Table 4.
Baseline and therapy characteristics of patients who received second-line therapy compared with patients who died before second-line therapy
| All patients n=450 (100%) | Patients who received second-line therapy n=199 (100%) | Patients who died before second-line therapy n=105 (100%) | |
| Age | |||
| ≤65 years >65 years |
274 (54.9) 203 (45.1) |
131 (65.8) 68 (34.2) |
49 (46.7) 56 (53.3) |
| Gender | |||
| Male Female |
285 (63.3) 165 (36.7) |
122 (61.3) 77 (38.7) |
65 (61.9) 40 (38.1) |
| Site of primary | |||
| Cutaneous Mucosal Uveal Unspecified or unknown |
357 (79.3) 5 (1.1) 4 (0.9) 84 (18.6) |
162 (81.4) 1 (0.5) 2 (1.0) 34 (17.1) |
84 (80.0) 2 (1.9) 1 (1.0) 18 (17.1) |
| BRAF status | |||
| V600 wildtype V600E/K mutation Unknown |
193 (42.9) 217 (48.2) 40 (8.9) |
59 (29.6) 137 (68.8) 3 (1.5) |
57 (54.3) 36 (34.3) 12 (11.4) |
| Previous adjuvant therapy in stage III | |||
| Yes No |
78 (17.3) 372 (82.7) |
41 (20.6) 158 (79.4) |
15 (14.3) 90 (85.7) |
| Previous adjuvant therapy in stage IV | |||
| Yes No |
20 (4.4) 430 (95.6) |
9 (4.5) 190 (95.5) |
5 (4.8) 100 (95.2) |
| ECOG performance status | |||
| 0 1 ≥2 Unknown |
164 (36.4) 84 (18.7) 30 (6.7) 172 (38.2) |
77 (38.7) 29 (14.6) 15 (7.5) 78 (39.2) |
30 (28.6) 27 (25.7) 11 (10.5) 37 (35.2) |
| Serum LDH | |||
| Normal (≤ULN) Elevated (>ULN) >10× ULN Unknown |
146 (32.4) 199 (44.2) 43 (9.6) 105 (23.3) |
70 (35.2) 78 (39.2) 19 (9.5) 51 (25.6) |
28 (26.7) 64 (61.0) 24 (9.6) 13 (12.4) |
| Extracranial affected organ sites | |||
| 0 1–2 ≥3 |
81 (18.0) 218 (48.4) 151 (33.6) |
30 (15.1) 104 (52.3) 65 (32.7) |
23 (21.9) 42 (40.0) 40 (38.1) |
| Number of brain metastases | |||
| 1 2–4 ≥5 Unknown |
114 (25.3) 111 (24.7) 157 (34.9) 68 (15.1) |
63 (31.7) 47 (23.6) 56 (28.1) 33 (16.6) |
17 (16.2) 32 (30.5) 44 (41.9) 12 (11.4) |
| Maximal size of brain metastases | |||
| ≤1 cm >1 cm Unknown |
127 (28.2) 136 (30.2) 187 (41.6) |
62 (31.2) 55 (27.6) 82 (41.2) |
21 (20.0) 40 (38.1) 44 (41.9) |
| Symptomatic brain metastases | |||
| No Yes Unknown |
291 (64.7) 118 (26.2) 41 (9.1) |
140 (70.4) 43 (21.6) 16 (8.0) |
52 (49.5) 45 (42.9) 8 (7.6) |
| Radiotherapy of brain metastases | |||
| None Stereotactic Conventional Stereotactic and conventional |
147 (32.7) 137 (30.4) 135 (30.0) 31 (6.9) |
34 (17.1) 77 (38.7) 68 (34.2) 20 (10.1) |
46 (43.8) 16 (15.2) 36 (34.3) 7 (6.7) |
| Surgery of brain metastases | |||
| No Yes |
340 (75.6) 110 (24.4) |
141 (70.9) 58 (29.1) |
84 (80.0) 21 (20.0) |
| Type of first-line systemic therapy | |||
| CTLA-4+PD-1 PD-1 BRAF+MEK |
175 (38.9) 161 (35.8) 114 (25.3) |
69 (34.7) 58 (29.1) 72 (36.2) |
35 (33.3) 44 (41.9) 26 (24.8) |
| Best overall response | |||
| CR PR SD PD Unknown |
42 (9.3) 120 (26.7) 62 (13.8) 189 (42.0) 36 (8.0) |
7 (3.5) 59 (29.6) 28 (14.1) 97 (48.7) 8 (4.0) |
3 (2.9) 11 (10.5) 19 (12.4) 63 (65.7) 9 (8.6) |
| Best extracranial response | |||
| NED CR PR SD PD Unknown |
35 (7.8) 51 (11.3) 105 (23.3) 75 (16.7) 106 (23.6) 78 (18.3) |
11 (5.5) 14 (7.0) 60 (30.2) 40 (20.1) 49 (24.6) 25 (12.6) |
12 (11.4) 3 (2.9) 8 (7.6) 16 (15.2) 44 (41.9) 22 (21.0) |
| Best intracranial response | |||
| CR PR SD PD Unknown |
70 (15.6) 104 (23.1) 60 (13.3) 135 (30.0) 81 (18.0) |
17 (8.5) 51 (25.6) 32 (16.1) 75 (37.7) 24 (12.1) |
10 (9.6) 12 (11.4) 11 (10.5) 44 (41.9) 28 (26.7) |
| Therapy end reason | |||
| Planned stop Toxicity Disease progression Patient wish Other Ongoing Lost to follow-up |
7 (1.6) 81 (18.0) 238 (52.9) 16 (3.6) 36 (8.0) 65 (14.4) 7 (1.5) |
1 (0.5) 41 (20.6) 147 (73.9) 4 (2.0) 6 (3.0) 0 (0.0) 0 (0.0) |
0 (0.0) 12 (11.4) 79 (75.2) 2 (1.9) 10 (9.5) 0 (0.0) 2 (1.9) |
| Progression | |||
| No Yes |
120 (26.7) 330 (73.3) |
14 (7.0) 185 (93.0) |
6 (5.7) 99 (94.3) |
| Death | |||
| No Yes |
236 (52.4) 214 (47.6) |
90 (45.2) 109 (54.8) |
0 (0.0) 105 (100.0) |
| Progression-free survival | |||
| Median in months (95% CI) | 4.7 (3.9 to 5.6) | 3.8 (2.7 to 5.0) | 2.1 (1.9 to 2.3) |
| Overall survival | |||
| Median in months (95% CI) | 21.5 (16.9 to 26.0) | 23.9 (19.8 to 28.0) | 19.5 (6.6 to 32.4) |
CR, complete response; PD, progressive disease; PR, partial response; SD, stable disease.