{"entity":{"id":"idea-tr1-therapeutic-drug-monitoring-for-oral-tkis","kind":"idea","name":"Measure blood levels of oral targeted drugs and adjust doses to a target range","aka":[],"tldr":"Blood levels of oral cancer pills vary several-fold between people on the same dose, so some are under-treated and others poisoned. Checking levels and adjusting the dose, as is routine for some antibiotics, could fix both.","summary":"Therapeutic drug monitoring (TDM) for oral kinase inhibitors and hormonal agents with established exposure-response relationships and high inter-patient variability (imatinib, sunitinib, pazopanib, abiraterone, tamoxifen via endoxifen, and newer agents), with dose adjustment to a target trough. Dutch multicentre TDM studies have shown feasibility and increased target attainment; outcome-powered randomised trials are lacking.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Wrong doses): FDA Oncology Center of Excellence, Project Optimus","url":"https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["kinase-inhibitors","endocrine-therapy"],"targets":[],"drugs":["imatinib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-dose-optimisation","b-toxicity-qol"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"TDM-guided dosing will increase the proportion of patients within the target exposure range from roughly half to over 80 percent and will improve PFS or reduce grade 3+ toxicity relative to fixed dosing in a randomised comparison.","rationale":"Adherence, food, interactions and pharmacogenetics cause large exposure variability; fixed dosing ignores it. TDM is standard for narrow-therapeutic-index drugs in other fields.","test":"A randomised trial of TDM-guided versus fixed dosing for two or three TKIs with the strongest exposure-response evidence, with PFS and toxicity endpoints.","maturity":"early-clinical","actor":"clinic","cost":"small","horizonYears":3},"route":"/ideas/idea-tr1-therapeutic-drug-monitoring-for-oral-tkis/","neighbours":{"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"imatinib","kind":"drug","name":"Imatinib","route":"/drugs/imatinib/"}],"bottleneck":[{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"},{"id":"b-dose-optimisation","kind":"bottleneck","name":"Wrong doses","route":"/bottlenecks/b-dose-optimisation/"}]}}