Therapeutic drug monitoring of intravenous busulfan in Thai children undergoing hematopoietic stem cell transplantation: A pilot study

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Research Article: Therapeutic drug monitoring of intravenous busulfan in Thai children undergoing hematopoietic stem cell transplantation: A pilot study
Author: Thaksin Jansing, Kleebsabai Sanpakit, Trai Tharnpanich, Thanjira Jiranantakan, Vachira Niphandwongkorn, Busba Chindavijak & Thanarat Suansanae
Email: researchrx.siam@gmail.com
Department/Faculty: Faculty of Pharmacy,  Siam University, Bangkok 10160
Published: Pediatric Hematology and Oncology. 2021 Mar 3, 1-14

Citation

Thaksin Jansing, Kleebsabai Sanpakit, Trai Tharnpanich, Thanjira Jiranantakan, Vachira Niphandwongkorn, Busba Chindavijak & Thanarat Suansanae. (2021). Therapeutic drug monitoring of intravenous busulfan in Thai children undergoing hematopoietic stem cell transplantation: A pilot study. Pediatric Hematology and Oncology, Mar 3, 1-14. doi: 10.1080/08880018.2020.1871136.


ABSTRACT

Busulfan (Bu) is commonly used in myeloablative conditioning regimens for children undergoing hematopoietic stem cell transplantation. The standard target area under the concentration-time curve (AUC) of Bu is approximately 900-1500 µM min. In previous studies using five fixed doses (0.8-1.2 mg/kg) for Bu without dose adjustment, 75% patients achieved the target AUC. The aim of this pilot study was to determine the percentage of target AUC for intravenous (IV) Bu in Thai children. IV Bu was administered every 6 h over 16 doses. Blood samples were collected for pharmacokinetic (PK) analysis after the first, ninth, and thirteenth doses of Bu. Seven patients (2-14 years; median 6 years) were diagnosed with thalassemia (n = 4), acute myeloid leukemia (n = 2), and pure red cell aplasia. Three, two, and two patients received Bu at 1.1, 1.2, and 0.8 mg/kg, respectively. The AUC of Bu varied from 292-1714 µM min (median = 804). Nine (42.86%), eleven (52.38%), and one (4.76%) AUC values were within, below, and above the target, respectively. The median (range) Bu clearance was 5.93 (1.91-14.65) mL/min/kg. In this study, 42.86% AUC value achieved the target, which was lower than that in previous studies. Therapeutic drug monitoring (TDM) of Bu should be considered in Thai children receiving five fixed doses of IV Bu, and dose adjustment should be performed as necessary. Further PK studies for Bu with a larger sample size are warranted for confirming the necessity of TDM in every step dose of Bu.(Trial registration numbers; TCTR20190528003).

Keywords: Area under the curve, busulfan, children, therapeutic drug monitoring, transplantation.


Therapeutic drug monitoring of intravenous busulfan in Thai children undergoing hematopoietic stem cell transplantation: A pilot study

Faculty of Pharmacy, Siam University, Bangkok, Thailand

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