Abstract
The Breast International Group (BIG) 1-98 study is a four-arm trial comparing 5 years of monotherapy with tamoxifen or with letrozole or with sequences of 2 years of one followed by 3 years of the other for postmenopausal women with endocrine-responsive early invasive breast cancer. From 1998 to 2003, BIG -98 enrolled 8,010 women. The enhanced design f the trial enabled two complementary analyses of efficacy and safety. Collection of tumor specimens further enabled treatment comparisons based on tumor biology. Reports of BIG 1-98 should be interpreted in relation to each individual patient as she weighs the costs and benefits of available treatments.Clinicaltrials.gov ID: NCT00004205.
Highlights
Reports of large trials of breast cancer confirm the value of aromatase inhibitors as adjuvant systemic therapy for postmenopausal women with endocrine-responsive early breast cancer [1,2,3,4,5,6,7,8,9]
Studies have shown that 5 years of adjuvant therapy with an aromatase inhibitor alone improved disease-free survival (DFS) and time to distant recurrence (TDR) in comparison with 5 years of tamoxifen in this population [1,2,3,12], and recently the Breast International Group (BIG) 1-98 trial showed improved overall survival (OS) with the aromatase inhibitor letrozole [13]
Letrozole significantly reduced the risk of a DFS event (hazard ratio (HR) = 0.81, 95% confidence interval (CI) 0.70 to 0.93; P = 0.003) and the risk of distant recurrence (HR = 0.73, 95% CI 0.60 to 0.88; P = 0.001)
Summary
Reports of large trials of breast cancer confirm the value of aromatase inhibitors as adjuvant systemic therapy for postmenopausal women with endocrine-responsive early breast cancer [1,2,3,4,5,6,7,8,9]. Studies have shown that 5 years of adjuvant therapy with an aromatase inhibitor alone improved disease-free survival (DFS) and time to distant recurrence (TDR) in comparison with 5 years of tamoxifen in this population [1,2,3,12], and recently the Breast International Group (BIG) 1-98 trial showed improved overall survival (OS) with the aromatase inhibitor letrozole [13]. Results were confirmed in an overview analysis [9]
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