Ten-Year Results of a Randomized Clinical Trial Comparing Radical Mastectomy and Total Mastectomy with or without Radiation

Abstract

In 1971 we began a randomized trial to compare alternative local and regional treatments of breast cancer, all of which employ breast removal. Life-table estimates were obtained for 1665 women enrolled in the study for a mean of 126 months. There were no significant differences among three groups of patients with clinically negative axillary nodes, with respect to disease-free survival, distant-disease--free survival, or overall survival (about 57 per cent) at 10 years. The patients were treated by radical mastectomy, total ("simple") mastectomy without axillary dissection but with regional irradiation, or total mastectomy without irradiation plus axillary dissection only if nodes were subsequently positive. Similarly, no differences were observed between patients with clinically positive nodes treated by radical mastectomy or by total mastectomy without axillary dissection but with regional irradiation. Survival at 10 years was about 38 per cent in both groups. Our findings indicate that the location of a breast tumor does not influence the prognosis and that irradiation of internal mammary nodes in patients with inner-quadrant lesions does not improve survival. The data also demonstrate that the results obtained at five years accurately predict the outcome at 10 years. We conclude that the variations of local and regional treatment used in this study are not important in determining survival of patients with breast cancer.

Radiation field design and regional control in sentinel lymph node‐positive breast cancer patients with omission of axillary dissection

“…However, we believe it was adequate, because >75% of the regional recurrences observed in the NSABP B-04 trial occurred within the first 24 months of surgery. 38 In contrast to the B-04 trial, a high percentage of patients in our study received systemic therapy, which greatly contributes to the low locoregional recurrence rates reported in patients with early stage breast cancer. 39,40 It is possible that longer surveillance may reveal an increase in axillary recurrences that initially were tempered by the receipt of systemic therapy.…”

Complications of Axillary Lymph Node Dissection in Treatment of Early Breast Cancer: A Comparison of MRM and BCS

“…Fisher et al were the first to support the hypothesis that axillary dissection has prognostic significance [23]. This led to the use of various options in the management of axilla, including axillary dissection, axillary clearance, axillary dissection with regional lymph node radiation, regional radiation alone, axillary sampling, endoscopic axillary clearance, sentinel lymph node biopsy, and observation [23][24][25][26][27][28][29].…”

Management of the positive axilla in 2017

“…Meanwhile, they also started questioning the extent of surgery for early stage breast cancer. In the 80s, two large studies namely the NSABP-B04 and the King's-Cambridge trials published their 10-year follow-up results after comparing AD plus radiotherapy (RT) with no treatment to the axilla in clinically node-negative patients [5][6]. In both studies, treating the axilla did decrease the recurrence rate significantly (1.4% for AD, 3.1% for RT, and 14% for no treatment), but did not improve the survival rate in early stage breast cancer patients.…”

“…The NSABP-B04 trial also reported a 40% metastatic rate on final pathology in clinically nodenegative patients but if the axilla did not receive any local treatment only a 15% axillary recurrence was identified [5]. After 1990s with breast cancer screening programs becoming more widely used, the rate of axillary positivity decreased to 22% [7].…”