Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer.

摘要: BACKGROUND: The aromatase inhibitor letrozole, as compared with tamoxifen, improves disease-free survival among postmenopausal women receptor-positive early breast cancer. It is unknown whether sequential treatment tamoxifen and letrozole superior to therapy alone. METHODS: In this randomized, phase 3, double-blind trial of the hormone-receptor-positive cancer in women, we randomly assigned receive 5 years monotherapy, or 2 one agent followed by 3 other. We treatments monotherapy 6182 also report a protocol-specified updated analysis versus 4922 women. RESULTS: At median follow-up 71 months after randomization, was not significantly improved either alone (hazard ratio for 1.05; 99% confidence interval [CI], 0.84 1.32; hazard 0.96; CI, 0.76 1.21). There were more relapses who than those showed that there nonsignificant difference overall between 0.87; 95% 0.75 1.02; P=0.08). rate adverse events expected on basis previous reports therapy. CONCLUSIONS: Among endocrine-responsive cancer, did improve survival. statistically significant. (ClinicalTrials.gov number, NCT00004205.)