Eileen Rakovitch1,2, Sameer Parpia3, Anne Koch4, Laval Grimard5, Hany Soliman6, Christiaan Stevens7, Francisco Perera8, Iwa Kong3, Senti Senthelal9, Margaret Anthes10, Ericka Wiebe11, Jeffrey Cao12, Mira Goldberg3, Sally Smith13, Luciana Spadafora3, Timothy J Whelan14. 1. Sunnybrook Health Sciences Centre, University of Toronto, T Wing 2075 Bayview Avenue, Toronto, ON, Canada. eileen.rakovitch@sunnybrook.ca. 2. IC/ES, Toronto, ON, Canada. eileen.rakovitch@sunnybrook.ca. 3. Juravinski Cancer Centre, McMaster University, 699 Concession Street, Hamilton, ON, Canada. 4. Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada. 5. The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, Canada. 6. Sunnybrook Health Sciences Centre, University of Toronto, T Wing 2075 Bayview Avenue, Toronto, ON, Canada. 7. Royal Victoria Regional Health Centre, Barrie, ON, Canada. 8. London Regional Cancer Centre, University of Western Ontario, London, ON, Canada. 9. Trillium Health Partners, Mississauga, ON, Canada. 10. Thunder Bay Regional Health Sciences Centre, Thunder Bay, ON, Canada. 11. Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada. 12. Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada. 13. BC Cancer Agency, University of British Columbia, Victoria, BC, Canada. 14. Juravinski Cancer Centre, McMaster University, 699 Concession Street, Hamilton, ON, Canada. whelan@hhsc.ca.
Abstract
BACKGROUND: Identification of women with DCIS who have a very low risk of local recurrence risk (LRR) after breast-conserving surgery (BCS) is needed to de-escalate therapy. We evaluated the impact of 10-year LRR estimates after BCS, calculated by the integration of a 12-gene molecular expression assay (Oncotype Breast DCIS Score®) and clinicopathological features (CPFs), on its ability to change radiation oncologists' recommendations for RT after BCS for DCIS. METHODS: Prospective cohort study of women with DCIS treated with BCS. Eligibility criteria were as follows: age > 45 years, tumor ≤ 2.5 cm, and margins ≥ 1 mm. Radiation oncologists provided 10-year LRR estimates without RT and recommendation for RT pre- and post-assay. Primary outcome was change in RT recommendation. RESULTS: 217 patients were evaluable, with mean age = 63 years, mean tumor size = 1.1 cm, and mean DCIS Score = 32; 140 (64%) were in the low-risk (<39), 32 (15%) were in the intermediate-risk (39-54), and 45 (21%) were in the high-risk groups (≥55). The assay led to a change in treatment recommendation in 76 (35.2%) (95%CI 29.1-41.8%) patients. RT recommendations decreased from 79% pre-assay to 50% post-assay (difference = 29%; 95%CI 22-35%) due to a significant increase in the proportion of patients with a predicted low LRR (< 10%) post-assay and recommendations to omit RT for those with a low predicted risk. The assay was associated with improved patient satisfaction and reduced decisional conflict. CONCLUSION: The DCIS Score assay combined with CPFs identified more women with an estimated low (<10%) 10-yr LR risk after BCS, leading to a significant decrease in recommendations for RT compared to estimates based on CPFs alone.
BACKGROUND: Identification of women with DCIS who have a very low risk of local recurrence risk (LRR) after breast-conserving surgery (BCS) is needed to de-escalate therapy. We evaluated the impact of 10-year LRR estimates after BCS, calculated by the integration of a 12-gene molecular expression assay (Oncotype Breast DCIS Score®) and clinicopathological features (CPFs), on its ability to change radiation oncologists' recommendations for RT after BCS for DCIS. METHODS: Prospective cohort study of women with DCIS treated with BCS. Eligibility criteria were as follows: age > 45 years, tumor ≤ 2.5 cm, and margins ≥ 1 mm. Radiation oncologists provided 10-year LRR estimates without RT and recommendation for RT pre- and post-assay. Primary outcome was change in RT recommendation. RESULTS: 217 patients were evaluable, with mean age = 63 years, mean tumor size = 1.1 cm, and mean DCIS Score = 32; 140 (64%) were in the low-risk (<39), 32 (15%) were in the intermediate-risk (39-54), and 45 (21%) were in the high-risk groups (≥55). The assay led to a change in treatment recommendation in 76 (35.2%) (95%CI 29.1-41.8%) patients. RT recommendations decreased from 79% pre-assay to 50% post-assay (difference = 29%; 95%CI 22-35%) due to a significant increase in the proportion of patients with a predicted low LRR (< 10%) post-assay and recommendations to omit RT for those with a low predicted risk. The assay was associated with improved patient satisfaction and reduced decisional conflict. CONCLUSION: The DCIS Score assay combined with CPFs identified more women with an estimated low (<10%) 10-yr LR risk after BCS, leading to a significant decrease in recommendations for RT compared to estimates based on CPFs alone.
Entities:
Keywords:
Assay; DCIS; De-escalation; Ductal carcinoma in situ; Genomic; Radiotherapy
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