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Gleevec beats interferon for initial CML therapy. (Open-Label Phase III Trial).

ORLANDO, FLA. -- Gleevec is significantly more effective than standard interferon-based therapy for the initial treatment of chronic myeloid leukemia, an open-label phase III trial has shown.

"Gleevec should now be considered the standard first-line therapy for CML," Dr. Brian Druker said at the annual meeting of the American Society of Clinical Oncology.

Of 1,106 patients with stable or chronic disease and in their first 6 months of diagnosis, those randomized to receive 400 mg/day of Gleevec (imatinib mesylate) orally were significantly more likely to experience complete or partial remission than those randomized to receive a target dose of 5 mIU/[m.sup.2] per day of subcutaneous interferon plus 20 mg/[m.sup.2] per day for 10 days a month of subcutaneous cytarabine arabinoside, said Dr. Druker, professor of medicine and program director of the leukemia center at Oregon Health Sciences University, Portland.

Based on measures of complete hematologic response and complete cytogenetic response at a median follow-up of 14 months, 68% of Gleevec patients and 7% of interferon patients had no detectable leukemia. Gleevec was 10 times more effective than the interferon regimen. Even more striking, 1.5% of Gleevec patients progressed to the accelerated phase or blast crisis, compared with 7% of interferon patients.

Additionally, Gleevec was generally well tolerated. Fewer than 1% of patients in the Gleevec group crossed over to the interferon group at 1 year, and 90% of patients remained on Gleevec at 1 year. After 1 year, 39% of interferon patients had crossed over to the Gleevec group; 30% remained on interferon therapy at 1 year.

Gleevec was approved last year for the treatment of CML patients who no longer respond to initial therapy and for patients in accelerated disease phase or blast crisis. This open-label international study is the first large-scale effort to evaluate Gleevec in newly diagnosed patients and the first to compare Gleevec to standard therapy.

"Even those of us that worked on Gleevec and have seen its remarkable results were astounded by just how much better Gleevec was," Dr. Druker said.

Although the results of this trial don't show a survival advantage, "I predict we will see an advantage within another 6 months" in patients receiving Gleevec, according to Dr. Stephen MacKinnon of University College London, who discussed the study results presented by Dr. Druker. The delay in time to disease progression is "as close a surrogate for survival as you can get."

And if a major response to Gleevec proves to be associated with long duration of survival, the need for bone marrow transplant in CML patients may be substantially delayed or avoided.

At the 400 mg/day dose, which costs about $25,000 per year, Gleevec is costly and not a cure for CML. Studies of alternate doses and combination regimens may improve outcomes and cut costs, he said.
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Title Annotation:chronic myeloid leukemia
Author:Worcester, Sharon
Publication:Internal Medicine News
Article Type:Product/Service Evaluation
Geographic Code:1USA
Date:Jul 15, 2002
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