Artikel
Model-based dose-finding for combination studies
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Veröffentlicht: | 26. Februar 2021 |
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Gliederung
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Increasingly, Phase I cancer trials consider combinations of agents. Typically, such a study would allow escalation of one agent at a time, provided the lower combination has been shown to be safe, with the goal of these studies usually being to find the maximum tolerated combination (MTC). In recent years a large range of different model-based and model-assisted approaches have been proposed, each claiming to be (at least in some instances) being better than the others.
In this presentation we will discuss several different model-based approaches for combination dose-finding studies and compare them in a comprehensive simulation study. We incorporate practical constraints in such studies when one of the agents is already in use (and hence has an established dose-level). We show that allowing the escalation methods to escalate freely without restricting to the dose of the established agent yields superior performance for all methods and find that, while all methods perform adequate, small improvements by using a model incorporating interactions can be achieved.
The authors declare that they have no competing interests.
The authors declare that an ethics committee vote is not required.