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A Randomized Trial Comparing Interferon-a! With Busulfan for Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase

A multicenter randomized study was conducted to compare the effect of intetferon-a (IFN-a) with that of busulfan in newly diagnosed patients with chronic myelogenous Ieukemia (CML) in chronic phase. From October 1988 to October 1991.170 patients were randomized to receive either IFN-a or busulfan. Of 159 eligible patients, 31 (38.8%) of 80 patients in the IFN-a group and 43 (54.4%) of 79 patients in the busulfan group achieved complete hematologic remission, and 38.8% in the IFN-a group and 43.0% in the busulfan group achieved partial hematologic remission. A complete cytogenetic response was induced in seven (8.8%) of 80 patients treated with IFN-a and two (2.5%) of 79 patients treated with busulfan, and a partial cytogenetic reaponw was 7.5% f6l80) end 2.5% (2/79), respectively. The difierence in major (complete and partial) cytogmetic response between the two groups was significant (P = .OM). At a median followup of 50 months, the p m l i e d 5-year survival rete was 54% in the IFN-a group and 32% in the busulfan group (P = .0230), and the predicted 5-year rate of remaining in chronic phase was 41% in the IFN-a group and 29% in the busulfan group