Which clinical trial demonstrated no significant differences in long-term outcome between node-negative patients who received a radical mastectomy (RM) and those who received a total mastectomy (TM) with or without nodal irradiation?

  • NSABP B-04:
    • A Protocol for the Evaluation of Radical Mastectomy and Total Mastectomy with and without Radiation in the Primary Treatment of Cancer of the Female Breast
    • Enrolled 1,079 patients:
      • With clinically node-negative disease
    • Randomized patients to:
      • Radical mastectomy (RM)
      • Total mastectomy (TM) plus local-regional axillary irradiation, or 
      • TM alone
    • An additional 586 patients:
      • With clinically node-positive disease
      • Were randomized to:
        • RM or 
        • TM plus radiation
    • An important point of this trial:
      • Is that none of these patients received systemic therapy
    • After 25 years of follow-up:
      • The study showed no significant difference in long-term outcome:
        • Between clinically node-negative patients:
          • Who received RM and those who received TM with or without radiation
        • Between clinically node-positive patients:
          • Who received RM vs.TM with nodal irradiation
      • When comparing the hazard ratio for death within the two arms:
        • The results show no survival advantage from RM
  • In patients with clinically node-negative disease:
    • Pathologic examination of the mastectomy specimen in patients treated with radical mastectomy:
      • Revealed that 40% of the patients had pathologically positive nodes
      • However, only 19% of patients treated with TM alone and no axillary surgeryhad an axillary recurrence:
        • Suggesting that not all occult axillary disease will progress into clinically meaningful disease:
          • Even in the absence of systemic therapy
  • NSABP B-06:
    • Phase III Total Mastectomy / Axillary Dissection vs Segmental Mastectomy / Axillary Dissection with or without Radiotherapy for Potentially Curable Breast Carcinoma
    • Compared lumpectomy and axillary node dissection with or without breast irradiation with modified radical mastectomy (MRM):
      • In patients with tumors 4 cm or less in greatest diameter
    • The results of this trial:
      • Demonstrating equivalent survival between the two surgical options:
        • Establish BCS as a viable surgical option for most patients with invasive breast cancer
  • The Milan I trial:
    • Compared 701 patients with invasive breast cancer up to 2 cm in size without clinically positive axillary lymph nodes
    • Randomized them into those who:
      • Received radical mastectomy and those who received quadrantectomy plus axillary dissection and radiotherapy
    • A recent analysis of the trial:
      • Showed no differences in OS between the two study groups
  • The NSABP B-17:
    • 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 irradiation:
        • In 818 patients with localized ductal carcinoma in situ
    • This trial concluded that:
      • Radiotherapy did not improve OS but that it did significantly decrease the rate of invasive or in situ in breast tumor recurrence in the ipsilateral breast
  • The EORTC Trial 10801:
    • Was a randomized multicenter trial:
      • That compared breast-conserving therapy with MRM for patients with invasive breast cancer less than 5 cm in diameter
    • At 10 years:
      • There was no difference between the two groups in:
        • OS or in distant metastasis-free rates
    • Locoregional recurrence at 10 years was:
      • 12% for the mastectomy group and 20% for the breast-conserving therapy group
  • References:
    • Fisher B, Montague E, Redmond C, Barton B, Borland D, Fisher ER, et al. 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(6 Suppl):2827-2839.
    • Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, 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(16):1233-1241.
    • Mamounas EP, Wickerham DL, Fisher B, Geyer CE, Julian TB, Wolmark N. The NSABP experience. In: Kuerer HM, ed. Kuerer’s Breast Surgical Oncology. New York, NY: McGraw-Hill Companies; 2010:475-508.
    • Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, et al. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002;347(16):1227-1232.
    • Fisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, 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(2):441-452.
    • Curran D, van Dongen JP, Aaronson NK, Kiebert G, Fentiman IS, Mignolet F, et al. Quality of life of early-stage breast cancer patients treated with radical mastectomy or breast-conserving procedures: results of EORTC Trial 10801. The European Organization for Research and Treatment of Cancer (EORTC), Breast Cancer Co-operative Group (BCCG

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