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Table 1 Baseline demographics and clinical characteristics

From: Activity and safety of SHR3680, a novel antiandrogen, in patients with metastatic castration-resistant prostate cancer: a phase I/II trial

 

40 mg (N = 3)

80 mg (N= 39)

160 mg (N = 73)

240 mg (N = 76)

360 mg (N = 3)

480 mg (N = 3)

Total (N = 197)

Age, years

  Median

68

68

67

66

66

63

67

  Range

66-77

45-80

54-80

49-79

66-79

58-71

45-80

ECOG performance status

  0

2 (66.7)

13 (33.3)

20 (27.4)

26 (34.2)

0

0

61 (31.0)

  1

1 (33.3)

26 (66.7)

53 (72.6)

50 (65.8)

3 (100)

3 (100)

136 (69.0)

Gleason score

  <9

2 (66.7)

18 (46.2)

43 (58.9)

34 (44.7)

1 (33.3)

2 (66.7)

100 (50.8)

  ≥9

1 (33.3)

14 (35.9)

28 (38.4)

37 (48.7)

1 (33.3)

1 (33.3)

82 (41.6)

  Unknown

0

7 (17.9)

2 (2.7)

5 (6.6)

1 (33.3)

0

15 (7.6)

PSA (ng/mL)

  Median

34.3

70.6

73.7

62.2

112.7

21.5

66.1

  Range

9.7-36.8

2.7-2384.0

3.7-4796.0

3.3-3382.0

19.7-757.8

11.0-96.5

2.7-4796.0

Alkaline phosphatase

  Normal

3 (100)

28 (71.8)

56 (76.7)

43 (56.6)

1 (33.3)

2 (66.7)

133 (67.5)

  Abnormal

0

11 (28.2)

17 (23.3)

33 (43.4)

2 (66.7)

1 (33.3)

64 (32.5)

Number of bone metastases

  ≤5

1 (33.3)

12 (30.8)

23 (31.5)

24 (31.6)

1 (33.3)

1 (33.3)

62 (31.5)

  >5

2 (66.7)

27 (69.2)

50 (68.5)

52 (68.4)

2 (66.7)

2 (66.7)

135 (68.5)

Visceral metastases*

  Yes

0

6 (15.4)

13 (17.8)

15 (19.7)

1 (33.3)

1 (33.3)

36 (18.3)

  No

3 (100)

33 (84.6)

60 (82.2)

61 (80.3)

2 (66.7)

2 (66.7)

161 (81.7)

Prior treatment

  Surgery of primary tumor

2 (66.7)

12 (30.8)

24 (32.9)

19 (25.0)

0

1 (33.3)

58 (29.4)

  Chemotherapy

0

19 (48.7)

29 (39.7)

32 (42.1)

0

2 (66.7)

82 (41.6)

  Radiotherapy

1 (33.3)

12 (30.8)

18 (24.7)

18 (23.7)

0

1 (33.3)

50 (25.4)

  1. Data are N (%), unless otherwise specified. * Metastasis to lymph node only are excluded. Abbreviations: ECOG Eastern Cooperative Oncology Group; PSA prostate-specific antigen