Introduction
Methods
Pharmacokinetic analyses
BCR-ABL Mutation analyses
Statistical analyses
Study conduct
Results
No | Age | Sex | Dasatinib dose | BM relapse | BCR-ABL mutation | EFS, day | Outcome / Event (cause of death) |
---|---|---|---|---|---|---|---|
1 | 56 | M | 100 mg QD | No | No | 624* | SCT in CMR |
2 | 56 | M | 100 mg QD | No | No | 149 | dead (infection) |
3 | 64 | F | 100 mg QD | No | No | 318 | CMR |
4 | 68 | M | 100 mg QD | Yes | T315I | 368 | dead (PD) |
5 | 67 | F | 100 mg QD | Yes | T315I | 197 | dead (PD) |
6 | 22 | F | 100 mg QD | No | No | 634* | SCT in CMR |
7 | 77 | M | 50 mg BID | Yes | T315I | 221 | dead (PD) |
8 | 63 | F | 50 mg QD | Yes | T315I | 106 | dead (PD) |
9 | 80 | F | 100 mg QD | No | No | 269 | CMR |
10 | 32 | M | 100 mg QD | No | No | 158 | CMR |
11 | 78 | M | 100 mg QD | Yes | No | 114 | dead (PD) |
T315I (n = 4) | Without T315I (n = 7) |
P-Value
| |
---|---|---|---|
median (quartile 1- quartile 3) | median (quartile 1- quartile 3) | ||
Sex † Female | 2 (50.0) | 3 (42.9) | 0.6515 |
Age (year) | 67 (64–72) | 56 (38.5 - 71) | 0.4121 |
Bodily weight (kg) | 50.3 (48.3 - 60.1) | 49.0 (44.2 - 52.8) | 0.7879 |
Body surface area (m2) | 1.49 (1.46 - 1.57) | 1.45 (1.39 - 1.57) | 0.6485 |
White blood cell (*103/mm3) | 2.4 (2.4 - 2.5) | 3.7 (2.15 - 5.85) | 0.3833 |
Red blood cell (*104 mm3) | 248 (241–282) | 291 (238–316) | 0.8333 |
Platelet (*104 /mm3) | 70 (50.5 - 77.5) | 135 (117–167) | 0.0167 |
Aspartate transaminase (IU/L) | 32.5 (19.5 - 50) | 33 (15.5 - 34) | 0.5273 |
Alanine transaminase (IU/L) | 23 (21–79) | 23 (14–73.5) | 0.7879 |
Serum albumin (g/dL) | 4.3 (4.0 - 4.5) | 3.9 (3.3 - 4.2) | 0.2303 |
Total bilirubin (mg/dL) | 0.4 (0.4 - 0.5) | 0.4 (0.4 - 0.9) | 0.9273 |
Serum creatinine (mg/dL) | 0.6 (0.5 - 0.8) | 0.6 (0.5 - 0.9) | 0.7879 |
Single dose (mg) | 100 (75–100) | 100 (100–100) | 0.7879 |
C0h (ng/mL) | 0.2 (0.1 - 0.4) | 0.0 (0.0 - 0.0) | 0.1091 |
C1h (ng/mL) | 13.2 (3.3 - 23.8) | 49.0 (23.6 - 66.7) | 0.0727 |
C2h (ng/mL) | 22.3 (5.8 - 43.8) | 111.6 (65.1 - 122.8) | 0.0242 |
C4h (ng/mL) | 34.6 (10.6 - 76.3) | 69.7 (66.9 - 95.3) | 0.1636 |
Cmax (ng/mL) | 43.8 (19.1 - 77.0) | 112.4 (95.3 - 122.8) | 0.0242 |
AUC0-4h (ng·h/mL) | 108.3 (49.2 - 139.2) | 268.3 (220.0 - 307.3) | 0.0061 |