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 Prepublished online as a Blood First Edition Paper on March 13, 2003; DOI 10.1182/blood-2003-01-0025.

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Blood, 1 July 2003, Vol. 102, No. 1, pp. 83-86

CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS

Result of high-dose imatinib mesylate in patients with Philadelphia chromosome—positive chronic myeloid leukemia after failure of interferon-{alpha}

Jorge Cortes, Francis Giles, Susan O'Brien, Deborah Thomas, Guillermo Garcia-Manero, Mary Beth Rios, Stefan Faderl, Srdan Verstovsek, Alessandra Ferrajoli, Emil J. Freireich, Moshe Talpaz, and Hagop Kantarjian

From the Department of Leukemia and Bioimmunotherapy, University of Texas, M. D. Anderson Cancer Center, Houston, TX.

Imatinib at 400 mg daily is effective in chronic-phase chronic myeloid leukemia (CML) after interferon failure, although only a few patients achieve a molecular remission. We investigated whether higher doses of imatinib may be more effective. Thirty-six patients with chronic-phase CML after failure on interferon-{alpha} were treated with 400 mg imatinib twice daily. Median time from diagnosis was 25 months (range, 10-135 months); 4 patients (11%) had clonal evolution. All 11 patients with active disease achieved complete hematologic response. Excluding patients with fewer than 35% Ph-positive metaphases before the start of therapy, 19 (90%) of 21 evaluable patients achieved a major cytogenetic response. Of 27 evaluable patients, 24 (89%) achieved a complete cytogenetic response. Quantitative polymerase chain reaction was performed in bone marrow every 3 months. Of 32 evaluable patients, 18 (56%) showed BCR-ABL/ABL percentage ratios lower than 0.045%, including 13 (41%) with undetectable levels. With a median follow-up of 15 months, all patients were alive in chronic phase. Toxicities were similar to those reported with standard dose; 71% of patients continue to receive 600 mg or more of imatinib daily. In conclusion, high-dose imatinib induces complete cytogenetic responses in most patients with chronic-phase CML after interferon failure. This is accompanied by a high rate of molecular remission. (Blood. 2003;102:83-86)


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