Breast Cancer Research and Treatment

, Volume 132, Issue 1, pp 197–203 | Cite as

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

  • Nicole L. Simone
  • Tu Dan
  • Joanna Shih
  • Sharon L. Smith
  • Linda Sciuto
  • Elena Lita
  • Marc E. Lippman
  • Eli Glatstein
  • Sandra M. Swain
  • David N. Danforth
  • Kevin Camphausen
Clinical Trial

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.

Keywords

Breast conserving therapy Mastectomy Radiation Randomized 

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

Supplementary material

10549_2011_1867_MOESM1_ESM.pdf (45 kb)
Supplementary material 1 (PDF 44 kb)

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Copyright information

© Springer Science+Business Media, LLC (Outside the USA) 2011

Authors and Affiliations

  • Nicole L. Simone
    • 1
  • Tu Dan
    • 1
  • Joanna Shih
    • 2
  • Sharon L. Smith
    • 1
  • Linda Sciuto
    • 1
  • Elena Lita
    • 1
  • Marc E. Lippman
    • 3
  • Eli Glatstein
    • 4
  • Sandra M. Swain
    • 5
  • David N. Danforth
    • 6
  • Kevin Camphausen
    • 1
  1. 1.Radiation Oncology Branch, National Cancer Institute/NIHBethesdaUSA
  2. 2.Biometric Research Branch, National Cancer Institute, National Institutes of HealthBethesdaUSA
  3. 3.Department of Medicine, Miller School of MedicineUniversity of MiamiMiamiUSA
  4. 4.Radiation OncologyUniversity of PennsylvaniaPhiladelphiaUSA
  5. 5.Washington Hospital Center, Washington Cancer InstituteWashington, DCUSA
  6. 6.Surgical Oncology Branch, National Cancer Institute, National Institutes of HealthBethesdaUSA

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