Table 1.
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 |