Patients and metrics of bosutinib exposure
Cancer
ONCOLOGY, DYSFUNCTION, CANCER
Based on appropriate PK and efficacy data availability, a total of 573 patients (from studies BELA, BFORE, B1871048) were included in the exposure–response analysis for MMR; for CCyR, the exposure–response analysis was conducted in Ph + patients only (Patient demographics and baseline laboratory values in the bosutinib arms of BELA, BFORE, and B1871048 are shown in Table Summary of baseline categorical and continuous covariates.
69.0 (35.0–136.0)
75.6 (35.0–125.0)
59.8 (33.2–102.8)
97.7 (40.0–249.0)
102.3 (32.5–250.5)
101.0 (36.9–196.8)AP, median (range),U/L
89.0 (30.5–792.0)
78.0 (28.0–508.0)
206.5 (99.0–791.0)Albumin, median (range),g/dL
4.4 (3.3–7.4)
4.3 (1.9–5.4)
4.5 (3.7–5.4)
23.0 (6.0–125.0)
21.0 (5.0–91.0)
25.0 (4.0–83.0)
24.0 (8.7–62.0)
24.0 (5.0–76.0)
26.0 (13.0–61.0)
0.5 (0.1–4.4)
0.5 (0.2–1.9)
0.6 (0.3–1.3)
13.1 (0–202.8)
26.2 (0.4–342.7)
18.7 (1.8–123.5)
386.0 (60.0–4189.0)
385.5 (72.0–2195.0)
458.0 (141.0–2133.0)Abbreviations: ALT, alanine aminotransferase; ANC, absolute neutrophil count; AP, alkaline phosphatase; AST, aspartate aminotransferase; CCL, creatinine clearance; ECOG PS, Eastern Cooperative Oncology Group Performance Status; NCI, National Cancer Institute Organ Dysfunction Working Group.Mean and median values for the derived exposure metrics by study are shown in Table 