Table 3.
Clinical outcomes by subgroup
| Cohort/subgroup | Best overall response, % (CR + PR) | N (PFS) | Median PFS (Q1, Q3), months | HR (95%CI) | N (OS) | Median OS (Q1, Q3), months | HR (95%CI) |
| Overall | 7.3 | 121 | 2.9 (1.5, 5.6) | 134 | 8.5 (3.6, 24.6) | ||
| Age group (yr) | |||||||
| < 651 | 7.7 | 61 | 3.5 (1.8, 7.1) | 69 | 8.5 (3.6, 23.4) | ||
| 65-75 | 9.8 | 42 | 2.3 (1, 10.3) | 1.40 (0.90-2.15) | 45 | 10.6 (4, 29.7) | 0.87 (0.53-1.44) |
| > 75 | 0 | 18 | 3.8 (1.5, 7.9) | 0.85 (0.48-1.52) | 18 | 6 (3.1, 31.6) | 1.09 (0.58-2.02) |
| Sex | |||||||
| Male1 | 7.4 | 91 | 2.8 (1.6, 5.4) | 92 | 7.1 (3.6, 21.8) | ||
| Female | 6.9 | 30 | 3.6 (1.3, 7.9) | 0.84 (0.53-1.32) | 31 | 14.2 (3.7, 30.3) | 0.68 (0.41-1.15) |
| Race | |||||||
| Asian1 | 12.0 | 25 | 3 (1.5, 5.4) | 25 | 10.6 (5.4, 23.4) | ||
| African-American | 7.7 | 12 | 4.5 (1.9, 6.7) | 0.90 (0.43-1.89) | 15 | 13.7 (1.8, 36.2) | 1.03 (0.47-2.27) |
| Native Hawaiian or other Pacific Islander | 0 | 1 | 2.8 (2.8, 2.8) | 1.37 (0.18-10.3) | 1 | 2.8 (2.8, 2.8) | 6.52 (0.82-51.7) |
| Caucasian | 6.4 | 77 | 2.6 (1.5, 6.4) | 0.89 (0.54-1.47) | 82 | 9.3 (4, 29.7) | 1.05 (0.59-1.84) |
| Child-Pugh Class | |||||||
| A1 | 9.1 | 43 | 3.1 (1.9, 5.4) | 47 | 10.6 (5.2, 24.6) | ||
| B | 10.2 | 50 | 2.6 (1.5, 5.6) | 1.23 (0.79-1.93) | 54 | 6.3 (2.8, 14.2) | 1.36 (0.84-2.19) |
| C | 0 | 11 | 1.4 (0.7, 2.5) | 3.27 (1.57-6.79)a | 12 | 3 (1.7, 4.2) | 4.49 (1.87-10.8)a |
| BCLC stage | |||||||
| 0 | 0 | 1 | 1 (1, 1) | NA | 1 | Not reached | NA |
| A1 | 9.1 | 10 | 10.8 (1, 14.8) | 12 | 23.4 (23.4, -) | ||
| B | 21.7 | 23 | 2.9 (1.5, 9.8) | 1.64 (0.68-3.96) | 24 | 9 (3.1, 22.6) | 4.67 (1.08-20.1) |
| C | 3.4 | 85 | 3 (1.6, 5.3) | 1.79 (0.80-3.98) | 93 | 7.1 (3.6, 24.6) | 4.35 (1.06-17.8) |
| D | 0 | 1 | 2.1 (2.1, 2.1) | NA | 1 | 5.4 (5.4, 5.4) | NA |
| ECOG | |||||||
| 01 | 12.5 | 25 | 5.1 (3, 10.5) | 27 | 29.1 (6, 30.3) | ||
| 1 | 6.2 | 94 | 2.4 (1.4, 5.2) | 1.70 (1.03-2.83)a | 102 | 6.3 (3.1, 14.2) | 2.02 (1.13-3.60) |
| Hepatitis B | |||||||
| No1 | 6.5 | 106 | 3 (1.5, 6) | 116 | 7.9 (3.6, 29.7) | ||
| Yes | 13.3 | 14 | 3 (1.9, 7.3) | 0.90 (0.48-1.70) | 15 | 9 (5.4, 21.8) | 1.31 (0.70-2.42) |
| Hepatitis C | |||||||
| No1 | 5.5 | 54 | 2.8 (1.5, 5.4) | 60 | 7.9 (5, 21.8) | ||
| Yes | 8.8 | 66 | 3 (1.5, 7.1) | 0.94 (0.63-1.39) | 71 | 9.3 (3.6, 29.1) | 0.85 (0.54-1.32) |
| Alcohol-related liver disease | |||||||
| No1 | 7.8 | 102 | 3 (1.5, 6.4) | 110 | 9 (3.7, 29.1) | ||
| Yes | 4.8 | 18 | 2.6 (2.1, 4.1) | 1.17 (0.68-2.00) | 21 | 7.1 (3.1, 13.4) | 1.46 (0.81-2.61) |
| Nonalcoholic fatty liver disease | |||||||
| No1 | 7.1 | 110 | 3 (1.6, 5.6) | 120 | 7.9 (3.7, 23.4) | ||
| Yes | 10.0 | 10 | 2.8 (1.4, 10.6) | 0.79 (0.38-1.63) | 11 | 10.6 (3.1, 29.7) | 0.71 (0.31-1.64) |
1
Reference. The subgroup within a categorical variable (e.g. age) that the other subgroup/s (within the same variable) are compared to for calculation of the Hazard Ratios reported.
a
P < 0.05. BCLC: Barcelona Clinic Liver Cancer; CI: Confidence interval; CR: Complete response; ECOG: Eastern Cooperative Oncology Group; HR: Hazard ratio; NA: Not applicable; OS: Overall survival; PFS: Progression-free survival; PR: Partial response; Q1: Quartile 1; Q3: Quartile 3.