Table 1 Characteristics of Phase 1 and 2 cohorts

From: Phase 2 study of circulating microRNA biomarkers in castration-resistant prostate cancer

 

Phase 1 cohort

Phase 2 cohort

 

Number of patients (%)

Median (range)

Number of patients (%)

Median (range)

Age (years)

97 (100)

65 (46–87)

87 (100)

72 (40–89)

Follow-up (months)

97 (100)

14 (3–63)

 

15 (0.7–45)

Status

    

 Alive

16 (16)

 

34 (39)

 

 Dead

81 (84)

 

53 (61)

 

PSA response

    

 Partial response

61 (63)

 

38 (44)

 

 Stable disease

25 (26)

 

22 (25)

 

 Progressive disease

11 (11)

 

19 (22)

 

 Unknown

 

8 (9)

 

Survival (months)

    

 All patients

 

17 (3–63)

 

20 (1–45)

 Partial response

 

24 (3–63)

 

23 (2–45)

 Stable disease

 

12 (5–28)

 

18 (1–30)

 Progressive disease

 

9 (3–29)

 

13 (2–32)

Gleason at diagnosis

    

 <7

7 (7)

 

6 (7)

 

 7

24 (25)

 

18 (21)

 

 >7

50 (52)

 

39 (45)

 

 Unknown

16 (16)

 

24 (27)

 

Serum PSA, baseline (μg l−1)

96 (99)

145 (0.6–3882)

84 (97)

96 (1.1–10054)

Haemoglobin, baseline (g l−1)

97 (100)

124 (67–162)

84 (97)

125 (79–168)

Alkaline Phosphatase, baseline (U l−1)

90 (93)

141 (15–2962)

82 (85)

132 (16–2199)

Metastasis

    

 None

5(5)

 

1 (1)

 

 Bone only

53 (55)

 

54 (62)

 

 Soft tissuea

39 (40)

 

29 (34)

 

 Unknown

 

3 (3)

 

Subsequent treatments

    

 Cabazitaxel

22 (23)

 

29 (33)

 

 Abiraterone

30 (31)

 

50 (57)

 

 Enzalutamide

2 (2)

 

21 (24)

 

 Mitoxantrone

12 (12)

 

10 (11)

 

 Otherb

1 (1)

 

9 (10)

 

 Unknown

32 (33)

 

6 (7)

 
  1. Abbreviation: PSA = prostate specific antigen.
  2. aVisceral metastases could not be distinguished from nodal metastases for the Phase 2 cohort.
  3. bCabozantinib, carboplatin, strontium, c-met inhibitor, paclitaxel, and cyclophosphamide.