Table 1.
Baseline Demographic and Disease Characteristics of Patients Randomly Assigned to Receive Lenvatinib, According to Eastern Cooperative Oncology Group Performance Status
| Parameter | Baseline ECOG PS 0 (n = 144) | Baseline ECOG PS 1 (n = 104) |
|---|---|---|
| Age, median, years (range) | 63.5 (30–80) | 63 (27–89) |
| Age group, n (%) | ||
| ≤65 years | 86 (59.7) | 64 (61.5) |
| >65 years | 58 (40.3) | 40 (38.5) |
| Weight, n (%) | ||
| <60 kg | 33 (22.9) | 22 (21.2) |
| ≥60 kg | 111 (77.1) | 82 (78.8) |
| Sum of target lesion diameters at baseline, median (mm) | 50.1 | 66.1 |
| No. of metastatic sites, n (%) | ||
| 0 | 3 (2.1) | 1 (1.0) |
| 1 | 45 (31.3) | 17 (16.3) |
| 2 | 46 (31.9) | 38 (36.5) |
| 3 | 37 (25.7) | 28 (26.9) |
| ≥4 | 13 (9.0) | 20 (19.2) |
| NLR level, n (%) | ||
| ≤3 | 76 (52.8) | 44 (42.3) |
| >3 | 68 (47.2) | 60 (57.7) |
| Absolute neutrophil count, 109/L, mean (SD) | 4.0 (1.7) | 4.5 (2.1) |
| Absolute lymphocyte count, 109/L, mean (SD) | 1.3 (0.5) | 1.3 (0.6) |
| Hypertension, n (%) | ||
| Yes | 81 (56.3) | 57 (54.8) |
| No | 63 (43.8) | 47 (45.2) |
| Diabetes, n (%) | ||
| Yes | 22 (15.3) | 14 (13.5) |
| No | 122 (84.7) | 90 (86.5) |
| Proteinuria, n (%) | ||
| Positive | 5 (3.5) | 4 (3.8) |
| Negative | 139 (96.5) | 100 (96.2) |
| Renal impairment,an (%) | ||
| Yes | 17 (11.8) | 10 (9.6) |
| No | 127 (88.2) | 94 (90.4) |
| Hepatic impairment,bn (%) | ||
| Yes | 19 (13.2) | 8 (7.7) |
| Mild | 17 (11.8) | 8 (7.7) |
| Moderate | 2 (1.4) | 0 |
| No | 125 (86.8) | 96 (92.3) |
These data include only patients with baseline ECOG PS values of 0 or 1.
a
Defined as baseline serum creatine clearance <60 mL/min.
b
Defined as a condition with Common Terminology Criteria for Adverse Events grade ≥1 for any of the following parameters: aspartate aminotransferase, alanine aminotransferase, and bilirubin at baseline; impairment is defined as mild if any parameter is grade 1; impairment is defined as moderate if any parameter is grade 2.
ECOG PS, Eastern Cooperative Oncology Group performance status; NLR, neutrophil-to-lymphocyte ratio; SD, standard deviation.