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See Latest ArticlesNilotinib for the frontline treatment of Ph+ chronic myeloid leukemia
Blood, 10/30/09
Rosti G et al. – Nilotinib is safe and very active in ECP CML. These data support a role for nilotinib for the frontline treatment of CML.
Methods- Phase-2 study
- 73 early chronic phase (ECP), untreated, Ph+ CML patients, received nilotinib at dose of 400 mg BID
- Primary endpoint was complete cytogenetic response (CCgR) rate at 1 year
- Median follow-up of 15 months, CCgR rate at 1 year was 96%, and major molecular response (MMolR) rate 85%
- During the first year, the treatment was interrupted at least once in 38 patients (52%).
- Responses rapid, with 78% CCgR and 52% MMolR at 3 mos
- Mean daily dose ranged between 600 and 800 mg in 74% of patients, 400 and 599 mg in 18% of patients and less than 400 mg in 8% of patients
- Dose interruptions mainly due to non-hematologic and biochemical side
- Myelosuppression irrelevant
- 1 patient progressed to blastic crisis after 6 months, 1 went off-treatment for lipase increase grade 4 (no pancreatitis)
- Nilotinib is safe and very active in ECP CML
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