NSABP B-18 Trial

he 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:
  • 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.
  • Fisher ER, Wang J, Bryant J, Fisher, Mamounas E, Wolmark N. Pathobiology ofpreoperative chemotherapy: findings from the National Surgical Adjuvant Breast and Bowel (NSABP) protocol B-18. Cancer. 2002;95:681-695.