Originally published as JCO Early Release 10.1200/JCO.2007.14.8833 on October 14 2008

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Assessment of the Accuracy of the Gail Model in Women With Atypical Hyperplasia

V. Shane Pankratz, Lynn C. Hartmann, Amy C. Degnim, Robert A. Vierkant, Karthik Ghosh, Celine M. Vachon, Marlene H. Frost, Shaun D. Maloney, Carol Reynolds, Judy C. Boughey

From the Divisions of Biostatistics, Medical Oncology, General Surgery, Internal Medicine, Epidemiology, and Anatomic Pathology, Mayo Clinic, Rochester, MN

Corresponding author: Lynn C. Hartmann, MD, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: hartmann.lynn{at}mayo.edu

Purpose An accurate estimate of a woman's breast cancer risk is essential for optimal patient counseling and management. Women with biopsy-confirmed atypical hyperplasia of the breast (atypia) are at high risk for breast cancer. The Gail model is widely used in these women, but has not been validated in them.

Patients and Methods Women with atypia were identified from the Mayo Benign Breast Disease (BBD) cohort (1967 to 1991). Their risk factors for breast cancer were obtained, and the Gail model was used to predict 5-year–and follow-up–specific risks for each woman. The predicted and observed numbers of breast cancers were compared, and the concordance between individual risk levels and outcomes was computed.

Results Of the 9,376 women in the BBD cohort, 331 women had atypia (3.5%). At a mean follow-up of 13.7 years, 58 of 331 (17.5%) patients had developed invasive breast cancer, 1.66 times more than the 34.9 predicted by the Gail model (95% CI, 1.29 to 2.15; P < .001). For individual women, the concordance between predicted and observed outcomes was low, with a concordance statistic of 0.50 (95% CI, 0.44 to 0.55).

Conclusion The Gail model significantly underestimates the risk of breast cancer in women with atypia. Its ability to discriminate women with atypia into those who did and did not develop breast cancer is limited. Health care professionals should be cautious when using the Gail model to counsel individual patients with atypia.

published online ahead of print at www.jco.org on October 13, 2008

Supported by DOD Center of Excellence Grant No. FEDDAMD17-02-1-0473-1; R01 CA46332, Susan G. Komen Breast Cancer Foundation Grant No. BCTR99-3152, Regis Foundation for Breast Cancer Research, and Fred C. and Katherine B. Andersen Foundation.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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Related Correspondence

• Underestimation of Risk by Gail Model Extends Beyond Women With Atypical Hyperplasia
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  JCO 2009 27: 1526 [Full Text]

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				E. Amir and O. Freedman Underestimation of Risk by Gail Model Extends Beyond Women With Atypical Hyperplasia J. Clin. Oncol., March 20, 2009; 27(9): 1526 - 1526. [Full Text] [PDF]

				J. C. Boughey, L. C. Hartmann, and V. S. Pankratz In Reply J. Clin. Oncol., March 20, 2009; 27(9): 1527 - 1527. [Full Text] [PDF]