Breast Cancer Clinical Trial
Official title:
Head-to-Head Comparison of 18-Gene-Based Clinical-Genomic Model and Oncotype DX 21-Gene Assay for Predicting Recurrence of Early-stage Breast Cancer
A recurrence index for distant recurrence (RI-DR), an 18-gene-based clinical-genomic model, has been developed for early-stage breast cancer (EBC). In this study, Investigators compared the prognostic performance of the RI-DR with the Oncotype DX (ODx) recurrence score (RS) for any recurrence risk type.
With improved diagnosis, breast cancer can now be detected at early stages, thus improving
survival rates. However, overtreatment is common; considering that the risk of recurrence is
low, patients may suffer from side effects without receiving the full benefits of adjuvant
therapies.
To overcome the imprecision of prognosis based on clinicopathologic factors, genomic tests
for breast cancer prognosis, such as the Oncotype DX® (ODx), MammaPrint®, and EndoPredict®
assay kits, are frequently utilized. These multigene panels were development based on
Caucasian populations, and may not suitable to Asian population due to the differences in the
incidence and lifestyle of breast cancer patients from different ethic backgrounds. To fiil
this gap, an 18-gene classifier (18-GC) based on the gene-expression profiling of Chinese
breast cancer patients was developed
In the current study, investigators combined clinical variables and genetic information to
generate a clinical-genomic model: RI-DR, a recurrence index for distant recurrence (based on
a genomic model and 6 clinical variables: age, tumor size, lymph node status, estrogen
receptor status, lymphovascular invasion, tumor grading).
By using tissues that have been tested with ODx, in this study, investigators evaluated the
performance of the RI-DR model with that of the ODx assay in the prognosis assessment of a
cohort of patients from Taiwan.
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