Table 3.
Baseline characteristics of patients enrolled in REFLECT
| Baseline variable | Lenvatinib, n (%) | Sorafenib, n (%) | SHARP, n (%) | Asia‐Pacific, n (%) |
|---|---|---|---|---|
| Randomized | 478 | 476 | 602 | 226 |
| ECOG performance status at baseline | ||||
| 0 | 301 (63) | 299 (63) | 325 (54) | 59 (26) |
| 1 | 177 (37) | 177 (37) | 231 (38) | 155 (69) |
| Macroscopic portal vein invasion, extrahepatic spread, or both | ||||
| Yes | 297 (62) | 297 (62) | 421 (70) | 179 (79) a |
| No | 181 (38) | 179 (38) | 181 (30) | 47 (21) |
| Body weight | ||||
| <60 kg | 151 (32) | 148 (31) | NA | NA |
| ≥60 kg | 327 (68) | 328 (69) | NA | NA |
| Baseline Child‐Pugh Score | ||||
| 5 (Child‐Pugh A) | 368 (77) | 357 (75) | 581 (97) | 220 (97) |
| 6 (Child‐Pugh A) | 107 (22) | 114 (24) | 581 (97) | 220 (97) |
| 7 (Child‐Pugh B) | 3 (0.6) | 4 (0.8) | 20 (3.2) | 6 (3) |
| 8 (Child‐Pugh B) | 0 | 1 (0.2) | 20 (3.2) | 6 (3) |
| 9 (Child‐Pugh B) | 20 (3.2) | 6 (3) | ||
| 10–15 (Child‐Pugh C) | 1 (0.2) | ‐ | ||
| BCLC Staging | ||||
| Stage B | 104 (22) | 92 (19) | 105 (17) | |
| Stage C | 374 (78) | 384 (81) | 496 (82) | |
| Baseline AFP | ||||
| <200 ng/mL | 255 (53) | 286 (60) | NA | NA |
| ≥200 ng/mL | 222 (46) | 187 (39) | NA | NA |
| Missing | 1 (0.2) | 3 (0.6) | ||
| Number of disease site | ||||
| 1 | 207 (43) | 207 (44) | 25 (10) | |
| 2 | 167 (35) | 183 (38) | 79 (35) | |
| ≥3 | 103 (22) | 86 (18) | 122 (54) | |
| Missing | 1 (0.2) | 0 | ||
| Sites of disease involvement | ||||
| Liver | 441 (92) | 430 (90) | ||
| Lung | 163 (34) | 144 (30) | 112 (50) | |
| Bone | 51 (11) | 43 (9) | ||
| Lymph node | 127 (27) | 141 (30) | 72 (32) | |
| Other sites | 82 (17) | 97 (20) | ||
| Etiology of underlying liver disease | ||||
| Hepatitis B infection | 259 (52) | 244 (51) | 111 (18) | 165 (73) |
| Hepatitis C infection | 103 (22) | 135 (28) | 169 (28) | 19 (8.4) |
| Alcohol abuse | 33 (7) | 23 (4.8) | 159 (26) |
Based on variables captured at stratification for randomization for REFLECT and as described in the Food and Drug Administration–approved package insert for Nexavar, supplement by publication of the SHARP trial and the published results for the ASIA‐Pacific trial.
a
ClinicalTrials.gov [10].
Abbreviations: AFP, Alpha Fetoprotein; BCLC, Barcelona Clinic Liver Cancer; ECOG, Eastern Cooperative Oncology Group.