NDLI: Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Berger, Marc Vekhoff, Anne Etienne, Gabriel Berthou, Christian Delmer, Alain Mahon, François-xavier Guilhot, François Eclache, Virginie Maloisel, Frederic Nicolini, Franck Emmanuel Gardembas, Martine Rousselot, Philippe Legros, Laurence Rea, Delphine Coiteux, Valérie Allard, Christian Preudhomme, Claude Roche-lestienne, Catherine Corm, Selim Guilhot, Joëlle Rigal-huguet, Françoise Guerci-bresler, Agnès Jourdan, Eric
Description	Author Affiliation: Preudhomme C ( Laboratoire d'Hématologie, Centre Hospitalier Universitaire de Lille, and INSERM Unité 837, Lille, France.)
Abstract	BACKGROUND: Imatinib (400 mg daily) is considered the best initial therapy for patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase. However, only a minority of patients treated with imatinib have a complete molecular remission. METHODS: We randomly assigned 636 patients with untreated chronic-phase CML to receive imatinib alone at a dose of 400 mg daily, imatinib (400 mg daily) plus cytarabine (20 mg per square meter of body-surface area per day on days 15 through 28 of each 28-day cycle) or pegylated interferon (peginterferon) alfa-2a (90 µg weekly), or imatinib alone at a dose of 600 mg daily. Molecular and cytogenetic responses, time to treatment failure, overall and event-free survival, and adverse events were assessed. An analysis of molecular response at 12 months was planned. A superior molecular response was defined as a decrease in the ratio of transcripts of the tyrosine kinase gene BCR-ABL to transcripts of ABL of 0.01% or less, corresponding to a reduction of 4 log(10) units or more from the baseline level, as assessed by means of a real-time quantitative polymerase-chain-reaction assay. RESULTS: At 12 months, the rates of cytogenetic response were similar among the four groups. The rate of a superior molecular response was significantly higher among patients receiving imatinib and peginterferon alfa-2a (30%) than among patients receiving 400 mg of imatinib alone (14%) (P=0.001). The rate was significantly higher among patients treated for more than 12 months than among those treated for 12 months or less. Gastrointestinal events were more frequent among patients receiving cytarabine, whereas rash and depression were more frequent among patients receiving peginterferon alfa-2a. CONCLUSIONS: As compared with other treatments, the addition of peginterferon alfa-2a to imatinib therapy resulted in significantly higher rates of molecular response in patients with chronic-phase CML. (Funded by the French Ministry of Health and others; ClinicalTrials.gov number, NCT00219739.).
ISSN	00284793
Issue Number	26
Volume Number	363
Journal	New England Journal of Medicine
e-ISSN	15334406
Language	English
Publisher	Massachusetts Medical Society (United States)
Publisher Date	2010-12-23
Publisher Place	United States
Access Restriction	Subscribed
Subject Keyword	Antineoplastic Combined Chemotherapy Protocols Therapeutic Use Interferon-alpha Administration & Dosage Leukemia, Myeloid, Chronic-Phase Drug Therapy Piperazines Polyethylene Glycols Pyrimidines Adult Anemia Chemically Induced Adverse Effects Benzamides Cytarabine Female Fusion Proteins, Bcr-abl Analysis Genetics Humans Imatinib Mesylate Mortality Pathology Male Middle Aged Neutropenia Proto-Oncogene Proteins C-abl RNA, Neoplasm Recombinant Proteins Remission Induction Stem Cells Drug Effects Survival Analysis Thrombocytopenia Transcription, Genetic Treatment Outcome Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Medicine
Content Type	Text
Resource Type	Article
Subject	Medicine

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