Table 1.
Baseline Demographic and Disease Characteristics (Full Analysis Set)
| Characteristic | Everolimus 70 mg/week (N = 99) | Everolimus 10 mg/day (N = 100) |
|---|---|---|
| Age, median y (range) | 61.0 (32–81) | 61.5 (25–84) |
| Sex, N (%) | ||
| Male | 52 (52.5) | 52 (52.0) |
| Female | 47 (47.5) | 48 (48.0) |
| WHO PS, N (%) | ||
| 0 | 45 (45.5) | 50 (50.0) |
| 1 | 52 (52.5) | 44 (44.0) |
| 2 | 2 (2.0) | 5 (5.0) |
| ≥1 | 54 (54.5) | 49 (49.0) |
| Missing | 0 | 1 (1.0) |
| Primary site of cancer, N (%) | ||
| Colon | 72 (72.7) | 76 (76.0) |
| Rectum | 21 (21.2) | 14 (14.0) |
| Other a | 6 (6.1) | 10 (10.0) |
| Histology/cytology, N (%) | ||
| Adenocarcinoma | 93 (93.9) | 95 (95.0) |
| Mucinous adenocarcinoma | 6(6.1) | 4 (4.0) |
| Other | 0 | 1 (1.0) |
| Histologic grade, N (%) | ||
| Well differentiated | 9 (9.1) | 13 (13.0) |
| Moderately differentiated | 78 (78.8) | 64 (64.0) |
| Poorly differentiated | 11 (11.1) | 17 (17.0) |
| Unknown | 1 (1.0) | 6 (6.0) |
| Time since initial diagnosis, N (%) | ||
| ≤12 months | 2 (2.0) | 3 (3.0) |
| >12 months to ≤ 24 months | 23 (23.2) | 23 (23.0) |
| >24 months | 74 (74.7) | 74 (74.0) |
| Number of organs involved, N (%) | ||
| ≤2 | 47 (47.5) | 52 (52.0) |
| >2 | 52 (52.5) | 48 (48.0) |
| Visceral involvement, N (%) | 97 (98.0) | 100 (100) |
| PIK3CA, N (%) | ||
| Wild-type | 76 (76.8) | 76 (76.0) |
| Mutation | 3 (3.0) | 5 (5.0) |
| Missing | 20 (20.2) | 19 (19.0) |
| PTEN expression, N (%) | ||
| Low | 43 (43.4) | 26 (26.0) |
| Normal | 30 (30.3) | 46 (46.0) |
| Missing | 26 (26.3) | 28 (28.0) |
| KRAS, N (%) | ||
| Wild type | 46 (46.5) | 40 (40.0) |
| Mutation | 33 (33.3) | 41 (41.0) |
| Missing | 20 (20.2) | 19 (19.0) |
| BRAF, N (%) | ||
| Wild type | 71 (71.2) | 72 (72.0) |
| Mutation | 8 (8.1) | 7 (7.0) |
| Missing | 20 (20.2) | 21 (21.0) |
a
Includes cecum (N = 5), colon and rectum (N = 3), rectosigmoid (N = 4), sigmoid colon (N = 2), colorectal (N = 1), and splenic-colon corner (N = 1).
PIK3CA, phosphatidylinositol 3-kinase catalytic subunit; PTEN, phosphatase and tensin homolog; WHO PS, World Health Organization performance status.