title: Radiotherapy or tamoxifen after conserving surgery for breast cancers of excellent prognosis: British Association of Surgical Oncology (BASO) II trial.
abstract: BACKGROUND
  The incidence of local recurrence (LR) after conservative surgery for early breast cancer without adjuvant therapy is unacceptably high even with favourable tumours. The aim of this study was to examine the effect of adjuvant therapies in tumours with excellent prognostic features.
  
  
  METHODS
  Patients with primary invasive breast cancer <2 cm diameter, grade 1 or good prognosis special type, and node negative, treated by wide local excision (WLE) with clear margins were randomised into a 2 × 2 clinical trial of factorial design with or without radiotherapy and with or without tamoxifen. Trial entry was allowed to either comparison or both.
  
  
  RESULTS
  The actuarial breast cancer specific survival in 1135 randomised patients at 10 years was 96%. Analysis by intention to treat showed that LR after WLE was reduced in patients randomised to radiotherapy (RT) (HR 0.37, CI 0.22-0.61 p<0.001) and to tamoxifen (HR 0.33, CI 0.15 - 0.70 p<0.004). Actuarial analysis of patients entered into the four-way randomisation showed that LR after WLE alone was 1.9% per annum (PA) versus 0.7% with RT alone and 0.8% with tamoxifen alone. No patient randomised to both adjuvant treatments developed LR. Analysis by treatment received showed LR at 2.2%PA for surgery alone versus 0.8% for either adjuvant radiotherapy or tamoxifen and 0.2% for both treatments.
  
  
  CONCLUSIONS
  Even in these patients with tumours of excellent prognosis, LR after conservative surgery without adjuvant therapy was still very high. This was reduced to a similar extent by either radiotherapy or tamoxifen but to a greater extent by the receipt of both treatments.
authors.affiliation: Nottingham City Hospital, Hucknall Rd., Nottingham NG5 1PB, United Kingdom.
authors.forename: R W
authors.initials: RW
authors.lastname: Blamey
authors.forename: T
authors.initials: T
authors.lastname: Bates
authors.forename: U
authors.initials: U
authors.lastname: Chetty
authors.forename: S W
authors.initials: SW
authors.lastname: Duffy
authors.forename: I O
authors.initials: IO
authors.lastname: Ellis
authors.forename: D
authors.initials: D
authors.lastname: George
authors.forename: E
authors.initials: E
authors.lastname: Mallon
authors.forename: M J
authors.initials: MJ
authors.lastname: Mitchell
authors.forename: I
authors.initials: I
authors.lastname: Monypenny
authors.forename: D A L
authors.initials: DA
authors.lastname: Morgan
authors.forename: R D
authors.initials: RD
authors.lastname: Macmillan
authors.forename: J
authors.initials: J
authors.lastname: Patnick
authors.forename: S E
authors.initials: SE
authors.lastname: Pinder
mesh_terms: D000328:Adult; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D059186:Chemoradiotherapy, Adjuvant; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011379:Prognosis; D011878:Radiotherapy / Q000379:methods*; D016019:Survival Analysis; D013629:Tamoxifen / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen