阿贝西利片是否会影响血清肌酐? |
本文旨在提供关于阿贝西利片对血清肌酐影响的相关信息,仅供医疗卫生专业人士参考。 |
回复:
阿贝西利可引起血清肌酐可逆性升高,而不会降低肾功能。
详细信息
在 MONARCH 1、MONARCH 2 和 MONARCH 3 试验中,血清肌酐升高是最常见的实验室异常,分别有 98%、97% 和 96% 的患者报道发生 1 级或 2 级事件。3-5
在健康受试者中,平均最大肌酐在给药后24小时比基线值增加约20%至35%,大约在给药后336小时(14天)恢复到基线值。1
在 MONARCH 2 和 MONARCH 3 研究中,由于肌酐升高而导致j降低剂量、漏服和停药的发生率 <2.5%,并且仅发生在阿贝西利组中。在 MONARCH 2 和 MONARCH 3 研究中,有 0.5% 和 2.4% 的患者因肌酐升高而降低剂量。在 MONARCH 2 和 MONARCH 3 研究中,1.4% 和 1.6% 的患者因肌酐升高而漏服。 MONARCH 2 研究中没有患者因肌酐升高而终止治疗,而 MONARCH 3 研究中有 1.2% 的患者因此终止治疗。6
其他肾功能指标(如血尿素氮、胱抑素 C 或基于胱抑素 C 计算的肾小球滤过率)应替代血清肌酐或基于肌酐的肾小球滤过率 (GFR) 计算估计值,如果
胱抑素 C 是一种小的蛋白质,由所有有核细胞产生,并存在于体液(包括血清)中。它以恒定的速率形成,并且由于其尺寸小而被肾小球自由过滤。胱抑素 C 是无法分泌的,并且被肾小管完全再吸收并分解。11与肌酐相比,胱抑素 C 一直被发现与 GFR 的标准指标具有更高的相关性。12
血清或血浆胱抑素 C 的测量是一种自动化测试,可以轻松获得,并且不需要对血样进行特殊处理或处置。13
上次审阅日期:2021年11月2日
参考文献
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Tolaney S, Lam AQ, Mukundan S, et al. Analysis of renal function in MONARCH 1: A phase 2 study of abemaciclib, a CDK4 & 6 inhibitor, as monotherapy, in patients with HR+/HER2- breast cancer, after chemotherapy for metastatic breast cancer (MBC). Cancer Res. 2017;77(4 suppl):P6-15-01. American Association for Cancer Research abstract P6-15-01. http://cancerres.aacrjournals.org/content/77/4_Supplement/P6-15-01
3Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, a phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2− metastatic breast cancer. Clin Cancer Res. 2017;23(17):5218-5224. http://dx.doi.org/10.1158/1078-0432.CCR-17-0754
4Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2− advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875-2884. https://doi.org/10.1200/JCO.2017.73.7585
5Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646. https://doi.org/10.1200/jco.2017.75.6155
6Rugo HS, Huober J, Garcia-Saenz JA, et al. Management of abemaciclib-associated adverse events in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: safety analysis of MONARCH 2 and MONARCH 3. Oncologist. 2021;26(1):e53-e65. http://dx.doi.org/10.1002/onco.13531
7Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.
8Milburn J, Jones R, Levy JB. Renal effects of novel antiretroviral drugs. Nephrol Dial Transplant. 2017;32(3):434-439. https://doi.org/10.1093/ndt/gfw064
9Shlipak MG, Matsushita K, Ärnlöv J, et al. Cystatin C versus creatinine in determining risk based on kidney function. N Engl J Med. 2013;369(10):932-943. https://doi.org/10.1056/NEJMoa1214234
10Chappell JC, Turner PK, Pak YA, et al. Abemaciclib inhibits renal tubular secretion without changing glomerular filtration rate. Clin Pharmacol Ther. 2019;105(5):1187-1195. https://doi.org/10.1002/cpt.1296
11Chew JSC, Saleem M, Florkowski CM, George PM. Cystatin C – a paradigm of evidence based laboratory medicine. Clin Biochem Rev. 2008;29(2):47-62. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2533150/
12Inker LA, Schmid CH, Tighiouart H, et al. Estimating glomerular filtration rate from serum creatinine and cystatin C. N Engl J Med. 2012;367(1):20-29. https://doi.org/10.1056/NEJMoa1114248
13Shlipak MG, Mattes MD, Peralta CA. Update on cystatin C: incorporation into clinical practice. Am J Kidney Dis. 2013;62(3):595-603. https://doi.org/10.1053/j.ajkd.2013.03.027