OBJECTIVETo evaluate the efficacy and safety of Gleevec (Imatinib) in the treatment of patients with Ph positive chronic myeloid leukemia in chronic phase (CML-CP).

METHODSA total of 54 CML-CP patients in whom previous therapy with interferon-alpha had been failed or untolerated, or relapsed after allogeneic stem cell transplantation (allo-SCT) were treated with 400 mg/d of oral Gleevec for 6 to 11 months.

RESULTFifty-three patients being able to evaluate achieved complete hematological response within 7 to 28 days. Fifty-two (98%) of them remained in this situation at last follow-up. One patient relapsed after 7 months' treatment, and progressed to accelerated phase. Gleevec induced major cytogenetic response in 37 patients (70%) and complete cytogenetic response in 27 (51%). Twenty-nine of 37 patients (78%) achieved major cytogenetic response within 3 months. Grade 3 neutropenia or thrombocytopenia occurred in about 10% of patients, which were manageable or tolerated. Grade 3 or 4 nonhematologic adverse effects were infrequent. Only 1 patient (2%) discontinued treatment because of drug-related adverse events.

CONCLUSIONSGleevec induced high rate of cytogenetic and hematologic responses in patients with CML-CP who failed in previous interferon therapy. The adverse effects were mild and manageable, or no need for treatment.