Baseline patient demographics and disease characteristics by treatment group within BIOSTORM and compared with the STORM population undergoing resection
| BIOSTORM (n=188) | STORM (n=900) | ||
| Sorafenib (n=83) | Placebo (n=105) | ||
| Age (years), median (range) | 63 (34–82) | 61 (26–84) | 58 (19–83) |
| ≥65 years, n (%)* | 39 (47.0) | 45 (42.9) | 267 (29.7) |
| Sex, n (%) | |||
| Male | 74 (89.2) | 92 (87.6) | 743 (82.6) |
| Female | 9 (10.8) | 13 (12.4) | 157 (17.4) |
| Race, n (%) | |||
| Asian | 61 (73.5) | 70 (66.7) | 605 (67.2) |
| White | 20 (24.1) | 34 (32.4) | 255 (28.3) |
| Other | 2 (2.4) | 1 (1.0) | 40 (4.4) |
| Region, n (%) | |||
| Americas (North, South) | 6 (7.2) | 8 (7.6) | 102 (11.3) |
| Asia-Pacific (including Australia, New Zealand) | 56 (67.5) | 68 (64.8) | 574 (63.8) |
| Europe | 21 (25.3) | 29 (27.6) | 224 (24.9) |
| Aetiology, n (%) | |||
| Hepatitis B only* | 38 (45.8) | 42 (40.0) | 486 (54.0) |
| Hepatitis C only* | 24 (28.9) | 37 (35.2) | 177 (19.7) |
| Alcohol only | 5 (6.0) | 6 (5.7) | 61 (6.8) |
| Unknown | 15 (18.1) | 13 (12.4) | 120 (13.3) |
| Other | 1 (1.2) | 7 (6.7) | 56 (6.2) |
| BCLC stage, n (%) | |||
| Very early stage (0) | 6 (7.2) | 8 (7.6) | |
| Early stage (A) | 77 (92.8) | 97 (92.4) | |
| Number of lesions, n (%) | |||
| 1 | 73 (88.0) | 99 (94.3) | 851 (94.6) |
| 2 | 9 (10.8) | 5 (4.8) | 41 (4.6) |
| ≥3 | 1 (1.2) | 1 (1.0) | 8 (0.9) |
| Maximum tumour size (mm), median (range) | 39 (12–145) | 35 (16–175) | 40 (10–200) |
| Microscopic vascular invasion, n (%)† | |||
| No | 49 (59.0) | 54 (51.4) | 607 (67.4) |
| Yes* | 33 (39.8) | 48 (45.7) | 293 (32.6) |
| Tumour satellites, n (%)† | |||
| No | 77 (92.8) | 96 (91.4) | 819 (91.0) |
| Yes | 5 (6.0) | 6 (5.7) | 81 (9.0) |
| Histological grade, n (%)‡ | |||
| 1 | 15 (18.1) | 17 (16.2) | 154 (17.1) |
| 2 | 53 (63.9) | 67 (63.8) | 576 (64.0) |
| 3 | 15 (18.1) | 20 (19.0) | 169 (18.8) |
| Risk of recurrence, n (%)† | |||
| Intermediate | 35 (42.2) | 45 (42.9) | 470 (52.2) |
| High* | 47 (56.6) | 57 (54.3) | 430 (47.8) |
| Months resection to random, median (range)§ | 1.8 (1.4–3.9) | 1.8 (1.3–7.2) | 2.6 |
| Liver cirrhosis present, n (%) | 48 (57.8) | 58 (55.2) | 513 (57.0) |
| Child-Pugh, n (%)¶ | |||
| 5 | 68 (81.9) | 85 (81.0) | 716 (79.6) |
| 6 | 14 (16.9) | 19 (18.1) | 161 (17.9) |
| 7 | 1 (1.2) | 1 (1.0) | 19 (2.1) |
| Albumin (g/dL), median (range) | 4.0 (2.9–4.7) | 4.0 (2.8–5.1) | 3.9 |
| Total bilirubin (mg/dL), median (range) | 0.5 (0.2–2) | 0.6 (0.2–2.3) | 0.6 |
| AFP (ng/mL), median (range) | 5.2 (1.8–313.6) | 5.8 (1.3–239.7) | 5.2 |
High risk of recurrence was considered if patients had either one tumour of any size plus microvascular invasion, satellite tumours, or poorly differentiated microscopic appearance, or two or three tumours each 3 cm or smaller in size. An intermediate risk was defined as a single tumour of 2 cm or larger with well-differentiated or moderately differentiated microscopic appearance, and the absence of microvascular invasion or satellite tumours. Presence of liver cirrhosis was determined according to Case Report Form.
*P<0.05 for comparisons between patients in BIOSTORM and STORM cohorts.
†Not available in four patients in BIOSTORM.
‡Not available in one patient in BIOSTORM and STORM.
§Months diagnosis to randomisation in STORM trial.
¶Four patients in STORM trial had Child-Pugh 8.
AFP, alpha-fetoprotein; BCLC, Barcelona Clinic Liver Cancer Group.