Phase III Comparison of Imatinib to Interferon in Newly Diagnosed Chronic Phase Patients

A phase III randomized study, comparing imatinib at 400 mg per day with interferon-a plus cytarabine (Ara-C) in newly diagnosed patients with chronic phase CML enrolled 1,106 patients from June 2000 to January 2001. Baseline characteristics of the 553 patients randomized to each treatment were well balanced for all features evaluated, including age, WBC, Sokal and Euro scores, and time from diagnosis. With a median follow-up of 19 months, patients randomized to imatinib had statistically significant better results than patients treated with interferon-a plus Ara-C in all parameters measured (Table 2), including rates of CHR, major and complete cyto-

Table 2 Phase III results of imatinib versus interferon plus cytarabine for newly diagnosed chronic phase CML patients (O'Brien et al. 2003)

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