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
Randomized Controlled Trial
. 2006 Dec 7;355(23):2408-17.
doi: 10.1056/NEJMoa062867.

Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia

Brian J Druker  1 , François Guilhot, Stephen G O'Brien, Insa Gathmann, Hagop Kantarjian, Norbert Gattermann, Michael W N Deininger, Richard T Silver, John M Goldman, Richard M Stone, Francisco Cervantes, Andreas Hochhaus, Bayard L Powell, Janice L Gabrilove, Philippe Rousselot, Josy Reiffers, Jan J Cornelissen, Timothy Hughes, Hermine Agis, Thomas Fischer, Gregor Verhoef, John Shepherd, Giuseppe Saglio, Alois Gratwohl, Johan L Nielsen, Jerald P Radich, Bengt Simonsson, Kerry Taylor, Michele Baccarani, Charlene So, Laurie Letvak, Richard A Larson; IRIS Investigators
Affiliations
Free article
Randomized Controlled Trial

Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia

Brian J Druker et al. N Engl J Med. .
Free article

Abstract

Background: The cause of chronic myeloid leukemia (CML) is a constitutively active BCR-ABL tyrosine kinase. Imatinib inhibits this kinase, and in a short-term study was superior to interferon alfa plus cytarabine for newly diagnosed CML in the chronic phase. For 5 years, we followed patients with CML who received imatinib as initial therapy.

Methods: We randomly assigned 553 patients to receive imatinib and 553 to receive interferon alfa plus cytarabine and then evaluated them for overall and event-free survival; progression to accelerated-phase CML or blast crisis; hematologic, cytogenetic, and molecular responses; and adverse events.

Results: The median follow-up was 60 months. Kaplan-Meier estimates of cumulative best rates of complete cytogenetic response among patients receiving imatinib were 69% by 12 months and 87% by 60 months. An estimated 7% of patients progressed to accelerated-phase CML or blast crisis, and the estimated overall survival of patients who received imatinib as initial therapy was 89% at 60 months. Patients who had a complete cytogenetic response or in whom levels of BCR-ABL transcripts had fallen by at least 3 log had a significantly lower risk of disease progression than did patients without a complete cytogenetic response (P<0.001). Grade 3 or 4 adverse events diminished over time, and there was no clinically significant change in the profile of adverse events.

Conclusions: After 5 years of follow-up, continuous treatment of chronic-phase CML with imatinib as initial therapy was found to induce durable responses in a high proportion of patients. (ClinicalTrials.gov number, NCT00006343 [ClinicalTrials.gov].)

PubMed Disclaimer

Comment in

  • Imatinib in chronic myeloid leukemia.
    Krause SW, Holler E. Krause SW, et al. N Engl J Med. 2007 Apr 26;356(17):1780; author reply 1780. doi: 10.1056/NEJMc063767. N Engl J Med. 2007. PMID: 17460235 No abstract available.

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

Publication types

MeSH terms

Associated data