NSABP B-14

  • NSABP B-14:
    • Randomized patients after surgery to:
      • Five years of tamoxifen or
      • 5 years of placebo:
        • To determine if there was a:
          • Significant survival advantage with the addition of endocrine therapy to:
            • ER-positive tumors
    • After 10 years of follow-up:
      • A statistically significant DFS benefit was derived:
        • With the use of tamoxifen for 5 years:
          • 69% vs 57%
            • P<0.0001
      • With a 37% reduction:
        • In the rate of contralateral breast cancer (P=0.007)
      • The most recent update of this trial:
        • Continues to demonstrate this survival benefit at 15 years:
          • Irrespective of age
          • Menopausal status, and
          • Tumor ER concentration
      • A follow-up question to protocol B-14:
        • Asked the recommended duration of tamoxifen therapy beyond 5 years:
          • The same patient population was then re-randomized to:
            • Five additional years of tamoxifen or
            • Five years of placebo
          • There was a significant disadvantage in:
            • DFS:
              • 86% vs 92%, P= 0.003 and
            • Distant DFS:
              • 90% vs 96%, P=0.01:
                • For patients who continued tamoxifen for more than 5 years versus those who took it for only 5 years
                  • The lack of benefit with additional tamoxifen use was independent of patient age

#Arrangoiz #BreastSurgeon #CancerSurgeon #SurgicalOncologist #Teacher

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