Prevention
Jose Pacheco MD
Goss et al.
Randomized, placebo-controlled, double-blind trial
Population -> post-menopausal women, at least 35 years of age or older with at least one of
the following: Age 60 years or older, Gail 5 year risk score greater than 1.66%, prior atypical
ductal or lobular hyperplasia or lobular carcinoma in situ, or DCIS with mastectomy.
N = 4560
Group 1
Exemestane
Annual incidence of invasive breast cancer -> 0.19%, HR 0.35, p = 0.002
Annual incidence of invasive + non-invasive breast cancers -> 0.35%, HR 0.47, p = 0.004
Adverse events 88%, p = 0.003
Group 2
Placebo
Annual incidence of invasive breast cancer -> 0.55%
Annual incidence of invasive + non-invasive breast cancers -> 0.77%
Adverse events 85%
ATAC group
Median follow-up period 47 months
Endpoints -> DFS, TTR, CLBC
Population -> adjuvant treatment of post-menopausal women with early stage breast cancer
Group 1
Anastrozole
Less frequent -> endometrial cancer, vaginal bleeding or discharge, cerebrovascular events, venous
thromboembolic events, hot flashes
More frequent -> musculoskeletal disorders and fractures
4 year DFS 86.9%, HR 0.86, p = 0.03
Benefit greater for those with HR positive tumors -> HR 0.82, p = 0.014
Group 2
Tamoxifen
4 year DFS 84.5%
Cuzick et al.
Population -> 7145 women ages 35 to 70 and at increased risk of
breast cancer
Group 1, n = 3579
Tamoxifen 20 mg/d for 5 years
Risk of invasive breast cancer HR 0.73, p = 0.004
No difference for ER negative tumors HR 1.00
Significant difference for ER positive tumors HR 0.66
Group 2, n = 3575
Placebo for 5 years
Fisher et al.
Population -> 13,388 women were randomly assigned to
receive placebo or tamoxifen for 5 years
Group 1
Tamoxifen
Rate of invasive breast cancer HR 0.57
Rate of non-invasive breast cancer HR 0.63
Rate of osteoporotic fractures HR 0.68
Group 2
Placebo
Fisher et al.
Population -> 13,388 women who were at increased risk for breast cancer
60 years of age or older
35-50 years of age with a 5 year predicted risk of at least 1.66%
History of lobular carcinoma in situ
Group 1, n = 6681
Group 2, n = 6706
Placebo
Vogel et al.
81 month median follow-up
Group 1
Tamoxifen 20 mg/d for 5 years
Group 2
Hartmann et al.
Retrospective study
Population -> women with a family history of breast cancer
who underwent prophylactic mastectomy
639 women (214 at high risk and 425 at moderate risk)
HR for breast cancer in moderate risk group -> HR 0.10, p < 0.001
HR for breast cancer in the high risk group -> HR 0.10
Control -> sisters of high risk probands who did not undergo
prophylactic mastectomy and Gail model in the patient
population
Median length of follow-up was 14 years
Domcheck et al.
Prospective, multi-center, cohort study
Population -> 2482 women who tested positive for BRCA1 or BRCA2
Risk reducing mastectomy
N = 257
No breast cancers diagnosed in this population (compared to 7% without)
Outcomes -> breast and ovarian cancer risk, cancer specific and overall mortality
Domcheck et al.