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From ASCO 2003
A phase II study of imatinib, idarrubicin and low dose of cytarabine in patients (pts) with chronic myeloid leukemia (CML) in blastic phase (BP)
Abstract No: 2480
Author(s): R. H. Alvarez, H. Kantarjian, S. Faderl, F. G. Giles, S. O'Brien, G. Garcia-Manero, M. B. Rios, M. Talpaz, J. Cortes,
MD Anderson Cancer Center; The University of Texas, MD Anderson Cancer Center., Houston, TX
Abstract:
CML in BP has poor prognosis with a median survival of 3-6 months despite aggressive therapy. Regimens including high dose of Ara-C and daunorubicin induce remissions in only 20% to 25% of pts with median survival of 3 months (Cortes J, Am J Med 1996; 100:555-570).
Imatinib, a specific tyrosine kinase inhibitor against c-abl and bcr-abl, induces as a single agent hematologic responses in 52% of patients with myeloid BP. However, responses are usually transient with a median duration of 10 months (Sawyers C, Blood 2002; 99: 3530-3539).
Imatinib is additive or synergistic in vitro with idarubicin and ara-C. We thus investigated the efficacy of imatinib at doses of 600 mg daily, Ara-C 10 mg/day subcutaneous, and Idarubicin 12 mg/m2 IV every 14 days in previously untreated pts or those who received <2 prior treatment regimens for blast phase CML. The eligibility
criteria included: Philadelphia chromosome-positive, performance status < 3.
Five pts were treated; 4 had received and failed imatinib as a single agent. Two pts had BP as their first manifestation of CML. The other 3 had been diagnosed for 4, 4.5 and 8.5 years respectively and had also failed IFN therapy; two of them had relapse BP and had received 2 prior therapies each for BP. The median WBC was 52.4 x 10 9/L (range, 5.7 to 91), peripheral blood blasts 30% (range, 0 to 91), and bone marrow blast 42% (range, 13 to 63).
All pts have been treated for a median of 36 days (range, 13 to 91). Two had extramedullary disease. Three pts achieved CR: 1 transient (8 weeks), 1 received allogeneic BMT in CR; and 1 is ongoing. Two of 3 pts had failed prior Imatinib. In addition, 1 pt had a transient hematological improvement (>50% reduction of blast in peripheral blood) and 1 died early.
Treatment has been well tolerated and delivered on an outpatient basis.
We conclude that this is an active regimen even in patients who had failed monotherapy with imatinib. Updated data with additional patients will be presented.
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