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Higher doses of cancer drug imatinib proven effective and safe

(WASHINGTON, April 1, 2004) The cancer drug imatinib mesylate, also known as Gleevec, has proven to be increasingly effective at higher doses, according to a new study published in the April 15, 2004, issue of Blood, the official journal of the American Society of Hematology.

Researchers from The University of Texas M. D. Anderson Cancer Center in Houston examined 114 patients recently diagnosed with chronic myelogenous leukemia (CML), a cancer that is diagnosed in about 4,600 people in the U.S. every year. CML is classified into three stages: chronic, accelerated, and blastic. Study participants were all in chronic phase, the least severe of the three. The current dosage recommended by the Food and Drug Administration for chronic phase CML patients is 400 mg of imatinib daily, with higher doses of 600 to 800 mg recommended only for patients in the later stages of CML. The researchers, hypothesizing that higher dosages given in the earlier chronic stage could be more effective than the standard treatment, provided patients with 800 mg of imatinib daily (administered in two 400 mg oral doses).

All of the patients in this study also had a genetic abnormality called Philadelphia translocation (common to 95 percent of CML patients) in which some of the DNA on chromosomes 9 and 22 are switched. A result of the switch is the development of a hybrid gene called BCR-ABL, which codes for an enzyme that causes the overproduction of white blood cells in the bone marrow, crowding out normal blood cells and platelets. Therefore, the primary goal of CML treatment is complete cytogenetic response (CCR), the elimination of cells with this genetic defect. Ninety percent of the patients in this study experienced CCR, a significantly greater result than seen in patients in a prior study who were taking the standard dosage of imatinib. Those patients had a CCR rate of 60 to 75 percent.

The high percentage of CCR among these patients is of significant imp
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Contact: Aislinn Raedy
araedy@hematology.org
202-776-0544
American Society of Hematology
1-Apr-2004


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