1697 / 1851
CAO/ARO/AIO-04 Trial
Primary Endpoint DFS
Median Follow-up: 50 months (range: 0.3-73)
Time between randomisation and the first of the
following events:
5-FU arm
n=623
5FU/OX arm
n=613
Incomplete local resection
(R2)
10
5
Locoregional recurrence after
R0/R1 resection (+/- distant
metastases)
23 (3.7%)
12 (2%)
Distant metastases / Progression
149
115
Death
Overall
Cancer / treatment related/surgical mortality
Unrelated
Unknown
106
69/4/6
26
1
96
54/7/4
31
0
First events for DFS (total)
198
159
Ref: Adapted from Rodel et al, ASCO 2014