Systemic adjuvant therapy in treatment of primary operable breast cancer: National Surgical Adjuvant Breast and Bowel Project experience.

This report provides an overview of information presented by us at a recent National Institutes of Health Consensus Development Conference on Adjuvant Chemotherapy. The data, derived from 7 randomized clinical trials conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) since 1958, permit us to conclude that the use of systemic adjuvant therapy is of benefit in both premenopausal and postmenopausal patients with primary breast cancer. Data from the first NSABP trial begun in 1958 with short-course perioperative thiotepa demonstrated a long-term survival benefit in premenopausal but not postmenopausal patients. Ten-year findings from a second trial evaluating response to melphalan (P) implemented in 1972 indicated that, when related to age and nodes, there was a benefit from this drug in both the 1-3 and greater than or equal to 4 positive node premenopausal groups but those with fewer nodes were most improved. In this group characterized by premenopausal women with 1-3 positive nodes, mortality was reduced 64% with a cumulative odds ratio of 3.25 (P = .009) at 10 years after surgery. When related to nuclear grade, there was a striking benefit in survival from P in patients less than or equal to 49 and greater than or equal to 50 years with undifferentiated tumors. The addition of 5-fluorouracil (F) to melphalan (PF) resulted in an increase in disease-free survival and survival over that observed with P in patients less than or equal to 49 and greater than or equal to 50 years of age.(ABSTRACT TRUNCATED AT 250 WORDS)