Abstract
BACKGROUND: The Gail model is the most well-known tool for breast cancer risk assessment worldwide. Although it was validated in various Western populations, inconsistent results were reported from Asian populations. We used data from a large case-control study and evaluated the discriminatory accuracy of the Gail model for breast cancer risk assessment among the Iranian female population. METHODS: We used data from 942 breast cancer patients and 975 healthy controls at the Cancer Institute of Iran, Tehran, Iran, in 2016. We refitted the Gail model to our case-control data (the IR-Gail model). We compared the discriminatory power of the IR-Gail with the original Gail model, using ROC curve analyses and estimation of the area under the ROC curve (AUC). RESULTS: Except for the history of biopsies that showed an extremely high relative risk (OR=9.1), the observed ORs were similar to the estimates observed in Gail's study. Incidence rates of breast cancer were extremely lower in Iran than in the USA, leading to a lower average absolute risk among the Iranian population (2.78, ±SD 2.45). The AUC was significantly improved after refitting the model, but it remained modest (0.636 vs. 0.627, ΔAUC = 0.009, bootstrapped P=0.008). We reported that the cut-point of 1.67 suggested in the Gail study did not discriminate between breast cancer patients and controls among the Iranian female population. CONCLUSION: Although the coefficients from the local study improved the discriminatory accuracy of the model, it remained modest. Cohort studies are warranted to evaluate the validity of the model for Iranian women.