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Abstract:
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In the era of targeted agents and immunotherapy agents in oncology, investigators are now recognizing that the paradigm of the Maximum Tolerated Dose may no longer reflect the best course of therapy for patients. Traditionally for cytotoxic chemotherapy agents, there has been a clear dose-response relationship between the level of drug and the efficacy response, with the limiting factor being the level of toxicity cancer patients can tolerate. However, for newer targeted oncology agents, there appears to be target saturation where additional drug only adds toxicity without added clinical benefit. To help better explore this phenomenon, we explore two Bayesian based methods to identify recommended phase 2 doses for future study. We explore a Bayesian non-parametric changepoint model that can simultaneously select multiple doses for study in future development plans.
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