SERM Data

Question 1

NSABP-1 cohort

Answer 1

Fisher et.al 1998
13, 388 patients (at risk for BC ==>
>60 y/o
35-59 w/ 5-years predicted risk 1.66^ on Gail MOdel
history of LCIS

Question 2

NSABP-1 Intervention

Answer 2

Randomized: placebo vs tamoxifen x 5 years

Question 3

NSABP-1 Results

Answer 3

Tamoxifen

• RRR 49% invasive BC
• RRR 50% noninvasive BC
• No significant difference in absolute risk reduction 2% (placebo) & 0.9% (tamoxifen)
• Increased Stage I uterine cancer (HR=2.58)

Greatest benefits for ADH (4-5x)

Question 4

NSABP-P2 STAR cohort

Answer 4

19.472 patients (vogel et. al. 2006)

post-menopausal women at increased risk of breast cancer

Question 5

NSABP-P2 STAR intervention

Answer 5

Tamoxifen 20mg qd v Raloxifene 60mg qd for 5 years

Question 6

NSAB-P2 STAR results

Answer 6

Invasive breast CA (same, 0.4%)

Tamoxifen: fewer nonivasive cases (DCIS/LCIS) (0.15 v 0.21%)

Raloxifene: reduced risk of uterine cancer (0.7 –> 0.5%)),
cataracts,
thromboembolic events

Same # of complications: osteoporotic fractures, other cancers, stroke, and heart disease;