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).
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.
Andersen
Jørn
J
Department of Oncology, Arhus University Hospital, Arhus Sygehus, Denmark.
Kamby
Claus
C
Ejlertsen
Bent
B
Cold
Søren
S
Ewertz
Marianne
M
Jacobsen
Erik H
EH
Philip
Preben
P
Møller
Knud A
KA
Jensen
Disa
D
Møller
Susanne
S
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
D013629:Tamoxifen; D019290:Megestrol Acetate