,8.5%(n=9)为1级,8.5%(n=8)为2级,%0.9(n=1)为3级肌酐升高。肌酐的增加发生在25%(n=12)的ribociclib使用者和12.1%(n=7)的palbociclib使用者中。没有患者由于肌酐升高而需要减少剂量或停止治疗。在高肌酐水平的患者中,36.8%(n=7)年龄超过65岁。那些有多种合并症的人,血尿素氮(BUN)>13.5mg/dl,肌酐>0.66mg/dl,BUN/肌酐比值>19.95,肾小球滤过率(GFR)>96.05ml/min,尿酸>4.69mg/dl。观察到肌酸酐水平的增加具有统计学显著性(p<0.001)。总之,这项研究表明,瑞博西尼和帕博西尼治疗后血清肌酐的增加与肾功能检查和伴随疾病的数量有关。关键词:CDK4/6抑制剂,肌酐升高,Palbociclib,Ribociclib.