Imatinib (Gleevec), a highly effective specific tyrosine kinase inhibitor, demonstrates a better side effect profile than interferon-alpha (IFN), which impairs patients' quality of life (QoL). This phase III international study evaluated QoL outcomes in 1,106 newly diagnosed patients with chronic-phase chronic myeloid leukemia (CML) who were randomized to receive either imatinib 400 mg daily or IFN up to 5 MU/m2/d with cytarabine (Ara-C) 20 mg/m2/d added for 10 days every month (IFN + LDAC). Crossover to the other treatment arm was permitted due to a lack of efficacy or treatment intolerance. QoL was assessed with the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) at baseline, monthly for 6 months and then at months 9, 12, and 18. The Trial Outcome Index (TOI; a composite endpoint of physical/functional/treatment-specific subscales) was the primary endpoint. Secondary endpoints measured were social/family well-being (SFWB) and emotional well-being (EWB). QoL was analyzed for the first 18 months of treatment using mixed effects growth curve models. The primary analyses were intention-to-treat (ITT); secondary analyses incorporated crossover as a time-dependent covariate. A total of 1,049 patients completed at least one QoL assessment. Two hundred sixty-one patients (50%) crossed over from IFN to imatinib and 11 (2%) crossed over from imatinib to IFN. There was a significant decline in TOI scores for the IFN treatment arm compared with preservation of baseline TOI scores in the imatinib arm (P < .001, ITT). Mean social/family and EWB scores were 22.8 and 19.5, respectively, for imatinib and 21.6 and 17.6, respectively, for IFN (P < .001, ITT). After crossing over from IFN to imatinib, patients experienced a significant (P < .001) increase in TOI scores. Imatinib offers clear QoL advantages over IFN as first-line treatment of chronic-phase CML. In addition, patients who crossed over to imatinib reported higher QoL than those who remained on IFN.
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