Mastectomy versus radiotherapy as treatment for stage I‐II breast cancer: A prospective randomized trial at the National Cancer Institute

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Abstract
In 1979, the National Cancer Institute in Bethesda, Maryland initiated a randomized, prospective trial to compare surgery versus radiation therapy in the treatment of stages I and II breast cancer. Surgical treatment consists of total mastectomy with axillary lymph node dissection (modified radical mastectomy) and breast reconstruction; radiation treatment consists of gross tumor excision, axillary lymph node dissection, and comprehensive irradiation including a boost dose to the tumor bed. All patients with pathologically positive axillary nodes receive 11 cycles of adjuvant Adriamycin®/Cytoxan® chemotherapy. As of December 1984, there have been 175 patients entered in the study. Twenty‐three patients have developed disease recurrence (12 mastectomy, 11 radiation), but it is too early to obtain definitive treatment‐related results.