Date of preparation March 2016 INT-ABR160015
1
5
16 11
84 46 24
1
4 3
1
1 1
OFF vs FF as 2
nd
-line therapy for APC*
(CONKO-003)
OFF
†
FF
Stratification:
Presence of metastases, duration of
1
st
-line gemcitabine therapy (3, 3–6, or >6 months),
KPS (70–80% or 90–100%)
Primary endpoint: OS
Secondary endpoints: TTP, tolerability
•
PD following
gemcitabine
1
st
-line therapy
•
KPS ≥70
•
Measureable
disease
100
80
60
20
0
40
Time (months)
86
0
3
12 15
24 27
38
33
6
9
18 21
30
0
76
34
6
5
1
1
0
1
14
7
5
3
1
1
84
20
3
3
2
2
1
2
9
7
2
2
2
FF
OFF
No at risk
100
80
60
20
0
40
Time (months)
No at risk
48
18
9 12
0 3 6
36
24
30
42
86
54
FF
OFF
2
10
22 15
76 59 37
4
6
5
3
0
1
Overall survival (%)
Progression-free survival (%)
OFF median 2.9 months (95% CI 2.4–3.2)
FF median 2.0 months (95% CI 1.6–2.3)
HR 0.68 (95% CI 0.50–0.94) p=0.019
OFF median 5.9 months (95% CI 4.1–7.4)
FF median 3.3 months (95% CI 2.7–4.0)
HR 0.66 (95% CI 0.48–0.91) p=0.010
R
1:1
Oettle et al. JCO 2014;32:2423-9
*>88% of patients had metastatic disease
†
OFF differs from FOLFOX (folinic acid, fluorouracil, and oxaliplatin)
with respect to the frequency of treatment administration: fluorouracil
is administered weekly for the first 4 weeks, and oxaliplatin is
administered on Days 8 and 22 of a 6-week cycle
Treatment sequencing algorithms (based on expert opinion) are emerging
