Table 1.
Patient demographics and baseline disease characteristics
| Elderly (aged ≥65 years) patient subgroup (n = 131) |
All patients (n = 577) |
|||
|---|---|---|---|---|
| Dacarbazine (n = 37) | Trabectedin (n = 94) | Dacarbazine (n = 193) | Trabectedin (n = 384) | |
| Age, y | ||||
| Median (range) | 70 (65, 79) | 69 (65, 81) | 56 (17, 79) | 57 (18, 81) |
| Sex | ||||
| Women | 25 (68) | 50 (53) | 140 (73) | 262 (68) |
| Men | 12 (32) | 44 (47) | 53 (28) | 122 (32) |
| Race | ||||
| White | 28 (76) | 74 (79) | 144 (75) | 300 (78) |
| Black or African American | 2 (5) | 11 (12) | 22 (11) | 48 (13) |
| Asian | 3 (8) | 5 (5) | 11 (6) | 11 (3) |
| American Indian or Alaska Native | 1 (3) | 1 (1) | 4 (2) | 1 (0.3) |
| Baseline BMI, kg/m2 | ||||
| <30 | 27 (73) | 67 (71) | 124 (64) | 227 (59) |
| ≥30 | 10 (27) | 27 (29) | 69 (36) | 157 (41) |
| Median (range) | 28.1 (18.2, 39.7) | 26.4 (17.2, 44.4) | 27.5 (13.3, 66.7) | 28.1 (14.5, 78.1) |
| Baseline BSA, m² | 35 (95) | 93 (99) | 172 (89) | 378 (98) |
| Median (range) | 1.7 (1.4, 2.2) | 1.8 (1.3, 2.4) | 1.8 (1.3, 2.4) | 1.8 (1.3, 2.6) |
| Histology | ||||
| Leiomyosarcoma | 27 (73) | 71 (76) | 141 (73) | 282 (73) |
| Nonuterine | 14 (38) | 49 (52) | 53 (27) | 138 (36) |
| Uterine | 13 (35) | 22 (23) | 88 (46) | 144 (38) |
| Liposarcoma | 10 (27) | 23 (25) | 52 (27) | 102 (27) |
| Dedifferentiated | 8 (22) | 16 (17) | 28 (15) | 49 (13) |
| Myxoid±round cell | 1 (3) | 4 (4) | 19 (10) | 42 (11) |
| Pleomorphic | 1 (3) | 3 (3) | 5 (3) | 11 (3) |
| Baseline ECOG performance status score | ||||
| 0 | 18 (49) | 43 (46) | 93 (48) | 184 (48) |
| 1 | 19 (51) | 51 (54) | 100 (52) | 200 (52) |
| Previous therapies | ||||
| Chemotherapy | 37 (100) | 94 (100) | 193 (100) | 384 (100) |
| Surgery | 32 (86) | 85 (90) | 178 (92) | 363 (95) |
| Radiation | 17 (46) | 43 (46) | 89 (46) | 197 (51) |
| Lines of prior chemotherapy | ||||
| 1 | 2 (5) | 15 (16) | 26 (13) | 46 (12) |
| 2 | 21 (57) | 50 (53) | 83 (43) | 176 (46) |
| ≥3 | 14 (38) | 29 (31) | 84 (44) | 162 (42) |
| Time from initial diagnosis to randomization, months | ||||
| Median (range) | 37.3 (8.8, 267.1) | 32.5 (4.5, 300.6) | 27.3 (1.6, 267.1) | 32.8 (2.5, 318.5) |
| Time from last disease progression to randomization, months | ||||
| Median (range) | 0.8 (0.2, 8.7) | 0.9 (0.2, 13.7) | 0.9 (0.1, 9.8) | 0.9 (0.0, 13.7) |
Values are presented as n (%) unless otherwise specified.
BMI, body mass index; BSA, body surface area; ECOG, Eastern Cooperative Oncology Group.