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

PURPOSE:

Quality of life (QOL) outcomes in patients with chronic myeloid leukemia (CML) were evaluated in an international phase III study.

PATIENTS AND 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.

CONCLUSION:

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: Elizabeth A Hahn, G Alastair Glendenning, Mark V Sorensen, Stacie A Hudgens, Brian J Druker, Francois Guilhot, Richard A Larson, Stephen G O'Brien, Deborah G Dobrez, Martee L Hensley, David Cella, IRIS Investigators
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 21 Issue 11 Pg. 2138-46 (Jun 01 2003) ISSN: 0732-183X [Print] United States
• PMID: 12775739 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Benzamides
• Interferon-alpha
• Piperazines
• Pyrimidines
• Cytarabine
• Imatinib Mesylate

Topics

• Adolescent
• Adult
• Aged
• Antineoplastic Agents (adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Benzamides
• Cross-Over Studies
• Cytarabine (administration & dosage)
• Female
• Humans
• Imatinib Mesylate
• Interferon-alpha (administration & dosage)
• Leukemia, Myeloid, Chronic-Phase (drug therapy)
• Logistic Models
• Male
• Middle Aged
• Multivariate Analysis
• Piperazines (adverse effects, therapeutic use)
• Prospective Studies
• Pyrimidines (adverse effects, therapeutic use)
• Quality of Life