title: Omission of radiotherapy in elderly patients with early breast cancer: 15-Year results of a prospective non-randomised trial.
abstract: BACKGROUND
  Whether radiotherapy (RT) is beneficial in elderly (⩾ 70 years) patients undergoing conservative surgery for early breast cancer has long been controversial. Recent randomised trials show that most elderly patients do not benefit from RT. We started a prospective non-randomised trial to address this issue in 1987 and now present results for the 627 consecutive pT1/2cN0 patients recruited, and treated by conservative surgery (quadrantectomy) and tamoxifen, and assigned non-randomly to RT or no RT.
  
  
  METHODS
  We used multivariate competing risks models to estimate 15-crude cumulative incidence (CCI) of ipsilateral breast tumour recurrence (IBTR), distant metastasis and breast cancer mortality. The models incorporated a propensity score as a measure of probability of receiving RT based on baseline characteristics, to account for the lack of randomisation.
  
  
  RESULTS
  For pT1 patients, 15-year CCIs of IBTR, distant metastasis and breast cancer death were indistinguishable in the RT and no RT groups. For pT2 patients, 15-year CCI of IBTR was much higher in those not given RT (14.6% versus 0.8%, p = 0.004), although breast cancer mortality and distant metastasis did not differ significantly between RT and no RT.
  
  
  CONCLUSIONS
  Consistent with the findings of recent randomised trials, our long-term data indicate that most elderly, ER-positive patients with pT1 cN0 breast cancer treated by quadrantectomy do not benefit from RT. The 14.6% CCI of IBTR in our pT2 patients is an additional finding not presented in the trials and suggests that RT should be administered to elderly patients with pT2 disease.
authors.affiliation: Breast Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. Electronic address: gabriele.martelli@istitutotumori.mi.it.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Martelli
authors.affiliation: Department of Clinical Science and Community Health, University of Milan, Milan, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Boracchi
authors.affiliation: Breast Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Guzzetti
authors.affiliation: Department of Clinical Science and Community Health, University of Milan, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Marano
authors.affiliation: Radiotherapy Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Lozza
authors.affiliation: Breast Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Agresti
authors.affiliation: Breast Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Ferraris
authors.affiliation: Breast Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Piromalli
authors.affiliation: Breast Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Greco
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D015999:Multivariate Analysis; D009367:Neoplasm Staging; D011446:Prospective Studies; D011878:Radiotherapy; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
keywords: Breast cancer; Breast-conserving surgery; Elderly patients; Quadrantectomy; Radiotherapy; Tamoxifen