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Letrozole therapy alone or in sequence with tamoxifen in women with breast cancer
New England Journal of Medicine, 09/23/09

Mouridsen H et al. – Among postmenopausal women with endocrine-responsive breast cancer, sequential treatment with letrozole and tamoxifen, as compared with letrozole monotherapy, did not improve disease-free survival. The difference in overall survival with letrozole monotherapy and tamoxifen monotherapy was not statistically significant.

Methods

Randomized, phase 3, double-blind trial of treatment of hormone-receptor–positive breast cancer in postmenopausal women
Randomly assigned women to receive 5 years of tamoxifen monotherapy, 5 years of letrozole monotherapy, or 2 years of treatment with one agent followed by 3 years of treatment with the other
Compared the sequential treatments with letrozole monotherapy among 6182 women and report a protocol-specified updated analysis of letrozole versus tamoxifen monotherapy in 4922 women
Report a protocol-specified updated analysis of letrozole versus tamoxifen monotherapy in 4922 women

Results

Median follow-up of 71 months after randomization
Disease-free survival not significantly improved with either sequential treatment as compared with letrozole alone (hazard ratio for tamoxifen followed by letrozole, 1.05; 99% confidence interval [CI], 0.84 to 1.32; hazard ratio for letrozole followed by tamoxifen, 0.96; 99% CI, 0.76 to 1.21)
More early relapses among women who were assigned to tamoxifen followed by letrozole than among those who were assigned to letrozole alone
Updated analysis of monotherapy showed a nonsignificant difference in overall survival between women assigned to treatment with letrozole and those assigned to treatment with tamoxifen (hazard ratio for letrozole, 0.87; 95% CI, 0.75 to 1.02)
Rate of adverse events as expected on the basis of previous reports of letrozole and tamoxifen therapy