title: Radiation therapy after breast-conserving surgery; first results of a randomised clinical trial in patients with low risk of recurrence.
abstract: To study the role of radiotherapy and tamoxifen after breast-conserving surgery (BCS) in patients with a favourable prognosis, a clinical trial was initiated by the German Breast Cancer Study Group. Between 1991 and 1998, 361 patients (pT1pN0M0, aged 45-75 years, receptor positive, grade I-II) were randomised to radiotherapy (yes/no) and tamoxifen for 2 years (yes/no) in a 2x2 factorial design; the exclusion of seven centres (14 patients) left 347 patients in the analysis. After a median follow-up of 5.9 years, 77 events concerning event-free survival have been observed. Since a strong interactive effect between radiotherapy and tamoxifen has been established, the results are presented in terms of the treatment effects for all four treatment groups separately. Mainly due to the presence of local recurrences, the event rate was about three times higher in the group with BCS only than in the other three groups. No difference could be established between the four treatment groups for distant disease-free survival rates. It is concluded that even in patients with a favourable prognosis, the avoidance of radiotherapy and tamoxifen after BCS increases the rate of local recurrences substantially.
authors.affiliation: Department of Surgery, Universitätsklinikum Charité Berlin, Germany.
authors.forename: K-J
authors.initials: KJ
authors.lastname: Winzer
authors.forename: R
authors.initials: R
authors.lastname: Sauer
authors.forename: W
authors.initials: W
authors.lastname: Sauerbrei
authors.forename: E
authors.initials: E
authors.lastname: Schneller
authors.forename: W
authors.initials: W
authors.lastname: Jaeger
authors.forename: M
authors.initials: M
authors.lastname: Braun
authors.forename: J
authors.initials: J
authors.lastname: Dunst
authors.forename: T
authors.initials: T
authors.lastname: Liersch
authors.forename: M
authors.initials: M
authors.lastname: Zedelius
authors.forename: K
authors.initials: K
authors.lastname: Brunnert
authors.forename: H
authors.initials: H
authors.lastname: Guski
authors.forename: C
authors.initials: C
authors.lastname: Schmoor
authors.forename: M
authors.initials: M
authors.lastname: Schumacher
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015412:Mastectomy, Segmental / Q000379:methods; D008875:Middle Aged; D013629:Tamoxifen / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D013629:Tamoxifen