title: Long-term results of breast conserving surgery vs. mastectomy for early stage invasive breast cancer: 20-year follow-up of the Danish randomized DBCG-82TM protocol.
abstract: The main objective of the present study aims at comparing the long-term efficacy of breast conserving surgery (BCS) vs. mastectomy (M) based on a randomized design. The Danish Breast Cancer Cooperative Group (DBCG) conducted the trial (DBCG-82TM) from January 1983 to March 1989 recruiting 1154 patients with invasive breast carcinoma. Follow-up time ended 1(st) May 2006 with a median follow-up time of 19.6 years (time span 17.1-23.3 years). Eligibility criteria included a one-sided, unifocal, primary operable breast carcinoma, patient age below 70 years, probability of satisfactory cosmetic outcome with BCS, and no evidence of disseminated disease. The patients accrued were grouped into three subsets: correctly randomized, suspicion of randomization error, and declining randomization. The main analyses focus on the subgroup of 793 correctly randomized patients representing 70% of the complete series. 10-year recurrence free survival (RFS) and 20-year overall survival (OS) based on intent to treat did not reveal significant differences in outcome between breast conserving surgery vs. mastectomy, p=0.95 and p=0.10, respectively. Including the complete series comprising 1133 eligible patients based on treatment in fact given similarly no significant difference between surgical options could be traced in outcome of 10-year RFS and 20-year OS, p=0.94 and p=0.24, respectively. The pattern of recurrences as a first event in breast conservation vs. mastectomy did not differ significantly irrespective of site, p=0.27. Looking into the type of local relapse, viz., new primaries vs. true recurrences, it appeared that new primaries were significantly associated to BCS, while true recurrences dominated among M treated patients (p<0.001). In conclusion, long-term data indicate that BCS in eligible patients proves as effective as mastectomy both regarding local tumour control, RFS and OS. Local failures as a first event consistent with new primaries are strongly associated with BCS, whereas true recurrence predominates after mastectomy.
authors.affiliation: The Danish Breast Cancer Cooperative Group, DBCG, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Mogens
authors.initials: M
authors.lastname: Blichert-Toft
authors.forename: Maja
authors.initials: M
authors.lastname: Nielsen
authors.forename: Maria
authors.initials: M
authors.lastname: Düring
authors.forename: Susanne
authors.initials: S
authors.lastname: Møller
authors.forename: Fritz
authors.initials: F
authors.lastname: Rank
authors.forename: Marie
authors.initials: M
authors.lastname: Overgaard
authors.forename: Henning T
authors.initials: HT
authors.lastname: Mouridsen
mesh_terms: D001943:Breast Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery*; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery*; D017024:Chemotherapy, Adjuvant; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008408:Mastectomy; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D018714:Radiotherapy, Adjuvant; D015996:Survival Rate