NSABP B-06, Phase III Total Mastectomy /Axillary Dissection vs. Segmental Mastectomy / Axillary Dissection with or without Radiotherapy

NSABP B-06, Phase III Total Mastectomy / Axillary Dissection vs. Segmental Mastectomy / Axillary Dissection with or without Radiotherapy for Potentially Curable Breast Carcinoma:
- Compared total mastectomy with lumpectomy alone and lumpectomy with irradiation:in patients with tumors four cm or less in greatest diameter
- All patients had an axillary lymph node dissection (ALND)
This trial, along with five other randomized prospective trials, was instrumental in:
- Establishing lumpectomy plus radiation therapy as the preferred treatment for women with early stage, operable breast cancer, as compared to mastectomy
After 20 years of follow-up:
- There were no observed differences in overall survival, or distant disease-free survival:
  - Between the total mastectomy group and the lumpectomy groups, with or without radiation
  - The hazard ratio (HR) for death with lumpectomy alone was 1.05 (95% confidence interval [CI] 0.90–1.23; P=0.51)
  - The HR for death with lumpectomy plus radiation was 0.97 (95% CI, 0.83–1.14; P=0.74):
    - Which were comparable to total mastectomy
NSABP B-04:
- Enrolled clinically node-negative patients and randomized them to:
  - RM, TM plus radiation, or TM alone
NSABP B-17:
- Compared lumpectomy alone to lumpectomy plus breast radiation in patients with localized ductal carcinoma in situ (DCIS)
NSABP B-32:
- Assigned clinically node-negative patients to either sentinel lymph node (SLN) resection plus ALND (group 1) or to SLN resection alone with ALND only if the SLNs were positive (group 2)
NSABP protocol B-43:
- Aims to evaluate the effect of trastuzumab on local recurrence in patients with HER2-positive DCIS treated with lumpectomy and whole-breast irradiation
References
- Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002;347(16):1233-1241.
- Fisher B, Montague E, Redmond C, Barton B, Borland D, Fisher ER, et al. Comparison of radical mastectomy with alternative treatments for primary breast cancer: a first report of results from a prospective randomized clinical trial. Cancer. 1977;39(6 Suppl):2827-2839.
- Mamounas EP, Wickerham DL, Fisher B, Geyer CE, Julian TB, Wolmark N. The NSABP experience. In: Kuerer HM, ed. Kuerer’s Breast Surgical Oncology. New York, NY: McGraw-Hill Companies; 2010:475-508.
- Fisher B, Dignam J, Wolmark N, Mamounas E, Constantino J, Poller W, et al. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998;16(2):441-452.
- Krag DN, Anderson SJ, Julian TB, Brown AM, Harlow SP, Constantino JP, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 Randomized Phase 3 Trial. Lancet Oncol. 2010;11(10):927-933.