NSABP B-17, B-32, B-43 Trials

  • NSABP B-17:
    • A Phase III Randomized Study of Postoperative Radiotherapy Following Segmental Mastectomy and Axillary Dissection in Patients with Noninvasive Intraductal Adenocarcinoma of the Breast:
      • Compared:
        • Lumpectomy alone to
        • Lumpectomy plus breast radiation
      • 818 patients with localized ductal carcinoma in situ (DCIS)
      • This trial concluded that:
        • Radiotherapy significantly decreases the rate of invasive cancer and DCIS in the ipsilateral breast:
          • By approximately 50%
  • NSABP B-32:
    • Was a randomized controlled phase III trial conducted at 80 centers in Canada and the U.S:
      • 5611 women with invasive breast cancer were randomly assigned to either:
        • Sentinel lymph node (SLN) resection plus ALND (group 1) or
        • To SLN resection alone with ALND:
          • Only if the SLNs were positive (group 2)
      • In the 3986 SLN-negative patients:
        • 8-year estimates for:
          • Overall survival:
            • Were 91.8% (95% CI, 90.4%–93.3%) in the first group and
            • 90.3% (88.8%–91.8%) in the second group
          • Treatment comparisons for disease-free survival:
            • Yielded an unadjusted HR of 1.05 (95% CI, 0.90–1.22; P=0.54)
            • Disease-specific survival was:
              • 82.4% (80.5%–84.4%) in group 1 and
              • 81.5% (79.6%–83.4%) in group 2
          • There were eight regional node recurrences as first events in group 1 and 14 in group 2 (P=0.22)
      • Patients are continuing follow-up for long-term assessment of survival and regional control
  • NSABP protocol B-43:
    • Aims to evaluate the effect of trastuzumab in HER2-positive DCIS
    • Patients with HER2-positive DCIS treated with BCS were randomized to:
      • Breast radiation alone versus
      • Breast radiation plus two doses of trastuzumab:
        • Starting on day 1 of breast radiation and repeated 3 weeks later
      • The primary endpoint:
        • Is the development of any breast cancer

REFERENCES

  1. Fisher B, Anderson S, Bryant J, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002;347:1233-1241.
  2. Fisher B, Dignam J, Wolmark N, et al. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998;16:441-452.
  3. Fisher B, Montague E, Redmond C. Comparison of radical mastectomy with alternative treatments for primary breast cancer: a first report of results from a prospective randomized clinical trial. Cancer. 1977;39:2827-2839.
  4. Krag DN, Anderson SJ, Julian TB, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomized phase 3 trial. Lancet Oncol. 2010;11:927-933.

#Arrangoiz #BreastSurgeon #BreastCancer #Cancer Surgeon #SurgicalOncologist

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