- 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 4 cm or less in greatest diameter
- All patients had an axillary lymph node dissection (ALND)
- This trial, along with 5 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
- Between the total mastectomy group and the lumpectomy groups, with or without radiation:
- Overall survival, or distant disease-free survival:
- There were no observed differences in:
- Phase III Total Mastectomy / Axillary Dissection vs. Segmental Mastectomy / Axillary Dissection with or without Radiotherapy for Potentially Curable Breast Carcinoma:
- NSABP B-04:
- Enrolled clinically node-negative patients and randomized them to radical mastectomy (RM), total mastectomy (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)
- Compared lumpectomy alone to lumpectomy plus breast radiation:
- 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.
Siziopilou KP, Anderson SJ, Cobleigh MA, Julian TB, Arthur DW, Zheng P, et al. Preliminary results of centralized HER2 testing in ductal carcinoma in situ (DCIS): NSABP B-43. Breast Cancer Res Treat. 2013;142(2):415-421.
Rodrigo Arrangoiz MS, MD, FACS, FSSO 