Two validation studies confirm that the Oncotype DX Breast DCIS Score test determines the 10-year risk of local recurrence. These studies, involving 1,587 patients, also showed that clinicians could more accurately assess patient risk with the Breast DCIS Score test, than traditional assessment methods (such as clinical and pathologic factors or nomograms) alone.1-3 The Breast DCIS Score test is the first clinically-validated, commercially available genomic test for patients with DCIS.
the first clinically-validated, commercially available genomic test for patients with DCIS
About the studies
Two studies including a diverse patient population and data that is reflective of real-world clinical practice.
- The first study, ECOG E5194 , was a large, independent, multicenter clinical trial. The Breast DCIS Score test was validated in a cohort of 327 patients who were selected for observation after surgical excision. The study found that the Breast DCIS Score test provides individualized estimates of the 10-year risk of local recurrence in patients with DCIS treated by breast conserving surgery alone.1
- The second study, the Ontario DCIS cohort was a large community-based, real-world registry of 1,260 DCIS patients who had breast-conserving surgery, with or without radiation therapy (XRT), and negative margins. This study confirmed the results from the first validation study—finding that the DCIS Score result stratifies patients based on the risk of local recurrence.2,3
Finding summary
These studies confirmed that the DCIS Score result1-3:
- Reveals the 10-year risk of local recurrence in patients with DCIS who underwent breast-conserving surgery with or without XRT.
- Is significantly associated with risk of an invasive local recurrence.
- Is significantly associated with risk of a DCIS local recurrence.
Meta-Analysis of validation studies
A meta-analysis was conducted to provide refined estimates of local recurrence risk, combining data from the two validation studies and integrating the effect of patient age and tumor size.
This analysis showed4:
- DCIS Score result and clinicopathologic features (tumor size, age at diagnosis, and year of diagnosis) contribute to the prognostic value of the 10-year risk of local recurrence estimate.
- Only the DCIS Score result contributes significantly to the prognostic value of the 10-year risk of invasive local recurrence.
- Improved assessment of local recurrence risk with combined DCIS Score-tumor size-age vs. either DCIS Score alone or tumor size-age.
- Using DCIS Score with tumor size and age, more women at higher risk are identified.
- Using DCIS Score with tumor size and age, more women at lower risk are identified.
Identifies more patients with very low risk of local recurrence4*
| DCIS Score result with tumor size and age |
|
| DCIS Score result only |
| Tumor size and age only |
|
Percentage of Patients with Risk ≤ 8% |
Identifies more patients at higher risk of local recurrence4*
| DCIS Score result with tumor size and age |
|
| DCIS Score result only |
| Tumor size and age only |
|
Percentage of Patients with Risk > 15% |
*Meta-analysis prediction for 10-year local recurrence risk, adjusted for diagnosis year of 2000 or later.
These results aid in individualizing the treatment decision-making process for patients with DCIS.
In addition, two decision impact studies demonstrated that integration of the DCIS Score result changed treatment recommendations. The studies showed that clinicians changed their recommendations approximately 30% of the time.5,6
Clinical references
Publications
Multigene Expression Assay and Benefit of Radiotherapy After Breast Conservation in Ductal Carcinoma in Situ
Rakovitch E, Nofech-Mozes S, Hanna W, et al. J Natl Cancer Inst. 2017.
Clinical Utility of the 12-Gene DCIS Score Assay: Impact on Radiotherapy Recommendations for Patients with Ductal Carcinoma In Situ
Manders JB, Kuerer HM, Smith BD et al. Ann Surg Oncol. 2016.
The impact of genomic testing on the recommendation for radiation therapy in patients with ductal carcinoma in situ: A prospective clinical utility assessment of the 12-gene DCIS Score Result
Alvarado M, Carter DL, Guenther JM, et al. J Surg Oncol. 2015.
A Population-Based Validation Study of the DCIS Score Predicting Recurrence Risk in Individuals Treated by Breast-Conserving Surgery Alone
Rakovitch E, Nofech-Mozes S, Hanna W, et al. Breast Cancer Res Treat. 2015.
A Multigene Expression Assay to Predict Local Recurrence Risk for Ductal Carcinoma In Situ of the Breast
Solin LJ, Gray R, Baehner FL, et al. J Natl Cancer Inst. 2013.
Poster Presentations
Comparison of predicted ipsilateral tumor recurrence risks in patients with DCIS of the breast after breast-conserving surgery by prognostic tools and physicians
Leonard C, Lei R, Antell A, et al. SABCS 2016.
Refined estimates of local recurrence risks and the impact of the DCIS Score adjusting for clinic-pathological features: Meta-analysis of E5194 and Ontario DCIS Cohort studies
Rakovitch E, Gray R, Baehner, F et al. ASCO 2017.
*Meta-analysis prediction for 10-year local recurrence risk, adjusted for diagnosis year of 2000 or later.