NSABP B-18 Trial

• The NSABP B-18 trial:
  • Was initiated in 1988 to determine:
    • Whether four cycles of doxorubicin and cyclophosphamide given preoperatively:
      • Improved survival and DFS:
        • When compared with the same chemotherapy given postoperatively
      • Secondary aims included:
        • The evaluation of preoperative chemotherapy:
          • In downstaging the primary breast tumor and involved axillary lymph nodes
  • Women aged 50 years or older:
    • Also received tamoxifen for 5 years
  • The results of the trial showed that:
    • With preoperative chemotherapy:
      • 36% of patients:
        • Achieved a clinical complete response
      • 43% of patients:
        • Achieved a clinical partial response
      • 13% of patients:
        • Achieved a pathologic complete response
    • Patients who received preoperative chemotherapy:
      • Were more likely to receive breast-conserving surgery:
        • 67% vs 60%:
          • Than patients receiving postoperative chemotherapy
    • There was no difference in:
      • DFS
      • Distant DFS
      • Overall survival:
        • Between the two groups
  • At 9 years:
    • The rate of ipsilateral breast tumor recurrence:
      • Was numerically higher in the preoperative chemotherapy group than the postoperative chemotherapy group (10.7% vs 7.6%):
        • Although this difference was not statistically significant (P=0.12)

REFERENCES

1. Fisher ER, Wang J, Bryant J, Fisher, Mamounas E, Wolmark N. Pathobiology of preoperative chemotherapy: findings from the National Surgical Adjuvant Breast and Bowel (NSABP) protocol B-18. Cancer. 2002;95:681-695.
2. Wolmark N, Wang J, Mamounas E, Bryant J, Fisher B. Preoperative chemotherapy in patients with operable breast cancer: nine-year results from National Surgical Adjuvant Breast and Bowel Project B-18. J Natl Cancer Inst Monogr. 2001:96-102.

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