Journal of Clinical Oncology, Vol 16, 2672-2685, Copyright © 1998 by American Society of Clinical Oncology
Effect of preoperative chemotherapy on the outcome of women with operable breast cancer
B Fisher, J Bryant, N Wolmark, E Mamounas, A Brown, ER Fisher, DL Wickerham, M Begovic, A DeCillis, A Robidoux, RG Margolese, AB Cruz Jr, JL Hoehn, AW Lees, NV Dimitrov and HD Bear
National Surgical Adjuvant Breast and Bowel Project Operations and Biostatistical Centers, Pittsburgh, PA, USA. bfisher@aherf.edu
PURPOSE: To determine, in women with primary operable breast cancer, if
preoperative doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan; AC)
therapy yields a better outcome than postoperative AC therapy, if a
relationship exists between outcome and tumor response to preoperative
chemotherapy, and if such therapy results in the performance of more
lumpectomies. PATIENTS AND METHODS: Women (1,523) enrolled onto National
Surgical Adjuvant Breast and Bowel Project (NSABP) B-18 were randomly
assigned to preoperative or postoperative AC therapy. Clinical tumor
response to preoperative therapy was graded as complete (cCR), partial
(cPR), or no response (cNR). Tumors with a cCR were further categorized as
either pathologic complete response (pCR) or invasive cells (pINV).
Disease-free survival (DFS), distant disease-free survival (DDFS), and
survival were estimated through 5 years and compared between treatment
groups. In the preoperative arm, proportional-hazards models were used to
investigate the relationship between outcome and tumor response. RESULTS:
There was no significant difference in DFS, DDFS, or survival (P = .99,
.70, and .83, respectively) among patients in either group. More patients
treated preoperatively than postoperatively underwent lumpectomy and
radiation therapy (67.8% v 59.8%, respectively). Rates of ipsilateral
breast tumor recurrence (IBTR) after lumpectomy were similar in both groups
(7.9% and 5.8%, respectively; P = .23). Outcome was better in women whose
tumors showed a pCR than in those with a pINV, cPR, or cNR (relapse-free
survival [RFS] rates, 85.7%, 76.9%, 68.1%, and 63.9%, respectively; P <
.0001), even when baseline prognostic variables were controlled. When
prognostic models were compared for each treatment group, the preoperative
model, which included breast tumor response as a variable, discriminated
outcome among patients to about the same degree as the postoperative model.
CONCLUSION: Preoperative chemotherapy is as effective as postoperative
chemotherapy, permits more lumpectomies, is appropriate for the treatment
of certain patients with stages I and II disease, and can be used to study
breast cancer biology. Tumor response to preoperative chemotherapy
correlates with outcome and could be a surrogate for evaluating the effect
of chemotherapy on micrometastases; however, knowledge of such a response
provided little prognostic information beyond that which resulted from
postoperative therapy.
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