- NSABP B-14:
- Randomized patients after surgery to:
- Five years of tamoxifen or
- 5 years of placebo:
- To determine if there was a:
- Significant survival advantage with the addition of endocrine therapy to:
- ER-positive tumors
- Significant survival advantage with the addition of endocrine therapy to:
- To determine if there was a:
- After 10 years of follow-up:
- A statistically significant DFS benefit was derived:
- With the use of tamoxifen for 5 years:
- 69% vs 57%
- P<0.0001
- 69% vs 57%
- With the use of tamoxifen for 5 years:
- With a 37% reduction:
- In the rate of contralateral breast cancer (P=0.007)
- The most recent update of this trial:
- Continues to demonstrate this survival benefit at 15 years:
- Irrespective of age
- Menopausal status, and
- Tumor ER concentration
- Continues to demonstrate this survival benefit at 15 years:
- A follow-up question to protocol B-14:
- Asked the recommended duration of tamoxifen therapy beyond 5 years:
- The same patient population was then re-randomized to:
- Five additional years of tamoxifen or
- Five years of placebo
- There was a significant disadvantage in:
- DFS:
- 86% vs 92%, P= 0.003 and
- Distant DFS:
- 90% vs 96%, P=0.01:
- For patients who continued tamoxifen for more than 5 years versus those who took it for only 5 years
- The lack of benefit with additional tamoxifen use was independent of patient age
- For patients who continued tamoxifen for more than 5 years versus those who took it for only 5 years
- 90% vs 96%, P=0.01:
- DFS:
- The same patient population was then re-randomized to:
- Asked the recommended duration of tamoxifen therapy beyond 5 years:
- A statistically significant DFS benefit was derived:
- Randomized patients after surgery to:
#Arrangoiz #BreastSurgeon #CancerSurgeon #SurgicalOncologist #Teacher
Rodrigo Arrangoiz MS, MD, FACS, FSSO 