title: Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: results from the IRIS Study.
abstract: OBJECTIVE
  Quality of life (QOL) outcomes in patients with chronic myeloid leukemia (CML) were evaluated in an international phase III study.
  
  
  METHODS
  Newly diagnosed patients with chronic phase CML were randomly assigned to imatinib or interferon alfa plus subcutaneous low-dose cytarabine (IFN+LDAC). Cross-over to the other treatment was permitted because of intolerance or lack of efficacy. Patients completed cancer-specific QOL (Functional Assessment of Cancer Therapy-Biologic Response Modifiers) and utility (Euro QoL-5D) questionnaires at baseline and during treatment (n = 1,049). The primary QOL end point was the Trial Outcome Index (TOI; a measure of physical function and well-being). Secondary end points included social and family well-being (SFWB), emotional well-being (EWB), and the utility score. Primary analyses were intention to treat with secondary analyses accounting for cross-over.
  
  
  RESULTS
  Patients receiving IFN+LDAC experienced a large decline in the TOI, whereas those receiving imatinib maintained their baseline level. Treatment differences at each visit were significant (P <.001) and clinically relevant in favor of imatinib. Mean SFWB, EWB, and utility scores were also significantly better for those patients taking imatinib. Patients who crossed over to imatinib experienced a large increase in TOI; significant (P <.001) differences were observed between patients who did and did not cross over in favor of imatinib.
  
  
  CONCLUSIONS
  Imatinib offers clear QOL advantages compared with IFN+LDAC as first-line treatment of chronic phase CML. In addition, patients who cross over to imatinib from IFN+LDAC experience a significant improvement in QOL compared with patients who continue to take IFN+LDAC.
authors.affiliation: Center on Outcomes, Research and Education, Evanston Northwestern Healthcare, 1001 University Pl, Ste 100, Evanston, IL 60201, USA. e-hahn@northwestern.edu
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Hahn
authors.forename: G Alastair
authors.initials: GA
authors.lastname: Glendenning
authors.forename: Mark V
authors.initials: MV
authors.lastname: Sorensen
authors.forename: Stacie A
authors.initials: SA
authors.lastname: Hudgens
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Druker
authors.forename: Francois
authors.initials: F
authors.lastname: Guilhot
authors.forename: Richard A
authors.initials: RA
authors.lastname: Larson
authors.forename: Stephen G
authors.initials: SG
authors.lastname: O'Brien
authors.forename: Deborah G
authors.initials: DG
authors.lastname: Dobrez
authors.forename: Martee L
authors.initials: ML
authors.lastname: Hensley
authors.forename: David
authors.initials: D
authors.lastname: Cella
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D001549:Benzamides; D018592:Cross-Over Studies; D003561:Cytarabine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D016898:Interferon-alpha / Q000008:administration & dosage; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D016898:Interferon-alpha; D010879:Piperazines; D011743:Pyrimidines; D003561:Cytarabine; D000068877:Imatinib Mesylate