Annals of Surgical Oncology

, Volume 21, Issue 2, pp 408–415 | Cite as

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

  • C. Tinterri
  • W. Gatzemeier
  • A. Costa
  • M. A. Gentilini
  • V. Zanini
  • L. Regolo
  • C. Pedrazzoli
  • E. Rondini
  • C. Amanti
  • G. Gentile
  • M. Taffurelli
  • P. Fenaroli
  • C. Tondini
  • G. Sacchetto
  • P. Sismondi
  • R. Murgo
  • M. Orlandi
  • E. Cianchetti
  • C. Andreoli
Breast Oncology

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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Copyright information

© Society of Surgical Oncology 2013

Authors and Affiliations

  • C. Tinterri
    • 1
  • W. Gatzemeier
    • 1
  • A. Costa
    • 2
  • M. A. Gentilini
    • 3
  • V. Zanini
    • 4
  • L. Regolo
    • 4
  • C. Pedrazzoli
    • 5
  • E. Rondini
    • 5
  • C. Amanti
    • 6
  • G. Gentile
    • 7
  • M. Taffurelli
    • 8
  • P. Fenaroli
    • 9
  • C. Tondini
    • 9
  • G. Sacchetto
    • 10
  • P. Sismondi
    • 11
  • R. Murgo
    • 12
  • M. Orlandi
    • 13
  • E. Cianchetti
    • 14
  • C. Andreoli
    • 1
  1. 1.Breast Unit, Istituto Clinico HumanitasRozzanoItaly
  2. 2.European School of OncologyMilanItaly
  3. 3.Center of Epidemiology and Clinical EvaluationTrentoItaly
  4. 4.Division of Surgery and SenologyThe Maugeri FoundationPaviaItaly
  5. 5.Division of SurgeryArcispedale Santa Maria NuovaReggio EmiliaItaly
  6. 6.Division of Surgery and Medical TechnologySant’ Andrea HospitalRomeItaly
  7. 7.Division of SurgeryS. Maria della Misericordia HospitalUdineItaly
  8. 8.Division of SurgeryS. Orsola Malpighi HospitalBolognaItaly
  9. 9.Breast UnitOspedali RiunitiBergamoItaly
  10. 10.Division of SurgeryGeneral Hospital AlbaAlbaItaly
  11. 11.Division of GynaecologyCancer Research Centre TorinoTurinItaly
  12. 12.Breast UnitCasa Sollievo della Sofferenza HospitalSan Giovanni RotondoItaly
  13. 13.Division of GynaecologyGeneral Hospital CiriéCiriéItaly
  14. 14.Breast UnitG. Bernabeo HospitalOrtonaItaly

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