Management of adverse events associated with bosutinib treatment of chronic-phase chronic myeloid leukemia: expert panel review

Table 2 Rates of selected AEs in key trials of bosutinib treatment of CP-CML

Patients, safety set	First-line study [6] Phase 3 BFORE trial (NCT02130557)		Subsequent-line study [1] Phase 1/2 study (NCT00261846)
	CP-CML, newly diagnosed		CP-CML, resistant/intolerant to prior therapy (combined imatinib-only and imatinib plus ≥ 1 additional TKI cohorts)*
	n = 268		n = 403
Follow-up	Minimum 12 months		Minimum 48 months
Adverse events, % of patients	All grades	Grade ≥ 3	All grades	Grade 3/4
Diarrhea	70	8	85	9
Nausea	35	0	47	1
Vomiting	18	1	37	3
Liver enzyme abnormalities
ALT increased	31	19	20	8
AST increased	23	10	16	3
Myelosuppression
Thrombocytopenia	35	14	40	26
Anemia	19	3	27	11
Neutropenia	11	7	18	12
Leukopenia	6	1	10	4

Abbreviations: ALT alanine aminotransferase, AST aspartate aminotransferase, CP chronic-phase, CML chronic myeloid leukemia, TKI tyrosine kinase inhibitor
*Two hundred eighty-four previously treated with imatinib only and 119 treated with both imatinib and ≥ 1 additional tyrosine kinase inhibitor

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