Palmieri, C 
ORCID: 0000-0001-9496-2718 and Macpherson, IR
(2021)
A review of the evidence base for utilizing Child-Pugh criteria for guiding dosing of anticancer drugs in patients wan cancer and liver impairment.
ESMO OPEN, 6 (3).
100162-.
Abstract
As the liver is vital for the metabolism of many anticancer drugs, determining the correct starting doses in cancer patients with liver impairment is key to safe prescription and prevention of unnecessary adverse effects. Clinicians typically use liver function tests when evaluating patients; however, prescribing information and summaries of product characteristics often suggest dosing of anticancer drugs in patients with liver impairment based on the Child-Pugh criteria, even though the criteria were not developed for this purpose. In this review, we assessed all the oncological small molecule and cytotoxic drugs approved by the United States Food and Drug Administration (FDA) over a 5-year period from 2014 to 2018. The various entry criteria related to these drugs-with respect to hepatic function-in key pivotal studies were compared with their approved dosing recommendations found in prescribing information and summaries of product characteristics. We found that 46% of drugs have dosing recommendations based on Child-Pugh criteria alone, despite the fact that only 8% of these drugs were tested within studies that used the Child-Pugh criteria as entry criteria. Moreover, we note that the data used to make recommendations based on Child-Pugh criteria are typically from small studies that may lack an appropriate patient population. We propose that these findings, along with details surrounding the development of the Child-Pugh criteria, call into question the validity and appropriateness of using Child-Pugh criteria for dosing recommendations of anticancer drugs.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | liver impairment, Child-Pugh criteria, dosing, anticancer drugs |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 18 Jan 2022 09:33 |
| Last Modified: | 18 Jan 2023 21:15 |
| DOI: | 10.1016/j.esmoop.2021.100162 |
| Open Access URL: | https://doi.org/10.1016/j.esmoop.2021.100162 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3147093 |
Dimensions
Dimensions
