Reassessing the Benefits and Harms of Risk-Reducing Medication Considering the Persistent Risk of Breast Cancer Mortality in Estrogen Receptor–Positive Breast Cancer

Author:

Jayasekera Jinani1ORCID,Zhao Amy2,Schechter Clyde3ORCID,Lowry Kathryn4ORCID,Yeh Jennifer M.5ORCID,Schwartz Marc D.2ORCID,O'Neill Suzanne2ORCID,Wernli Karen J.6ORCID,Stout Natasha7ORCID,Mandelblatt Jeanne2ORCID,Kurian Allison W.8ORCID,Isaacs Claudine2ORCID

Affiliation:

1. Population and Community Health Sciences Branch, Intramural Research Program, National Institute on Minority Health and Health Disparities, National Institutes of Health, Bethesda, MD

2. Department of Oncology, Georgetown University Medical Center and Cancer Prevention and Control Program, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC

3. Departments of Family and Social Medicine and Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY

4. Department of Radiology, University of Washington, Seattle Cancer Care Alliance, Seattle, WA

5. Department of Pediatrics, Harvard Medical School, Boston Children's Hospital, Boston, MA

6. Kaiser Permanente Washington Health Research Institute, Seattle, WA

7. Department of Population Medicine, Harvard Medical School, Harvard Pilgrim Healthcare Institute, Boston, MA

8. Departments of Medicine and of Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA

Abstract

PURPOSE Recent studies, including a meta-analysis of 88 trials, have shown higher than expected rates of recurrence and death in hormone receptor–positive breast cancer. These new findings suggest a need to re-evaluate the use of risk-reducing medication to avoid invasive breast cancer and breast cancer death in high-risk women. METHODS We adapted an established Cancer Intervention and Surveillance Modeling Network model to evaluate the lifetime benefits and harms of risk-reducing medication in women with a ≥ 3% 5-year risk of developing breast cancer according to the Breast Cancer Surveillance Consortium risk calculator. Model input parameters were derived from meta-analyses, clinical trials, and large observational data. We evaluated the effects of 5 years of risk-reducing medication (tamoxifen/aromatase inhibitors) with annual screening mammography ± magnetic resonance imaging (MRI) compared with no screening, MRI, or risk-reducing medication. The modeled outcomes included invasive breast cancer, breast cancer death, side effects, false positives, and overdiagnosis. We conducted subgroup analyses for individual risk factors such as age, family history, and prior biopsy. RESULTS Risk-reducing tamoxifen with annual screening (± MRI) decreased the risk of invasive breast cancer by 40% and breast cancer death by 57%, compared with no tamoxifen or screening. This is equivalent to an absolute reduction of 95 invasive breast cancers, and 42 breast cancer deaths per 1,000 high-risk women. However, these drugs are associated with side effects. For example, tamoxifen could increase the number of endometrial cancers up to 11 per 1,000 high-risk women. Benefits and harms varied by individual characteristics. CONCLUSION The addition of risk-reducing medication to screening could further decrease the risk of breast cancer death. Clinical guidelines for high-risk women should consider integrating shared decision making for risk-reducing medication and screening on the basis of individual risk factors.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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