PALOMA-1: Progression-free survival
(ITT population): Cohort 1 and Cohort 2
Cohort 1: ER+/HER2− advanced breast cancer
Cohort 2: ER+/HER2− advanced breast cancer with CCDN1 amplification and/or loss of p16
Finn RS, et al. Lancet Oncol 2015;16:25–35
34 26
23 18 15
13 11
8
8
5
1
50 41
37 29 21 15 10
5
32 15
10
8
5
4
4
3
3
1
49 33
26 20 14 10
2
PAL + LET
LET
Number of patients at risk
100
90
80
70
60
50
40
30
20
10
0
0
4
8 12 16 20 24 28 32 36 40
100
90
80
70
60
50
40
30
20
10
0
0
4
8 12 16 20 24 28 32 36 40
Cohort 1:
ER+/HER2− advanced breast cancer
Cohort 2:
ER+/HER2− advanced breast cancer
with
CCDN1
amplification and/or loss of p16
Letrozole
Letrozole
Palbociclib + letrozole
Time (months)
PFS probability (%)
Time (MONTHS)
Palbociclib + letrozole
PFS probability (%)
Cohort 1
PAL + LET
(N=34)
LET
(N=32)
Number of Events (%)
15 (44)
25 (78)
Median PFS
, months
(95% CI)
26.1
(11.2, NE)
5.7
(2.6, 10.5)
Hazard Ratio
(95% CI)
0.299
(0.156, 0.572)
P value
<0.0001
Cohort 2
PAL + LET
(N=50)
LET
(N=49)
Number of Events (%)
26 (52)
34 (69)
Median PFS
, months
(95% CI)
18.1
(13.1, 27.5)
11.1
(7.1, 16.4)
Hazard Ratio
(95% CI)
0.508
(0.303, 0.853)
P value
0.0046
