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) |
|---|---|
| Pages (from-to) | 1189-1194 |
| Number of pages | 6 |
| Journal | Leukemia |
| Volume | 26 |
| Issue number | 6 |
| DOIs | |
| State | Published - Jun 1 2012 |
| Externally published | Yes |
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Keywords
- BCR-ABL
- chronic myeloid leukemia (CML)
- imatinib
- Nilotinib
ASJC Scopus subject areas
- Hematology
- Oncology
- Cancer Research
Cite this
Nilotinib in patients with Ph + chronic myeloid leukemia in accelerated phase following imatinib resistance or intolerance : 24-month follow-up results. / Le Coutre, P. D.; Giles, F. J.; Hochhaus, A.; Apperley, J. F.; Ossenkoppele, G. J.; Blakesley, R.; Shou, Y.; Gallagher, N. J.; Baccarani, M.; Cortes, J.; Kantarjian, H. M.
In: Leukemia, Vol. 26, No. 6, 01.06.2012, p. 1189-1194.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Nilotinib in patients with Ph + chronic myeloid leukemia in accelerated phase following imatinib resistance or intolerance
T2 - 24-month follow-up results
AU - Le Coutre, P. D.
AU - Giles, F. J.
AU - Hochhaus, A.
AU - Apperley, J. F.
AU - Ossenkoppele, G. J.
AU - Blakesley, R.
AU - Shou, Y.
AU - Gallagher, N. J.
AU - Baccarani, M.
AU - Cortes, J.
AU - Kantarjian, H. M.
PY - 2012/6/1
Y1 - 2012/6/1
N2 - 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.
AB - 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.
KW - BCR-ABL
KW - chronic myeloid leukemia (CML)
KW - imatinib
KW - Nilotinib
UR - http://www.scopus.com/inward/record.url?scp=84862028031&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84862028031&partnerID=8YFLogxK
U2 - 10.1038/leu.2011.323
DO - 10.1038/leu.2011.323
M3 - Article
C2 - 22076466
AN - SCOPUS:84862028031
VL - 26
SP - 1189
EP - 1194
JO - Leukemia
JF - Leukemia
SN - 0887-6924
IS - 6
ER -