Table 1.
Baseline demographic and disease characteristics of patients in the D1q3w arm, the D1D8q4w arm, and overall
| Characteristic | D1q3w (n = 29) | D1D8q4w (n = 25) | All patients (N = 54) |
|---|---|---|---|
| Mean age, years (range) | 59.1 (32–83) | 55.0 (19–75) | 57.2 (19–83) |
| Gender, n (%) | |||
| Male | 16 (55.2) | 15 (60.0) | 31 (57.4) |
| Female | 13 (44.8) | 10 (40.0) | 23 (42.6) |
| Race | |||
| Caucasian | 19 (65.5) | 18 (72.0) | 37 (68.5) |
| Asian | 9 (31.0) | 5 (20.0) | 14 (25.9) |
| African American | 1 (3.4) | 1 (4.0) | 2 (3.7) |
| Missing | 0 | 1 (4.0) | 1 (1.9) |
| Clinical stage | |||
| III | 2 (6.9) | 3 (12.0) | 5 (9.3) |
| IV | 24 (82.8) | 19 (76.0) | 43 (79.6) |
| Not assessed | 3 (10.3) | 3 (12.0) | 6 (11.1) |
| ECOG PS, n (%) | |||
| 0 | 11 (37.9) | 17 (68.0) | 28 (51.2) |
| 1 | 18 (62.1) | 8 (32.0) | 26 (48.1) |
| Tumor classification | |||
| Soft-tissue sarcoma | 10 (34.5) | 15 (60.0) | 25 (46.3) |
| DDLPS | 6 (20.7) | 6 (24.0) | 12 (22.2) |
| WDLPS | 3 (10.3) | 4 (16.0) | 7 (13.0) |
| Melanoma | 2 (6.9) | 2 (8.0) | 4 (7.4) |
| Head and neck cancers | 1 (3.4) | 2 (8.0) | 3 (5.6) |
| Uterine sarcoma | 2 (6.9) | 1 (4.0) | 3 (5.6) |
| Colorectal carcinoma | 1 (3.4) | 1 (4.0) | 2 (3.7) |
| Biliary tract carcinoma | 2 (6.9) | 0 | 2 (3.7) |
| Breast cancer | 2 (6.9) | 0 | 2 (3.7) |
| Small intestine carcinoma | 2 (6.9) | 0 | 2 (3.7) |
| Other tumor typesa | 7 (24.1) | 4 (16.0) | 11 (20.4) |
| Median number of prior systemic therapies (range) | 3 (0–11) | 2 (0–8) | 2 (0–11) |
| ≥2 prior therapies | 20 (69.0) | 17 (68.0) | 37 (68.5) |
| MDM2 status (central assessment) | |||
| Amplified | 14 (48.3) | 14 (56.0) | 28 (51.9) |
| Not amplified | 11 (37.9) | 7 (28.0) | 18 (33.3) |
| Not assessed/missing | 4 (13.8) | 4 (16.0) | 8 (14.8) |
| TP53 mutation (central assessment) | |||
| Yes | 2 (6.9) | 0 | 2 (3.7) |
| No | 14 (48.3) | 18 (72.0) | 32 (59.3) |
| Not assessed/missing | 13 (44.8) | 7 (28.0) | 20 (37.0) |
Abbreviation: ECOG PS, Eastern Cooperative Oncology Group performance status.
aOther tumor types included adrenal cancer, anal cancer, cancer of the ureter, cancer of the urethra and penis, cancers of unknown primary site, endometrial carcinoma, gastrointestinal tract cancer, non–small cell lung cancer, and pancreatic cancer.