Randomized trials of tamoxifen vs. AIs in the adjuvant breast cancer setting

Clinical trial comparison(s)N. of cases(menopausal status)Follow (years)upOverall resultsPredictive effects by BMIReferences
ATAC
A vs. T
4,939 (post)8.3A better than TA better than T at all BMI levels
A less effective when BMI ≥ 30 for DDFS
A relative benefit of A vs. T when BMI low
[7]
TEAM
E vs. T → E
4,700 (post)5.1E = T
95% CI (0.39–0.84)
E better than T (2.75 years) at all BMI levels, significant in BMI > 30 (DDFS HR = 0.57, 95% CI = 0.39–0.84)
E better than T → E (5.1 years) for any BMI (ns), BMI > 30 (DDFS HR = 0.75, 95% CI = 0.56–1.01 and OS HR = 0.71, 95% CI = 0.51–1.01)
[10]
ABCSG-12
A + G vs. T + G
1,684 (pre)5.2A + G = T + G (DFS)
A + G worse than T + G (OS)
BMI < 25: A = T (DFS, OS)
BMI ≥ 25: A worse than T
HR = 1.49, 95% CI = 0.93–2.03 (DFS)
HR = 3.03, 95% CI = 1.35–6.82 (OS)
[8]
BIG 1–98
L vs. T vs.
L → T vs. T → L
4,760 (post)8.7L better than T
(DFS, DDFS, OS)
L → T or T → L = L
Treatment by BMI interactions (ns)
L vs. T HR: 0.77 NW, 0.68 OW, 0.78 OB
[11]

N.: number of cases; A: anastrozole; T: tamoxifen; L: letrozole; E: exemestane; G: goserelin; T → E: tamoxifen followed by exemestane; L → T: letrozole followed by tamoxifen; T → L: tamoxifen followed by letrozole; BIG 1–98: breast international group 1–98 trial; NW: normal weight; OW: overweight; OB: obese; DDFS: distant disease-free survival; DFS: disease-free survival; OS: overall survival; ns: not significant