Table 1.
Characteristics of patients
|
Pooled data (n = 66) |
Comparative trial (n = 37) |
Single‐arm trial (n = 29) |
|
|---|---|---|---|
| Sex | |||
| Male, n (%) | 38 (57.6) | 21 (56.8) | 17 (58.6) |
| Female, n (%) | 28 (42.4) | 16 (43.2) | 12 (41.4) |
| Age (y) | |||
| Median (range) | 38.0 [21, 77] | 39.0 [21, 77] | 38.0 [25, 60] |
| PS | |||
| 0, n (%) | 38 (57.6) | 22 (59.5) | 16 (55.2) |
| 1, n (%) | 28 (42.4) | 15 (40.5) | 13 (44.8) |
| Histological type by central pathology review | |||
| Myxoid liposarcoma, n (%) | 22 (33.3) | 14 (37.8) | 8 (27.6) |
| Synovial sarcoma, n (%) | 17 (25.8) | 7 (18.9) | 10 (34.5) |
| Mesenchymal chondrosarcoma, n (%) | 6 (9.1) | 3 (8.1) | 3 (10.3) |
| Extraskeletal Ewing sarcoma, n (%) | 5 (7.6) | 3 (8.1) | 2 (6.9) |
| Alveolar rhabdomyosarcoma, n (%) | 5 (7.6) | 2 (5.4) | 3 (10.3) |
| Alveolar soft part sarcoma, n (%) | 4 (6.1) | 3 (8.1) | 1 (3.4) |
| Extraskeletal myxoid chondrosarcoma, n (%) | 2 (3.0) | 2 (5.4) | 0 (0.0) |
| Clear cell sarcoma, n (%) | 2 (3.0) | 1 (2.7) | 1 (3.4) |
| Dermatofibrosarcoma protuberans, n (%) | 1 (1.5) | 1 (2.7) | 0 (0.0) |
| Angiomatoid fibrous histiocytoma, n (%) | 1 (1.5) | 1 (2.7) | 0 (0.0) |
| Desmoplastic small round cell tumor, n (%) | 1 (1.5) | 0 (0.0) | 1 (3.4) |
| Histological grade | |||
| High, n (%) | 41 (62.1) | 23 (62.2) | 18 (62.1) |
| Intermediate, n (%) | 16 (24.2) | 8 (21.6) | 8 (27.6) |
| Low, n (%) | 2 (3.0) | 2 (5.4) | 0 (0.0) |
| Not assessed or unknown, n (%) | 7 (10.6) | 4 (10.8) | 3 (10.3) |
| Primary lesion | |||
| Lower limbs, n (%) | 36 (54.5) | 21 (56.8) | 15 (51.7) |
| Abdomen/pelvis, n (%) | 7 (10.6) | 3 (8.1) | 4 (13.8) |
| Face, n (%) | 5 (7.6) | 1 (2.7) | 4 (13.8) |
| Intrathoracic, n (%) | 3 (4.5) | 3 (8.1) | 0 (0.0) |
| Neck, n (%) | 3 (4.5) | 2 (5.4) | 1 (3.4) |
| Retroperitoneum, n (%) | 3 (4.5) | 1 (2.7) | 2 (6.9) |
| Other, n (%) | 9 (13.6) | 6 (16.2) | 3 (10.3) |
| Site by independent radiologic image assessment* | |||
| Lung, n (%) | 43 (65.2) | 25 (67.6) | 18 (62.1) |
| Peritonea, n (%) | 22 (33.3) | 12 (32.4) | 10 (34.5) |
| Lymph node, n (%) | 20 (30.3) | 11 (29.7) | 9 (31.0) |
| Pleura, n (%) | 19 (28.8) | 11 (29.7) | 8 (27.6) |
| Muscle, n (%) | 16 (24.2) | 9 (24.3) | 7 (24.1) |
| Bone, n (%) | 16 (24.2) | 11 (29.7) | 5 (17.2) |
| Other, n (%) | 15 (22.7) | 10 (27.0) | 5 (17.2) |
| Sum of the diameters of target lesions by independent radiologic image assessment (mm) | |||
| Median (range) | 97.65 [10.0, 443.9] | 91.70 [10.0, 443.9] | 134.20 [25.7, 422.7] |
| Number of prior regimens of systemic anticancer agents | |||
| Median (range) | 1.0 [0,4] | 1.0 [0,3] | 2.0 [0,4] |
Abbreviation: PS, Performance Status.
*
Multiple answers allowed.