title: Efficient reduction of loco-regional recurrences but no effect on mortality twenty years after postmastectomy radiation in premenopausal women with stage II breast cancer - a randomized trial from the South Sweden Breast Cancer Group.
abstract: OBJECTIVE
  To study long term loco-regional and distant recurrence rate and survival after post-mastectomy radiotherapy in combination with oral cyclophosphamide in premenopausal women with stage II breast cancer.
  
  
  METHODS
  A three-armed randomized multicenter phase III trial comparing 1) Radiotherapy (RT) 2) RT+ oral cyclophosphamide for one year (RT+C) and 3) Oral cyclophosphamide only (C). Radiotherapy was administered, in 20 fractions, to 48Gy to the axilla and parasternal lymph nodes, 45Gy to infra- and supraclavicular fossae and 38Gy to the chest wall. Cyclophosphamide was prescribed as 12 courses of 130mg/m(2) od for 14 days every 4 weeks.
  
  
  METHODS
  367 patients from 15 surgical departments in Southern Sweden, representing 80% of all eligible patients, were included in the trial between 1978-1983. Median age was 47 years, median tumour size was 25mm, and 33% of the patients were lymph node negative. Median follow-up time was 24 years.
  
  
  RESULTS
  RT reduced the risk at twenty years for loco-regional recurrence in C-treated patients at twenty years with 75% (13.9% vs. 3.5%). The risk reduction was highly significant in both N0 and N+ patients. No reduction in systemic disease or mortality was observed.
  
  
  CONCLUSIONS
  Post-mastectomy radiotherapy reduced loco-regional recurrences in this premenopausal population, but no effect was seen on mortality with 20 years follow-up.
authors.affiliation: Department of Oncology, Lund University Hospital, Lund, Sweden. fredrika.killander@med.lu.se
authors.forename: Fredrika
authors.initials: F
authors.lastname: Killander
authors.forename: Harald
authors.initials: H
authors.lastname: Anderson
authors.forename: Stefan
authors.initials: S
authors.lastname: Rydén
authors.forename: Torgil
authors.initials: T
authors.lastname: Möller
authors.forename: L O
authors.initials: LO
authors.lastname: Hafström
authors.forename: Per
authors.initials: P
authors.lastname: Malmström
mesh_terms: D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D015411:Mastectomy, Modified Radical; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000453:epidemiology / Q000517:prevention & control*; D016019:Survival Analysis; D013548:Sweden / Q000453:epidemiology
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003520:Cyclophosphamide