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Twenty-five year results of the national cancer institute randomized breast conservation trial

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Abstract

Breast conservation therapy (BCT) consisting of lumpectomy and postoperative radiation has become an accepted alternative to mastectomy (MRM) for the treatment of early stage breast cancer. We currently report the 25 year outcomes of a single institution, prospective, randomized clinical trial at the National Cancer Institute. 237 women with pathologically confirmed invasive breast tumors 5 cm or less were accrued between 1979 and 1987 and randomized to receive either BCT or MRM. Overall survival was the primary endpoint. Patients with node positive disease were included and treated with doxorubicin and cyclophosphamide. Both arms received axillary dissection. BCT patients had radiation to the whole breast followed by a boost. At a median follow-up of 25.7 years, overall survival was 43.8% for the MRM group and 37.9% for BCT (P = 0.38). Although the cumulative incidence of a disease-free survival event was higher in BCT patients (29.0% MRM vs. 56.4% BCT, P = 0.0017), the additional treatment failures were primarily isolated ipsilateral breast tumor recurrences (IBTR’s) requiring salvage mastectomy. 22.3% of BCT patients experienced an IBTR. Distant disease and second cancers were similar in both arms. After 25 years, long term survival between BCT and MRM continues to be similar in patients treated for early stage breast cancer. Patients receiving BCT may be at risk for additional treatment-related morbidity, which may occur as a late event. Further studies are required to delineate patients at higher risk for these events, and prolonged follow up should be encouraged after treatment for all women.

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Abbreviations

BCT:

Breast conserving therapy

MRM:

Modified radical mastectomy

IBTR:

Ipsilateral breast tumor recurrence

NIH:

National Institutes of Health

NCI:

National Cancer Institute

EBCTG:

Early Breast Cancer Trialists Group

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Acknowledgments

This research was supported in part by the Intramural Research Program of the National Cancer Institute at the National Institutes of Health. Tu Dan was supported by the Clinical Research Training Program, a public–private partnership supported jointly by NIH and Pfizer, Inc.

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Authors and Affiliations

  1. Radiation Oncology Branch, National Cancer Institute/NIH, Building 10-CRC, Room B2-3500, 10 Center Drive, Bethesda, MD, 20892, USA

    Nicole L. Simone, Tu Dan, Sharon L. Smith, Linda Sciuto, Elena Lita & Kevin Camphausen

  2. Biometric Research Branch, National Cancer Institute, National Institutes of Health, 6130 Executive Blvd, Bethesda, MD, 20892, USA

    Joanna Shih

  3. Department of Medicine, Miller School of Medicine, University of Miami, Miami, FL, USA

    Marc E. Lippman

  4. Radiation Oncology, University of Pennsylvania, 3400 Spruce Street, 2 Donner Building, Philadelphia, PA, 19104, USA

    Eli Glatstein

  5. Washington Hospital Center, Washington Cancer Institute, 110 Irving St. NW, Washington, DC, DC, 20010, USA

    Sandra M. Swain

  6. Surgical Oncology Branch, National Cancer Institute, National Institutes of Health, 10 Center Dr, Bethesda, MD, 20892, USA

    David N. Danforth

Authors
  1. Nicole L. Simone
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  2. Tu Dan
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  3. Joanna Shih
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  4. Sharon L. Smith
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  5. Linda Sciuto
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  6. Elena Lita
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  7. Marc E. Lippman
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  8. Eli Glatstein
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  9. Sandra M. Swain
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  10. David N. Danforth
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  11. Kevin Camphausen
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Corresponding author

Correspondence to Nicole L. Simone.

Additional information

Trial registration: clinicaltrials.gov:NCT00026845.

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Simone, N.L., Dan, T., Shih, J. et al. Twenty-five year results of the national cancer institute randomized breast conservation trial. Breast Cancer Res Treat 132, 197–203 (2012). https://doi.org/10.1007/s10549-011-1867-6

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  • DOI: https://doi.org/10.1007/s10549-011-1867-6

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