Table 1. Baseline Patient Characteristics of the Total Soft Tissue Sarcoma Population.
| Characteristic | No. (%) | |
|---|---|---|
| Doxorubicin + olaratumab (n = 258) | Doxorubicin + placebo (n = 251) | |
| Age, median (range), y | 57.0 (23-84) | 57.0 (20-82) |
| <65 | 180 (69.8) | 180 (71.7) |
| ≥65 | 78 (30.2) | 71 (28.3) |
| Sex | ||
| Male | 114 (44.2) | 99 (39.4) |
| Female | 144 (55.8) | 152 (60.6) |
| Racea | ||
| White | 186 (72.1) | 193 (76.9) |
| Asian | 50 (19.4) | 48 (19.1) |
| Black or African American | 12 (4.7) | 2 (0.8) |
| Otherb | 10 (3.9) | 8 (3.2) |
| Hispanic or Latino ethnicitya | 26 (10.1) | 29 (11.6) |
| Geographic region | ||
| Europe | 108 (41.9) | 106 (42.2) |
| North America | 88 (34.1) | 85 (33.9) |
| Rest of the world | 62 (24.0) | 60 (23.9) |
| EGOG PSc | ||
| 0 (Capable of normal activity) | 153 (59.3) | 150 (59.8) |
| 1 (Restricted in strenuous activity) | 105 (40.7) | 101 (40.2) |
| Histology | ||
| Leiomyosarcoma | 119 (46.1) | 115 (45.8) |
| Liposarcoma | 48 (18.6) | 43 (17.1) |
| Pleomorphic sarcoma | 34 (13.2) | 30 (12.0) |
| Otherd | 57 (22.1) | 63 (25.1) |
| Duration of disease, median (range), mo | 11.3 (0-260) | 11.8 (0-192) |
| Metastatic disease at randomization | 216 (83.7) | 206 (82.1) |
| Prior systemic therapiese | 73 (28.3) | 69 (27.5) |
| Neoadjuvant | 1 (0.4) | 1 (0.4) |
| Adjuvant | 8 (3.1) | 10 (4.0) |
| Locally advanced | 14 (5.4) | 9 (3.6) |
| Metastatic | 59 (22.9) | 54 (21.5) |
| Prior radiation therapy | 87 (33.7) | 85 (33.9) |
Abbreviation: ECOG PS, Eastern Cooperative Oncology Group performance status.
Race/ethnicity were self-reported by participants through fixed categories on study case report form.
Other race categories were American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, multiple, and not reported.
The ECOG PS 5-point scale defines 0 as fully active, able to carry on all predisease performance without restriction, and defines 1 as restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
One patient had lymphoma, which is not a subtype of soft tissue sarcoma, and therefore enrollment of this patient was a protocol violation.
Prior systemic therapies were not mutually exclusive.