Clinical Practice Guidelines for Risk Assessment to Identify Women at High Risk of Breast Cancer: Chinese Society of Breast Surgery (CSBrS) Practice Guidelines 2021
Breast cancer remains the most prevalent malignancy among women in China, with approximately 304,000 new cases diagnosed in 2015 alone, accounting for 17.1% of all new cancers among women. Given the significant burden of breast cancer, there is a pressing need for standardized clinical practices to identify women at high risk of developing the disease. The Chinese Society of Breast Surgery (CSBrS) has developed comprehensive guidelines to address this need, focusing on risk assessment tools, genetic testing, and personalized risk reduction strategies. These guidelines aim to provide a reference for clinicians and public health service staff in China, ensuring that women at high risk receive appropriate screening and preventive interventions.
Population Under Consideration
The CSBrS guidelines emphasize the importance of risk assessment for specific populations. The primary target group includes asymptomatic women aged 35 years and older who have no current or previous diagnosis of breast cancer or ductal carcinoma in situ (DCIS). This recommendation is based on the understanding that early identification of high-risk individuals can lead to timely interventions that may reduce the likelihood of developing breast cancer. Additionally, women with a history of atypical hyperplasia or lobular carcinoma in situ are also considered candidates for risk assessment. These conditions are recognized as significant risk predictors rather than precancerous diseases, underscoring the need for vigilant monitoring and risk management in these individuals.
Assessment Tools
To identify women at high risk of breast cancer, the CSBrS guidelines recommend the use of validated risk assessment tools. The Gail Model, a widely used statistical method, is one such tool. It predicts the individual probability of developing breast cancer over the next 5 or 10 years or a lifetime. However, the Gail Model was initially developed for white women and may overestimate the risk for Asian women, including Chinese women. To address this limitation, the CSBrS guidelines highlight the availability of an online risk assessment tool specifically designed for Chinese women. This tool incorporates risk factors such as age, history of benign breast tumors, diabetes, residence, body mass index, life satisfaction score, and the number of abortions. The online tool has demonstrated a higher level of discriminatory accuracy compared to other models, with C statistic values of 0.73 and 0.72 in development and validation populations, respectively. This tool is accessible to the public, providing a user-friendly platform for risk assessment.
Genetic Testing for BRCA1/2 Mutations
Genetic testing for BRCA1 and BRCA2 mutations is a critical component of breast cancer risk assessment, particularly for women with a family history of the disease. The CSBrS guidelines recommend that women with a likelihood of inherited predisposition to breast cancer based on personal or family history should be offered genetic counseling. This counseling is essential to guide decision-making regarding genetic testing. The guidelines specify that priority for genetic testing should be given to cancer patients within the family (index cases), as this can provide valuable information for other family members.
The indications for genetic testing include confirmed carriers of harmful BRCA1/2 mutations among close family members, multiple cases of breast cancer in the family, male family members with breast cancer, close family members diagnosed with breast cancer before age 50, and close family members with two primary types of BRCA-related cancer (such as ovarian and breast cancer) or two primary tumors (such as bilateral or multifocal/multicentric breast cancer). The prevalence of BRCA1 or BRCA2 mutations among women diagnosed with sporadic breast cancer in China is 5.37%, and carriers of these mutations have a significantly higher probability of developing breast cancer before age 79 compared to the general population.
Risk Stratification and Personalized Interventions
The primary goal of breast cancer risk assessment is to distinguish individuals at greater risk from those with average risk, enabling personalized risk reduction strategies. The CSBrS guidelines acknowledge that there is no single cutoff for defining increased absolute risk of breast cancer for all women worldwide. However, the modified Gail Model sets a risk threshold of at least 1.67% for the 5-year risk of breast cancer. While this model has been adapted for Asian and Pacific Islander women, its applicability to Chinese women remains limited due to differences in population reference standards.
To address this gap, the CSBrS experts reviewed several risk stratification models developed for Chinese women. These models, which include predictors such as age, history of benign breast tumors, diabetes, residence, body mass index, life satisfaction score, and number of abortions, have shown modest discriminatory accuracy. However, one model demonstrated superior performance, with C statistic values of 0.73 and 0.72 in development and validation populations, respectively. This model forms the basis of the online risk assessment tool recommended by the CSBrS.
Considerations for Risk-Reducing Interventions
The CSBrS guidelines emphasize that risk assessment should be repeated when there is a significant change in breast cancer risk factors, such as a new diagnosis of breast disease in a family member or a change in lifestyle. However, the guidelines do not provide specific recommendations on risk-reducing medications for women with increased risk of breast cancer, as evidence specific to Chinese populations is still lacking. Instead, clinicians are encouraged to consider additional factors and engage in discussions with women undergoing risk assessment to address the aims of assessment, limitations of the current evidence, and potential risk-reducing interventions.
Psychological counseling is also recommended for women identified as being at high risk of breast cancer. This counseling aims to minimize the psychological distress associated with risk status and to provide support for women as they navigate the complexities of risk assessment and potential interventions.
Conclusion
The CSBrS guidelines for breast cancer risk assessment provide a comprehensive framework for identifying women at high risk of developing the disease. By incorporating validated risk assessment tools, genetic testing for BRCA1/2 mutations, and personalized risk reduction strategies, these guidelines aim to improve early detection and prevention efforts in China. The guidelines also highlight the need for further research to develop risk assessment tools and interventions specifically tailored to Chinese women. Clinicians and public health service staff are encouraged to use these guidelines as a reference in their practice, ensuring that women at high risk of breast cancer receive the care and support they need.
doi.org/10.1097/CM9.0000000000001502
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