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Breast-Conservative Surgery With and Without Radiotherapy in Patients Aged 55–75 Years With Early-Stage Breast Cancer: A Prospective, Randomized, Multicenter Trial Analysis After 108 Months of Median Follow-up

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Objectives

Breast-conserving therapy (BCT), including postoperative whole breast irradiation (WBI), is generally accepted as the treatment of choice for most patients with early-stage breast cancer. The question whether WBI is mandatory in all patients remains one of the most controversial issues in BCT. To answer this question, a randomized, prospective, multicentre study was launched in January 2001. Primary endpoints of the study were to assess the cumulative incidence of in-breast-recurrences (IBR) and overall survival (OAS) after conservative surgery (BCS) with or without WBI.

Methods

From January 2001 until December 2005, 749 patients with unifocal infiltrating breast cancer up to 25 mm, 0–3 positive axillary lymph nodes, no extensive intraductal component or lymphvascular invasion from 11 centres in Italy, were randomly assigned to BCS+WBI (arm 1:373 patients) or BCS alone (arm 2:376 patients). Treatment arms were well balanced in terms of baseline characteristics. Systemic adjuvant therapy was administered according to the institutional policies. Kaplan–Meier method was used for survival analysis and log-rank test to evaluate the difference between the two arms.

Results (Last Analysis 31.12.2012)

After median follow-up of 108 months, 12 (3.4 %) IBR were observed in arm 1 and 16 (4.4 %) in arm 2. OAS was 81.4 % in arm 1 and 83.7 % in arm 2. There was no statistically significant difference regarding IBR and death in the two treatment groups.

Conclusions

These data are promising and suggest that WBI after BCS can be omitted in selected patients with early stage breast cancer without exposing them to an increased risk of local recurrence and death. Longer follow-up is needed to further consolidate these results.

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References

  1. Veronesi U, Saccozzi R, Del Vecchio M, Banfi A, Clemente C, De Lena M, Gallus G, Greco M, Luini A, Marubini E. Comparing radical mastectomy with quadrantectomy, axillary dissection, and radiotherapy in patients with small cancers of the breast. N Engl J Med. 1981;305:6–11.

    Article  CAS  PubMed  Google Scholar 

  2. Fisher B, Bauer M, Margolese R, Poisson R, Pilch Y, Redmond C, Fisher E, Wolmark N, Deutsch M, Montague E. Five-year results of a randomized trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med. 1985; 312:665–73.

    Article  CAS  PubMed  Google Scholar 

  3. NIH Consensus Conference. Treatment of early-stage breast cancer. JAMA. 1991;265:391–5.

    Article  Google Scholar 

  4. Fisher B, Anderson S, Bryant J, Margolese R, Deutsch M, Fisher E, Jeong J, Wolmark N. 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;347:1233–41.

    Article  PubMed  Google Scholar 

  5. Veronesi U, Luini A, Galimberti V, Zurrida S. Conservation approaches for the management of stage I/II carcinoma of the breast: Milan Cancer Institute Trials. World J Surg. 1994;18:70–5.

    Article  CAS  PubMed  Google Scholar 

  6. Clark RM, Whelan T, Levine M, et al. Randomized clinical trial of irradiation following lumpectomy and axillary dissection for node-negative breast cancer: an update. J Natl Cancer Inst. 1996;88:1659–64.

    Article  CAS  PubMed  Google Scholar 

  7. Forrest AP, Stewart HJ, Evering D, et al. Randomized controlled trial of conservation therapy for breast cancer: 6-year analysis of the Scottish trial. Lancet. 1996;348:708-13.

    Article  CAS  PubMed  Google Scholar 

  8. Liljegren G, Holmberg L, Bergh J, Lindgren A, Tabár L, Nordgren H, Adami HO and the Uppsala-Örebro Breast Cancer Study Group. 10-year results after sector resection with or without postoperative radiotherapy for stage I breast cancer: a randomized trial. J Clin Oncol. 1999;17:2326–33.

    Google Scholar 

  9. Winzer KJ, Sauerbrei W, Braun M, et al. Radiation therapy and tamoxifen after breast-conserving surgery: updated results of a 2 × 2 randomised clinical trial in patients with low risk of recurrence. Eur J Cancer. 2010;46:95–101.

    Article  CAS  PubMed  Google Scholar 

  10. Malmstrom P, Holmberg L, Anderson H, et al. Breast conservation surgery, with and without radiotherapy, in women with lymph node-negative breast cancer: a randomised clinical trial in a population with access to public mammography screening. Eur J Cancer. 2003;39:1690–7.

    Article  CAS  PubMed  Google Scholar 

  11. Schnitt SJ, Hayman J, Gelman R, et al. A prospective study of conservative surgery alone in the treatment of selected patients with stage I breast cancer. Cancer. 1996;77:1094–100.

    Article  CAS  PubMed  Google Scholar 

  12. Holli K, Saaristo R, Isola J, Joensuu H, Hakama M. Lumpectomy with or without postoperative radiotherapy for breast cancer with favourable prognostic features: results of a randomized study. Br J Cancer. 2001;84:164–9.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  13. Veronesi U. Luini A. Del Vecchio M, et al. Radiotherapy after breast-preserving surgery in women with localized cancer of the breast. N Engl J Med. 1993;328:1587–91.

    Article  CAS  PubMed  Google Scholar 

  14. Veronesi U, Marubini E. Del Vecchio M, et al. Local recurrences and distant metastases after conservative breast cancer treatment: partly independent events. J Natl Cancer Inst. 1995;87:19–27.

    Article  CAS  PubMed  Google Scholar 

  15. Veronesi U, Marubini E, Mariani L, Galimberti V, Luini A, Veronesi P, et al. Radiotherapy after breast-conserving surgery in small breast carcinoma: long- term results of a randomized trial. Ann Oncol. 2001;12:997–1003.

    Article  CAS  PubMed  Google Scholar 

  16. Veronesi U, Stafyla V, Luini A, Veronesi P. Breast cancer: from “maximum tolerable” to “minimum effective” treatment. Front Oncol. 2012;2:125.

    Google Scholar 

  17. AIRO 1997 Standard di riferimento nell’irradiazione del cancro della mammella in stadio iniziale. A cura di Valdagni R (coordinatore), Amichetti M, Bignardi M, Cazzaniga LF, Ciocca M, Cosentino D, Gatti MG, Guenzi M, Lozza L, Maiorana A, Orecchia R, Pacini P, Zucali R. Rusconi Editore; 1997.

  18. Locker AP, Ellis IO, Morgan DA, Elston CW, Mitchell A, Blamey RW. Factors influencing local recurrence after excision and radiotherapy for primary breast cancer. Br J Surg. 1989;76:890–4.

    Article  CAS  PubMed  Google Scholar 

  19. Hughes KS, Schnaper LA, Berry D, et al. Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer. N Engl J Med. 2004;351:971–7.

    Article  CAS  PubMed  Google Scholar 

  20. Hughes KS, Schnaper LA, Cirrincione C, et al. Lumpectomy plus tamoxifen with or without irradiation in women age 70 or older with early breast cancer. J Clin Oncol. 2010;28:69s (suppl; abstr 507).

  21. Fyles AW, McCready DR, Manchul LA, et al. Tamoxifen with or without breast irradiation in women 50 years of age or older with early breast cancer. N Engl J Med. 2004;351:963-70.

    Article  CAS  PubMed  Google Scholar 

  22. Fisher B, Bryant J, Dignam JJ, et al. Tamoxifen, radiation therapy, or both for prevention of ipsilateral breast tumor recurrence after lumpectomy in women with invasive breast cancers of one centimeter or less. J Clin Oncol. 2002;20:4141–9.

    Article  CAS  PubMed  Google Scholar 

  23. Darby S, McGale P, Correa C, et al. Effect of radiotherapy after breast conserving surgery on 10-year recurrence and 15-year breast cancer death: Meta-analysis of individual patient data for 10,801 women in 17 randomised trials. Lancet. 2011;378:1707-16.

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgment

The authors express gratitude to Pinuccia Valagussa, Statistical Centre National Cancer Institute, Milan, Italy, for her support in statistical analysis and data management and William Russell-Edu, Librarian, European Institute of Oncology, Milan, Italy for the final editing.

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Authors and Affiliations

  1. Breast Unit, Istituto Clinico Humanitas, Rozzano, Milan, Italy

    C. Tinterri MD, W. Gatzemeier MD & C. Andreoli MD

  2. European School of Oncology, Milan, Italy

    A. Costa MD

  3. Center of Epidemiology and Clinical Evaluation, Trento, Italy

    M. A. Gentilini PhD

  4. Division of Surgery and Senology, The Maugeri Foundation, Pavia, Italy

    V. Zanini MD & L. Regolo MD

  5. Division of Surgery, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy

    C. Pedrazzoli MD & E. Rondini MD

  6. Division of Surgery and Medical Technology, Sant’ Andrea Hospital, Rome, Italy

    C. Amanti MD

  7. Division of Surgery, S. Maria della Misericordia Hospital, Udine, Italy

    G. Gentile MD

  8. Division of Surgery, S. Orsola Malpighi Hospital, Bologna, Italy

    M. Taffurelli MD

  9. Breast Unit, Ospedali Riuniti, Bergamo, Italy

    P. Fenaroli MD & C. Tondini MD

  10. Division of Surgery, General Hospital Alba, Alba, Italy

    G. Sacchetto MD

  11. Division of Gynaecology, Cancer Research Centre Torino, Turin, Italy

    P. Sismondi MD

  12. Breast Unit, Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy

    R. Murgo MD

  13. Division of Gynaecology, General Hospital Cirié, Cirié, Italy

    M. Orlandi MD

  14. Breast Unit, G. Bernabeo Hospital, Ortona, Italy

    E. Cianchetti MD

Authors
  1. C. Tinterri MD
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  2. W. Gatzemeier MD
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  3. A. Costa MD
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  4. M. A. Gentilini PhD
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  5. V. Zanini MD
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  6. L. Regolo MD
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  7. C. Pedrazzoli MD
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  8. E. Rondini MD
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  9. C. Amanti MD
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  10. G. Gentile MD
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  11. M. Taffurelli MD
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  12. P. Fenaroli MD
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  13. C. Tondini MD
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  14. G. Sacchetto MD
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  15. P. Sismondi MD
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  16. R. Murgo MD
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  17. M. Orlandi MD
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  18. E. Cianchetti MD
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  19. C. Andreoli MD
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Corresponding author

Correspondence to W. Gatzemeier MD.

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Tinterri, C., Gatzemeier, W., Costa, A. et al. Breast-Conservative Surgery With and Without Radiotherapy in Patients Aged 55–75 Years With Early-Stage Breast Cancer: A Prospective, Randomized, Multicenter Trial Analysis After 108 Months of Median Follow-up. Ann Surg Oncol 21, 408–415 (2014). https://doi.org/10.1245/s10434-013-3233-x

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  • DOI: https://doi.org/10.1245/s10434-013-3233-x

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