Potential Impact of Revised NCI Eligibility Criteria Guidance: Prior Malignancy Exclusion in Breast Cancer Clinical Trials.

ABSTRACT:

Background

Many individuals with cancer have survived a prior cancer and for this reason may have been excluded from clinical trials. Recent NCI guidance recommends including these individuals, especially when the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low. Using breast cancer as an example, we determined the potential effect this policy change may have on clinical trial accrual.

Patients and methods

We reviewed protocols of NCI-sponsored breast cancer clinical trials activated in 1991 through 2016. We quantified prevalence of prior cancer-related exclusion criteria and assessed the association with trial characteristics using Fisher's exact tests. Using SEER data, we estimated the prevalence and timing of prior primary (non

SUBMITTER: Perez M 

PROVIDER: S-EPMC9906999 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature