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


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.


Breast conserving therapy Mastectomy Radiation Randomized 



Breast conserving therapy


Modified radical mastectomy


Ipsilateral breast tumor recurrence


National Institutes of Health


National Cancer Institute


Early Breast Cancer Trialists Group

Supplementary material

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


  1. 1.
    Anderson JR, Cain KC, Gelber RD (2008) Analysis of survival by tumor response and other comparisons of time-to-event by outcome variables. J Clin Oncol 26:3913–3915. doi:10.1200/JCO.2008.16.1000 PubMedCrossRefGoogle Scholar
  2. 2.
    Anderson SJ, Wapnir I, Dignam JJ, Fisher B, Mamounas EP, Jeong JH, Geyer CE Jr, Wickerham DL, Costantino JP, Wolmark N (2009) Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in patients treated by breast-conserving therapy in five National Surgical Adjuvant Breast and Bowel Project protocols of node-negative breast cancer. J Clin Oncol 27:2466–2473. doi:10.1200/JCO.2008.19.8424 PubMedCrossRefGoogle Scholar
  3. 3.
    Arriagada R, Le MG, Rochard F, Contesso G (1996) Conservative treatment versus mastectomy in early breast cancer: patterns of failure with 15 years of follow-up data. Institut Gustave-Roussy Breast Cancer Group. J Clin Oncol 14:1558–1564PubMedGoogle Scholar
  4. 4.
    Blichert-Toft M, Nielsen M, During M, Moller S, Rank F, Overgaard M, Mouridsen HT (2008) Long-term results of breast conserving surgery vs. mastectomy for early stage invasive breast cancer: 20-year follow-up of the Danish randomized DBCG-82TM protocol. Acta Oncol 47:672–681. doi:10.1080/02841860801971439 PubMedCrossRefGoogle Scholar
  5. 5.
    Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans E, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y (2005) Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet 366:2087–2106. doi:10.1016/S0140-6736(05)67887-7 PubMedGoogle Scholar
  6. 6.
    Correa CR, Litt HI, Hwang WT, Ferrari VA, Solin LJ, Harris EE (2007) Coronary artery findings after left-sided compared with right-sided radiation treatment for early-stage breast cancer. J Clin Oncol 25:3031–3037. doi:10.1200/JCO.2006.08.6595 PubMedCrossRefGoogle Scholar
  7. 7.
    Danforth DN Jr, Findlay PA, McDonald HD, Lippman ME, Reichert CM, d’Angelo T, Gorrell CR, Gerber NL, Lichter AS, Rosenberg SA et al (1986) Complete axillary lymph node dissection for stage I–II carcinoma of the breast. J Clin Oncol 4:655–662PubMedGoogle Scholar
  8. 8.
    Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N (2002) 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 347:1233–1241. doi:10.1056/NEJMoa022152347/16/1233 PubMedCrossRefGoogle Scholar
  9. 9.
    Fisher B, Redmond C, Fisher ER, Bauer M, Wolmark N, Wickerham DL, Deutsch M, Montague E, Margolese R, Foster R (1985) Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation. N Engl J Med 312:674–681. doi:10.1056/NEJM198503143121102 PubMedCrossRefGoogle Scholar
  10. 10.
    Giuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M (2011) Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA 305:569–575. doi:10.1001/jama.2011.90 Google Scholar
  11. 11.
    Halsted WS (1894) The results of operations for the cure of cancer of the breast performed at the Johns Hopkins Hospital from June, 1889, to January, 1894. Ann Surg 20:497–555PubMedCrossRefGoogle Scholar
  12. 12.
    Jacobson JA, Danforth DN, Cowan KH, d’Angelo T, Steinberg SM, Pierce L, Lippman ME, Lichter AS, Glatstein E, Okunieff P (1995) Ten-year results of a comparison of conservation with mastectomy in the treatment of stage I and II breast cancer. N Engl J Med 332:907–911. doi:10.1056/NEJM199504063321402 PubMedCrossRefGoogle Scholar
  13. 13.
    Lichter AS, Lippman ME, Danforth DN Jr, d’Angelo T, Steinberg SM, de Moss E, MacDonald HD, Reichert CM, Merino M, Swain SM et al (1992) Mastectomy versus breast-conserving therapy in the treatment of stage I and II carcinoma of the breast: a randomized trial at the National Cancer Institute. J Clin Oncol 10:976–983PubMedGoogle Scholar
  14. 14.
    Lippman ME, Lichter AS, Edwards BK, Gorrell CR, d’Angelo T, DeMoss EV (1984) The impact of primary irradiation treatment of localized breast cancer on the ability to administer systemic adjuvant chemotherapy. J Clin Oncol 2:21–27PubMedGoogle Scholar
  15. 15.
    Poggi MM, Danforth DN, Sciuto LC, Smith SL, Steinberg SM, Liewehr DJ, Menard C, Lippman ME, Lichter AS, Altemus RM (2003) Eighteen-year results in the treatment of early breast carcinoma with mastectomy versus breast conservation therapy: the National Cancer Institute randomized trial. Cancer 98:697–702. doi:10.1002/cncr.11580 PubMedCrossRefGoogle Scholar
  16. 16.
    Smith TE, Lee D, Turner BC, Carter D, Haffty BG (2000) True recurrence vs new primary ipsilateral breast tumor relapse: an analysis of clinical and pathologic differences and their implications in natural history, prognoses, and therapeutic management. Int J Radiat Oncol Biol Phys 48:1281–1289PubMedCrossRefGoogle Scholar
  17. 17.
    van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, van der Schueren E, Helle PA, van Zijl K, Bartelink H (2000) Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst 92:1143–1150PubMedCrossRefGoogle Scholar
  18. 18.
    Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E (2002) Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med 347:1227–1232. doi:10.1056/NEJMoa020989347/16/1227 PubMedCrossRefGoogle Scholar
  19. 19.
    Vinh-Hung V, Verschraegen C (2004) Breast-conserving surgery with or without radiotherapy: pooled-analysis for risks of ipsilateral breast tumor recurrence and mortality. J Natl Cancer Inst 96:115–121PubMedCrossRefGoogle Scholar
  20. 20.
    Wapnir IL, Anderson SJ, Mamounas EP, Geyer CE Jr, Jeong JH, Tan-Chiu E, Fisher B, Wolmark N (2006) Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in five National Surgical Adjuvant Breast and Bowel Project node-positive adjuvant breast cancer trials. J Clin Oncol 24:2028–2037. doi:10.1200/JCO.2005.04.3273 PubMedCrossRefGoogle Scholar

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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