Table 1. Patient characteristics at study enrollment.
| ITT (n=274) | PP (n=244) | |||||
|---|---|---|---|---|---|---|
| Standard chemotherapy (n=133) | Sensitivity-directed chemotherapy (n=141) | Standard chemotherapy (n=122) | Sensitivity-directed chemotherapy (n=122) | |||
| DTIC (n=133) | Treo + Gem/AraC (n=66) | Cis + Tax (n=75) | DTIC (n=122) | Treo + Gem/AraC (n=58) | Cis + Tax (n=64) | |
| Age | ||||||
| ≤ 65 | 81 (60.9%) | 45 (68.2%) | 43 (57.3%) | 74 (60.7%) | 38 (65.5%) | 37 (57.8%) |
| > 65 | 52 (39.1%) | 21 (31.8%) | 32 (42.7%) | 48 (39.3%) | 20 (34.5%) | 27 (42.2%) |
| Sex | ||||||
| Male | 75 (56.4%) | 39 (59.1%) | 45 (60.0%) | 70 (57.4%) | 33 (56.9%) | 40 (62.5%) |
| Female | 58 (43.6%) | 27 (40.9%) | 30 (40.0%) | 52 (42.6%) | 25 (43.1%) | 24 (37.5%) |
| Localization of primary | ||||||
| Skin | 102 (76.7%) | 52 (78.8%) | 60 (80.0%) | 95 (77.9%) | 47 (81.0%) | 50 (78.1%) |
| Occult/MUP | 18 (13.5%) | 8 (12.1%) | 10 (13.3%) | 18 (14.8%) | 6 (10.3%) | 10 (15.7%) |
| Mucosa | 6 (4.5%) | 4 (6.1%) | 3 (4.0%) | 6 (4.9%) | 4 (6.9%) | 2 (3.1%) |
| Not specified | 7 (5.3%) | 2 (3.0%) | 2 (2.7%) | 3 (2.5%) | 1 (1.7%) | 2 (3.1%) |
| AJCC M category | ||||||
| M1a | 20 (15.0%) | 13 (19.7%) | 12 (16.0%) | 20 (16.4%) | 13 (22.4%) | 11 (17.2%) |
| M1b | 36 (27.1%) | 15 (22.7%) | 25 (33.3%) | 33 (27.0%) | 14 (24.2%) | 23 (35.9%) |
| M1c | 76 (57.8%) | 38 (57.6%) | 37 (49.4%) | 69 (56.6%) | 31 (53.4%) | 30 (46.9%) |
| Not specified | 1 (<1%) | 0 (0%) | 1 (1.3%) | 0 (0%) | 0 (0%) | 0 (0%) |
| ECOG performance status | ||||||
| 0 | 96 (72.8%) | 48 (72.7%) | 52 (69.3%) | 91 (74.6%) | 42 (72.4%) | 46 (71.9%) |
| 1 | 36 (27.1%) | 18 (27.3%) | 22 (29.3%) | 31 (25.4%) | 16 (27.6%) | 17 (26.5%) |
| Not specified | 1 (<1%) | 0 (0%) | 1 (1.3%) | 0 (0%) | 0 (0%) | 1 (1.6%) |
| Serum LDH1 | ||||||
| Normal (≤ ULN) | 66 (49.6%) | 38 (57.6%) | 29 (38.7%) | 63 (51.6%) | 33 (56.9%) | 24 (37.5%) |
| Elevated (> ULN) | 67 (50.4%) | 28 (42.4%) | 46 (61.3%) | 59 (48.4%) | 25 (43.1%) | 40 (62.5%) |
| Sum of longest diameters of target lesions | ||||||
| ≤ 10 cm | 89 (66.9%) | 50 (75.7%) | 60 (80.0%) | 85 (69.7%) | 44 (75.9%) | 50 (78.1%) |
| > 10 cm | 34 (25.6%) | 14 (21.3%) | 9 (12.0%) | 33 (27.0%) | 13 (22.4%) | 8 (12.5%) |
| Not specified | 10 (7.5%) | 2 (3.0%) | 6 (8.0%) | 4 (3.3%) | 1 (1.7%) | 6 (9.4%) |
| Previous systemic therapy in stage III | ||||||
| Yes | 59 (44.4%) | 31 (47.0%) | 42 (56.0%) | 55 (45.1%) | 30 (51.7%) | 35 (54.7%) |
| No | 67 (50.4%) | 33 (50.0%) | 31 (41.3%) | 64 (52.4%) | 27 (46.6%) | 27 (42.2%) |
| Not specified | 7 (5.2%) | 2 (3.0%) | 2 (2.7%) | 3 (2.5%) | 1 (1.7%) | 2 (3.1%) |
| Previous systemic therapy in stage IV | ||||||
| Yes | 20 (15.0%) | 4 (6.0%) | 12 (16.0%) | 18 (14.8%) | 4 (6.9%) | 11 (17.2%) |
| No | 106 (79.8%) | 59 (89.4%) | 61 (81.3%) | 101 (82.7%) | 52 (89.7%) | 51 (79.7%) |
| Not specified | 7 (5.2%) | 3 (4.6%) | 2 (2.7%) | 3 (2.5%) | 2 (3.4%) | 2 (3.1%) |
| Localization of biopsy for chemosensitivity testing | ||||||
| Skin | 59 (44.4%) | 29 (43.9%) | 44 (58.7%) | 58 (47.5%) | 27 (46.6%) | 35 (54.7%) |
| Lymph node | 40 (30.0%) | 22 (33.3%) | 21 (28.0%) | 37 (30.3%) | 20 (34.4%) | 19 (29.7%) |
| Organ | 30 (22.6%) | 14 (21.2%) | 9 (12.0%) | 23 (18.9%) | 11 (19.0%) | 9 (14.1%) |
| Not specified | 4 (3.0%) | 1 (1.5%) | 1 (1.3%) | 4 (3.3%) | 0 (0%) | 1 (1.6%) |
| Chemosensitivity test result | ||||||
| Chemosensitive (BICSI≤100) | 34 (25.6%) | 32 (48.5%) | 8 (10.7%) | 31 (25.4%) | 29 (50.0%) | 8 (12.5%) |
| Chemoresistant (BICSI>100) | 99 (74.4%) | 34 (51.5%) | 67 (89.3%) | 91 (74.6%) | 29 (50.0%) | 56 (87.5%) |
Percentages are given per column, representing the treatment groups. 1Serum lactate dehydrogenase (LDH) values were classified according to the upper limits of normal (ULN) of the respective study centers. Previous systemic therapies in stage III or IV were immunotherapies in most of cases (interferon-alpha, interleukin-2, vaccination). DTIC, dacarbazine; Treo, treosulfan; Gem, gemcitabine; AraC, cytarabine; Cis, cisplatine; Tax, paclitaxel; AJCC, American Joint Committee on Cancer; ECOG, Eastern Cooperative Oncology Group.