The NSABP B-14 Trial

  • The NSABP B14 trial:
    • Was a randomized, double blind, placebo-controlled trial:
      • Of postoperative therapy with tamoxifen (10 mg BID)
      • In 2644 patients
      • With ER-positive histologically node-negative breast cancers
    • Patients were administered the drug:
      • For at least 5 years
    • After 15 years of follow-up:
      • Compared with placebo:
        • Tamoxifen treated patients were found to have benefited irrespective of:
          • Age, menopausal status, or ER concentration for:
            • RFS:
              • 78% tamoxifen vs 65% placebo
            • OS:
              • 71% tamoxifen vs 65% placebo
        • A multivariate analysis indicated that:
          • All subgroups investigated:
            • Showed benefit from tamoxifen treatment:
              • This included a:
                • Reduction in rate of treatment failure at local and distant sites
                • A reduction in rate of incidence of new tumors in the contralateral breast
                • A reduction in loco-regional recurrence after lumpectomy and breast irradiation
  • While the NSABP B-14 is known for:
    • Establishing tamoxifen:
      • As an effective therapy in:
        • ER-positive, node-negative patients:
          • Disease-free survival and OS were found to decrease over the 15-year follow-up:
            • In a subset of patients originally thought to have a favorable prognosis:
              • These findings prompted researchers to find a way to optimize treatment in this group:
                • Thus, the NSABP conducted the B-20 trial:
                  • To evaluate the value of adding chemotherapy to tamoxifen for treatment regimens in ER-positive, node-negative patients
  • Results from the B-20 trial after a 12-year follow-up:
    • Demonstrated a significant improvement in disease-free survival:
      • With the addition of chemotherapy to tamoxifen when compared to tamoxifen alone

REFERENCES

  1. Fisher B, Costantino J, Redmond C et al. A randomized trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor positive tumors. N Engl J Med. 1989;320:479-484.
  2. Fisher B, Jeong JH, Bryant, et al. Treatment of lymph-node-negative, oestrogen-receptor-positive breast cancer: long-term findings from National Surgical Adjuvant Breast and Bowel Project randomized clinical trials. Lancet. 2004;364:858-868.
  3. Newman LA, Mamounas EP. Review of breast cancer clinical trials conducted by the National Surgical Adjuvant Breast Project. Surg Clin N Am. 2007;87:279-305.

#Arrangoiz #Surgeon #Cancer #BreastSurgeon #CancerSurgeon #SurgicalOncologist #BreastCancer #NSABP

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