Michael Alvarado1, Dennis L Carter2, J Michael Guenther3, James Hagans4, Rachel Y Lei2, Charles E Leonard5, Jennifer Manders6, Amy P Sing7, Michael S Broder8, Dasha Cherepanov8, Eunice Chang8, Marianne Eagan8, Wendy Hsiao9, Michael J Schultz10. 1. University of California, San Francisco, California. 2. Rocky Mountain Cancer Centers, Aurora, Colorado. 3. St. Elizabeth Healthcare, Edgewood, Kentucky. 4. The Surgical Center of Central Arkansas, Little Rock, Arkansas. 5. Rocky Mountain Cancer Centers, Littleton, Colorado. 6. The Christ Hospital, Cincinnati, Ohio. 7. Genomic Health, Inc., Redwood City, California. 8. Partnership for Health Analytic Research, LLC, Beverly Hills, California. 9. University of Southern California, Los Angeles, California. 10. University of Maryland St. Joseph Medical Center, Towson, Maryland.
Abstract
BACKGROUND AND OBJECTIVES: Twenty percent of breast cancers are ductal carcinoma in situ (DCIS), with 15-60% having a local recurrence (LR) after surgery. Radiotherapy reduces LR by 50% but has not impacted survival. The validated Oncotype DX(®) 12-gene assay (DCIS Score) provides individualized 10-year LR estimates. This is the first study to assess whether DCIS Score impacts physicians' recommendations for radiation. METHODS: Ten sites enrolled women (9/2012-2/2014) with DCIS eligible for breast-conserving therapy, excluding patients with invasive carcinoma and planned mastectomy. Prospective data collected included clinicopathologic factors, DCIS Score assay, and treatment recommendation before and after the assay result was known. RESULTS: In 115 patients (median age: 61 years; 74.8% postmenopausal), median DCIS size was 8 mm; 20% were nuclear grade 1, 46.1% grade 2; 64.4% reported necrosis. 86.1% were ER+, 79.1% PR+ (immunohistochemistry assay). Median DCIS Score: 29 (range: 0-85). Pre-assay, 73% (95%CI: 64.0-80.9%) had radiotherapy recommendations vs. 59.1% (95%CI: 49.6-68.2%) post-assay (P= 0.008). Physicians rated DCIS Score as the most impactful factor in planning treatment. CONCLUSIONS: The radiotherapy recommendation changed from pre-assay to post-assay 31.3% (95%CI: 23.0-40.6%) of the time--a clinically significant change. This study supports the clinical utility of the DCIS Score and indicates that the test provides additional, individualized information on LR risk.
BACKGROUND AND OBJECTIVES: Twenty percent of breast cancers are ductal carcinoma in situ (DCIS), with 15-60% having a local recurrence (LR) after surgery. Radiotherapy reduces LR by 50% but has not impacted survival. The validated Oncotype DX(®) 12-gene assay (DCIS Score) provides individualized 10-year LR estimates. This is the first study to assess whether DCIS Score impacts physicians' recommendations for radiation. METHODS: Ten sites enrolled women (9/2012-2/2014) with DCIS eligible for breast-conserving therapy, excluding patients with invasive carcinoma and planned mastectomy. Prospective data collected included clinicopathologic factors, DCIS Score assay, and treatment recommendation before and after the assay result was known. RESULTS: In 115 patients (median age: 61 years; 74.8% postmenopausal), median DCIS size was 8 mm; 20% were nuclear grade 1, 46.1% grade 2; 64.4% reported necrosis. 86.1% were ER+, 79.1% PR+ (immunohistochemistry assay). Median DCIS Score: 29 (range: 0-85). Pre-assay, 73% (95%CI: 64.0-80.9%) had radiotherapy recommendations vs. 59.1% (95%CI: 49.6-68.2%) post-assay (P= 0.008). Physicians rated DCIS Score as the most impactful factor in planning treatment. CONCLUSIONS: The radiotherapy recommendation changed from pre-assay to post-assay 31.3% (95%CI: 23.0-40.6%) of the time--a clinically significant change. This study supports the clinical utility of the DCIS Score and indicates that the test provides additional, individualized information on LR risk.
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Authors: Jennifer B Manders; Henry M Kuerer; Benjamin D Smith; Cornelia McCluskey; William B Farrar; Thomas G Frazier; Linna Li; Charles E Leonard; Dennis L Carter; Sheema Chawla; Lori E Medeiros; J Michael Guenther; Lauren E Castellini; Daniel J Buchholz; Eleftherios P Mamounas; Irene L Wapnir; Kathleen C Horst; Anees Chagpar; Suzanne B Evans; Adam I Riker; Faisal S Vali; Lawrence J Solin; Lisa Jablon; Abram Recht; Ranjna Sharma; Ruixiao Lu; Amy P Sing; E Shelley Hwang; Julia White Journal: Ann Surg Oncol Date: 2016-10-04 Impact factor: 5.344