Table 2.
Comparison between the low and normal PMI groups at baseline.
| Variable | Normal PMI (n = 67) | Low PMI (n = 63) | P-value |
|---|---|---|---|
| Observation period after initiation of LEN (months) | 12.3 (8.4–17.3) | 9.8 (7.3–17.1) | 0.18 |
| Sex (male/female) | 49/18 | 58/5 | 0.005 |
| Age (years) | 70 (65–76) | 70 (65–76) | 0.725 |
| Body weight (kg) | 62.8 (56.0–68.7) | 60.9 (54.5–69.2) | 0.415 |
| BMI (kg/m2) | 23.9 (22.1–25.9) | 23.0 (20.6–25.0) | 0.087 |
| Child–Pugh class (A/B) | 61/6 | 55/8 | 0.496 |
| mALBI grade (1/2a/2b/3) | 26/16/24/1 | 22/15/23/3 | 0.532 |
| TNM stage (I/II/III/IVA/IVB) | 13/19/14/21 | 8/28/12/15 | 0.585 |
| Up-to-7 criteria (in/out/no liver tumor) | 23/36/8 | 26/34/3 | 0.457 |
| Macrovascular invasion (yes/no/no liver tumor) | 27/32/8 | 22/38/3 | 0.354 |
| Metastasis (yes/no) | 21/46 | 15/48 | 0.341 |
| HCC (recurrence/naive) | 57/10 | 54/9 | 0.921 |
| Total bilirubin (mg/dL) | 0.9 (0.7–1.0) | 0.8 (0.7–1.0) | 0.664 |
| Albumin (g/dL) | 3.7 (3.4–4.0) | 3.7 (3.4–4.1) | 0.83 |
| Prothrombin time-international normalized ratio | 1.05 (0.98–1.13) | 1.04 (0.96–1.13) | 0.432 |
| Platelet count (× 104/μL) | 14.1 (9.9–17.0) | 15.3 (12.1–20.7) | 0.111 |
| Choline-esterase (U/L)** | 191 (155–239) | 207 (136–271) | 0.511 |
| Total cholesterol (mg/dL)** | 172 (157–186) | 162 (143–180) | 0.096 |
| Triglyceride (mg/dL)** | 104 (78–139) | 93 (66–114) | 0.093 |
| LDL-C (mg/dL)** | 91 (71–118) | 89 (62–113) | 0.279 |
| Hemoglobin A1c (%)** | 5.9 (5.4–6.6) | 5.8 (5.5–6.5) | 0.672 |
| Ammonia (μg/dL)** | 48 (37–63) | 46 (39–63) | 0.771 |
| AFP (ng/dL) | 97.2 (8.1–1875) | 25.0 (6.7–354) | 0.119 |
| PIVKA-II (mAU/mL) | 460 (37–2133) | 485 (65–2047) | 0.949 |
| Initial dose of LEN (4/8/12 mg) | 3/37/27 | 5/39/19 | 0.185 |
| Initial dose down (yes/no) | 16/51 | 21/42 | 0.236 |
| Dose down during administration (yes/no/unknown) | 34/31/2 | 29/32/2 | 0.596 |
| Administration period of LEN (months) | 8.2 (3.3–12.5) | 6.7 (2.6–12.0) | 0.267 |
| Discontinued LEN (yes/no) | 45/22 | 52/11 | 0.045 |
| Reason for discontinuing LEN (adverse event/PD/other) | 16/20/9 | 23/24/5 | 0.39 |
| 1st mRECIST assessment (CR/PR/SD/PD/no assessment) | 0/28/20/17/2 | 0/17/18/25/3 | 0.044 |
| Received other treatments after discontinuing LEN (yes/no) | 34/11 | 25/27 | 0.006 |
| ΔPMI/m (cm2/m2) | 0.07 (0.00–0.26) | 0.05 (–0.01–0.16) | 0.226 |
| ΔPMI/m rate (%) | 1.13 (–0.02–4.04) | 0.91 (–0.26–3.49) | 0.539 |
| Death (yes/no) | 24/43 | 28/35 | 0.319 |
Significant values are in [bold].
Values are presented as the median (interquartile range). LEN lenvatinib, BMI body mass index, 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.
Low PMI group: PMI < 6.0 cm2/m2 for men and < 3.4 cm2/m2 for women, normal PMI group: PMI ≥ 6.0 cm2/m2 for men and ≥ 3.4 cm2/m2 for women.
**Calculated using the available data.