- The National Surgical Adjuvant Breast and Bowel Project (NSABP) B-14 trial was a randomized, double-blind, placebo-controlled trial of postoperative tamoxifen treatment (10 mg BID) for breast cancer patients with ER+ tumors and histologically negative lymph nodes.
- Patient population:
- 2644 patients with ER+ histologically node-negative breast cancers
- Patients were administered the drug for at least 5 years
- After 15 years of follow-up, compared with placebo:
- Tamoxifen-treated patients were found to have benefited irrespective of age, menopausal status, or ER concentration for:
- RFS:
- 78% tamoxifen vs. 65% placebo
- OS:
- 71% tamoxifen vs. 65% placebo
- RFS:
- A multivariate analysis indicated that all subgroups investigated showed benefit from tamoxifen treatment:
- This included a reduction in rate of treatment failure at local and distant sites, a reduction in rate of incidence of new tumors in the contralateral breast, and a reduction in loco-regional recurrence after lumpectomy and breast irradiation
- Tamoxifen-treated patients were found to have benefited irrespective of age, menopausal status, or ER concentration for:
- Patient population:
- While NSABP B-14 is known for establishing tamoxifen as an effective adjuvant therapy in ER+, node-negative patients:
- Disease-free survival and OS were found to decrease over the 15-year follow-up in a subset of patients originally thought to have a favorable prognosis:
- These findings prompted researchers to find a way to optimize treatment in this group:
- Thus, the NSABP conducted the B-20 trial to evaluate the value of adding chemotherapy to tamoxifen for treatment regimens in ER+, node-negative patients:
- Results from the B-20 trial after a 12-year follow-up demonstrated a significant improvement in disease-free survival with the addition of chemotherapy to tamoxifen when compared to tamoxifen alone
- Thus, the NSABP conducted the B-20 trial to evaluate the value of adding chemotherapy to tamoxifen for treatment regimens in ER+, node-negative patients:
- These findings prompted researchers to find a way to optimize treatment in this group:
- Disease-free survival and OS were found to decrease over the 15-year follow-up in a subset of patients originally thought to have a favorable prognosis:
References
1. Fisher B, Costantino J, Redmond C, Poisson R, Bowman D, Couture J, et al. A randomized trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor positive tumors. N Engl J Med.1989;320(8):479-484.
2. Fisher B, Jeong JH, Bryant, Anderson S, Dignam J, Fisher ER, et al. Treatment of lymph-node-negative, oestrogen-receptor-positive breast cancer: long-term findings from National Surgical Adjuvant Breast and Bowel Project randomized clinical trials. Lancet. 2004;364(9437):858-868.
3. Newman LA, Mamounas EP. Review of breast cancer clinical trials conducted by the National Surgical Adjuvant Breast Project. Surg Clin N Am. 2007;87(2):279-305.
Rodrigo Arrangoiz MS, MD, FACS, FSSO 