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