NSABP B-27 Trial

• In the NSABP B-27 trial:
  • 2,411 women with operable breast cancer were randomly assigned to receive:
    • Preoperative AC followed by surgery
    • Preoperative AC followed by docetaxel then surgery
    • AC followed by surgery and then docetaxel
      • Tamoxifen was initiated concurrently with chemotherapy
  • The addition of docetaxel, preoperatively or postoperatively:
    • Did not significantly improve OS or DFS
  • The sample size of the study:
    • Was deemed insufficient to yield significance for the moderate improved DFS:
      • However, in the subset of patients with a clinical partial response to AC:
        • The addition of preoperative docetaxel (but not postoperative docetaxel):
          • Resulted in a significant increase in DFS compared with AC alone:
            • Hazard ratio, 0.71; 95% confidence interval, 0.55–0.91; P=.007
  • There was a significant decrease in the cumulative incidence of all local recurrence as first events:
    • In the two groups treated with docetaxel:
      • Approximately half of which was accounted for by ipsilateral breast tumor recurrences in women treated with breast-conserving therapy

References

1. Bear HD, Anderson S, Smith RE, Geyer Jr CE, Mamounas EP, Fisher B, et al. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006;24(13):2019-2027.

2. NSABP clinical trials overview. Protocol B-27. A randomized trial comparing preoperative doxorubicin (adriamycin) cyclophosphamide (AC) to preoperative AC followed by preoperative docetaxel (taxotere) and to preoperative ac followed by postoperative docetaxel in patients with operable carcinoma of the breast. National Surgical Adjuvant Breast and Bowel Project website. http://www.nsabp.pitt.edu/B-27.asp. Accessed May 15, 2020.