Lee Catherine S, Alwan Laura M, Sun Xiaocui, McLean Katherine A, Urban Renata R
Department of Pharmacy, University of Washington Medical Center, Seattle, WA, USA
Department of Pharmacy, University of Washington Medical Center, Seattle, WA, USA.
J Oncol Pharm Pract. 2016 Dec;22(6):771-776. doi: 10.1177/1078155215609987. Epub 2015 Oct 6.
Proteinuria leading to nephrotic syndrome is a rare adverse event arising from treatment with bevacizumab. There is limited evidence to guide the frequency and appropriate test for monitoring for proteinuria. The purpose of this study was to determine the prevalence and severity of proteinuria during bevacizumab administration to patients with gynecologic malignancies, and to evaluate risk factors associated with this toxicity; a secondary objective was to evaluate the cost of routine proteinuria monitoring to assess for opportunities of cost containment that could change clinical practice.
A retrospective chart review was performed at an academic gynecologic oncology clinic. Women over 18 years of age with a diagnosed gynecologic malignancy were evaluated for the development of proteinuria while receiving bevacizumab treatment as measured by a urine protein-to-creatinine ratio. Patient and disease-specific risk factors were evaluated using logistic regression to determine correlations of risk factors to development of proteinuria. Cost assessment was performed using institution-specific data for urine laboratory tests.
Eighty-nine patients were identified, and the overall prevalence of proteinuria of any grade was 35%. The mean number of bevacizumab cycles was 13 (2-64 cycles). The majority of patients experienced grade 1 proteinuria (70%, 62 patients). Grade 3 proteinuria was observed in two patients (2%). There was a trend toward increased bevacizumab cycles associated with increased grade proteinuria (p = 0.053), however there were no factors significantly associated with the development of proteinuria as measured by urine protein-to-creatinine ratio.
Monitoring of urine protein-to-creatinine ratios with each cycle may be unnecessary due to the low prevalence of grade 3 proteinuria observed. Additionally, urine protein-to-creatinine ratios may not provide adequate assessment of proteinuria toxicity associated with bevacizumab therapy. Potential cost savings opportunities for the institution can be realized with a cost-reductive monitoring algorithm that will utilize less costly laboratory techniques for patients at high risk of developing proteinuria.
导致肾病综合征的蛋白尿是贝伐单抗治疗引发的一种罕见不良事件。指导蛋白尿监测频率及合适检测方法的证据有限。本研究的目的是确定妇科恶性肿瘤患者接受贝伐单抗治疗期间蛋白尿的患病率和严重程度,并评估与此毒性相关的危险因素;次要目的是评估常规蛋白尿监测的成本,以寻找可能改变临床实践的成本控制机会。
在一家学术性妇科肿瘤诊所进行了一项回顾性病历审查。对18岁以上诊断为妇科恶性肿瘤的女性在接受贝伐单抗治疗期间的蛋白尿发生情况进行评估,通过尿蛋白与肌酐比值来衡量。使用逻辑回归评估患者和疾病特异性危险因素,以确定危险因素与蛋白尿发生之间的相关性。利用机构特定的尿液实验室检测数据进行成本评估。
共纳入89例患者,任何级别的蛋白尿总体患病率为35%。贝伐单抗治疗周期的平均数为13个(2 - 64个周期)。大多数患者经历1级蛋白尿(70%,62例)。2例患者出现3级蛋白尿(2%)。随着贝伐单抗治疗周期增加,蛋白尿级别有升高趋势(p = 0.053),然而,以尿蛋白与肌酐比值衡量,没有因素与蛋白尿的发生显著相关。
由于观察到3级蛋白尿的患病率较低,每个周期监测尿蛋白与肌酐比值可能没有必要。此外,尿蛋白与肌酐比值可能无法充分评估与贝伐单抗治疗相关的蛋白尿毒性。通过采用成本降低的监测算法,对有蛋白尿发生高风险的患者使用成本较低的实验室技术,可为机构实现潜在的成本节约机会。