Abstract
Nilotinib (Tasigna) is a potent and selective BCR-ABL inhibitor approved for use in patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase (CML-CP) and in patients with CML-CP and accelerated phase (CML-AP) who are resistant to or intolerant of imatinib. Patients with CML-AP (N=137) with at least 24 months of follow-up or who discontinued early were evaluated to determine the efficacy and tolerability of nilotinib. The majority (55%) of patients achieved a confirmed hematologic response, and 31% attained a confirmed complete hematologic response on nilotinib treatment. Overall, 32% of patients achieved major cytogenetic responses (MCyR), with most being complete cytogenetic responses. Responses were durable, with 66% of patients maintaining MCyR at 24 months. The estimated overall and progression-free survival rates at 24 months were 70% and 33%, respectively. Grade 3/4 neutropenia and thrombocytopenia were each observed in 42% of patients. Non-hematologic adverse events were mostly mild to moderate; the safety profile of nilotinib has not changed with longer follow-up. In all, 20 (15%) patients remained on study at data cutoff. In summary, nilotinib has a manageable safety profile, and can provide favorable long-term outcomes in the pretreated CML-AP patient population for whom treatment options are limited.
Original language | English (US) |
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Pages (from-to) | 1189-1194 |
Number of pages | 6 |
Journal | Leukemia |
Volume | 26 |
Issue number | 6 |
DOIs | |
State | Published - Jun 2012 |
Funding
We thank Analysis Group Inc., Boston, MA, USA for conducting and assisting with statistical analyses. JFA is grateful for support from the NIHR Biomedical Research Centre funding scheme. Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals. We thank Daniel Hutta, PhD and Erinn Goldman, PhD for medical editorial assistance with this manuscript. Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals, sponsors of this study.
Keywords
- BCR-ABL
- Nilotinib
- chronic myeloid leukemia (CML)
- imatinib
ASJC Scopus subject areas
- Hematology
- Oncology
- Cancer Research