Safety

In an ongoing Phase 3 trial of adult patients with newly diagnosed CP Ph+ CML,
Most common adverse reactions for BOSULIF vs imatinib
ALT=alanine aminotransferase; ARs=adverse reactions; AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase; SGPT=serum glutamic-pyruvic transaminase; ULN=upper limit of normal.
At the time of the 12-month analysis, 1 patient receiving BOSULIF died vs 6 patients receiving imatinib.2
Discontinuation rates due to ARs
14.2% of patients discontinued treatment due to ARs in the BOSULIF arm vs 10.6% in the imatinib arm2
The most common ARs leading to discontinuation of BOSULIF were ALT increase (4.9%) and AST increase (2.2%)
The most common ARs leading to discontinuation of imatinib were thrombocytopenia (1.5%) and myalgia (1.1%)
Most cases of transaminase elevations occurred early in treatment1
Liver function ARs occurred in 40% of patients receiving BOSULIF vs 14% of patients receiving imatinib2
Of patients receiving BOSULIF who experienced transaminase elevations of any grade, 79% experienced their first event within the first 3 months1
The median time to onset of increased ALT and AST was 32 and 43 days, respectively, and the median duration was 20 and 15 days, respectively
Rates of fluid retention
Pleural effusion events were reported in 1.9% of patients treated with BOSULIF and 1.5% of patients treated with imatinib; none were Grade 3 or higher2
Peripheral edema was reported in 4.1% of patients receiving BOSULIF vs 13.6% of patients receiving imatinib2
One patient (0.4%) receiving BOSULIF experienced severe fluid retention of Grade 3 pericardial effusion1
Incidence of cardiaca and vascular events
Cardiac events occurred in 5.2% of patients receiving BOSULIF and 5.3% of patients receiving imatinib2
Cardiac events of Grade ≥3 occurred in 0.7% of patients receiving BOSULIF (1 event of pericardial effusion and 1 event of supraventricular tachycardia) vs 0.4% of patients receiving imatinib (1 event of QTc prolongation) per investigator assessment2
One patient in the group treated with BOSULIF experienced a Grade 3 QTc prolongation (>500 msec)1
Rates of peripheral vascular events were 1.5% with BOSULIF vs 1.1% with imatinib2
Cardiovascular events occurred in 3.0% of patients receiving BOSULIF and 0.4% of patients receiving imatinib2,b
There were no deaths due to cardiovascular toxicity
Patients with uncontrolled or significant cardiovascular disease, including prolonged QT interval, were excluded by protocol.1
Diarrhea was manageable (primarily Grade 1 or 2). Monitor and manage patients using standards of care, including antidiarrheals, antiemetics, and fluid replacement. Withhold, dose reduce, or discontinue BOSULIF as necessary1,2
Learn more about select adverse reactions, including therapy management suggestions and dose adjustments.
aIncludes Medical Dictionary for Regulatory Activities (MedDRA) high-level group terms (HLGT) Cardiac arrhythmias, Heart failures, and Pericardial disorders under the system organ class (SOC) Cardiac disorders; the preferred terms Cardiac death, Sudden cardiac death, Sudden death, and Ejection fraction decreased; and the standardized MedDRA query Torsade de pointes/QT prolongation (narrow).3
bCardiovascular includes the MedDRA HLGT Coronary artery disorders. Cerebrovascular includes the high-level terms Central nervous system hemorrhages and cerebrovascular accidents, Central nervous system vascular disorders not elsewhere classified (NEC), Transient cerebrovascular events, Vascular imaging procedures NEC, and Vascular therapeutic procedures NEC. Peripheral vascular includes the HLGTs Arteriosclerosis, stenosis, vascular insufficiency and necrosis and Embolism and thrombosis as well as the high-level terms Arterial therapeutic procedures (excluding aortic), Non-site specific vascular disorders NEC and Peripheral vascular disorders NEC (excluding flushing and hot flash).3
ALT=alanine aminotransferase; ARs=adverse reactions; AST=aspartate aminotransferase; Ph+=Philadelphia chromosome–positive.
References
1.
BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
2.
Cortes JE, Gambacorti-Passerini C, Deininger MW, et al. Bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia: results from the randomized BFORE trial. J Clin Oncol. 2018;36(3):231-237.
3.
Data on file. Pfizer Inc, New York, NY.