Table 1.
Patient and disease characteristics at baseline.
| Patients | Modified Intent-to-Treat Set (mITT) 1 n = 128 |
|
|---|---|---|
| Age at study entry (years) | Median (range) | 58.5 (23–84) |
| ≤60 years | 70 (54.7%) | |
| >60 years | 58 (45.3%) | |
| ≤70 years | 99 (77.3%) | |
| >70 years | 29 (22.7%) | |
| Gender | Female | 65 (50.8%) |
| Male | 63 (49.2%) | |
| Histology | Leiomyosarcoma | 45 (35.2%) |
| Liposarcoma | 23 (18.0%) | |
| Pleomorphic undifferentiated sarcoma | 20 (15.6%) | |
| Synovial sarcoma | 8 (6.3%) | |
| Fibrosarcoma | 8 (6.3%) | |
| Angiosarcoma | 1 (0.8%) | |
| Other | 23 (18.0%) | |
| Site of primary tumor | Lower extremity | 23 (18.0%) |
| Abdomen (retroperitoneal) | 20 (15.6%) | |
| Upper extremity | 17 (13.3%) | |
| Uterus | 15 (11.7%) | |
| Abdomen (intraperitoneal) | 11 (8.6%) | |
| Other | 42 (32.8%) | |
| Eastern Cooperative Oncology Group (ECOG) performance status | 0 | 34 (26.6%) |
| 1 | 66 (51.6%) | |
| 2 | 10 (7.8%) | |
| 3 | 1 (0.8%) | |
| 4 | 1 (0.8%) | |
| Missing | 16 (12.5%) | |
| Tumor grade according to the French Federation of Cancer Centers Sarcoma Group grading systems (FNCLCC) 2 | Grade 1 | 13 (17.3%) |
| Grade 2 | 21 (28.0%) | |
| Grade 3 | 34 (45.3%) | |
| Grade X 3 | 6 (8.0%) | |
| Missing | 1 (1.3%) | |
| According to the Union for International Cancer Control (UICC) 2 | Grade 1 | 5 (9.3%) |
| Grade 2 | 9 (16.7%) | |
| Grade 3 | 23 (42.6%) | |
| Grade 4 | 3 (5.6%) | |
| Grade X 3 | 13 (24.1%) | |
| Missing | 1 (1.9%) | |
| Tumor stage according to the American Joint Committee on Cancer (AJCC) | Ia | 3 (2.3) |
| Ib | 7 (5.5) | |
| IIa | 4 (3.1) | |
| IIb | 5 (3.9) | |
| III | 15 (11.7) | |
| IV | 26 (20.3) | |
| Unknown | 68 (53.1) | |
| Time from first diagnosis to first treatment (months); n = 125 | Median (range) | 0.4 (0.0–149.7) |
| Time from diagnosis to last treatment before trabectedin (months); n = 125 | Median (range) | 15.9 (0.0–250.2) |
| Time from last progression to trabectedin treatment (months); n = 95 | Median (range) | 0.9 (0.0–2.5) |
1 Modified intent-to-treat set (mITT) included all patients who received at least one dose of trabectedin, signed informed consent and did not violate any inclusion or exclusion criterion. 2 One patient had no documented grading according to both FNCLCC and UICC and was counted in both grading categories as missing. 3 Tumor grade could not be assessed.