Skip to main content

Table 1 Baseline characteristics and demographics (FAS)

From: A multicenter, dose-finding, phase 1b study of imatinib in combination with alpelisib as third-line treatment in patients with advanced gastrointestinal stromal tumor

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)

  1. ECOG Eastern Cooperative Oncology Group, FAS full analysis set