Table 4.
Comparison between the severe and mild atrophy groups.
| Variable | Time of start of taking LEN | Time of end of taking LEN | ||||
|---|---|---|---|---|---|---|
| Mild atrophy (n = 65) | Severe atrophy (n = 65) | P value | Mild atrophy | Severe atrophy | P value | |
| Observation period after initiation of LEN (months) | 13.8 (9.2–18.9) | 8.7 (6.0–14.8) | < 0.001 | |||
| Sex (male/female) | 54/11 | 53/12 | 0.822 | |||
| Age (years) | 70 (66–76) | 70 (64–75) | 0.597 | |||
| Body weight (kg) | 62.8 (57.4–69.5) | 60.7 (55.0–68.0) | 0.174 | |||
| BMI (kg/m2) | 23.9 (22.0–25.7) | 22.6 (20.8–25.1) | 0.054 | |||
| Child–Pugh score (5/6/7/8/9/10-/unknown) | 42/18/4/1/0/0/0 | 37/19/6/2/1/0/0 | 0.285 | 17/11/8/6/0/0/23 | 8/17/7/9/2/4/18 | 0.014 |
| Child–Pugh class (A/B/C/unknown) | 60/5/0/0 | 56/9/0/0 | 0.261 | 28/14/0/23 | 25/18/4/18 | 0.126 |
| ALBI score | –2.48 (–2.77 to –2.14) | –2.31 (–2.65 to –2.08) | 0.129 | –2.28 (–2.51 to –1.95) | –2.05 (–2.39 to –1.59) | 0.049 |
| mALBI grade (1/2a/2b/3/unknown) | 29/13/22/1/0 | 19/18/25/3/0 | 0.114 | 8/10/19/5/23 | 5/8/26/8/18 | 0.137 |
| TNM Stage (II/III/IVA/IVB/unknown) | 10/26/10/19 | 11/21/16/17 | 0.905 | 3/9/11/18/24 | 6/14/10/18/17 | 0.305 |
| HCC (recurrence/naive) | 57/8 | 54/11 | 0.460 | |||
| Total bilirubin (mg/dL) | 0.8 (0.6–1.0) | 0.8 (0.7–1.0) | 0.445 | 0.9 (0.7–1.3) | 1.1 (0.7–1.9) | 0.358 |
| Albumin (g/dL) | 3.8 (3.4–4.1) | 3.6 (3.4–3.9) | 0.125 | 3.6 (3.2–3.8) | 3.4 (2.9–3.7) | 0.035 |
| Prothrombin time-international normalized ratio | 1.05 (0.97–1.15) | 1.05 (0.98–1.12) | 0.817 | 1.03 (0.96–1.12) | 1.02 (0.98–1.20) | 0.799 |
| Platelet count (× 104/μL) | 14.1 (10.0–17.7) | 15.0 (10.8–18.9) | 0.568 | 13.2 (8.5–17.5) | 13.1 (10.2–18.8) | 0.351 |
| Choline-esterase (U/L) ** | 216 (171–264) | 173 (138–244) | 0.024 | 190 (145–257) | 150 (107–197) | 0.001 |
| Total cholesterol (mg/dL)** | 170 (147–189) | 162 (149–177) | 0.380 | 168 (130–204) | 158 (121–204) | 0.468 |
| Triglyceride (mg/dL)** | 91 (70–129) | 104 (77–135) | 0.219 | 98 (62–147) | 82 (68–108) | 0.646 |
| LDL-L (mg/dL)** | 85 (64–114) | 93 (70–115) | 0.478 | 97 (71–128) | 92 (63–115) | 0.446 |
| Hemoglobin A1c (%)** | 5.7 (5.5–6.5) | 5.9 (5.5–6.5) | 0.761 | 5.6 (5.3–6.1) | 5.3 (5.1–6.1) | 0.322 |
| Ammonia (μg/dL)** | 46 (34–55) | 53 (41–66) | 0.040 | 45 (30–52) | 47 (34–66) | 0.164 |
| AFP (ng/dL) | 31.8 (5.8–415) | 97.2 (8.5–2156) | 0.181 | 64.1 (5.1–1574) | 59.8 (6.5–1875) | 0.571 |
| PIVKA-II (mAU/mL) | 424 (39–1719) | 663 (80.3–2136) | 0.368 | 1825 (296–17,882) | 2251 (210–16,902) | 0.837 |
| Initial dose of LEN (4/8/12 mg) | 2/35/28 | 6/41/18 | 0.037 | |||
| Initial dose down (yes/no) | 15/50 | 22/43 | 0.176 | |||
| Dose down during administration (yes/no/unknown) | 37/25/3 | 26/38/1 | 0.033 | |||
| Administration period of LEN (months) | 9.4 (4.6–13.8) | 6.0 (2.7–9.4) | 0.015 | |||
| Discontinued LEN (yes/no) | 48/17 | 49/16 | 0.843 | |||
| Reason for discontinuing LEN (adverse event/PD/other) (n = 97) | 16/26/6 | 23/18/8 | 0.175 | |||
| Receiving other treatments after discontinuing LEN (yes/no) (n = 97) | 37/11 | 22/27 | 0.001 | |||
| The 1st mRECIST assessment (CR/PR/SD/PD/unknown) | 0/25/16/20/4 | 0/20/22/22/1 | 0.446 | |||
| Death (yes/no) | 22/43 | 30/35 | 0.154 | |||
| PMI (cm2/m2) | 5.58 (4.48–7.22) | 5.66 (4.79–6.61) | 0.773 | 5.91 (4.38–7.03) | 4.26 (3.59–5.32) | < 0.001 |
| ΔPMI/m (cm2/m2) | –0.01 (–0.13–0.3) | 0.19 (0.13–0.45) | < 0.001 | |||
Significant values are in [bold].
Values are presented as median (interquartile range). LEN lenvatinib, BMI body mass index, ALBI albumin-bilirubin, 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.
Severe atrophy group: ΔPMI/m rate ≥ 1%, Mild atrophy group: ΔPMI/m rate < 1%.
(ΔPMI/m rate: rate of change in PMI per month during administration of LEN).
**Calculated using the available data.