To determine if a genomic test can identify patients with hormone receptor-positive, HER2-negative early breast cancer who are most likely to benefit from anthracycline-containing chemotherapy.
Approach:
Study Design: Analysis of real-world data from 1,259 patients in the FLEX registry with stage I–III disease, requiring high-risk results on the MammaPrint 70-gene assay and a Luminal B tumor profile on the BluePrint 80-gene test.
Treatment Comparison: Patients received either an anthracycline- and taxane-based regimen or a taxane/cyclophosphamide regimen after surgery.
Key Findings:
High-risk category was not uniform; High Risk 2 patients had better invasive disease-free survival with anthracycline treatment.
High Risk 1 patients had similar outcomes regardless of anthracycline inclusion.
Standard clinical features did not distinguish patients benefiting from anthracyclines.
Interpretation:
The study illustrates the value of genomic profiling in predicting benefit from specific cancer therapies.
Limitations:
Analysis based on an observational registry with a median follow-up of just over three years.
Statistical methods were used to reduce treatment-selection bias, but further validation is needed.
Conclusion:
Additional validation, including analyses from randomized clinical trials, will be necessary before broader clinical adoption.
Researchers reported that an artificial intelligence workflow maintained high interpretive accuracy while reducing urine drug test sign-out time in a supervised clinical laboratory setting.