Determining doses for backfill cohorts based on patient-reported outcome.

ABSTRACT:

Background

Incorporating backfill cohorts in phase I oncology trials is a recently developed strategy for dose optimization. However, the efficacy assessment window is long in general, causing a lag in identifying ineffective doses and more patients being backfilled to those doses. There is necessity to investigate how to use patient-reported outcomes (PRO) to determine doses for backfill cohorts.

Methods

We propose a unified Bayesian design framework, called 'Backfill-QoL', to utilize patient-reported quality of life (QoL) data into phase I oncology trials with backfill cohorts, including methods for trial monitoring, algorithm for dose-finding, and criteria for dose selection. Simulation studies and sensitivity analyses are conducted to evaluate the proposed Backfill-QoL d

SUBMITTER: Chen X 

PROVIDER: S-EPMC11546322 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature