Infant Chemotherapy Dosing Guidance

Pharmacological evidence based dosing guidance for the treatment of neonates and infants

The treatment of cancer in neonates and infants is complicated by marked physiological changes during the first year of life. Optimal dosing in this population is uncertain as dose regimens are commonly not evidence based and dosing strategies are frequently inconsistent between tumour types and treatment protocols. As part of a recent review published in the European Journal of Cancer, we have collated available published pharmacological evidence supporting dosing regimens in neonates and infants for a wide range of cytotoxic drugs.

This systematic review, a collaboration between Newcastle University and colleagues at the University Medical Center Utrecht and Princess Máxima Center for Pediatric Oncology, involved ranking the available data by a defined level of evidence (1-5). Evidence was awarded the highest level (Level 1) if population based pharmacokinetic modelling was conducted including infants in the population. The lowest level of evidence (Level 5) was awarded to findings derived from mechanism based reasoning or expert opinion. For further details on these evidence rankings please refer to the published article (Nijstad et al., Eur J Cancer 2022).

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Dosing Recommendations

To determine a grade of dose recommendation (A-D) the levels of evidence were assessed on a consensus basis, with recommended dosing approaches indicated as appropriate.

A Sufficient pharmacological evidence available to recommend dosing in neonates/infants
B Some pharmacokinetic evidence to guide dosing in neonates/infants available but more information is needed
C Paediatric pharmacokinetic data available but no studies in neonates/infants or inconsistent data
D No relevant pharmacological data available

This internet resource aims to present the published evidence-based dosing guidance for cytotoxic drugs in neonates and infants in an accessible and adaptable manner.

About Us

Newcastle Cancer Centre Pharmacology Group

The Newcastle Cancer Centre Pharmacology Group is a dedicated team of experienced researchers at Newcastle University.

We work in close collaboration with many organisations including:

  • the CRUK Centre for Drug Development
  • academic groups
  • pharma and biotech companies conducting clinical pharmacology studies across various phases of clinical trials

We aim to develop novel and innovative pharmacokinetic and pharmacodynamic biomarker assays. This enables the analysis of clinical samples.

Our research has contributed to:

  • development of new anticancer drugs
  • introduction of new treatment guidelines
  • development of novel drug formulations in both adult and paediatric cancer settings