TY - JOUR
T1 - A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast
AU - Solin, Lawrence J.
AU - Gray, Robert
AU - Baehner, Frederick L.
AU - Butler, Steven M.
AU - Hughes, Lorie L.
AU - Yoshizawa, Carl
AU - Cherbavaz, Diana B.
AU - Shak, Steven
AU - Page, David L.
AU - Sledge, George W.
AU - Davidson, Nancy E.
AU - Ingle, James N.
AU - Perez, Edith A.
AU - Wood, William C.
AU - Sparano, Joseph A.
AU - Badve, Sunil
N1 - Funding Information:
This work was supported in part by Public Health Service Grants CA23318, CA66636, CA21115, CA13650, CA49883, CA49957, CA39229, CA25224, and CA14958, and by the National Cancer Institute, the National Institutes of Health, and the Department of Health and Human Services. Other supporting grants include Genomic Health, Inc. and The Breast Cancer Research Foundation.
PY - 2013/5/15
Y1 - 2013/5/15
N2 - Background For women with ductal carcinoma in situ (DCIS) of the breast, the risk of developing an ipsilateral breast event (IBE; defined as local recurrence of DCIS or invasive carcinoma) after surgical excision without radiation is not well defined by clinical and pathologic characteristics. Methods The Oncotype DX breast cancer assay was performed for patients with DCIS treated with surgical excision without radiation in the Eastern Cooperative Oncology Group (ECOG) E5194 study. The association of the prospectively defined DCIS Score (calculated from seven cancer-related genes and five reference genes) with the risk of developing an IBE was analyzed using Cox regression. All statistical tests were two-sided. Results There were 327 patients with adequate tissue for analysis. The continuous DCIS Score was statistically significantly associated with the risk of developing an IBE (hazard ratio [HR] = 2.31, 95% confidence interval [CI] = 1.15 to 4.49; P =. 02) when adjusted for tamoxifen use (prespecified primary analysis) and with invasive IBE (unadjusted HR = 3.68, 95% CI = 1.34 to 9.62; P =. 01). For the prespecified DCIS risk groups of low, intermediate, and high, the 10-year risks of developing an IBE were 10.6%, 26.7%, and 25.9%, respectively, and for an invasive IBE, 3.7%, 12.3%, and 19.2%, respectively (both log rank P ≤. 006). In multivariable analyses, factors associated with IBE risk were DCIS Score, tumor size, and menopausal status (all P ≤. 02). Conclusions The DCIS Score quantifies IBE risk and invasive IBE risk, complements traditional clinical and pathologic factors, and provides a new clinical tool to improve selecting individualized treatment for women with DCIS who meet the ECOG E5194 criteria.
AB - Background For women with ductal carcinoma in situ (DCIS) of the breast, the risk of developing an ipsilateral breast event (IBE; defined as local recurrence of DCIS or invasive carcinoma) after surgical excision without radiation is not well defined by clinical and pathologic characteristics. Methods The Oncotype DX breast cancer assay was performed for patients with DCIS treated with surgical excision without radiation in the Eastern Cooperative Oncology Group (ECOG) E5194 study. The association of the prospectively defined DCIS Score (calculated from seven cancer-related genes and five reference genes) with the risk of developing an IBE was analyzed using Cox regression. All statistical tests were two-sided. Results There were 327 patients with adequate tissue for analysis. The continuous DCIS Score was statistically significantly associated with the risk of developing an IBE (hazard ratio [HR] = 2.31, 95% confidence interval [CI] = 1.15 to 4.49; P =. 02) when adjusted for tamoxifen use (prespecified primary analysis) and with invasive IBE (unadjusted HR = 3.68, 95% CI = 1.34 to 9.62; P =. 01). For the prespecified DCIS risk groups of low, intermediate, and high, the 10-year risks of developing an IBE were 10.6%, 26.7%, and 25.9%, respectively, and for an invasive IBE, 3.7%, 12.3%, and 19.2%, respectively (both log rank P ≤. 006). In multivariable analyses, factors associated with IBE risk were DCIS Score, tumor size, and menopausal status (all P ≤. 02). Conclusions The DCIS Score quantifies IBE risk and invasive IBE risk, complements traditional clinical and pathologic factors, and provides a new clinical tool to improve selecting individualized treatment for women with DCIS who meet the ECOG E5194 criteria.
UR - http://www.scopus.com/inward/record.url?scp=84877950429&partnerID=8YFLogxK
U2 - 10.1093/jnci/djt067
DO - 10.1093/jnci/djt067
M3 - Article
C2 - 23641039
AN - SCOPUS:84877950429
SN - 0027-8874
VL - 105
SP - 701
EP - 710
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
IS - 10
ER -