Table 1.
Baseline Demographic and Disease Characteristics
| Variable | No. (%) of Patients |
|
|---|---|---|
| Trabectedin (n = 345) | Dacarbazine (n = 173) | |
| Age, years | ||
| Median (range) | 57 (18.0-81.0) | 56 (17.0-79.0) |
| Sex | ||
| Male | 107 (31) | 47 (27) |
| Female | 238 (69) | 126 (73) |
| Baseline BMI, kg/m2 | ||
| Median (range) | 28.21 (14.5-78.1) | 27.05 (13.3-66.7) |
| Histology | ||
| Leiomyosarcoma | 252 (73) | 126 (73) |
| Uterine | 134 (39) | 78 (45) |
| Nonuterine | 118 (34) | 48 (28) |
| Liposarcoma | 93 (27) | 47 (27) |
| Myxoid ± round cell | 38 (11) | 19 (11) |
| Pleomorphic | 10 (3) | 3 (2) |
| Dedifferentiated | 45 (13) | 25 (15) |
| Baseline ECOG performance status score | ||
| 0 | 171 (50) | 86 (50) |
| 1 | 174 (50) | 87 (50) |
| Lines of prior chemotherapy | ||
| 1 | 38 (11) | 23 (13) |
| 2 | 160 (46) | 75 (43) |
| 3 | 87 (25) | 43 (25) |
| 4 | 37 (11) | 21 (12) |
| > 4 | 23 (7) | 11 (6) |
| Best response to last line of previous chemotherapy | ||
| Complete response | 4 (1) | 3 (2) |
| Partial response | 28 (8) | 14 (8) |
| No change (stable disease) | 114 (33) | 51 (30) |
| Progression of disease | 198 (57) | 103 (60) |
| Unknown/missing | 1 (0) | 2 (1) |
| Previous surgery for malignancy | ||
| Yes | 327 (95) | 158 (91) |
| No | 18 (5) | 15 (9) |
| Previous radiotherapy for malignancy | ||
| Yes | 176 (51) | 80 (46) |
| No | 169 (49) | 93 (54) |
| Time from initial diagnosis to random assignment, months | ||
| Median (range) | 33.94 (2.5-318.5) | 27.10 (1.6-267.1) |
| Time from last disease progression to random assignment, months | ||
| Median (range) | 0.85 (0.0-13.7) | 0.82 (0.1-9.8) |
NOTE. Percentages were calculated with the number of patients randomly assigned to each treatment group as the denominator.
Abbreviations: BMI, body mass index; ECOG, Eastern Cooperative Oncology Group.