Seminars in hematology
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Seminars in hematology · Apr 2003
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialQuality of life on imatinib.
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/m(2)/d with cytarabine (Ara-C) 20 mg/m(2)/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. ⋯ 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. Semin Hematol 40(suppl 2):31-36.
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Seminars in hematology · Apr 2003
Randomized Controlled Trial Multicenter Study Clinical TrialImatinib in patients with newly diagnosed chronic-phase chronic myeloid leukemia.
The International Randomized Study of Interferon and STI571 (IRIS) study prospectively compared imatinib with interferon-alpha/low-dose cytarabine (IFN/LDAC) in 1,106 newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML). Patients not responding to or intolerant of their assigned treatment were allowed to cross over. At 18 months, the projected probability of achieving a complete cytogenetic response was 76.2% for imatinib and 14.5% for IFN/LDAC, respectively (P <.01). ⋯ Most cross-overs to imatinib were due to interferon-intolerance. Overall survival was not different in the two groups at 19 months, reflecting efficient rescue of IFN/LDAC failures with imatinib. Imatinib should now be considered the standard therapy for newly diagnosed patients with CML.