Table 1. A summary of the AI trials that have been reported to date.
n | AI | Design | Age | ER+ | % n+ | FU | DFS HR | Events AI/TAM | DFS P val | OS | Deaths AI/TAM | OS P val | ref | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ATAC | 5216 | A | sub | 64 | 100 | 35 | 100 | 0.85 | 618/702 | 0.003 | 0.97 | 472/477 | NS | 1 |
BIG 1-98 | 4922 | L | sub | 61 | 98 | 41 | 76 | 0.88 | 509/565 | 0.03 | 0.87 | 303/343 | 0.08 | 2 |
IES | 4602 | E | sw | n/s | 100 | 48 | 56 | 0.75 | 339/439 | 0.0001 | 0.83 | 210/251 | 0.05 | 3 |
ABCSG-8 | 2922 | A | sw | n/s | 100 | 25 | 72 | 0.79 | 202/235 | 0.038 | 0.77 | 130/157 | 0.025 | 4 |
ARNO-95 | 979 | A | sw | 61 | 97 | 25 | 30 | 0.66 | 36/47 | 0.049 | 0.53 | 15/28 | 0.045 | 5 |
ITA/GROCTA | 828 | A,AG | sw | 64 | 100 | 85 | 78 | not stated | 0.61 | 48/74 | 0.007 | 6 | ||
NSABP B33 | 1598 | E | ext | 60 | 100 | 48 | 30 | 0.68 | 37/52 | 0.07 | 1.0 | 16/13 | NS | 7 |
MA17 | 5187 | L | ext | 62 | 97 | 46 | 64 | 0.68 | 164/235 | 0.0001 | 1.0 | 154/155 | NS | 8 |
Abbreviations: sub=substitution, sw=switching, ext=extension. A=Anastrozole, L=Letrozole, E=Exemestane, AG=Aminogluthemide.
Those trials that have a statistically significant mortality benefit are highlighted in pink. This table clearly shows that only the switching trials have been able to show a mortality benefit from the AIs.
Refs: 1=ATAC Trialists, 2008; 2=Mouridsen et al, 2008; 3=Coombes et al, 2007; 4=Jakesz et al, 2008; 5=Kaufmann et al, 2007; 6=Boccardo et al, 2007; 7=Mamounas et al, 2008; 8=Ingle et al, 2008a.
All these analyses are intent to treat (ITT) with no adjustment for crossover and patients are kept in their originally assigned groups even if they crossed over from the control arm to the investigational arm. However, for the ATAC and IES data presented in this table, the ER unknown or ER-negative patients are excluded from analysis.
For MA17, a 2005 report showed an OS advantage in the node-positive subgroup; this was not seen in the most recent results, probably because of a high crossover rate.
For ATAC, the figure in the table is for the ER-positive subgroup.