TY - JOUR
T1 - Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance
T2 - 24-month follow-up results
AU - Kantarjian, Hagop M.
AU - Giles, Francis J.
AU - Bhalla, Kapil N.
AU - Pinilla-Ibarz, Javier
AU - Larson, Richard A.
AU - Gattermann, Norbert
AU - Ottmann, Oliver G.
AU - Hochhaus, Andreas
AU - Radich, Jerald P.
AU - Saglio, Giuseppe
AU - Hughes, Timothy P.
AU - Martinelli, Giovanni
AU - Kim, Dong Wook
AU - Shou, Yaping
AU - Gallagher, Neil J.
AU - Blakesley, Rick
AU - Baccarani, Michele
AU - Cortes, Jorge
AU - Le Coutre, Philipp D.
PY - 2011/1/27
Y1 - 2011/1/27
N2 - Nilotinib is a potent selective inhibitor of the BCR-ABL tyrosine kinase approved for use in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP), and in CML-CP and CML-accelerated phase after imatinib failure. Nilotinib (400 mg twice daily) was approved on the basis of the initial results of this phase 2 open-label study. The primary study endpoint was the proportion of patients achieving major cytogenetic response (CyR). All patients were followed for ≥ 24 months or discontinued early. Of 321 patients, 124 (39%) continue on nilotinib treatment. Overall, 59% of patients achieved major CyR; this was completeCyR (CCyR) in 44%. Of patients achieving CCyR, 56% achieved major molecular response. CyRs were durable, with 84% of patients who achieved CCyR maintaining response at 24 months. The overall survival at 24 months was 87%. Adverse events were mostly mild to moderate, generally transient, and easily managed. This study indicates that nilotinib is effective, with a manageable safety profile, and can provide favorable long-term benefits for patients with CML-CP after imatinib failure. This trial was registered at www.clinicaltrials.gov as #NCT00109707.
AB - Nilotinib is a potent selective inhibitor of the BCR-ABL tyrosine kinase approved for use in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP), and in CML-CP and CML-accelerated phase after imatinib failure. Nilotinib (400 mg twice daily) was approved on the basis of the initial results of this phase 2 open-label study. The primary study endpoint was the proportion of patients achieving major cytogenetic response (CyR). All patients were followed for ≥ 24 months or discontinued early. Of 321 patients, 124 (39%) continue on nilotinib treatment. Overall, 59% of patients achieved major CyR; this was completeCyR (CCyR) in 44%. Of patients achieving CCyR, 56% achieved major molecular response. CyRs were durable, with 84% of patients who achieved CCyR maintaining response at 24 months. The overall survival at 24 months was 87%. Adverse events were mostly mild to moderate, generally transient, and easily managed. This study indicates that nilotinib is effective, with a manageable safety profile, and can provide favorable long-term benefits for patients with CML-CP after imatinib failure. This trial was registered at www.clinicaltrials.gov as #NCT00109707.
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U2 - 10.1182/blood-2010-03-277152
DO - 10.1182/blood-2010-03-277152
M3 - Article
C2 - 21098399
AN - SCOPUS:79251546724
SN - 0006-4971
VL - 117
SP - 1141
EP - 1145
JO - Blood
JF - Blood
IS - 4
ER -