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 Blood, 1 October 2004, Vol. 104, No. 7, pp. 1979-1988.
Prepublished online as a Blood First Edition Paper on June 15, 2004; DOI 10.1182/blood-2004-02-0711.

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CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS

Long-term survival benefit and improved complete cytogenetic and molecular response rates with imatinib mesylate in Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia after failure of interferon-{alpha}

Hagop M. Kantarjian, Jorge E. Cortes, Susan O'Brien, Rajyalakshmi Luthra, Francis Giles, Srdan Verstovsek, Stefan Faderl, Deborah Thomas, Guillermo Garcia-Manero, Mary Beth Rios, Jianqin Shan, Dan Jones, and Moshe Talpaz

From the Departments of Leukemia, Bioimmunotherapy, and Hematopathology, The University of Texas M. D. Anderson Cancer Center, Houston.

We reviewed 261 patients with chronicphase chronic myelogenous leukemia (CML) after interferon-{alpha} (IFN-{alpha}) failure treated with imatinib mesylate 400 mg daily. With a median follow-up time of 45 months, the major cytogenetic response rate was 73% and the complete cytogenetic response rate 63%. The estimated 4-year survival rate was 86%. Multivariate analysis for survival identified hematologic resistance to IFN-{alpha} (P = .01), splenomegaly (P = .03), and lack of any cytogenetic response after 3 months of therapy (P = .01) to have independent poor prognostic significance. Patients could be divided into good(no adverse factors), intermediate(1 adverse factor), and poor-risk groups (2 or 3 adverse factors; 12% of patients) with estimated 4-year survival rates of 96%, 86%, and 49%, respectively (P < .000 01). The 4-year cumulative major molecular response (quantitative reverse transcriptase–polymerase chain reaction [Q-PCR] = BCR-ABL/ABL less than 0.05%) rate was 43% and complete molecular response rate (BCR-ABL undetectable) 26%. Compared with a historical group of 251 similar patients treated with nonimatinib therapies, imatinib mesylate was associated with a better 4-year survival rate (86% versus 43%; P < .0001); the survival advantage was confirmed by multivariate analysis (hazard ratio, 0.19; P < .0001).


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