title: [Results of imatinib therapy in late-stage chronic myeloid leukemia after treatment with interferon-alpha].
abstract: BACKGROUND
  Chronic myelogenous leukemia is characterised by the presence of Philadelphia translocation and consecutive expression of bcr-abl oncogene with enhanced tyrosine kinase activity, which is known to be the essential pathogenetic event in the disease. Imatinib (Glivec, formerly STI571) is a highly selective inhibitor of the bcr-abl tyrosine kinase which has shown a promising therapeutic activity in chronic myeloid leukemia as the first molecularly targeted antinoplastic treatment.
  
  
  METHODS
  Between January 2001 and October 2001, 54 patients with chronic phase CML, resistant or intolerant to interferon-alpha were enrolled into the Novartis Expanded Access Study (Protocol 0113). Patients characteristics were as follows: male/female: 32/22, median age: 49 years (range: 22-75), median duration of disease: 44 months (range: 3-152). All patients received 400 mg imatinib orally.
  
  
  RESULTS
  Complete hematologic response was obtained in 53 patients (96%) within 4 weeks. Major cytogenetic response (< 35% Ph+ metaphasis) was achieved after 6 months in 62.9%, and after 12 months in 64.8% of patients. Three patients progressed during the treatment (loss of complete hematologic response or cytogenetic response 1, blastic phase 2). The treatment was well tolerated, with mild side effects. Main non-hematologic side effects were weight gain and fluid retention.
  
  
  CONCLUSIONS
  The results confirm that imatinib is highly active in inducing complete hematologic response and major cytogenetic response in most patients who failed interferon-alpha. Treatment was well tolerated with rare and mild adverse events and impressive improvement of quality of life.
authors.affiliation: Pécsi Tudományegyetem, Orvos- és Egészségtudományi Centrum, Altalános Orvostudományi Kar, I. Belklinika.
authors.forename: Lenke
authors.initials: L
authors.lastname: Molnár
authors.forename: Agnes
authors.initials: A
authors.lastname: Nagy
authors.forename: Marianna
authors.initials: M
authors.lastname: Dávid
authors.forename: Arpád
authors.initials: A
authors.lastname: Szomor
authors.forename: Gábor
authors.initials: G
authors.lastname: Méhes
authors.forename: Gábor
authors.initials: G
authors.lastname: Kovács
authors.forename: Hajna
authors.initials: H
authors.lastname: Losonczy
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001549:Benzamides; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D016898:Interferon-alpha / Q000627:therapeutic use; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D016898:Interferon-alpha; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate