Table 1.
Demographic and pathologic data with comparison between TLPLDC versus placebo in the ITT and PT cohorts
| Category | ITT analysis | PT analysis | ||||
|---|---|---|---|---|---|---|
| TLPLDC | Placebo | p value | TLPLDC | Placebo | p value | |
| Age, years | ||||||
| Median | 63.6 | 59.4 | 0.076 | 64.9 | 60.9 | 0.036 |
| IQR | 55.6–73.0 | 49.5–67.8 | 58.2–74.9 | 50.3–70.2 | ||
| Race | ||||||
| Asian | 0 (0) | 1 (2.4) | 0.320 | 0 (0) | 1 (3.1) | 0.203 |
| Black | 0 (0) | 1 (2.4) | 0 (0) | 1 (3.1) | ||
| Hispanic | 3 (2.9) | 1 (2.4) | 0 (0) | 1 (3.1) | ||
| Native American | 1 (1.0) | 0 (0) | 1 (1.5) | 0 (0) | ||
| Unknown | 1 (1.0) | 0 (0) | 1 (1.5) | 0 (0) | ||
| White | 98 (95.1) | 38 (92.7) | 64 (97) | 29 (90.6) | ||
| Disease type | ||||||
| Primary | 73 (70.9) | 22 (53.7) | 0.049 | 45 (68.2) | 19 (59.4) | 0.390 |
| Recurrent | 30 (29.1) | 19 (46.3) | 21 (31.8) | 13 (40.6) | ||
| Ulceration | ||||||
| Present | 17 (16.5) | 12 (29.3) | 0.316 | 9 (13.6) | 10 (31.3) | 0.225 |
| Absent | 22 (21.4) | 7 (17.1) | 17 (25.8) | 6 (18.8) | ||
| Not available | 64 (62.1) | 22 (53.7) | 40 (60.6) | 16 (50.0) | ||
| TILs | ||||||
| Brisk | 3 (2.9) | 2 (4.9) | 0.462 | 2 (3.0) | 2 (6.3) | 0.319 |
| Mild | 2 (1.9) | 0 (0) | 2 (3.0) | 0 (0) | ||
| Non-brisk | 14 (13.6) | 10 (24.4) | 8 (12.1) | 7 (21.9) | ||
| Absent | 8 (7.8) | 1 (2.4) | 6 (9.1) | 0 (0) | ||
| Not available | 76 (73.8) | 28 (68.3) | 48 (72.7) | 23 (71.9) | ||
| In-transit disease | ||||||
| Present | 9 (8.7) | 1 (2.4) | 0.420 | 6 (9.1) | 1 (3.1) | 0.568 |
| Absent | 31 (30.1) | 10 (24.4) | 19 (28.8) | 7 (21.9) | ||
| Not available | 63 (61.2) | 30 (73.2) | 41 (62.1) | 24 (75.0) | ||
| Satellites | ||||||
| Present | 5 (4.8) | 1 (2.4) | 0.851 | 3 (4.5) | 1 (3.1) | 0.893 |
| Absent | 37 (35.9) | 13 (31.7) | 24 (36.4) | 10 (31.2) | ||
| Not available | 61 (59.2) | 27 (65.9) | 39 (59.1) | 21 (65.6) | ||
| Lymphatic invasion | ||||||
| Present | 15 (14.6) | 2 (4.9) | 0.442 | 8 (12.1) | 1 (3.1) | 0.502 |
| Absent | 33 (32.0) | 14 (34.2) | 20 (30.3) | 10 (31.2) | ||
| Not available | 55 (53.4) | 25 (60.9) | 38 (57.6) | 21 (65.6) | ||
| Primary location | ||||||
| Extremity | 39 (37.9) | 18 (43.9) | 0.779 | 25 (37.9) | 14 (43.8) | 0.805 |
| Trunk | 24 (23.3) | 7 (17.1) | 15 (22.7) | 6 (18.8) | ||
| Head and neck | 16 (15.5) | 6 (14.6) | 11 (16.7) | 6 (18.8) | ||
| Axillary | 12 (11.7) | 6 (14.6) | 9 (13.6) | 4 (12.5) | ||
| Inguinal | 5 (4.9) | 1 (2.4) | 3 (4.5) | 1 (3.1) | ||
| Intra-abdominal | 3 (2.9) | 1 (2.4) | 2 (3.0) | 0 (0) | ||
| Lung | 3 (2.9) | 1 (2.4) | 0 (0) | 1 (3.1) | ||
| Unknown | 1 (1.0) | 1 (2.4) | 1 (1.5) | 0 (0) | ||
| Margins | ||||||
| Positive | 26 (25.2) | 13 (31.7) | 0.756 | 15 (22.7) | 9 (28.1) | 0.413 |
| Negative | 46 (44.7) | 19 (46.3) | 27 (40.9) | 16 (50.0) | ||
| Not available | 31 (30.1) | 9 (22.0) | 24 (36.4) | 7 (21.9) | ||
| BRAF mutation | ||||||
| Yes | 48 (46.6) | 16 (39.0) | 0.538 | 30 (45.5) | 10 (31.3) | 0.385 |
| No | 38 (36.9) | 14 (34.1) | 24 (36.4) | 13 (40.6) | ||
| Not available | 17 (16.5) | 11 (26.8) | 12 (18.2) | 9 (28.1) | ||
Data are expressed as n (%) unless otherwise specified
TLPLDC tumor lysate, particle-loaded, dendritic cell, ITT intention-to-treat, PT per treatment, IQR interquartile range, TILs tumor-infiltrating lymphocytes