Table 1.
Baseline characteristics of participants.
| Variable | Total (n = 130) |
|---|---|
| Observation period after initiation of LEN (months) | 11.0 (7.7–17.2) |
| Sex (male/female) | 107/23 |
| Age (years) | 70 (65–76) |
| Body weight (kg) | 61.8 (55.2–69.0) |
| BMI (kg/m2) | 23.5 (21.2–25.3) |
| Etiology (HBV/HCV/alcohol/NAFLD/other) | 28/35/37/26/4 |
| Child–Pugh class (A/B) | 116/14 |
| mALBI grade (1/2a/2b/3) | 48/31/47/4 |
| TNM stage (II/III/IVA/IVB) | 21/47/26/36 |
| Maximum tumor diameter (cm) | 4 (2.5–7.5) |
| Number of tumors | 4 (2–10) |
| Up-to-7 criteria (in/out/no liver tumor) | 49/70/11 |
| Macrovascular invasion (yes/no/no liver tumor) | 49/70/11 |
| Metastasis (yes/no) | 36/94 |
| HCC (recurrence/naive) | 111/19 |
| Total bilirubin (mg/dL) | 0.8 (0.7–1.0) |
| Albumin (g/dL) | 3.7 (3.4–4.1) |
| Prothrombin time-international normalized ratio | 1.05 (0.97–1.13) |
| Platelet count (× 104/μL) | 14.7 (10.1–18.6) |
| Choline-esterase (U/L)** | 198 (151–258) |
| Total cholesterol (mg/dL)** | 165 (147–181) |
| Triglyceride (mg/dL)** | 98 (75–131) |
| LDL-C (mg/dL)** | 89 (69–115) |
| Hemoglobin A1c (%)** | 5.9 (5.5–6.5) |
| Ammonia (μg/dL)** | 48 (37–63) |
| AFP (ng/dL) | 56.7 (7.3–669) |
| PIVKA-II (mAU/mL) | 483.5 (55.5–2094) |
| Initial dose of LEN (4/8/12 mg) | 8/76/46 |
| Initial dose down (yes/no) | 37/93 |
| Dose down during administration (yes/no/unknown) | 63/63/4 |
| Administration period of LEN (months) | 7.7 (3.1–12.2) |
| Discontinued LEN (yes/no) | 97/33 |
| Reason for discontinuing LEN (adverse event/PD/other) | 39/44/14 |
| 1st mRECIST assessment (CR/PR/SD/PD/no assessment) | 0/45/38/42/5 |
| Received other treatments after discontinuing LEN (yes/no) | 59/38 |
| PMI (cm2/m2) | 5.62 (4.63–6.87) |
| Male (cm2/m2) | 5.73 (4.79–7.23) |
| Female (cm2/m2) | 4.63 (3.55–5.64) |
| ΔPMI/m (cm2/m2) | 0.05 (− 0.01 to 0.19) |
| ΔPMI/m rate (%) | 0.99 (− 0.12 to 3.80) |
| Death (yes/no) | 52/78 |
Values are presented as the median (interquartile range). LEN lenvatinib, BMI body mass index, HBV hepatitis B virus, HCV hepatitis C virus, NAFLD non-alcoholic fatty liver disease, mALBI modified albumin-bilirubin, TNM tumor node metastasis, HCC hepatocellular carcinoma, LCL-C low density lipoprotein cholesterol, AFP alpha fetoprotein, PIVKA-II protein induced by Vitamin K absence or antagonists-II, PD progressive disease, mRECIST Modified Response Evaluation Criteria in Solid Tumors, CR complete response, PR partial response, SD stable disease, PMI psoas muscle index, ΔPMI/m change in PMI per month, ΔPMI/m rate rate of change in PMI per month during administration of LEN.
**Calculated using the available data.