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Prepublished online as a Blood First Edition Paper on August 29, 2002; DOI 10.1182/blood-2002-02-0545.
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Blood, 1 January 2003, Vol. 101, No. 1, pp. 97-100
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Brief report
Imatinib mesylate therapy in newly diagnosed patients with
Philadelphia chromosome-positive chronic myelogenous leukemia: high
incidence of early complete and major cytogenetic
responses
Hagop M. Kantarjian,
Jorge E. Cortes,
Susan O'Brien,
Francis Giles,
Guillermo Garcia-Manero,
Stefan Faderl,
Deborah Thomas,
Sima Jeha,
Mary Beth Rios,
Laurie Letvak,
Kathy Bochinski,
Ralph Arlinghaus, and
Moshe Talpaz
From the Departments of Leukemia, Bioimmunotherapy, and
Molecular Pathology, University of Texas M. D. Anderson Cancer
Center, Houston; and Novartis Pharmaceuticals, East Hanover, NJ.
Fifty patients with Philadelphia chromosome-positive
(Ph+) chronic myelogenous leukemia (CML) in early chronic
phase received imatinib mesylate, 400 mg orally daily. After a median
follow-up of 9 months, 49 patients (98%) achieved a complete
hematologic response and 45 patients (90%) achieved a major
cytogenetic response, complete in 36 patients (72%). Compared with
similar patients who received interferon- with or without
hydroxyurea or other interferon- combination regimens, those
receiving imatinib mesylate had higher incidences of complete and major
(Ph < 35%) cytogenetic responses at 3 months (34% and 74% versus
1%-4% and 9%-24%, respectively), 6 months (52% and 80% versus
3%-7% and 11%-28%, respectively), and 9 months (60% and 77%
versus 5%-11% and 14%-30%, respectively; P < .001).
Competitive quantitative polymerase chain reaction (QPCR) studies at 9 months showed a median QPCR value (ratio of BCR-ABL/ABL transcripts
× 100) of 0.59% overall and of 0.24% (range, 0.001%-29.5%) for
complete cytogenetic response.
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