Table 3.
Prognostic factors for progression-free survival and overall survival in Study-2.
| a. Cox hazard analysis for PFS | HR | 95%CI | P value |
|---|---|---|---|
| Age ≥ 75 years | 1.059 | 0.863–1.300 | 0.583 |
| Female gender | 1.013 | 0.802–1.280 | 0.912 |
| ECOG PS 2 | 0.946 | 0.377–2.374 | 0.906 |
| NAFLD/NASH | 0.730 | 0.562–0.978 | 0.019 |
| ALT ≥ 30 U/L | 1.240 | 1.022–1.522 | 0.030 |
| Platelet count ≥ 10 (104/µL) | 0.935 | 0.732–1.194 | 0.588 |
| Elevated FIB-4 index (≥ 3.25) | 1.122 | 0.892–1.412 | 0.326 |
| mALBI grade 2b | 1.172 | 0.945–1.453 | 0.148 |
| AFP ≥ 400 ng/mL | 1.272 | 1.031–1.569 | 0.025 |
| TNM-LCSGJ stage IV | 1.194 | 0.818–1.742 | 0.358 |
| BCLC stage C | 1.043 | 0.713–1.526 | 0.827 |
| Reduced starting dose | 1.215 | 0.980–1.505 | 0.076 |
| Treatment as later line | 0.880 | 0.718–1.079 | 0.219 |
| Results of stepwise regression method | |||
| NAFLD/NASH | 0.763 | 0.594–0.982 | 0.036 |
| ALT ≥ 30 U/L | 1.247 | 1.023–1.520 | 0.029 |
| mALBI grade 2b | 1.236 | 1.003–1.523 | 0.047 |
| AFP ≥ 400 ng/mL | 1.294 | 1.055–1.588 | 0.014 |
| b. Cox hazard analysis for OS | HR | 95%CI | P value |
|---|---|---|---|
| Age ≥ 75 years | 1.167 | 0.904–1.505 | 0.236 |
| Female gender | 1.141 | 0.862–1.510 | 0.358 |
| ECOG PS 2 | 1.106 | 0.394–3.105 | 0.848 |
| NAFLD/NASH | 0.758 | 0.550–1.046 | 0.092 |
| ALT ≥ 30 U/L | 1.188 | 0.934–1.512 | 0.160 |
| Platelet count ≥ 10 (104/µL) | 1.038 | 0.772–1.396 | 0.805 |
| Elevated FIB-4 index (≥ 3.25) | 1.102 | 0.808–1.468 | 0.506 |
| mALBI grade 2b | 1.764 | 1.376–2.262 | < 0.001 |
| AFP ≥ 400 ng/mL | 1.367 | 1.059–1.765 | 0.016 |
| TNM-LCSGJ stage IV | 1.183 | 0.762–1.837 | 0.454 |
| BCLC stage C | 1.174 | 0.756–1.824 | 0.475 |
| Reduced starting dose | 1.055 | 0.807–1.380 | 0.694 |
| Treatment as later line | 0.737 | 0.574–0.946 | 0.017 |
| Results of stepwise regression method | |||
| mALBI grade 2b | 1.875 | 1.481–2.375 | < 0.001 |
| AFP ≥ 400 ng/mL | 1.402 | 1.089–1.805 | 0.009 |
| BCLC stage C | 1.297 | 1.019–1.652 | 0.035 |
| Treatment as later line | 0.737 | 0.578–0.939 | 0.014 |
ALT alanine aminotransferase, NAFLD non-alcoholic fatty liver disease, NASH non-alcoholic steatohepatitis, ECOG PS Eastern Cooperative Oncology Group performance status, ALBI score: albumin-bilirubin score, mALBI grade modified ALBI grade, AFP alpha-fetoprotein, TNM LCSGJ 6th tumor node metastasis stage by Liver Cancer Study Group of Japan 6th edition, BCLC stage Barcelona Clinic Liver Cancer stage.