Pankratz V Shane, Hartmann Lynn C, Degnim Amy C, Vierkant Robert A, Ghosh Karthik, Vachon Celine M, Frost Marlene H, Maloney Shaun D, Reynolds Carol, Boughey Judy C
Division of Biostatistics, Medical Oncology, General Surgery, Internal Medicine, Epidemiology, and Anatomic Pathology, Mayo Clinic, Rochester, MN 55905, USA.
J Clin Oncol. 2008 Nov 20;26(33):5374-9. doi: 10.1200/JCO.2007.14.8833. Epub 2008 Oct 14.
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.
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.
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).
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.
准确评估女性患乳腺癌的风险对于最佳的患者咨询和管理至关重要。经活检证实患有乳腺非典型增生（异型增生）的女性患乳腺癌的风险很高。盖尔模型在这些女性中被广泛使用，但尚未在她们身上得到验证。
从梅奥良性乳腺疾病（BBD）队列（1967年至1991年）中识别出患有异型增生的女性。获取她们患乳腺癌的风险因素，并使用盖尔模型预测每位女性5年及随访期间的特定风险。比较预测的和观察到的乳腺癌病例数，并计算个体风险水平与结果之间的一致性。
在BBD队列的9376名女性中，331名女性患有异型增生（3.5%）。平均随访13.7年时，331名患者中有58名（17.5%）发生了浸润性乳腺癌，是盖尔模型预测的34.9例的1.66倍（95%CI，1.29至2.15；P<.001）。对于个体女性，预测结果与观察结果之间的一致性较低，一致性统计量为0.50（95%CI，0.44至0.55）。
盖尔模型显著低估了患有异型增生女性患乳腺癌的风险。它区分患有异型增生且患乳腺癌和未患乳腺癌女性的能力有限。医疗保健专业人员在使用盖尔模型为患有异型增生的个体患者提供咨询时应谨慎。
