Baseline characteristics | Alpelisib 200 mg + Imatinib (N = 4) | Alpelisib 250 mg + Imatinib (N = 6) | Alpelisib 350 mg + Imatinib (N = 46) | Total (N = 56) |
---|---|---|---|---|
Age, years | ||||
Median (range) | 61.5 (47–74) | 56.0 (34–67) | 59.0 (31–80) | 59.0 (31–80) |
Age category, n (%) | ||||
< 65 years | 2 (50.0) | 4 (66.7) | 34 (73.9) | 40 (71.4) |
≥ 65 years | 2 (50.0) | 2 (33.3) | 12 (26.1) | 16 (28.6) |
Sex, n (%) | ||||
Female | 1 (25.0) | 1 (16.7) | 17 (37.0) | 19 (33.9) |
Male | 3 (75.0) | 5 (83.3) | 29 (63.3) | 37 (66.1) |
Race, n (%) | ||||
Caucasian | 4 (100) | 6 (100) | 43 (93.5) | 53 (94.6) |
Black | 0 | 0 | 2 (4.3) | 2 (3.6) |
Pacific Islander | 0 | 0 | 1 (2.2) | 1 (1.8) |
Ethnicity, n (%) | ||||
Other | 0 | 3 (50.0) | 38 (82.6) | 41 (73.2) |
Hispanic or Latino | 3 (75.0) | 0 | 5 (10.9) | 8 (14.3) |
Not reported | 1 (25.0) | 3 (50.0) | 3 (6.5) | 7 (12.5) |
ECOG performance status | ||||
0 | 2 (50.0) | 3 (50.0) | 28 (60.9) | 33 (58.9) |
1 | 2 (50.0) | 3 (50.0) | 16 (34.8) | 21 (37.5) |
2 | 0 | 0 | 1 (2.2) | 1 (1.8) |
Missing | 0 | 0 | 1 (2.2) | 1 (1.8) |
Primary site of cancer | ||||
Small intestine | 3 (75.0) | 2 (33.3) | 21 (45.7) | 26 (46.4) |
Stomach | 0 | 2 (33.3) | 9 (19.6) | 11 (19.6) |
Peritoneum | 1 (25.0) | 0 | 6 (13.0) | 7 (12.5) |
Abdominal region | 0 | 2 (33.3) | 4 (8.7) | 6 (10.7) |
Omentum | 0 | 0 | 2 (4.3) | 2 (3.6) |
Other | 0 | 0 | 4 (8.7) | 4 (7.1) |
Site of active disease | ||||
Liver | 3 (75.0) | 5 (83.3) | 31 (67.4) | 39 (69.6) |
Peritoneum | 3 (75.0) | 4 (66.7) | 28 (60.9) | 35 (62.5) |
Abdominal region | 0 | 1 (16.7) | 23 (50.0) | 24 (42.9) |
Small intestine | 0 | 2 (33.3) | 14 (30.4) | 16 (28.6) |
Omentum | 0 | 0 | 11 (23.9) | 11 (19.6) |
Lung | 2 (50.0) | 2 (33.3) | 7 (15.2) | 11 (19.6) |
Stomach | 0 | 0 | 3 (6.5) | 3 (5.4) |
Large intestine | 0 | 1 (16.7) | 2 (4.3) | 3 (5.4) |
Esophagus | 0 | 0 | 1 (2.2) | 1 (1.8) |
Other | 3 (75.0) | 3 (50.0) | 20 (43.5) | 26 (46.4) |
Prior anti-neoplastic medication – number of regimens | ||||
2 | 0 | 2 (33.3) | 16 (34.8) | 18 (32.1) |
3 | 0 | 1 (16.7) | 20 (43.5) | 21 (37.5) |
4 | 1 (25.0) | 0 | 5 (10.9) | 6 (10.7) |
≥ 5 | 3 (75.0) | 3 (50.0) | 5 (10.9) | 11 (19.6) |
Time since initial diagnosis to first dose of study treatment (months), median (range) | 47.38 (18.4–124.2) | 69.14 (25.3–151.4) | 72.25 (10.4–192.3) | 64.66 (10.4–192.3) |