CML-CP CML-AP CML-BC CML-BC CML-BC
(myeloid) (lymphoid) (unknown)
FIGURE 3 Phase II nilotinib response in imatinib-resistant/imatinib-intolerant chronic myelogenous leukemia (CML) patients. Phase II results showing percent of patients in each phase of CML. Chronic phase, accelerated phase, blast crisis (BC)-myeloid, BC-lymphoid, and BC-unknown) with complete and partial cytogenetic responses. Abbreviations: AP, accelerated phase; BC, blast crisis; CCyR, complete cytogenetic response; CML, chronic myelogenous leukemia; CP, chronic phase; PCyR, partial cytogenetic response.
(7% grade 1 or 2 and 7% grade 3 or 4), increased lipase (5% grade 3 or 4), and increased AST and/or ALT (1% grade 1 or 2 and 3% grade 3 or 4) (25). The frequency and grade of bilirubin elevations increased with nilotinib dose, but these rises were generally self-limiting and resolved with continued dosing of nilotinib (25). Analysis of ECGs indicated one instance of increased QTcF (5-15 msec). One patient had two treatment-related adverse cardiac events (grade 1 pericardial effusion and grade 2 atrial fibrillation) (25).
In the open-label phase II trial of nilotinib, adverse events that occurred in >10% of patients with CML included thrombocytopenia (32%), headache (29%), fatigue (29%), nausea (28%), pruritus (27%), rash (27%), anemia (26%), diarrhea (25%), neutropenia (21%), vomiting (20%), muscle spasms (20%), constipation and arthralgia (17% each), bone pain, myalgia, and peripheral edema (13% each), and abdominal pain and dyspepsia (12% each) (26-28).
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