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Table 2 Patient disposition and dose intensity for the study treatment

From: Correlation of plasma concentration and adverse effects of bosutinib: standard dose or dose-escalation regimens of bosutinib treatment for patients with chronic myeloid leukemia

All patients during day 1 to day 180 Standard dose (n = 10) Dose escalation (n = 15) P value
Interruption, n (%) 9 (90.0%) 2 (13.3%) < 0.001
 Diarrhea 9 (90.0%) 0 (0.0%)  
 Liver dysfunctions 5 (50.0%) 2 (13.3%)  
 Skin rash 2 (20.0%) 0 (0.0%)  
 Cytopenia 3 (30.0%) 0 (0.0%)  
 Elevation of lipase 1 (10.0%) 0 (0.0%)  
Median (range) day to the first interruption of bosutinib 17.5 (8–180) 180 (35–180) < 0.001
Total median (range) duration of treatment interruption (days) 35 (8–81) 14 (14–14) 0.013
Dose reduction, n (%) 8 (80.0%) 8 (53.3%) 0.182
Discontinuation of treatment, n (%) 3 (30.0%) 1 (6.6%) 0.127
 Adverse events 2 (20.0%)a 1 (6.6%)  
 Progression disease 1 (10.0%) 0 (0.0%)  
On day 180 after beginning therapy Standard dose (n = 7) Dose escalation (n = 14) P value
Final dose: 100/200/300/400/500 mg QD, n 0/0/5/1/1 (mean 343 mg/day) 1/2/4/4/3 (mean 346 mg/day) 0.403
Median (range) duration of administration (days) 157.0 (99–180) 180.0 (166–180) < 0.001
Median (range) cumulative dose for 6 months (mg) 51,700 (32,800–90,000) 53,550 (29,700–75,600) 1.000
Median (range) dose intensity of bosutinib (mg/day) 309.8 (182.2–500.0) 295.0 (165.0–420.0) 1.000
Median (range) plasma trough concentration (ng/mL) 63.7 (31.9–126.0) (mean = 75.1) 63.0 (31.4–113.0) (mean = 65.8) 0.588
  1. aTwo patients discontinued bosutinib due to pancytopenia (n = 1) and elevation of lipase (n = 1)