# Model-informed individual dosing with drug-level monitoring for every oral cancer drug

Source: https://onco.cc/ideas/idea-moon-individualised-dosing-all-oral-drugs/  
OnCo record `idea-moon-individualised-dosing-all-oral-drugs` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

People differ several-fold in how they absorb and clear cancer pills. Measure blood levels and adjust each person's dose, as is routine for some antibiotics and transplant drugs.

## Summary

Exposure to oral kinase inhibitors and endocrine agents varies widely between patients and correlates with both toxicity and efficacy (imatinib, abiraterone, tamoxifen metabolites, sunitinib). Therapeutic drug monitoring is standard in other fields but rare in oncology. The proposal is a programme defining exposure targets for the top 30 oral anticancer drugs, a low-cost assay network, and model-informed precision dosing software integrated into prescribing, tested in randomised trials against fixed dosing.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Exposure-guided dosing reduces grade 3+ toxicity and discontinuation by a third while maintaining or improving progression-free survival compared with fixed labelled dosing.
- Rationale: Fixed dosing at the maximum tolerated dose ignores known pharmacokinetic variability; the analytic and modelling tools are mature and cheap relative to the drugs.
- Proposed test: Randomised trial of exposure-guided versus fixed dosing across five oral agents with composite toxicity-discontinuation primary and PFS non-inferiority secondary endpoints.
- Maturity: early-clinical
- Actor: clinic

## Sources

- Bottleneck evidence (Wrong doses): FDA Oncology Center of Excellence, Project Optimus: https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus

## Connected records

- technologies: [Endocrine therapy (SERMs, AIs, SERDs)](https://onco.cc/technologies/endocrine-therapy/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Imatinib](https://onco.cc/drugs/imatinib/)
- bottlenecks: [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/), [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)

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