Table 2.
Best objective response evaluated by RECIST 1.1 and mRECIST in HCC patients in the first-line setting or with prior systemic therapy failure
| Parameter, n (%) | Entire cohort (n = 71) | RECIST v1.1 | mRECIST | |||||
|---|---|---|---|---|---|---|---|---|
| RECIST v1.1 | mRECIST | First-line setting | Systemic therapy-experienced | p Value | First-line setting | Systemic therapy-experienced | p Value | |
| (n = 44) | (n = 27) | (n = 44) | (n = 27) | |||||
| CR | 1 (1.5) | 4 (5.6) | 1 (2.3) | 0 (0) | 1 | 3 (6.8) | 1 (3.7) | 1 |
| PR | 19 (28.4) | 37 (52.1) | 14 (31.8) | 5 (18.5) | 0.219 | 26 (59.1) | 11 (40.7) | 0.133 |
| SD | 36 (53.7) | 16 (22.5) | 22 (50) | 14 (51.9) | 0.88 | 9 (20.5) | 7 (25.9) | 0.592 |
| PD | 15 (21.1) | 14 (19.7) | 7 (15.9) | 8 (29.6) | 0.737 | 6 (13.6) | 8 (29.6) | 0.1 |
| ORR | 20 (28.2) | 41 (57.7) | 15 (34.1) | 5 (18.5) | 0.157 | 29 (65.9) | 12 (44.4) | 0.075 |
| DCR | 56 (78.9) | 57 (80.3) | 37 (84.1) | 19 (70.4) | 0.169 | 38 (86.4) | 19 (70.4) | 0.1 |
| For responders | ||||||||
| Median TTR, months (range) | 2.3 (1.8–8.6) | 2.17 (1–8) | 2.4 (1.8–8.6) | 2.3 (1.93–4.13) | 0.117 | 2.2 (1–8) | 2.03 (1–3) | 0.09 |
| Estimate DOR, months (95% CI) | 9.3 (NE) | 7.0 (3.4–10.6) | 7.0 (4.4–9.5) | NE | 0.13 | 9 (3.6–14.4) | 6.8 (0–15.4) | 0.612 |
CR complete response, DCR disease control rate, DOR duration of response, mRECIST modified RECIST, ORR objective response rate, PD progressive disease, PR partial response, SD stable disease, TTR time to response, NE not estimable