Stratified cox regression analysis of extrahepatic recurrence-free survival (ERFS) by groups
| Huaier | Control | HR | 95% CI | |||
| n | Mean ERFS (weeks) | n | Mean ERFS (weeks) | |||
| All patients (FAS) | 686 | 89.3 | 316 | 84.3 | 0.559 | 0.403 to 0.774 |
| Sex | ||||||
| Male | 573 | 89.4 | 275 | 83.9 | 0.551 | 0.388 to 0.784 |
| Female | 113 | 88.4 | 41 | 86.1 | 0.601 | 0.252 to 1.432 |
| Age (years) | ||||||
| <65 | 565 | 89.3 | 255 | 83.6 | 0.531 | 0.371 to 0.76 |
| ≥65 | 121 | 82.0 | 61 | 87.2 | 0.704 | 0.319 to 1.552 |
| No of tumours | ||||||
| Single tumour | 595 | 89.6 | 274 | 84.0 | 0.532 | 0.376 to 0.754 |
| Multiple tumours | 91 | 87.3 | 42 | 84.7 | 0.764 | 0.301 to 1.941 |
| Size of tumour (cm) | ||||||
| <2 | 55 | 821.8 | 25 | 86.0 | 0.354 | 0.079 to 1.548 |
| ≥2, <5 | 340 | 91.6 | 149 | 89.2 | 0.684 | 0.388 to 1.206 |
| ≥5, <10 | 240 | 77.3 | 100 | 80.3 | 0.554 | 0.335 to 0.918 |
| ≥10 | 51 | 74.6 | 42 | 64.8 | 0.538 | 0.25 to 1.155 |
| Tumour capsule | ||||||
| Yes | 537 | 88.8 | 246 | 84.3 | 0.606 | 0.42 to 0.874 |
| No | 149 | 83.5 | 70 | 84.3 | 0.406 | 0.196 to 0.84 |
| Child-Pugh class | ||||||
| A | 643 | 89.9 | 291 | 84.8 | 0.534 | 0.378 to 0.756 |
| B | 43 | 79.6 | 25 | 66.3 | 0.9 | 0.349 to 2.32 |
| BCLC status | ||||||
| A | 547 | 89.7 | 239 | 88.2 | 0.726 | 0.486 to 1.086 |
| B | 139 | 87.5 | 77 | 71.8 | 0.33 | 0.182 to 0.596 |
| Virus infection | ||||||
| (–) | 129 | 87.4 | 76 | 85.6 | 0.379 | 0.168 to 0.855 |
| HBV | 544 | 89.6 | 234 | 83.6 | 0.545 | 0.375 to 0.792 |
| HCV | 8 | – | 5 | – | – | – |
| Others | 5 | – | 1 | – | – | – |
| Edmondson-Steiner grade | ||||||
| I | 76 | 93.6 | 33 | 70.1 | 0.886 | 0.229 to 3.429 |
| II | 412 | 89.0 | 190 | 83.3 | 0.574 | 0.378 to 0.872 |
| III | 190 | 80.8 | 84 | 81.2 | 0.441 | 0.246 to 0.793 |
| IV | 8 | 88.4 | 9 | 19.6 | 2.405 | 0.216 to 26.72 |
| Liver cirrhosis | ||||||
| No | 213 | 83.1 | 118 | 85.0 | 0.567 | 0.309 to 1.042 |
| Yes | 473 | 88.8 | 198 | 83.4 | 0.546 | 0.371 to 0.804 |
| AFP (ng/mL) | ||||||
| <400 | 465 | 91.5 | 201 | 87.5 | 0.563 | 0.356 to 0.89 |
| ≥400 | 219 | 83.7 | 111 | 76.6 | 0.591 | 0.369 to 0.944 |
| TNM class | ||||||
| I | 595 | 89.6 | 274 | 84 | 0.532 | 0.376 to 0.754 |
| II | 49 | 94.2 | 22 | 72.6 | 0.376 | 0.053 to 2.684 |
| III | 42 | 56.7 | 20 | 80.5 | 1.087 | 0.370 to 3.189 |
| Ascites | ||||||
| No | 634 | 89.7 | 290 | 85.5 | 0.548 | 0.386 to 0.778 |
| Yes | 52 | 84.8 | 26 | 39.4 | 0.637 | 0.260 to 1.560 |
| Splenomegaly | ||||||
| No | 575 | 89.0 | 263 | 85.3 | 0.583 | 0.407 to 0.836 |
| Yes | 111 | 90.5 | 53 | 74.9 | 0.457 | 0.211 to 0.988 |
The association between ERFS and those baseline stratification factors, including sex, age, number of tumours, size of tumour, with or without tumour capsule, Child-Pugh class, BCLC status, virus infection status, Edmondson-Steiner grade, with or without liver cirrhosis, AFP level, TNM class, ascites and with or without splenomegaly, respectively, was analysed by Cox proportional-hazards model to generate crude HRs and 95% CIs.
AFP, alpha-fetoprotein; BCLC, Barcelona Clinic Liver Cancer Staging System; FAS, full analysis set.