Study on Monitoring of Imatinib Serum Level Guides Management of Chronic Myelogenous Leukemia Patients

doi:10.13523/j.cb.20190904

China Biotechnology

2019, Vol. 39

Issue (9): 25-32 DOI: 10.13523/j.cb.20190904

Orginal Article

Study on Monitoring of Imatinib Serum Level Guides Management of Chronic Myelogenous Leukemia Patients

ZHANG Jian¹,JIANG Zhi-ping¹,XU Ping²,HE Qun¹,WANG Qing²,ZHU Yan²,ZHAO Xie-lan^1,^*(

)

1 Department of Hematology Xiangya Hospital Central South University, Changsha 410008, China
2 Department of Pharmacy the Second Xiangya Hospital of Central South University, Changsha 410011, China

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Abstract

Objective: To assess if therapeutic drug monitoring (TDM)of imatinib used for chronic myelogenous leukemia (CML) patients led to improve clinical outcome and reduce side effects compared to empiric adjustments.Methods: Patients followed between 2013 to 2018 at CML Center of Xiangya Hospital are performed. Primary outcomes are composite remission at 3, 6, 12 and 18 months in those with empiric adjustments versus TDM-guided optimization.Results: There are 51 patients who are included in the study. Among them, 35 are in the experimental group and 16 are in the control group. The results show that when taking imatinib 400mg/d, the serum level is 568.00~3 989.66ng/ml, the mean (standard deviation): 1 716.46ng/ml (788.96); when taking imatinib 300mg/d, serum level is 720.89~1 497.11ng/ml, mean (standard deviation): 971.67ng/ml (204.02). The serum level at the time of achieving a stable molecular response is higher than that the time when the stable molecular response is not achieved. There are significant differences in adverse reaction ratings between the two groups. The incidence of adverse reactions of grade III and above in the experimental group is significantly smaller than that of the control group.Conclusions: There is a large individual difference in the steady serum level of imatinib, and this individual difference is related to efficacy and adverse reactions. TDM can reduce the adverse effects while ensuring efficacy in the treatment of CML patients. The results still require further validation of large sample clinical trials. The reasons for individual differences in imatinib drug metabolism require further investigation of large sample pharmacogenetics studies.

Key words： Chronic myelogenous leukemia Imatinib Therapeutic drug monitoring

Received: 06 August 2019 Published: 20 September 2019

ZTFLH:

R557

Corresponding Authors: Xie-lan ZHAO E-mail: zhaoxl9198@163.com

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	Jian ZHANG
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	Yan ZHU
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Cite this article:

ZHANG Jian,JIANG Zhi-ping,XU Ping,HE Qun,WANG Qing,ZHU Yan,ZHAO Xie-lan. Study on Monitoring of Imatinib Serum Level Guides Management of Chronic Myelogenous Leukemia Patients. China Biotechnology, 2019, 39(9): 25-32.

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https://manu60.magtech.com.cn/biotech/10.13523/j.cb.20190904 OR https://manu60.magtech.com.cn/biotech/Y2019/V39/I9/25

Fig.1 TDM process

Table 1 Patient Baseline Characteristics

Fig.2 Serum level at 400mg/d

Fig.3 Serum level at 300mg/d

Fig.4 Comparison of serum level before and after TDM

Fig.5 Clinical efficacy of imatinib (1)At 3 months (b)At 6 months (c)At 12 months (d)At 18 months

Fig.6 Relationship between serum level and clinical efficacy

Table 2 Comparison of the incidence of adverse reactions of different systems in the two groups

Table 3 Comparison of the incidence of different grades of adverse reactions in the two groups

Fig.7 Comparison of the incidence of different system adverse reaction in the two groups

Fig.8 Comparison of the incidence of different grades adverse reaction in the two groups

Fig.9 Relationship between serum level and different grades of adverse reactions


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