Time (months)
PIK3CA mutations were detected in 33% of patients who provided baseline plasma samples for cell-free
DNA analysis (129/395)
PALOMA-3: Treatment effect by PIK3CA status
PFS, progression-free survival; HR, hazard ratio; CI, confidence interval
PIK3CA
-wild-type patients (n=266)
Patients with
PIK3CA
mutations (n=129)
0
1
2
3
4
5
6
7
8
9 10 11 12 13 14
0
20
40
60
80
100
180 173 146 141 129 129 112 110 56 53 17 11
4
4
0
86 80 55 52 39 38 31 30 15 15 10
5
0
0
0
Palbociclib + fulvestrant
Placebo + fulvestrant
Number at risk
Placebo + fulvestrant (n=86)
Palbociclib + fulvestrant (n=180)
0
1
2
3
4
5
6
7
8
9 10 11 12 13 14
0
20
40
60
80
100
85 82 67 64 56 55 44 44 23 23 12 10
2
2
0
44 44 28 27 20 20 12 12
4
4
1
1
1
1
0
Palbociclib + fulvestrant
Placebo + fulvestrant
Number at risk
Placebo + fulvestrant (n=44)
PIK3CA
status did not influence the magnitude of PFS benefit from palbociclib
(HR=0·45 for
PIK3CA
wild-type, HR=0·48 for
PIK3CA
mutation positive, P
interaction
= 0·83)
Palbociclib + fulvestrant (n=85)
HR (95% CI) 0.48
(0.30-0.78)
P=0.002
HR (95% CI) 0.45
(0.31-0.64)
P=0.001
PFS%
Time (months)
PFS%
Cristofanilli M, et al. Lancet Oncol 2016)
