Journal of Clinical Oncology, Vol 15, 2483-2493, Copyright © 1997 by American Society of Clinical Oncology
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
B Fisher, A Brown, E Mamounas, S Wieand, A Robidoux, RG Margolese, AB Cruz Jr, ER Fisher, DL Wickerham, N Wolmark, A DeCillis, JL Hoehn, AW Lees and NV Dimitrov
Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Shadyside Hospital, PA, USA. nsabpbf@pitt.edu
PURPOSE: To determine whether preoperative doxorubicin and cyclophosphamide
(AC) permits more lumpectomies to be performed and decreases the incidence
of positive nodes in women with primary breast cancer. PATIENTS AND
METHODS: Women (n = 1,523) were randomized to National Surgical Adjuvant
Breast and Bowel Project (NSABP) B-18; 759 eligible patients received
postoperative AC and 747, preoperative AC. The clinical size of breast and
axillary tumors was determined before each of four cycles of AC and before
surgery. Tumor response to preoperative therapy was clinically complete
(cCR), partial (cPR), stable (cSD), or progressive disease (cPD). Tissue
from patients with a cCR was evaluated for a pathologic complete response
(pCR). RESULTS: Breast tumor size was reduced in 80% of patients after
preoperative therapy; 36% had a cCR. Tumor size and clinical nodal status
were independent predictors of cCR. Twenty-six percent of women with a cCR
had a pCR. Clinical nodal response 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 pathologically negative nodes. Before
randomization, lumpectomy was proposed for 86% of women with tumors < or
= 2 cm, 70% with tumors 2.1 to 5.0 cm, and 3% with tumors > or = 5.1 cm.
Clinical tumor size and nodal status influenced the physician's decision.
Overall, 12% more lumpectomies were performed in the preoperative group; in
women with tumors > or = 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 occurred in women with tumors > or = 5 cm, since
women with tumors less than 5 cm were already lumpectomy candidates.
Preoperative therapy should be considered for the initial management of
breast tumors judged too large for lumpectomy.
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