Table 1. Patient baseline characteristics.
| Baseline characteristic | Patients (N = 146) |
|---|---|
| Median age (range), years | 60 (22–86) |
| Age group (years), n (%) | |
| <65 | 95 (65.1) |
| ≥65 | 51 (34.9) |
| Sex, n (%) | |
| Female | 85 (58.2) |
| Male | 61 (41.8) |
| ECOG, n (%) | |
| 0 | 54 (37.0) |
| 1 | 91 (62.3) |
| 2 | 1 (0.7) |
| Tumor type,a n (%) | |
| Colorectal | 18 (12.3) |
| Sarcoma | 14 (9.6) |
| Ovarian | 12 (8.2) |
| Cervix | 11 (7.5) |
| Head and neck squamous cell carcinoma | 11 (7.5) |
| Anal | 10 (6.8) |
| Prior therapies, n (%) | |
| Median (range) | 3.0 (1–13) |
| 1 | 29 (19.9) |
| 2 | 40 (27.4) |
| 3 | 21 (14.4) |
| 4 | 19 (13.0) |
| ≥5 | 37 (25.3) |
| Genetic analysis based on central assessment,b n (%) | |
| PIK3CA mutation | 50 (32.4) |
| PTEN mutation or loss (non-immunohistochemistry) | 29 (19.9) |
| PTEN loss by immunohistochemistryc | 23 (15.8) |
| PIK3CA amplification | 10 (6.8) |
| PIK3R1 mutation | 6 (4.1) |
aOther tumors in <5% of patients were gall bladder, gastroesophageal junction (n = 6 each), bladder (n = 5), liver, gall bladder ducts, neuroendocrine, skin non-melanoma, small intestine, thyroid, vaginal (n = 4 each), esophagus, germ cell tumor, pancreas (n = 3 each), melanoma, salivary gland, appendix (n = 2 each), and unknown primary (n = 6). Other histologies (n = 4) included only one patient each.
bAn individual patient could be counted in multiple categories.
cPTEN loss by immunohistochemistry is based on local assessment.
Abbreviation: ECOG, Eastern Cooperative Oncology Group.