Predictors of early treatment discontinuation in patients enrolled on Phase I oncology trials.

ABSTRACT:

Purpose

Patients who do not complete one cycle of therapy on Phase I trials for reasons other than dose limiting toxicity (DLT) are considered inevaluable for toxicity and must be replaced.

Methods

Individual records from patients enrolled to NCI-sponsored Phase I trials activated between 2000 and 2010 were used. Early discontinuation was defined as the failure to begin cycle 2 for reasons other than a DLT during cycle 1. A multinomial logistic regression with a 3-level nominal outcome (early discontinuation, DLT during cycle 1, and continuation to cycl1e 2) was used with continuation to cycle 2 serving as the reference category. The final model was used to create two risk scores. An independent external cohort was used to validate these models.

Results

Data from 3079

SUBMITTER: Hyman DM 

PROVIDER: S-EPMC4662493 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature