Simulation Modeling to Extend Clinical Trials of Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Early Breast Cancer.

ABSTRACT:

Purpose

The Trial Assigning Individualized Options for Treatment (TAILORx) found chemotherapy could be omitted in many women with hormone receptor-positive, HER2-negative, node-negative breast cancer and 21-gene recurrence scores (RS) 11-25, but left unanswered questions. We used simulation modeling to fill these gaps.

Methods

We simulated women eligible for TAILORx using joint distributions of patient and tumor characteristics and RS from TAILORx data; treatment effects by RS from other trials; and competing mortality from the Surveillance, Epidemiology, and End Results program database. The model simulations replicated TAILORx design, and then tested treatment effects on 9-year distant recurrence-free survival (DRFS) in 14 new scenarios: eight subgroups defined by a

SUBMITTER: Jayasekera J 

PROVIDER: S-EPMC7049983 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature