Abstract
In the BIG 1-98 study the aromatase inhibitor, letrozole, produced statistically significant reductions in disease-free survival and distant recurrence compared with tamoxifen in postmenopausal women with endocrine-responsive early-stage breast cancer. In this trial, patients were randomized to 5 years of monotherapy with either tamoxifen or letrozole or to 2 years of letrozole followed by 3 years of tamoxifen, or tamoxifen for 2 years followed by 3 years of letrozole. Owing to the survival benefit demonstrated for patients in the letrozole arm, the tamoxifen arm was unblinded to allow patients to receive letrozole. Of the 2,459 patients enrolled in the tamoxifen monotherapy arm, 619 (25%) selected to crossover to receive letrozole. This selective crossover could lead to an underestimation of the benefit for letrozole, so Colleoni et al. investigated whether letrozole monotherapy could prolong overall survival.
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