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Randomized Controlled Trial Multicenter Study Clinical Trial
Two years of adjuvant tamoxifen in premenopausal patients with breast cancer: a randomised, controlled trial with long-term follow-up.
- Lisa Rydén, Per-Ebbe Jönsson, Gunilla Chebil, Monika Dufmats, Mårten Fernö, Karin Jirström, Ann-Christin Källström, Göran Landberg, Olle Stål, Sten Thorstenson, Bo Nordenskjöld, South Swedish Breast Cancer Group, and South-East Swedish Breast Cancer Group.
- Department of Surgery, Helsingborgs Lasarett, SE-251 85 Helsingborg, Sweden. lisa.ryden@pat.mas.lu.se
- Eur. J. Cancer. 2005 Jan 1; 41 (2): 256-64.
AbstractAdjuvant tamoxifen treatment increases recurrence-free survival (RFS) and overall survival (OS) in early breast cancer, although in premenopausal patients the number of studies comparing tamoxifen vs no treatment are limited. We report herein the effect on RFS of adjuvant tamoxifen treatment in a multicentre trial of premenopausal patients with stage II breast cancer patients randomised between 1986 and 1991 to 2 years of tamoxifen treatment (n=276) or no treatment (n=288). The receptor status of the tumour was known for 541 (96%) of the patients included. Tamoxifen treatment significantly increased RFS in patients with hormone receptor-positive (oestrogen receptor-positive (ER+) and/or progesterone receptor-positive (PR+)) tumours (Relative Risk (RR) 0.65; 95% Confidence Interval (CI): 0.48-0.89, P=0.006), and the beneficial effect of tamoxifen was extended to patients with indicators of poor prognosis, such as young age and nodal-positivity. PR status was a significant predictor of response to tamoxifen in multivariate models with testing of interactions of hormone receptor status and adjuvant therapy.
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