USPSTF Guidance: When to Use Medication to Reduce Breast Cancer Risk
Both USPSTF and ASCO have released guidance on the use of medications to reduce breast cancer risk in women who meet a certain risk threshold. The USPSTF guidance (2019) is in alignment with ASCO in the recommendation of aromatase inhibitors, along with tamoxifen and raloxifene, as drugs suitable for use as risk-reducing medications for women at increased risk for breast cancer and at low risk for adverse medication effect (Grade B – offer or provide this service).
All patients should initially be assessed to determine if they are at high risk for breast cancer and if so, appropriate referral should be considered in the following circumstances
Personal history of breast cancer, LCIS or DCIS
Personal history of mantle radiation for Hodgkin’s lymphoma
Personal or family history suggestive of high risk for pathogenic variants in BRCA1, BRCA2 and other high or intermediate risk genes that may cause heritable cancer syndromes
If patients do not meet the above high risk criteria, an absolute 5 year risk score can be calculated using a validated assessment tool (see ‘Learn More – Primary Sources’ below; both publicly available)
Gail or Breast Cancer Surveillance Consortium (BCSC) Risk Calculator for women who are ≥ 35 years of age are validated 5-year risk assessment tools
BCSC Risk Calculator includes field for breast density
Alternatives to the above as per the USPSTF, clinicians may consider a combination of risk factors including (but not limited to)
Age 65 years or older with 1 first-degree relative with breast cancer
45 years or older with more than 1 first-degree relative with breast cancer or 1 first-degree relative who developed breast cancer before age 50 years
40 years or older with a first-degree relative with bilateral breast cancer
Presence of atypical ductal or lobular hyperplasia or lobular carcinoma in situ on a prior biopsy.
Based on data review, the USPSTF and ASCO determined that certain medications have the potential to reduce the risk of estrogen receptor positive breast cancer by almost 50% in women above a certain 5-year risk threshold cut-off (see thresholds below). An individualized approach which integrates personal and family medical history is used to determine the best risk reduction approach.
5-year risk threshold cut-offs:
USPSTF recommends 3% (1/33) risk of breast cancer in next 5 years
ASCO recommends 1.66% (1/60) risk of breast cancer in the next 5 years
Medication options recommended by the USPSTF include
Tamoxifen, raloxifene, and aromatase inhibitors all reduce primary breast cancer risk in postmenopausal women
Use of raloxifene and aromatase inhibitors is indicated only in postmenopausal women
Only tamoxifen is indicated for risk-reduction of primary breast cancer in premenopausal women
SERMs such as Tamoxifen and Raloxifene can significantly reduce risk of ‘estrogen receptor positive’ breast cancer
Aromatase inhibitors are also appropriate
NCCN: Risk-reduction agents for women age ≥35 years and older
Tamoxifen for premenopausal women only
Tamoxifen, raloxifene, anastrozole, or exemestane may be used in postmenopausal women
ACOG: Tamoxifen and raloxifene may be considered for risk reduction of breast cancer in women with BRCA genetic mutations
Raloxifene only in postmenopausal women
Aromatase an alternative in women who cannot use tamoxifen
Monitor women on tamoxifen for endometrial hyperplasia (see ‘Related ObG Topics’ below)
AAFP: Supports the USPSTF recommendation
5-year risk assessment is not appropriate as an initial assessment in high risk families
Referral to genetic counseling should be made if there is a significant family history of cancers including non-breast malignancies, such as colon, ovarian and uterine
Paternal family history of breast and other cancers is critical in this setting and requires a multiple generation pedigree analysis
See “USPSTF Guidelines for Primary Care Clinicians: BRCA-Related Cancer Risk Assessment” in Related ObG Topics below
USPSTF recommends against the use of medications to reduce breast cancer risk in women ≥ 35 who are not at increased risk (Grade D – discourage the use of this service)
Harms Associated with Risk Reduction Medications
Tamoxifen and raloxifene are associated with small to moderate harms
Increased risk for VTE
Tamoxifen > raloxifene | Greater risk in older women
Tamoxifen increases risk for endometrial cancer (not raloxifene)
Hot flashes common with both
Aromatase inhibitors are associated with small to moderate harms including
Hot flashes | GI symptoms | MSK pain | Possible cardiovascular events (e.g., stroke)
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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