title: Breast-conserving treatment with or without radiotherapy in ductal carcinoma In Situ: 15-year recurrence rates and outcome after a recurrence, from the EORTC 10853 randomized phase III trial.
abstract: OBJECTIVE
  Adjuvant radiotherapy (RT) after a local excision (LE) for ductal carcinoma in situ (DCIS) aims at reduction of the incidence of a local recurrence (LR). We analyzed the long-term risk on developing LR and its impact on survival after local treatment for DCIS.
  
  
  METHODS
  Between 1986 and 1996, 1,010 women with complete LE of DCIS less than 5 cm were randomly assigned to no further treatment (LE group, n = 503) or RT (LE+RT group, n = 507). The median follow-up time was 15.8 years.
  
  
  RESULTS
  Radiotherapy reduced the risk of any LR by 48% (hazard ratio [HR], 0.52; 95% CI, 0.40 to 0.68; P < .001). The 15-year LR-free rate was 69% in the LE group, which was increased to 82% in the LE+RT group. The 15-year invasive LR-free rate was 84% in the LE group and 90% in the LE+RT group (HR, 0.61; 95% CI, 0.42 to 0.87). The differences in LR in both arms did not lead to differences in breast cancer-specific survival (BCSS; HR, 1.07; 95% CI, 0.60 to 1.91) or overall survival (OS; HR, 1.02; 95% CI, 0.71 to 1.44). Patients with invasive LR had a significantly worse BCSS (HR, 17.66; 95% CI, 8.86 to 35.18) and OS (HR, 5.17; 95% CI, 3.09 to 8.66) compared with those who did not experience recurrence. A lower overall salvage mastectomy rate after LR was observed in the LE+RT group than in the LE group (13% v 19%, respectively).
  
  
  CONCLUSIONS
  At 15 years, almost one in three nonirradiated women developed an LR after LE for DCIS. RT reduced this risk by a factor of 2. Although women who developed an invasive recurrence had worse survival, the long-term prognosis was good and independent of the given treatment.
authors.affiliation: Mila Donker, Harry Bartelink, and Emiel J.T. Rutgers, The Netherlands Cancer Institute; Nina Bijker, Academic Medical Center, Amsterdam, the Netherlands; Saskia Litière, Gustavo Werutsky, and Nicole Duez, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium; Jean-Pierre Julien, Centre Henri-Becquerel, Rouen; Philippe Rouanet, Centre Régional de Lutte Contre le Cancer, Val d'Aurelle, Montpellier; Christine Tunon de Lara, Bergonie Institute, Bordeaux, France; Ian S. Fentiman, Guy's Hospital, London, United Kingdom; and Roberto Agresti, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Mila
authors.initials: M
authors.lastname: Donker
authors.forename: Saskia
authors.initials: S
authors.lastname: Litière
authors.forename: Gustavo
authors.initials: G
authors.lastname: Werutsky
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Julien
authors.forename: Ian S
authors.initials: IS
authors.lastname: Fentiman
authors.forename: Roberto
authors.initials: R
authors.lastname: Agresti
authors.forename: Philippe
authors.initials: P
authors.lastname: Rouanet
authors.forename: Christine Tunon
authors.initials: CT
authors.lastname: de Lara
authors.forename: Harry
authors.initials: H
authors.lastname: Bartelink
authors.forename: Nicole
authors.initials: N
authors.lastname: Duez
authors.forename: Emiel J T
authors.initials: EJ
authors.lastname: Rutgers
authors.forename: Nina
authors.initials: N
authors.lastname: Bijker
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D002278:Carcinoma in Situ / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology / Q000401:mortality; D016016:Proportional Hazards Models; D018714:Radiotherapy, Adjuvant; D016896:Treatment Outcome