Table 1.
Patients' characteristics
| Response categories |
Total (n = 344) | ||||
|---|---|---|---|---|---|
| PFS < 6 months and OS < 18 months (n = 180) | PFS < 6 months and OS ≥ 18 months (n = 40) | PFS ≥ 6 months and OS < 18 months (n = 48) | PFS ≥ 6 months and OS ≥ 18 months (n = 76) | ||
| Age (years) | |||||
| Median | 54 | 57 | 55 | 51 | 54 |
| Q1–Q3 | 42–65 | 46–64 | 45–64 | 34–62 | 41–64 |
| Gender [n (%)] | |||||
| Male | 83 (46.1) | 16 (40.0) | 25 (52.1) | 24 (31.6) | 148 (43.0) |
| Female | 97 (53.9) | 24 (60.0) | 23 (47.9) | 52 (68.4) | 196 (57.0) |
| Performance status | |||||
| 0 | 78 (43.3) | 29 (72.5) | 17 (35.4) | 47 (61.8) | 171 (49.7) |
| 1 | 102 (56.7) | 11 (27.5) | 31 (64.6) | 29 (38.2) | 173 (50.3) |
| Site of primary | |||||
| Extremities | 63 (35.0) | 14 (35) | 19 (39.6) | 27 (35.5) | 123 (35.8) |
| Retro-/intra-abdominal | 35 (19.4) | 8 (20.0) | 6 (12.5) | 16 (21.1) | 65 (18.9) |
| Visceral | 38 (21.7) | 12 (30.0) | 8 (15.8) | 16 (21.1) | 74 (21.5) |
| Other | 44 (24.4) | 6 (15.0) | 15 (33.3) | 17 (22.4) | 82 (23.8) |
| Histology (central review) | |||||
| Leiomyosarcoma | 60 (33.3) | 27 (67.5) | 17 (35.4) | 33 (43.4) | 137 (39.8) |
| Synovial sarcoma | 39 (21.7) | 4 (10.0) | 13 (27.1) | 12 (15.8) | 68 (19.8) |
| Other | 81 (45.0) | 9 (22.5) | 18 (37.5) | 31 (40.8) | 139 (40.4) |
| Tumor grade (central review) | |||||
| Low | 10 (5.6) | 2 (5.0) | 3 (6.3) | 13 (17.1) | 28 (8.1) |
| Intermediate | 55 (30.6) | 14 (35.0) | 15 (31.3) | 29 (38.2) | 113 (32.8) |
| High | 114 (63.3) | 24 (60.0) | 29 (60.4) | 34 (44.7) | 201 (58.4) |
| Unknown | 1 (0.6) | 0 (0.0) | 1 (2.1) | 0 (0.0) | 2 (0.6) |
| Best overall response | |||||
| Partial response | 7 (3.9) | 3 (7.5) | 9 (18.8) | 18 (23.7) | 37 (10.8) |
| Stable disease | 78 (43.3) | 24 (60.0) | 37 (77.1) | 58 (76.3) | 197 (57.3) |
| Progressive diseasea | 95 (52.8) | 13 (32.5) | 2 (2.1) | 0 (0.0) | 110 (32.0) |
| Baseline lymphocyte countb | |||||
| Grade 0 | 115 (63.9) | 28 (70.0) | 25 (52.1) | 54 (71.1) | 222 (64.5) |
| Grade 1 | 33 (18.3) | 9 (22.5) | 10 (20.8) | 12 (15.8) | 64 (18.6) |
| Grade ≥ 2 | 32 (17.2) | 3 (7.5) | 13 (27.1) | 10 (13.2) | 57 (16.5) |
| Baseline hemoglobinb | |||||
| Grade 0 | 68 (37.8) | 23 (57.5) | 18 (37.5) | 49 (64.5) | 158 (45.9) |
| Grade ≥ 1 | 111 (61.7) | 17 (42.5) | 30 (62.5) | 27 (35.5) | 185 (53.8) |
aIncluding patients dying before first response assessment (early death) and non-evaluable best response.
bNote that for one patient from the phase II study, no baseline hematology data were available.