A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast

Lawrence J. Solin, Robert Gray, Frederick L. Baehner, Steven M. Butler, Lorie L. Hughes, Carl Yoshizawa, Diana B. Cherbavaz, Steven Shak, David L. Page, George W. Sledge, Nancy E. Davidson, James N. Ingle, Edith A. Perez, William C. Wood, Joseph A. Sparano, Sunil Badve

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)701-710
Number of pages10
JournalJournal of the National Cancer Institute
Volume105
Issue number10
DOIs
StatePublished - May 15 2013

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Carcinoma, Intraductal, Noninfiltrating
Breast
Recurrence
Confidence Intervals
Radiation
Neoplasm Genes
Tamoxifen
Statistical Factor Analysis
Breast Neoplasms
Carcinoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Solin, L. J., Gray, R., Baehner, F. L., Butler, S. M., Hughes, L. L., Yoshizawa, C., ... Badve, S. (2013). A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast. Journal of the National Cancer Institute, 105(10), 701-710. https://doi.org/10.1093/jnci/djt067

A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast. / Solin, Lawrence J.; Gray, Robert; Baehner, Frederick L.; Butler, Steven M.; Hughes, Lorie L.; Yoshizawa, Carl; Cherbavaz, Diana B.; Shak, Steven; Page, David L.; Sledge, George W.; Davidson, Nancy E.; Ingle, James N.; Perez, Edith A.; Wood, William C.; Sparano, Joseph A.; Badve, Sunil.

In: Journal of the National Cancer Institute, Vol. 105, No. 10, 15.05.2013, p. 701-710.

Research output: Contribution to journalArticle

Solin, LJ, Gray, R, Baehner, FL, Butler, SM, Hughes, LL, Yoshizawa, C, Cherbavaz, DB, Shak, S, Page, DL, Sledge, GW, Davidson, NE, Ingle, JN, Perez, EA, Wood, WC, Sparano, JA & Badve, S 2013, 'A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast', Journal of the National Cancer Institute, vol. 105, no. 10, pp. 701-710. https://doi.org/10.1093/jnci/djt067
Solin, Lawrence J. ; Gray, Robert ; Baehner, Frederick L. ; Butler, Steven M. ; Hughes, Lorie L. ; Yoshizawa, Carl ; Cherbavaz, Diana B. ; Shak, Steven ; Page, David L. ; Sledge, George W. ; Davidson, Nancy E. ; Ingle, James N. ; Perez, Edith A. ; Wood, William C. ; Sparano, Joseph A. ; Badve, Sunil. / A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast. In: Journal of the National Cancer Institute. 2013 ; Vol. 105, No. 10. pp. 701-710.
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abstract = "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.",
author = "Solin, {Lawrence J.} and Robert Gray and Baehner, {Frederick L.} and Butler, {Steven M.} and Hughes, {Lorie L.} and Carl Yoshizawa and Cherbavaz, {Diana B.} and Steven Shak and Page, {David L.} and Sledge, {George W.} and Davidson, {Nancy E.} and Ingle, {James N.} and Perez, {Edith A.} and Wood, {William C.} and Sparano, {Joseph A.} and Sunil Badve",
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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

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.

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