title: Tamoxifen for one year versus two years versus 6 months of Tamoxifen and 6 months of megestrol acetate: a randomized comparison in postmenopausal patients with high-risk breast cancer (DBCG 89C).
abstract: From January 1, 1990 to December 31, 1994, DBCG conducted a randomised trial in 1 615 postmenopausal women with operable, high-risk, receptor-positive or -unknown breast cancer. The patients were after surgery randomised to Tamoxifen for 1 year (TAM1), Tamoxifen for 2 years (TAM 2) or Tamoxifen for 6 months followed by megestrol acetate for 6 months (TAM/MA). When the preplanned sample size of 1 500 patients was reached it was decided to continue randomisation to TAM1 or TAM2 and the study was finally closed December 31, 1996. With a median follow-up of more than 10 years, there was no difference in disease-free survival (DFS) or overall survival (OS) among the three treatment arms. Similar results were obtained in the original and extended comparisons of Tamoxifen for 1 versus 2 years. A multivariate analysis in the per-protocol treated patients did not show significant differences in hazard ratios for DFS or OS among the three arms. Side-effects were rare but more common in the TAM2 and TAM/MA arms.
authors.affiliation: Department of Oncology, Arhus University Hospital, Arhus Sygehus, Denmark.
authors.forename: Jørn
authors.initials: J
authors.lastname: Andersen
authors.forename: Claus
authors.initials: C
authors.lastname: Kamby
authors.forename: Bent
authors.initials: B
authors.lastname: Ejlertsen
authors.forename: Søren
authors.initials: S
authors.lastname: Cold
authors.forename: Marianne
authors.initials: M
authors.lastname: Ewertz
authors.forename: Erik H
authors.initials: EH
authors.lastname: Jacobsen
authors.forename: Preben
authors.initials: P
authors.lastname: Philip
authors.forename: Knud A
authors.initials: KA
authors.lastname: Møller
authors.forename: Disa
authors.initials: D
authors.lastname: Jensen
authors.forename: Susanne
authors.initials: S
authors.lastname: Møller
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental; D019290:Megestrol Acetate / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D017698:Postmenopause; D012307:Risk Factors; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D013629:Tamoxifen; D019290:Megestrol Acetate