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Therapeutic Drug Monitoring of Oral Targeted Anticancer Drugs: Achievements, Experiences, Challenges, and the Path
Maud B A van der Kleij1,2, Karolijn W M Groot Beumer1, Stijn L W Koolen2,3
1Department of Clinical Pharmacology, Division of Medical Oncology, The Netherlands Cancer Institute, Amsterdam.
Background:
The introduction of oral targeted anticancer drugs has revolutionized anticancer treatments. Exposure to these drugs is often affected by individual, disease, or drug characteristics. As a result, these drugs often show high interpatient variability in drug exposure. Therapeutic drug monitoring (TDM) is a useful tool for addressing the underlying problems of this variability: unnecessary toxicity and suboptimal efficacy. In this overview article, the authors discuss achievements, experiences, and current challenges of TDM for oral targeted anticancer drugs in clinical practice and highlight directions for future research.
Methods:
PubMed was searched for relevant clinical studies on TDM of oral targeted anticancer drugs.
Results:
TDM for oral targeted anticancer drugs should be routinely conducted when exposure-response or exposure-toxicity relationships are established to avoid underexposure or overexposure, and on indication, to achieve reasonable drug exposure in individual cases when exposure is suspected to be outside the therapeutic index. The current challenges in supporting TDM for oral targeted anticancer drugs include the absence of compelling prospective evidence on clinical outcomes and the paucity of pharmacokinetic data for newly approved drugs. Future studies should address these issues.
Conclusions:
Advancing TDM of oral targeted anticancer drugs requires finding the right drugs, the right patients, the right drug exposure targets, the right sampling methods, and the right evidence. Addressing these issues can facilitate clinical implementation and ensure that TDM can be applied for both older and newly approved oral targeted anticancer drugs.
Insights
Therapeutic drug monitoring (TDM) for oral targeted anticancer drugs is crucial for managing variability in patient exposure. Routine TDM helps optimize efficacy and minimize toxicity, though more evidence is needed for wider implementation.
Area of Science:
- Pharmacology
- Oncology
- Clinical Pharmacy
Background:
- Oral targeted anticancer drugs have transformed cancer treatment but exhibit significant interpatient variability in exposure due to individual, disease, or drug factors.
- This variability can lead to suboptimal efficacy or unnecessary toxicity, highlighting the need for effective management strategies.
- Therapeutic drug monitoring (TDM) offers a valuable approach to address and mitigate these issues in clinical practice.
Purpose of the Study:
- To provide an overview of the achievements, experiences, and current challenges associated with TDM for oral targeted anticancer drugs.
- To identify key areas for future research to advance the clinical implementation of TDM for these agents.
Main Methods:
- A comprehensive literature search was conducted using PubMed to identify relevant clinical studies.
- The focus was on studies pertaining to the therapeutic drug monitoring of oral targeted anticancer drugs.
Main Results:
- Routine TDM for oral targeted anticancer drugs is recommended when exposure-response or exposure-toxicity relationships are established, aiming to prevent underexposure or overexposure.
- TDM is also indicated for individual cases where drug exposure is suspected to be outside the therapeutic index.
- Current challenges include a lack of robust prospective evidence on clinical outcomes and limited pharmacokinetic data for new drugs.
Conclusions:
- Advancing TDM requires careful selection of drugs, patients, exposure targets, and sampling methods, supported by strong evidence.
- Addressing these factors will facilitate broader clinical implementation of TDM for both existing and newly approved oral targeted anticancer drugs.
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