Table 3 Appearance of liver dysfunction and diarrhea within 180 days after treatment
Number of patients | Standard dose (n = 10) | Dose escalation (n = 15) | P value |
|---|---|---|---|
Patient with liver dysfunction (> grade 1) (%) | 5 (50.0%) | 4 (26.7%) | 0.234 |
Maximum grade (grade 2/3/4) | 4/1/0 | 1/2/1 | |
Day of the appearance of liver dysfunction (> grade 1), median (range) | 28 (19–57) | 53.5 (35–112) | |
Cumulative dose until the appearance of liver dysfunction over grade 2, mg, median (range) | 8500 (6500–20,500) | 11,300 (5500–36,300) | 0.806 |
Dose at the appearance of liver dysfunction over grade 2, median (range) | 400 (400–500) | 350 (200–500) | 0.241 |
Discontinuation of bosutinib due to liver dysfunction (%) | 0 (0%) | 1 (6.6%) | |
Patient with diarrhea (all grade) (%) | 10 (100%) | 11 (73.3%) | 0.075 |
Maximum grade (grade 0/1/2/3/4) | 0/4/3/3/0 | 4/6/2/3/0 | |
Day of the first appearance of diarrhea, median (range) | 1 (1–5) | 19 (1–148) | < 0.0001 |
Dose at the first appearance of diarrhea (100/200/300/400/500 mg) | 0/0/0/0/10 | 4/3/1/3/0 | |
Cumulative days of diarrhea, median (range) | 20.5 (3–47) | 6 (1–27) | 0.104 |
Discontinuation of bosutinib due to diarrhea (%) | 0 (0%) | 0 (0%) |