A Pharmacometric Analysis of Patient-Reported Outcomes in Breast Cancer Patients Through Item Response Theory.

ABSTRACT:

Purpose

An item response theory (IRT) pharmacometric framework is presented to characterize Functional Assessment of Cancer Therapy-Breast (FACT-B) data in locally-advanced or metastatic breast cancer patients treated with ado-trastuzumab emtansine (T-DM1) or capecitabine-plus-lapatinib.

Methods

In the IRT model, four latent well-being variables, based on FACT-B general subscales, were used to describe the physical, social/family, emotional and functional well-being. Each breast cancer subscale item was reassigned to one of the other subscales. Longitudinal changes in FACT-B responses and covariate effects were investigated.

Results

The IRT model could describe both item-level and subscale-level FACT-B data. Non-Asian patients showed better baseline social/family and

SUBMITTER: Schindler E 

PROVIDER: S-EPMC5908825 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature