Table 2 Outcome results in the main phase III clinical trials testing adjuvant aromatase inhibitors
From: Status of adjuvant endocrine therapy for breast cancer
Study | Arms | DFS hazard ratio (95% CI) | TTR or RFS hazard ratio (95% CI) | TTDR or DRFI or DRFS or DDFS hazard ratio (95% CI) | BCFI or BCFS hazard ratio (95% CI) | OS hazard ratio (95% CI) |
|---|---|---|---|---|---|---|
Monotherapy analysis (versus tamoxifen) | ||||||
ATAC [53] 120-month follow-up | A versus T versus T + A (5 years) | 0.91 (0.83-0.99) P = 0.04 | TTR 0.84 (0.75-0.93) P = 0.001 | TTDR 0.87 (0.77-0.99) P = 0.03 | NA | 0.97 (0.88-1.08) P = 0.6 |
HR+ patients 0.86 (0.78-0.95) P = 0.003 | HR+ patients 0.79 (0.70-0.89) P = 0.0002 | HR+ patients 0.85 (0.73-0.98) P = 0.02 | HR+ patients 0.95 (0.84-1.06) P = 0.4 | |||
BIG 1-98 [54] 8.1-year follow-up | L versus T | 0.53 (0.78-0.96) P = 0.007 | NA | DRFI 0.86 (0.74-0.998) P = 0.047 | BCFI 0.86 (0.76-0.98) P = 0.03 | 0.87 (0.77-0.999) P = 0.048 |
IPCW 0.82 (0.74-0.92) P <0.0002 |  | IPCW 0.79 (0.68-0.92) P = 0.003 | IPCW 0.80 (0.70-0.92) P = 0.002 | IPCW 0.79 (0.69-0.90) P <0.0006 | ||
TEAM [45] 2.75-year follow-up (before the switch) | Upfront E (2.75 years) versus T | 0.89 (0.77-1.03) P = 0.12 | NA | NA | NA | NA |
Sequential therapy analysis | ||||||
IES [46] 91-month follow-up | T→ E versus T→ T (5 years) | 0.81 (0.72-0.91) P <0.001 | NA | TTDR 0.84 (0.73-0.97) P = 0.01 | BCFS 0.81 (0.71-0.92) P <0.001 | 0.53 (0.75-0.99) P <0.04 |
ARNO 95 [47] 30.1-month follow-up | T (2 years)→A (3 years) versus T (2 years)→T (3 years) | 0.66 (0.44-1.00) P = 0.049 | NA | NA | NA | 0.53 (0.28-0.99) P = 0.045 |
ABCSG Trial 8 [48] 60-month follow-up | T (2 years)→A (3 years) versus T (5 years) | 0.91 (0.75-1.103) P = 0.33 | RFS 0.80 (0.631-1.013) P = 0.06 | DRFS 0.78 (0.60-0.99) P = 0.046 | NA | 0.87 (0.64-1.16) P = 0.33 |
ITA [49] 128-month follow-up | T (2-3 years)→A (5 years) versus T (5 years) | NA | RFS 0.64 (0.44-0.94) P = 0.02 | NA | BCFS 0.72 (0.44-1.17) P = 0.2 | 0.79 (0.52-1.21) P = 0.3 |
BIG 1-98 [54] 8.1-year follow-up | L→T versus T→L (5 years) | L→T 1.06 (0.91-1.23) P = 0.48 | NA | L→T DRFI 1.14 (0.92-1.42) P = 0.24 | L→T BCFI 1.10 (0.91-1.32) P = 0.34 | L→T 0.97 (0.80-1.19) P = 0.79 |
T→L 1.07 (0.92-1.25) P = 0.36 | T→L 1.23 (0.99-1.53) P = 0.06 | T→L 1.16 (0.96-1.40) P = 0.12 | T→L 1.10 (0.90-1.33) P = 0.36 | |||
TEAM [55] 5-year follow-up (after the switch) | E (5 years) versus sequential T→E | 1.06 (0.91-1.24) P = 0.42 | RFS 1.06 (0.88-1.28) P = 0.53 | NA | NA | 1.00 (0.89-1.14) P >0.99 |
Extended therapy analysis | ||||||
MA.17 [56] 64-month follow-up | L versus placebo | 0.68 (0.56-0.83) P <0.001 | NA | DDFS 0.81 (0.63-1.04) P = 0.09 | NA | 0.99 (0.79-1.24) P = 0.83 |
IPCW 0.52 (0.45-0.61) P <0.001 | IPCW 0.51 (0.42-0.61) P <0.001 | IPCW 0.61 (0.52-0.71) P <0.001 | ||||
SCC 0.58 (0.47-0.72) P <0.001 | SCC 0.68 (0.52-0.88) P = 0.004 | SCC 0.76 (0.60-0.96) P = 0.02 | ||||
ABCSG Trial 6 [51] 62.3-month follow-up | A (3 years) versus no further treatment | NA | RFS 0.62 (0.40-0.96) P = 0.031 | DFRS 0.53 (0.29-0.96) P = 0.034 | NA | 0.89 (0.59-1.34) P = 0.57 |
NSABP-33 [52] 30-month follow-up | E (5 years) versus placebo (5 years) | 0.68 P = 0.07 | RFS 0.44 P = 0.004 | NA | NA | NA |