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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

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 on behalf of the IRIS Investigators

From the Center on Outcomes, Research and Education, Evanston Northwestern Healthcare, Evanston; The University of Chicago, Chicago, IL; Novartis Pharmaceuticals Corporation, East Hanover, NJ; Oregon Health Sciences University, Portland, OR; Centre Hospitalier Universitaire de Poitiers, Poitiers, France; The University of Newcastle, Newcastle, United Kingdom; and Novartis AG, Basel, Switzerland.

Address reprint requests to Elizabeth A. Hahn, Center on Outcomes, Research and Education, 1001 University Pl, Ste 100, Evanston, IL 60201; email: e-hahn{at}northwestern.edu.

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.

Supported by Novartis Pharma.

Presented in part at the 7th Congress of the European Haematology Association (Florence, Italy, June 2002) and at the 2002 Annual Meeting of the American Society of Hematology (Philadelphia, PA, December 2002).

E.H., M.S,, S.H., B.D., F.G., R.L., S.O., D.D., and D.C. are consultants to Novartis Pharma; G.G. and M.H. are employees of Novartis Pharma.

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