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.
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