A utility-based Bayesian optimal interval (U-BOIN) phase I/II design to identify the optimal biological dose for targeted and immune therapies.

ABSTRACT: In the era of targeted therapy and immunotherapy, the objective of dose finding is often to identify the optimal biological dose (OBD), rather than the maximum tolerated dose. We develop a utility-based Bayesian optimal interval (U-BOIN) phase I/II design to find the OBD. We jointly model toxicity and efficacy using a multinomial-Dirichlet model, and employ a utility function to measure dose risk-benefit trade-off. The U-BOIN design consists of two seamless stages. In stage I, the Bayesian optimal interval design is used to quickly explore the dose space and collect preliminary toxicity and efficacy data. In stage II, we continuously update the posterior estimate of the utility for each dose after each cohort, using accumulating efficacy and toxicity from both stages I and II, and then use

SUBMITTER: Zhou Y 

PROVIDER: S-EPMC7927960 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature