Table 1. Patient characteristics.
| Validation set 1 127 (100.0%) |
Validation set 2 70 (100.0%) |
||||
|---|---|---|---|---|---|
| Gender | male | 77 | (60.6%) | 44 | (62.8%) |
| female | 50 | (39.4%) | 26 | (37.1%) | |
| Median age/years (range) | 61.6 | (16.4–91.2) | 62.3 | (25.9–90.8) | |
| Localization of primary | skin | 87 | (68.5%) | 53 | (75.7%) |
| mucosa | 8 | (6.3%) | 3 | (4.3%) | |
| uvea | 2 | (1.6%) | 3 | (4.3%) | |
| occult | 14 | (11.0%) | 8 | (11.4%) | |
| unknown | 16 | (12.6%) | 3 | (4.3%) | |
| M category (AJCC) | M1a | 12 | (9.4%) | 5 | (7.1%) |
| M1b | 18 | (14.2%) | 6 | (8.6%) | |
| M1c | 82 | (64.6%) | 55 | (78.6%) | |
| unknown | 15 | (11.8%) | 4 | (5.7%) | |
| Serum LDH | ≤ UNL | 43 | (33.9%) | 19 | (27.1%) |
| > UNL | 69 | (54.3%) | 47 | (67.2%) | |
| unknown | 15 | (11.8%) | 4 | (5.7%) | |
| ECOG performance status | 0 | 43 | (33.9%) | 46 | (65.7%) |
| 1 | 34 | (26.8%) | 22 | (31.4%) | |
| ≥ 2 | 19 | (15.0%) | 2 | (2.9%) | |
| unknown | 31 | (24.3%) | 0 | (0.0%) | |
| Metastatic site biopsied for chemosensitivity testing | skin/subcutaneous | 63 | (49.6%) | 50 | (71.4%) |
| lymph node | 51 | (40.2%) | 15 | (21.4%) | |
| visceral organ | 13 | (10.2%) | 5 | (7.1%) | |
| Best chemosensitivity index | median/mean (range) | 131/136 | (1–360) | 150/154 | (7–315) |
| ≤ 100 | 44 | (34.6%) | 17 | (24.3%) | |
| > 100 | 83 | (65.4%) | 53 | (75.7%) | |
| First therapy after chemosensitivity testing1 | chemotherapy | 80 | (63.0%) | 61 | (87.1%) |
| sensitivity-directed | 52 | (40.9%) | 37 | (52.9%) | |
| cisplatin + paclitaxel | 18 | (14.2%) | 22 | (31.4%) | |
| cisplatin + gemcitabine | 9 | (7.1%) | 0 | (0.0%) | |
| treosulfan + gemcitabine | 25 | (19.8%) | 15 | (21.4%) | |
| not sensitivity-directed | 28 | (22.0%) | 24 | (34.3%) | |
| dacarbazine (DTIC) | 20 | (15.7%) | 24 | (34.3%) | |
| other chemo regimen | 8 | (6.3%) | 0 | (0.0%) | |
| immunotherapy | 15 | (11.8%) | 3 | (4.3%) | |
| other/supportive therapy | 25 | (19.7%) | 6 | (8.6%) | |
| unknown | 7 | (5.5%) | 0 | (0.0%) | |
| SERPINB1 relative gene expression2 | median/mean (range) | 0.88/1.08 | (0.04–4.61) | n.d. | |
| SERPINB1 protein expression score2 | median/mean (range) | n.d. | 4.0/3.7 | (0–5) | |
1
First systemic treatment given to the patient after the procedure of chemosensitivity testing
2
SERPINB1 expression as detected in tissue samples obtained for chemosensitivity testing (for details see Patients and Methods)
Abbreviations: AJCC, American Joint Committee on Cancer; LDH, lactate dehydrogenase; UNL, upper normal limit; ECOG, Eastern Cooperative Oncology Group