EFFECT OF PREOPERATIVE CHEMOTHERAPY ON LOCAL-REGIONAL DISEASE IN WOMEN WITH OPERABLE BREAST-CANCER - FINDINGS FROM NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT B-18

Purpose: To determine whether preoperative doxorubicin and cyclophosph amide (AC) permits more lumpectomies to be performed and decreases the incidence of positive nodes in women with primary breast cancer. Pati ents and Methods: Women (n = 1,523) were randomized to National Surgic al Adjuvant Breast and Bowel Project (NSABP) B-18; 759 eligible patien ts received postoperative AC and 747, preoperative AC, The clinical si ze of breast and axillary tumors was determined before each of four cy cles of AC and before surgery, Tumor response to preoperative therapy was clinically complete (cCR), partial (cPR), stable (cSD), or progres sive disease (cPD). Tissue from patients with a cCR was evaluated for a pathologic complete response (pCR). Results: Breast tumor size was r educed in 80% of patients after preoperative therapy; 36% had a cCR. T umor size and clinical nodal status were independent predictors of cCR , Twenty-six percent of women with a cCR had a pCR. Clinical nodal res ponse occurred in 89% of node-positive patients: 73% had a cCR and 44% of those had a pCR, There was a 37% increase in the incidence of path ologically negative nodes. Before randomization, lumpectomy was propos ed for 86% of women with tumors less than or equal to 2 cm, 70% with t umors 2.1 to 5.0 cm, and 3% with tumors greater than or equal to 5.1 c m. Clinical tumor size and nodal status influenced the physician's dec ision, Overall, 12% more lumpectomies were performed in the preoperati ve group; in women with tumors greater than or equal to 5.1 cm, there was a 175% increase. Conclusion: Preoperative therapy reduced the size of most breast tumors and decreased the incidence of positive nodes. The greatest increase in lumpectomy after preoperative therapy occurre d in women with tumors greater than or equal to 5 cm, since women with tumors less than 5 cm were already lumpectomy candidates, Preoperativ e therapy should be considered for the initial management of breast ru mors judged too large for lumpectomy. (C) 1997 by American Society of Clinical Oncology.