Table 1.
Patients characteristics. The whole cohort is described as well as the two groups of patients treated or not with the full course of four cures of ipilimumab. Adverse events were graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 4.0).
| Patients | Whole cohort n = 77 | < Four cures of Ipilimumab n = 25 | Four cures of Ipilimumab n = 52 | p value |
|---|---|---|---|---|
| Age, mean (SD) y | 59.8 (16.6) | 59.8 (16.3) | 59.8 (17.0) | 1 |
| Women, no. (%) | 35 (45) | 11 (44) | 24 (46) | 1 |
| AJCC stage at inclusion, no. (%) | 0.81 | |||
| IIIc | 8 (10) | 4 (16) | 4 (8) | |
| IV | 4 (5) | 1 (4) | 3 (6) | |
| IVM1a | 2 (3) | 0 | 2 (4) | |
| IVM1b | 7 (9) | 2 (8) | 5 (10) | |
| IVM1c | 56 (73) | 18 (72) | 38 (73) | |
| Response at week 16 (WHO), no. (%) | 0.01 | |||
| CR | 1 (1) | 0 | 1 (2) | |
| PR | 4 (5) | 0 | 4 (8) | |
| SD | 19 (25) | 6 (24) | 13 (25) | |
| PD | 36 (47) | 8 (32) | 28 (54) | |
| Death < w16 | 17 (22) | 11 (44) | 6 (12) | |
| Overall survival (95 % CI) | 0.10 | |||
| at 6 mo | 62 % (52 to 74) | 36% (21 to 61) | 75% (64 to 88) | |
| at 12 mo | 25 % (17 to 37) | 20% (9 to 44) | 28% (18 to 43) | |
| at 24 mo | 11 % (5 to 21) | 12% (4 to 35) | 10% (4 to 24) | |
| Adverse events, no. (%) | ||||
| Total | 36 (47) | 15 (60) | 21 (40) | 0.14 |
| Grade 3 | 16 (21) | 10 (40) | 6 (12) | 0.007 |
| Grade 4 | 2 (3) | 1 (4) | 1 (2) | 0.55 |