Table 1.
Clinical features of u-HCC patients at first progression of disease (N = 99)
| Parameters | A group (n = 26) | B group (n = 73) | p value |
|---|---|---|---|
| At introducing LEN | |||
| Age, yearsa | 73 (64–78) | 72 (65–78) | 0.924 |
| Gender, male:female | 19:7 | 59:14 | 0.414 |
| Etiology, HCV:HBV:alcohol:other | 16:2:0:8 | 30:14:12:17 | 0.037 |
| BMI, kg/m2a | 22.4 (20.2–25.1) | 21.8 (19.1–23.9) | 0.252 |
| ECOG PS at LEN introduction, 0:1 | 22:4 | 69:4 | 0.201 |
| Platelets, ≥104/µLa | 13.1 (10.2–15.5) | 14.2 (11.1–17.3) | 0.207 |
| AST, U/La | 46 (32–63) | 39 (26–59) | 0.118 |
| ALT, U/La | 38 (22–56) | 27 (19–44) | 0.101 |
| Total bilirubin, mg/dLa | 0.8 (0.6–1.0) | 0.7 (0.5–0.8) | 0.023 |
| Albumin, g/dLa | 3.8 (3.6–4.1) | 3.8 (3.5–4.1) | 0.921 |
| Prothrombin time, %a | 86.1 (77.0–91.0) | 93.0 (82.0–102.0) | 0.044 |
| eGFR, mL/min/1.73 m2a | 71.0 (60.5–92.3) | 72.4 (57.0–81.3) | 0.534 |
| AFP, ng/mL at LEN introductiona (AFP <100:≥100 ng/mL) | 306.5 (11.5–1,898.3) | 24.0 (3.9–473.2) | 0.034 (0.108) |
| (10:16) | (43:30) | ||
| Started with reduced dose of LEN | 5 (19.2%) | 16 (21.9%) | 1.000 |
| Past history of SOR | 15 (57.7%) | 29 (39.7%) | 0.167 |
| Past history of REG | 5 (19.2%) | 7 (9.6%) | 0.291 |
| ALBI score at LEN introductiona | −2.48 (−2.30 to −2.61) | −2.57 (−2.24 to −2.79) | 0.504 |
| mALBI grade at introducing LEN, 1:2a:2b:3 | 7:12:7:0 | 34:19:20:0 | 0.127 |
| Child-Pugh score, 5:6 | 18:8 | 52:21 | 1.0 |
| Intrahepatic tumor size, none:<2:2–5:>5 cm (maximum) | 2:2:16:6 | 10:22:25:16 | 0.043 |
| Intrahepatic tumor, n, none:single:multiple | 2:3:21 | 10:7:56 | 0.785 |
| Positive for MVI, % | 2 (7.7) | 3 (4.1) | 0.604 |
| Positive for EHM, % | 12 (46.2) | 30 (41.1) | 0.653 |
| TNM-LCSGJ at LEN introduction, II:III:IVa:IVb | 0:9:4:13 | 17:20:6:30 | 0.022 |
| BCLC stage at LEN introduction, A:B:C | 0:10:16 | 2:33:38 | 0.729 |
| Best response (CR:PR:SD:PD)b | 0:8:11:7 | 3:23:31:16 | 0.862 |
| At time of PDb | |||
| ECOG PS at time of PD,b 0:1:2:3 | 13:8:2:3 | 53:17:3:0 | 0.015 |
| Frequency of decline of ECOG PS from baseline, % | 11 (42.3) | 19 (26.0) | 0.141 |
| AFP, ng/mLa at time of PDb (AFP <100:≥100 ng/mL) | 604.1 (16.2–6,227.5) | 48.5 (6.1–522.4) | 0.016 (0.038) |
| (9:17) | (44:29) | ||
| Delta ALBI score at time of PDb from baselinea | 0.24 (−0.05–0.69) | 0.25 (0.01–0.47) | 0.691 |
| ALBI scorea at time of PDb | −2.18 (−2.19 to −2.64) | −2.35 (−1.94 to −2.65) | 0.467 |
| mALBI grade at time of PD,b 1:2a:2b:3 | 8:4:11:3 | 21:21:25:6 | 0.571 |
| Child-Pugh score at time of PD,b 5:6:7:8:9: ≥10 (frequency of | 11:5:5:2:3:0 (16, 61.5%) | 37:19:8:4:3:2 (56, 76.7%) | 0.612 (0.199) |
| Child-Pugh class A, %) | |||
| TNM-LCSGJ at time of PD,b II:III:Iva:IVb | 0:7:4:15 | 8:23:6:36 | 0.243 |
| BCLC stage at time of PD, A:B:C:D | 0:3:20:3 | 1:21:50:1 | 0.034 |
| Postprogression treatment, BSC:SOR:REG:RAM:HAIC | 17:4:3:1:1 | na | na |
| PD pattern (appearance of new EHM:appearance of MVI: appearance of | |||
| intrahepatic new lesion:increasing size without new lesion) | 4:1:9:12 | 10:3:29:31 | 0.939 |
| Period of LEN administration, monthsa | 4.5 (2.2–7.5) | 11.4 (6.8–16.3) | <0.001 |
| Difference between time of LEN administration discontinuation and | |||
| PD,b monthsa | 0 (−0.4 to 0.10) | 4.1 (2.3–7.3) | <0.001 |
| Death during observation period, % | 19 (73.1%) | 33 (45.2%) | 0.021 |
| Observation period, monthsa | 7.5 (5.5–12.2) | 15.4 (10.3–21.0) | <0.001 |
| IPWa | 3.02 (2.19–4.29) | 1.23 (1.10–1.45) | <0.001 |
u-HCC, unresectable hepatocellular carcinoma; HCV, hepatitis C virus; HBV, hepatitis B virus; BMI, body mass index; ECOG PS, Eastern Cooperative Oncology Group performance status; AST, aspartate transaminase; ALT, alanine aminotransferase; AFP, alpha-fetoprotein; eGFR, estimated glomerular filtration rate; ALBI, albumin-bilirubin; mALBI, modified ALBI grade; MVI, major portal vein tumor thrombosis (Vp3 and Vp4); EHM, extrahepatic metastasis; BCLC, Barcelona Clinic Liver Cancer stage; EHM, extrahepatic metastasis; TNM-LCSGJ 6th, tumor node metastasis stage by Liver Cancer Study Group of Japan, 6th edition; RECIST, Response Evaluation Criteria In Solid Tumors version 1.1; CR, complete response; PR, partial response; SD, stable disease; PD, progression of disease; BSC, best supportive care; SOR, sorafenib; REG, regorafenib; RAM, ramucirumab; HAIC, hepatic arterial infusion chemotherapy; na, not applicable; LEN, lenvatinib; IPW, inverse probability weighting.
Median values (interquartile range) are shown as numbers, unless otherwise indicated.
Evaluated by RECIST 1.1.