Table 1. Patient characteristics stratified by TP53 and CDKN2A mutations.
| TP53mut | TP53WT | P Value | CDKN2Amut | CDKN2AWT | P Value | QuadWT | Not Quad WT | P Value | |
|---|---|---|---|---|---|---|---|---|---|
| (N = 21) | (N = 81) | (N = 14) | (N = 88) | (N = 12) | (N = 90) | ||||
| Age at diagnosis | 0.83 a | 0.50 a | 0.15a | ||||||
| Median | 60.7 | 62.3 | 63.9 | 61.2 | 71.9 | 60.8 | |||
| Range | (32.4–82.2) | (22.8–91.0) | (31.6–88.5) | (22.8–91.0) | (41.3–77.3) | (22.8–91.0) | |||
| Gender | 0.74 b | 0.87 b | 0.67b | ||||||
| Male | 14 (66.7%) | 57 (70.4%) | 10 (71.4%) | 61 (69.3%) | 9 (75.0%) | 62 (68.9%) | |||
| Female | 7 (33.3%) | 24 (29.6%) | 4 (28.6%) | 27 (30.7%) | 3 (25.0%) | 28 (31.1%) | |||
| Ethnicity | 0.05 b | 0.69 b | 0.71b | ||||||
| Caucasian | 20 (95.2%) | 81 (100.0%) | 14 (100.0%) | 87 (98.9%) | 12 (100.0%) | 89 (98.9%) | |||
| Hispanic | 1 (4.8%) | 0 (0%) | 0 (0%) | 1 (1.1%) | 0 (0%) | 1 (1.1%) | |||
| Sites of Disease | |||||||||
| CNS | 3 (16.7%) | 20 (26.7%) | 0.38 b | 3 (23.1%) | 20 (25.0%) | 0.88 b | 4 (36.4%) | 19 (23.2%) | 0.34b |
| Liver | 5 (27.8%) | 19 (25.3%) | 0.83 b | 5 (38.5%) | 19 (23.8%) | 0.26 b | 5 (45.5%) | 19 (23.2%) | 0.11b |
| Lung | 10 (55.6%) | 37 (49.3%) | 0.64 b | 8 (61.5%) | 39 (48.8%) | 0.39 b | 9 (81.8%) | 38 (46.3%) | 0.03b |
| Adrenal | 1 (5.6%) | 6 (8.0%) | 0.72 b | 2 (15.4%) | 5 (6.3%) | 0.25 b | 1 (9.1%) | 6 (7.3%) | 0.83b |
| Bone | 4 (22.2%) | 16 (21.3%) | 0.93 b | 0 (0%) | 20 (25.0%) | 0.04 b | 2 (18.2%) | 18 (22.0%) | 0.78b |
| Skin | 2 (11.1%) | 16 (21.3%) | 0.32 b | 0 (0%) | 18 (22.5%) | 0.06 b | 1 (9.1%) | 17 (20.7%) | 0.36b |
| Lymph Node | 8 (44.4%) | 33 (44.0%) | 0.97 b | 7 (53.8%) | 34 (42.5%) | 0.44 b | 6 (54.5%) | 35 (42.7%) | 0.46b |
| Other | 4 (25.0%) | 20 (29.0%) | 0.75 b | 6 (50.0%) | 18 (24.7%) | 0.07 b | 1 (10.0%) | 23 (30.7%) | 0.17b |
| Melanoma Subtype | 0.10 b | 0.80 b | 0.41b | ||||||
| Cutaneous | 15 (71.4%) | 70 (86.4%) | 12 (85.7%) | 73 (83.0%) | 11 (91.7%) | 74 (82.2%) | |||
| Unknown Primary | 6 (28.6%) | 11 (13.6%) | 2 (14.3%) | 15 (17.0%) | 1 (8.3%) | 16 (17.8%) | |||
| Metastases | 0.32 b | 0.81 b | 0.95b | ||||||
| Yes | 18 (85.7%) | 75 (92.6%) | 13 (92.9%) | 80 (90.9%) | 11 (91.7%) | 82 (91.1%) | |||
| No | 3 (14.3%) | 6 (7.4%) | 1 (7.1%) | 8 (9.1%) | 1 (8.3%) | 8 (8.9%) | |||
| Name of Therapy | 0.14 b | 0.68 b | 0.03b | ||||||
| Pembrolizumab | 7 (33.3%) | 46 (56.8%) | 8 (57.1%) | 45 (51.1%) | 7 (58.3%) | 46 (51.1%) | |||
| Nivolumab | 1 (4.8%) | 5 (6.2%) | 0 (0%) | 6 (6.8%) | 3 (25.0%) | 3 (3.3%) | |||
| Ipilimumab | 11 (52.4%) | 23 (28.4%) | 5 (35.7%) | 29 (33.0%) | 2 (16.7%) | 32 (35.6%) | |||
| Nivolumab/Ipilimumab | 2 (9.5%) | 3 (3.7%) | 0 (0%) | 5 (5.7%) | 0 (0%) | 5 (5.6%) | |||
| Other therapy | 0 (0%) | 4 (4.9%) | 1 (7.1%) | 3 (3.4%) | 0 (0%) | 4 (4.4%) | |||
| Other Therapy Name | - | - | - | ||||||
| Ipilimumab/Dabrafenib | 0 (0%) | 1 (25.0%) | 0 (0.0%) | 1 (33.3%) | 0 (0%) | 1 (25.0%) | |||
| Ipilimumab/Dacarbazine | 0 (0%) | 1 (25.0%) | 1 (100.0%) | 0 (0%) | 0 (0%) | 1 (25.0%) | |||
| Pembrolizumab/Indoximod | 0 (0%) | 2 (50.0%) | 0 (0.0%) | 2 (66.7%) | 0 (0%) | 2 (50.0%) | |||
| Lines of Therapy | 0.84 b | 0.43 b | 0.87b | ||||||
| 1 | 18 (85.7%) | 68 (84.0%) | 12 (85.7%) | 74 (84.1%) | 11 (91.7%) | 75 (83.3%) | |||
| 2 | 3 (14.3%) | 10 (12.3%) | 1 (7.1%) | 12 (13.6%) | 1 (8.3%) | 12 (13.3%) | |||
| 3 | 0 (0%) | 1 (1.2%) | 0 (0%) | 1 (1.1%) | 0 (0%) | 1 (1.1%) | |||
| 4 | 0 (0%) | 2 (2.5%) | 1 (7.1%) | 1 (1.1%) | 0 (0%) | 2 (2.2%) | |||
| LDH elevated c | 0.45 b | 0.06 b | 0.09b | ||||||
| Yes | 2 (10.5%) | 16 (21.6%) | 1 (8.3%) | 17 (21.0%) | 4 (33.3%) | 14 (17.3%) | |||
| No | 13 (68.4%) | 40 (54.1%) | 5 (41.7%) | 48 (59.3%) | 8 (66.7%) | 45 (55.6%) | |||
| Not tested | 4 (21.1%) | 18 (24.3%) | 6 (50.0%) | 16 (19.8%) | 0 (0%) | 22 (27.2%) | |||
| Number of metastatic sites | 0.79 b | 0.38 a | 0.35 | ||||||
| Median Number of Sites | 1.0 | 2.0 | 0.48a | 2.0 | 1.5 | 2.0 | 2.0 | 0.32a | |
| Range | 0–5.0 | 0–5.0 | 0–5.0 | 0–5.0 | 0–4.0 | 0–5.0 | |||
| Response Rate (ORR) d | 0.30 b | 0.54 b | 0.73b | ||||||
| ORR | 9 (47.4%) | 23 (34.3%) | 5 (45.5%) | 27 (36.0%) | 5 (41.7%) | 27 (36.5%) | |||
| Disease Control Rate (DCR) d | 0.58 b | 0.15 b | 0.86b | ||||||
| DCR | 11 (57.9%) | 34 (50.7%) | 8 (72.7%) | 37 (49.3%) | 6 (50.0%) | 39 (52.7%) | |||
|
Duration of Immunotherapy (months) e |
0.87 a | 0.50 a | 0.54a | ||||||
| Median | 2 | 3 | 4.0 | 3.0 | 3.0 | 2.0 | |||
| Range | 1.0–9.0 | 0–13.0 | 0–9.0 | 0–13.0 | 1.0–9.0 | 0–13.0 |
a Wilcoxon rank-sum test;
b Chi square test;
c 9 subjects missing LDH data;
d 16 subjects missing response data;
e 24 subjects with incomplete duration data;
Overall response rate (ORR) = complete response + partial response; disease control rate (DCR) = complete response + partial response + stable disease; TP53mut: TP53 pathogenic mutation; TP53WT: TP53 wild type; CDKN2Amut: CDKN2A pathogenic mutation; CDKN2AWT: CDKN2A wild type; QuadWT: Quadruple wild type; TTP: Time to progression