A LONG-TERM FOLLOW-UP OF A RANDOMIZED TRIAL COMPARING INTERFERON-ALPHA WITH BUSULFAN FOR CHRONIC MYELOGENOUS LEUKEMIA

To evaluate the long-term effectiveness of interferon-alpha (IFN-alpha ) therapy in patients with chronic myelogenous leukemia (CML) in chron ic phase, we examined the updated outcomes of 159 patients who had bee n enrolled between 1988 and 1991 into a randomized trial comparing IFN -alpha with busulfan. At a median follow-up of 73 months, the median s urvival was 71 months in the IFN-alpha group and 55 months in the busu lfan group (P = 0.0563), and the median time of remaining in chronic p hase was 58 months in the IFN-alpha group and 39 months in the busulfa n group (P = 0.4676). Landmark analysis showed a significant advantage in survival (P = 0.009) and duration of chronic phase (P = 0.0001) in patients with any cytogenetic response among the IFN-alpha group. Abo ut half patients were discontinued IFN-alpha administration in spite o f cytogenetic response in this study. It appears that continuation of IFN-alpha might possibly confer a survival advantage. Pretreatment fac tors associated with cytogenetic response included high hemoglobin lev el, low percentage of peripheral basophils and low leukocyte counts. M ultivariate analysis identified lower percentage of bone marrow basoph ilia (P = 0.007) for survival advantage. If a group with a very good p rognosis is predicted by a new prognostic model, it might be an option to wait for bone marrow transplantation. (C) 1998 Elsevier Science Lt d. All rights reserved.