Either hydroxyurea or busulfan as single agents can provide hematological control in the majority of patients (>75%) with chronic-phase CML. These hematological 'remissions' are characterized by persistence of Philadelphia chromosome-positive cells in the marrow, with inevitable progression to the blastic phase. Suppression of Philadelphia chromosome posi-tivity has been observed occasionally during treatment with busulfan or hydroxyurea, usually in the setting of therapy-induced myelosuppression, and is transient. A prospective, randomized trial comparing these two agents in chronic-phase CML found a significantly prolonged median duration of the chronic phase in hydroxyurea-treated patients: 47 months versus 37 months with busulfan (P = 0.04). Overall survival was also superior in hydroxyurea-treated patients, with a median survival of 58 months versus 45 months (P = 0.008) in the busulfan group. Additionally, hydroxyurea has a lower toxicity profile than busulfan.
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