Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2011 Jan 27;117(4):1141-5.
doi: 10.1182/blood-2010-03-277152. Epub 2010 Nov 22.

Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results

Hagop M Kantarjian  1 , Francis J Giles, Kapil N Bhalla, Javier Pinilla-Ibarz, Richard A Larson, Norbert Gattermann, Oliver G Ottmann, Andreas Hochhaus, Jerald P Radich, Giuseppe Saglio, Timothy P Hughes, Giovanni Martinelli, Dong-Wook Kim, Yaping Shou, Neil J Gallagher, Rick Blakesley, Michele Baccarani, Jorge Cortes, Philipp D le Coutre
Affiliations
Clinical Trial

Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results

Hagop M Kantarjian et al. Blood. .

Abstract

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 complete CyR (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.

Trial registration: ClinicalTrials.gov NCT00109707.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Major (MCyR) and complete cytogenetic response (CCyR) in patients with a minimum follow up of 24 months (N = 321).
Figure 2
Figure 2
Cytogenetic and molecular responses in patients with and without CHR at baseline (N = 321). CCyR indicates complete cytogenetic response; CHR, complete hematologic response; MCyR, major cytogenetic response; MMR, major molecular response (BCR-ABL ≤ 0.1% on the international scale). *n for MMR as follows: 294 patients for all, 105 with baseline CHR, and 189 without baseline CHR.
Figure 3
Figure 3
Kaplan-Meier estimate of progression-free survival (N = 321).
Figure 4
Figure 4
Kaplan-Meier estimate of event-free survival (N = 321).
Figure 5
Figure 5
Kaplan-Meier estimate of overall survival (N = 321).
See this image and copyright information in PMC

References

    1. Faderl S, Talpaz M, Estrov Z, O'Brien S, Kurzrock R, Kantarjian HM. The biology of chronic myeloid leukemia. N Engl J Med. 1999;341(3):164–172. - PubMed
    1. Sawyers CL. Chronic myeloid leukemia. N Engl J Med. 1999;340(17):1330–1340. - PubMed
    1. Druker BJ, Sawyers CL, Kantarjian H, et al. Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia and acute lymphoblastic leukemia with the Philadelphia chromosome. N Engl J Med. 2001;344(14):1038–1042. - PubMed
    1. Druker BJ, Tamura S, Buchdunger E, et al. Effects of a selective inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells. Nat Med. 1996;2(5):561–566. - PubMed
    1. Hochhaus A, O'Brien SG, Guilhot F, et al. Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia. Leukemia. 2009;23(6):1054–1061. - PubMed

Publication types

MeSH terms

Associated data