Table 1.
Patients characteristics of the whole collective (n=380) considering combined immunotherapy at first line or not at first line
| Baseline characteristics | Total | CombiIT first line | CombiIT not first line | P value* |
| N (%) | ||||
| Sex | ||||
| Male | 240 (63.2) | 165 (66) | 75 (57.7) | 0.111 |
| Female | 140 (36.8) | 85 (44) | 55 (42.3) | |
| Age (years) at the time of CombiIT | ||||
| <54 | 153 (40.3) | 90 (36) | 63 (48.5) | 0.024 |
| 54–64 | 105 (27.6) | 69 (27.6) | 36 (27.7) | |
| >64 | 122 (32.1) | 91 (36.4) | 31 (23.8) | |
| BRAF status | ||||
| BRAF wild type | 138 (36.3) | 112 (44.8) | 26 (20) | < 0.0001 |
| BRAF mutant | 242 (63.7) | 138 (55.2) | 104 (80) | |
| LDH level† | ||||
| Normal | 189 (51.4) | 131 (54.1) | 58 (46.0) | 0.223 |
| Elevated | 133 (36.1) | 85 (35.1) | 48 (38.1) | |
| 2×>ULN | 46 (12.5) | 26 (10.8) | 20 (15.9) | |
| S100B level† | ||||
| Normal | 109 (32.8) | 69 (31.2) | 40 (36.4) | 0.597 |
| Elevated | 156 (47) | 106 (47.7) | 50 (45.4) | |
| 10×>ULN | 67 (20.2) | 47 (21.1) | 20 (18.2) | |
| Number of MBM at the time of CombiIT† | ||||
| 1–3 | 167 (46.8) | 127 (53.6) | 40 (33.3) | < 0.0001 |
| >3 | 190 (53.2) | 110 (46.4) | 80 (66.7) | |
| ECOG-PS† | ||||
| 0 | 249 (66.4) | 168 (67.7) | 81 (63.8) | 0.741 |
| 1 | 87 (23.2) | 55 (22.2) | 32 (25.2) | |
| >1 | 39 (10.4) | 25 (10.1) | 14 (11) | |
| Presence of symptoms† | ||||
| Yes | 60 (31) | 44 (32.1) | 16 (28.6) | 0.629 |
| No | 133 (69) | 93 (67.9) | 40 (71.4) | |
| Local therapy | ||||
| STR/surgery‡ | 220 (57.9) | 135 (54) | 85 (65.4) | 0.011 |
| No local therapy | 90 (23.7) | 71 (28.4) | 19 (14.6) | |
| WBRT | 70 (18.4) | 44 (17.6) | 26 (20) | |
Bold values indicate statistically significant results.
*Pearson’s χ2 test.
†Denotes variables for which the missing/unknown values were excluded from the analysis.
‡Ten patients (4.5%) received only surgery. Four patients receiving STR/surgery before combined immunotherapy and two patients receiving STR/surgery after combined immunotherapy were treated with the two techniques within an interval of 2 weeks.
CombiIT, nivolumab plus ipilimumab; ECOG-PS, Eastern Cooperative Oncology Group performance status; MBM, melanoma brain metastases; n, number of patients in each subgroup; STR, stereotactic radiosurgery; ULN, upper level normal; WBRT, whole brain radiotherapy.