J-ALEX: PFS by IRF in subgroups
Multiple stratified Cox regression using prognostic factors
including brain metastases showed consistent treatment effect (HR = 0.34)
Nokihara, et al, ASCO 2016 (Abs. 9008)
Subgroup
Alectinib
(n=103)
Crizotinib
(n=104)
HR (95% CI)
n
Events
n
Events
Overall
103
25
104
58
0.34 (0.21–0.54)
ECOG PS
0/1
101
24
102
57
0.33 (0.20–0.53)
2
2
1
2
1
1.41 (0.08–23.57)
Prior chemotherapy
0
66
15
67
35
0.30 (0.17–0.56)
1
37
10
37
23
0.39 (0.18–0.83)
Clinical stage
Postoperative recurrence
24
6
26
13
0.49 (0.18–1.30)
Stage IIIB/IV
79
19
78
45
0.31 (0.18–0.52)
Age group
≥75
12
3
10
5
0.28 (0.06–1.19)
<75
91
22
94
53
0.34 (0.21–0.56)
Smoking status
Never smoker
56
18
61
33
0.50 (0.28–0.89)
Past or Current smoker
47
7
43
25
0.18 (0.08–0.42)
Brain metastases at
baseline
Yes
14
1
29
16
0.08 (0.01–0.61)
No
89
24
75
42
0.39 (0.23–0.64)
ALK testing method
IHC and FISH
96
21
94
52
0.30 (0.18–0.50)
RT-PCR
7
4
10
6
0.80 (0.22–2.90)
Sex
Female
62
16
63
37
0.31 (0.17–0.57)
Male
41
9
41
21
0.35 (0.16–0.77)
Favours Alectinib
Favours Crizotinib
0.01
1.0
100
0.1
10
INDICACIÓN NO APROBADA, EN INVESTIGACIÓN
