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Twenty-five year results of the national cancer institute randomized breast conservation 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.
AuthorsNicole 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
JournalBreast cancer research and treatment (Breast Cancer Res Treat) Vol. 132 Issue 1 Pg. 197-203 (Feb 2012) ISSN: 1573-7217 [Electronic] Netherlands
PMID22113254 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Topics
  • Breast Neoplasms (mortality, radiotherapy, surgery)
  • Combined Modality Therapy
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Humans
  • Kaplan-Meier Estimate
  • Mastectomy, Modified Radical
  • Mastectomy, Segmental
  • Middle Aged
  • National Cancer Institute (U.S.)
  • Neoplasm Recurrence, Local
  • Proportional Hazards Models
  • Prospective Studies
  • Treatment Outcome
  • United States

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