Table 2.
Outcomes of nivolumab by dose
| Total (n=47) |
Standard-dose group (n=29) |
Low-dose group (n=18) |
P values | |
| Best response | ||||
| CR | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.206 |
| PR | 7 (14.9) | 4 (13.8) | 3 (16.7) | |
| SD | 7 (14.9) | 3 (10.3) | 4 (22.2) | |
| PD | 27 (57.5) | 20 (69.0) | 7 (38.9) | |
| MR | 4 (8.5) | 1 (3.4) | 3 (16.7) | |
| NE | 2 (4.2) | 1 (3.4) | 1 (5.5) | |
| Best ORR* | 14.9 | 13.8 | 16.7 | 0.788 |
| Best DCR† | 29.8 | 24.1 | 38.9 | 0.282 |
| Progression-free survival | ||||
| Median months (95% CI) | 1.1 (0.8 to 3.0) | 1.0 (0.6 to 1.7) | 3.0 (0.8 to nr) | 0.242 |
| Overall survival | ||||
| Median months (95% CI) | 12.5 (6.5 to nr) | 8.2 (3.1 to nr) | 12.5 (7.0 to nr) | 0.305 |
| Treatment duration | ||||
| Mean±SD (range) | 2.7±3.1 (0.1–11.9) | 2.8±3.7 (0.1–11.9) | 2.5±1.8 (0.5–6.0) | 0.463 |
| Follow-up duration | ||||
| Mean±SD (range) | 5.2±3.9 (0.5–14.2) | 5.6±4.1 (0.5–14.2) | 4.7±3.5 (0.5–12.7) | 0.622 |
*ORR was calculated as summation of CRs and PRs over number of patients multiplied by 100.
†DCR was calculated as summation of CRs, PRs and SDs over number of patients multiplied by 100.
CR, complete response; DCR, disease control rate; MR, mixed response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response.