Abstract
Introduction
There are known correlations between axitinib exposure and treatment response. The
aim of the article was to study relationships between the axitinib steady-state trough
concentration and the treatment efficacy and toxicity.
Patients and methods
35 patients (24 men and 11 women), treated or initiating treatment with axitinib,
were included in the study over the period 2016-2019. Blood samples were collected
following 2 weeks of treatment (in patients who initiated the therapy) and at the
end of Cycles 1, 2, and 3 thereafter (in the entire study population). For concentration
measurements, high-performance liquid chromatography - mass spectrometry (HPLC-MS)
was applied. Treatment efficacy was assessed according to the RECIST 1.1 criteria.
Therapy toxicity was evaluated according to the CTCAE criteria.
Results
A statistically significant relationship between the first measured axitinib trough
concentration (Ctrough first) value and treatment response (P = .004) as well as the median progression-free survival (mPFS) (P = .003) was observed. The association between axitinib Ctrough first and the median overall survival (mOS) was not statistically significant (P = .142). A statistically significant relationship was observed between the mean trough
concentration from 3-month observation (Ctrough 1-3m) and treatment response (P = .008) as well as mPFS (P = .001), without a significant relationship for mOS (P = .097). At least grade 3 adverse reactions were meaningfully associated with Ctrough first (P = .012) and Ctrough 1-3m (P = .003).
Conclusion
There are significant relationships between axitinib Ctrough and treatment response, PFS, and grade ≥ 3 toxicity. The data collected may be used
to determine indications for axitinib therapy monitoring based on Ctrough measurements.
Keywords
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Article info
Publication history
Published online: March 11, 2022
Accepted:
March 6,
2022
Received in revised form:
February 18,
2022
Received:
June 26,
2021
Identification
Copyright
© 2022 Elsevier Inc. All rights reserved.
