ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024
Exposure-Response-Based Multiattribute Clinical Utility Score Framework to Facilitate Optimal Dose Selection for Oncology Drugs.
Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed.
- A Perspective on the Use of Poisson Versus Logistic Regression in Exposure-Response Analysis: Insights and Considerations.CPT: pharmacometrics & systems pharmacology · 2025Article
- De-Escalating Anticancer Treatment: Watch Your Step.Cancers · 2025Review
- Combining Response and Toxicity Data to Implement Project Optimus.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Article
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10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe advent of new therapeutic modalities highlighted deficiencies in the traditional maximum tolerated dose approach for oncology drug dose selection and prompted the Food and Drug Administration (FDA)'s
methodsModel-predicted outcomes for each clinically relevant end point, informed by ER modeling, are converted to a CUS using a user-defined utility function. Thereafter, individual CUS is integrated into a single score with user-defined weighting for each end point. The user-defined weighting feature allows the user to incorporate expert knowledge/understanding into weighing the product's benefit versus risk profile.
resultsTo validate the framework, data were leveraged from over 50 oncology programs from 2019 to 2023 on the basis of FDA new drug application/biologics license application review packages and/or related literature studies. Five representative cases were selected for in-depth evaluation. Results showed that the optimal benefit-risk ratio (highest CUS) was consistently observed at PK exposures synonymous with recommended doses. A recurring theme across cases was a greater emphasis on safety over efficacy in oncology drug dose determination.
conclusionThe ER-based CUS framework offers a strategic tool to navigate the complexities of dose selection in oncology programs. It serves as a pillar to the importance of integrative data analysis, aligning with the vision of
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