Characteristic
Events / Patients
HR (95% CI)
lenvatinib vs
sorafenib
Median (months)
Lenvatinib Sorafenib
Lenvatinib Sorafenib
Age
<65 yrs
203/270
204/283
0.94 (0.77, 1.15)
12.4
11.4
≥65 yrs
148/208
146/193
0.84 (0.66, 1.07)
14.6
13.4
Sex
Male
293/405
293/401
0.91 (0.77, 1.07)
13.4
12.4
Female
58/73
57/75
0.84 (0.56, 1.26)
15.3
11.4
Region
Asia-Pacific
243/321
248/319
0.86 (0.72, 1.02)
13.5
11.0
Western
108/157
102/157
1.08 (0.82, 1.42)
13.6
14.2
ECOG-PS
PS=0
221/304
223/301
0.88 (0.73, 1.06)
14.6
12.8
PS=1
130/174
127/175
0.97 (0.76, 1.25)
10.7
10.3
Body weight
<60 kg
110/153
113/146
0.85 (0.65, 1.11)
13.4
10.3
≥60 kg
241/325
237/330
0.95 (0.79, 1.14)
13.7
12.5
MVI, EHS, or both
Yes
250/329
259/336
0.87 (0.73, 1.04)
11.5
9.8
No
101/149
91/140
1.05 (0.79, 1.40)
18.0
18.0
AFP at baseline
<200 ng/mL 167/255
193/286
0.91 (0.74, 1.12)
19.5
16.3
≥200 ng/mL 183/222
154/187
0.78 (0.63, 0.98)
10.4
8.2
Aetiology
HBV
196/259
186/244
0.83 (0.68, 1.02)
13.4
10.2
HCV
75/103
97/135
0.91 (0.66, 1.26)
15.3
14.1
Alcohol
22/33
15/23
1.03 (0.47, 2.28)
14.1
11.9
BCLC staging
Stage B
71/104
65/92
0.91 (0.65, 1.28)
18.5
17.3
Stage C
280/374
285/384
0.92 (0.77, 1.08)
11.8
10.3
PT anticancer
therapy
Yes
143/206
175/243
0.84 (0.67, 1.06)
19.5
17.0
No
208/272
175/233
0.91 (0.74, 1.11)
10.5
7.9
PT anticancer
procedures
Yes
63/99
82/112
0.71 (0.51, 1.01)
23.0
19.6
No
288/379
268/364
0.94 (0.79, 1.11)
11.6
10.1
PT anticancer
medication
Yes
110/156
132/184
0.87 (0.67, 1.14)
20.8
17.0
No
241/322
218/292
0.90 (0.75, 1.09)
11.5
9.1
Overall
351/478
350/476
0.92 (0.79, 1.06)
13.6
12.3
AFP = alpha-fetoprotein; BCLC = Barcelona Clinic Liver Cancer; CI = confidence interval; ECOG-PS = Eastern Cooperative Oncology Group Performance Status;
EHS = extrahepatic spread; HBV = hepatitis B virus; HCV = hepatitis C virus; MVI = macroscopic portal vein invasion; OS = overall survival;
PS = performance status; PT = post-treatment.
1. Kudo M
et al
.
Lancet
. 2018;pii:S0140-6736(18)30207–1.
REFLECT TRIAL
Forest Plot of OS in Subgroup Analyses
Favours
lenvatinib
Favours
sorafenib
1
0.5
2