myelogenous leukaemia patients in chronic phase cytarabine for the treatment of Philadelphia-positive chronic Results of a prospective phase II study combining imatinib mesylate and

Abstract In Chronic myelogenous leukemia (CML) imatinib mesylate has been shown to selectively inhibit the tyrosine kinase domain of the oncogenic bcr-abl fusion protein. Using this agent alone high rate of cytogenetic responses were recorded. However several mechanisms of resistance have been described. In vitro studies examining the effects of imatinib mesylate plus cytarabine have shown synergistic anti-proliferative effects of this combination. Thus the CML French Group decided to perform a phase II trial testing a combination of imatinib mesylate and low dose cytarabine for 30 previously untreated patients in chronic phase. Treatment was administered on 28 days cycles. Patients were treated continuously with imatinib mesylate orally at a dose of 400 mg daily. Cytarabine was given on days 15-28 of each cycle at an initial dose of 20 mg/m²/day via subcutaneous injection. Adverse events were frequently observed with grade 3 or 4 hematologic toxicities and non hematologic toxicities in 53% (n=16) and in 23% (n= 7) of patients respectively. The cumulative incidence of complete cytogenetic response (CCR) at 12 months was 83% and at 6 months 100% of the patients achieved complete hematologic response (CHR) . We concluded that the combination was safe and promising given the rate of responses.From bloodjournal.hematologylibrary.org by guest on June 8, 2013. For personal use only.