Introduction
Patients and methods
Selection of patients
Study design
Efficacy
Safety
Statistical analyses
Results
Patient disposition and baseline characteristics
Exposure
Efficacy
ALP dynamics and response
ALP | PSA | |||
---|---|---|---|---|
At 12 weeks | At EOT | At 12 weeks | At EOT | |
Change from baseline, % (N = 49) | ||||
Mean ± SD | −19.3 ± 30.1 | −1.9 ± 61.9 | 97.4 ± 164.9 | 280.5 ± 500.8 |
Median | −23.5 | −13.8 | 54.4 | 86.1 |
Min | −75.0 | −65.0 | –81.0 | –99.0 |
Max | 110.0 | 262.0 | 914.0 | 2403.0 |
95% CI | −28.0, −10.7 | −19.7, 15.8 | 50.1, 144.8 | 136.7, 424.4 |
Response rate, n (%) | ||||
≥30% reduction | ||||
Unconfirmed | 18 (37) | 17 (35) | 3 (6) | 4 (8) |
Confirmeda
| 15 (31) | 11 (22) | 3 (6) | 4 (8) |
≥50% reduction | ||||
Unconfirmed | 5 (10) | 7 (14) | 2 (4) | 3 (6) |
Confirmeda
| 5 (10) | 4 (8) | 2 (4) | 3 (6) |
PSA dynamics and response
Overall survival and symptomatic skeletal events
Safety
TEAEs, n (%) | All grade | Grade ≥ 3a
|
---|---|---|
Any | 44 (90) | 19 (39) |
Hematological AE | ||
Anemia | 16 (33) | 7 (14) |
Lymphocyte count decreased | 15 (31) | 7 (14) |
Platelet count decreased | 8 (16) | 1 (2) |
White blood cell decreased | 5 (10) | 0 |
Neutrophil count decreased | 3 (6) | 0 |
Non-hematological AE | ||
Anorexia | 13 (27) | 5 (10) |
Nausea | 12 (24) | 0 |
Bone pain | 11 (22) | 5 (10) |
Constipation | 8 (16) | 0 |
Weight loss | 8 (16) | 0 |
Dental caries | 4 (8) | 2 (4) |
Diarrhea | 7 (14) | 0 |
Malaise | 6 (12) | 0 |
Vomiting | 5 (10) | 0 |
Dental caries | 4 (8) | 2 (4) |
Hypophosphatemia | 3 (6) | 2 (4) |
Aspartate aminotransferase increased | 3 (6) | 1 (2) |
Edema limbs | 3 (6) | 0 |
Renal and urinary disorders—otherb
| 3 (6) | 0 |
Skin infection | 3 (6) | 0 |
Upper respiratory infection | 3 (6) | 0 |
Treatment-emergent SAEs, n (%) | All | Drug-related |
---|---|---|
Any | 12 (24) | 3 (6) |
Bone pain | 5 (10) | 1 (2) |
Anemia | 1 (2) | 1 (2) |
Blood and lymphatic system disorders—otherc
| 1 (2) | 1 (2) |
Anorexia | 1 (2) | 0 |
Gum infection | 1 (2) | 0 |
General disorders and administration site conditions—otherd
| 1 (2) | 0 |
Platelet count decreased | 1 (2) | 0 |
Pneumonia | 1 (2) | 0 |
Tumor pain | 1 (2) | 0 |
Efficacy and safety according to prior docetaxel use
With prior docetaxel (N = 27) | Without prior docetaxel (N = 22) | |||
---|---|---|---|---|
All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | |
TEAEs, n (%) | ||||
Any | 26 (96) | 14 (52) | 18 (82) | 5 (23) |
Leading to drug discontinuation | 3 (11)a
| 3 (11)a
| 0 | 0 |
Leading to drug interruption | 1 (4) | 1 (4) | 0 | 0 |
Hematological TEAEs, n (%) | ||||
Anemia | 11 (41) | 6 (22) | 5 (23) | 1 (5) |
Lymphocyte count decreased | 11 (41) | 5 (19)c
| 4 (18) | 2 (9) |
Platelet count decreased | 5 (19) | 1 (4) | 3 (14) | 0 |
White blood cell decreased | 3 (11) | 0 | 2 (9) | 0 |
Neutrophil count decreased | 3 (11) | 0 | 0 | 0 |
Blood and lymphatic system disorders—otherb
| 1 (4) | 1 (4) | 0 | 0 |
Treatment-emergent SAEs, n (%) | ||||
Any | 9 (33) | 6 (22) | 3 (14) | 1 (5) |