- Tamoxifen and raloxifene:
- Reduce the risk of invasive breast cancer in high-risk women when compared to placebo:
- But are associated with increased vasomotor symptoms
- In the NSABP P-2 / STAR trial:
- When compared to raloxifene, tamoxifen use:
- Resulted in higher rates of:
- Uterine cancer:
- 2 / 1000 vs. 1.5 / 1000
- Deep vein thrombosis:
- 2.29 / 1000 vs 1.69 / 1000
- Pulmonary embolism:
- 1.41 / 1000 vs. 0.96 / 1000
- Uterine cancer:
- Resulted in higher rates of:
- When compared to raloxifene, tamoxifen use:
- Use of concomitant hormone replacement therapy with tamoxifen or raloxifene:
- Was not allowed in the STAR trial:
- Is discouraged in the 2013 American Society of Clinical Oncology chemoprevention guidelines
- Was not allowed in the STAR trial:
- Reduce the risk of invasive breast cancer in high-risk women when compared to placebo:
- Aromatase inhibitors:
- Are not associated with a risk of thrombosis
- In the MAP.3 prevention trial:
- Exemestane significantly reduced the incidence of invasive breast cancer:
- Was not associated with serious adverse effects
- Resulted in only minimal changes in health-related quality of life
- However, it is not FDA-approved for chemoprevention of breast cancer:
- But can be used in an off-label manner
- Exemestane significantly reduced the incidence of invasive breast cancer:
- Decision tables weighing the risks and benefits of chemoprevention agents are available:
- Can identify the most appropriate drug with the fewest side effects for each individual patient
- Compliance with chemoprevention varies by the agent used:
- In the MAP.3 trial
- 85% of enrolled women were compliant with exemestane,
- Whereas in the NSABP P-1 trial:
- 76% of women with compliant with tamoxifen
- In the MAP.3 trial
- In clinical practice:
- Overall compliance with chemoprevention is even lower:
- With a study by Flanagan and colleagues:
- Reporting a 61% rate of completion of planned chemoprevention in high-risk patients.
- With a study by Flanagan and colleagues:
- Overall compliance with chemoprevention is even lower:
- References:
- Visvanathan K, Hurley P, Bantug E, Brown P, Col NF, Cuzick J, et al. Use of pharmacologic interventions for breast cancer risk reduction: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2013;31(23):2942-2962.
- Freedman AN, Yu B, Gail MH, Costantino JP, Graubard BI, Vogel VG, et al. Benefit/risk assessment for breast cancer chemoprevention with raloxifene or tamoxifen for women age 50 years or older. J Clin Oncol.2011;29(17):2327-2333.
- Goss PE, Ingle JN, Ales-Martinez JE, Cheung AM, Chlebowski RT, Wactawski-Wende J, et al. Exemestane for breast-cancer prevention in postmenopausal women. N Engl J Med. 2011;364(25):2381-2391.
- Nelson HD, Fu R, Humphrey L, et al. Comparative Effectiveness of Medications To Reduce Risk of Primary Breast Cancer in Women[Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2009 Sep. (AHRQ Comparative Effectiveness Reviews, No. 17.)
- Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998;90(18):1371-1388.
- Flanagan MR, Zabor EC, Stempel M, Mangino DA, Morrow M, Pilewskie ML. Chemoprevention Uptake for Breast Cancer Risk Reduction Varies by Risk Factor. Ann Surg Oncol. 2019;26(7):2127-2135.
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Rodrigo Arrangoiz MS, MD, FACS, FSSO 