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Nilotinib for the frontline treatment of Ph(+) chronic myeloid leukemia
- Publication Year :
- 2009
-
Abstract
- Nilotinib has a higher binding affinity and selectivity for BCR-ABL with respect to imatinib and is an effective treatment of chronic myeloid leukemia (CML) after imatinib failure. In a phase 2 study, 73 early chronic-phase, untreated, Ph+ CML patients, received nilotinib at a dose of 400 mg twice daily. The primary endpoint was the complete cytogenetic response (CCgR) rate at 1 year. With a median follow-up of 15 months, the CCgR rate at 1 year was 96%, and the major molecular response rate 85%. Responses were rapid, with 78% CCgR and 52% major molecular response at 3 months. During the first year, the treatment was interrupted at least once in 38 patients (52%). The mean daily dose ranged between 600 and 800 mg in 74% of patients, 400 and 599 mg in 18% of patients, and was less than 400 mg in 8% of patients. Dose interruptions were mainly due to nonhematologic and biochemical side effects. Myelosuppression was irrelevant. One patient progressed to blastic crisis after 6 months; one went off-treatment for lipase increase grade 4 (no pancreatitis). Nilotinib is safe and very active in early chronic-phase CML. These data support a role for nilotinib for the frontline treatment of CML. This study was registered at ClinicalTrials.gov as NCT00481052.
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
Aged
Aged, 80 and over
Antineoplastic Agents
Female
Fusion Proteins, bcr-abl
Humans
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Middle Aged
Pyrimidines
Treatment Outcome
Young Adult
Hematology
Biochemistry
Cell Biology
Immunology
medicine.drug_class
bcr-abl
NILOTINIB
Phases of clinical research
Gastroenterology
Tyrosine-kinase inhibitor
Internal medicine
hemic and lymphatic diseases
medicine
80 and over
Chronic
CHRONIC MYELOID LEUKEMIA
Leukemia
business.industry
Myeloid leukemia
Fusion Proteins
Imatinib
medicine.disease
Surgery
Nilotinib
BCR-ABL Positive
business
Chronic myelogenous leukemia
medicine.drug
Myelogenous
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....9122900d3e2958a4eb1f3019dac6f75a