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)
2008; Taylor & Francis; Volume: 47; Issue: 4 Linguagem: Inglês
10.1080/02841860802014882
ISSN1651-226X
AutoresJørn Andersen, Claus Kamby, Bent Ejlertsen, Søren Cold, Marianne Ewertz, E.H. Jacobsen, Preben Philip, Knud A. Møller, Disa Jensen, Susanne Møller,
Tópico(s)Cancer Treatment and Pharmacology
ResumoFrom 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.
Referência(s)