CHAPEL HILL -- Combining a newly formulated drug with one that is already a standard treatment slows the progression of multiple myeloma, an advanced cancer of the bone marrow cells, according to a clinical trial led by a University of North Carolina at Chapel Hill School of Medicine researcher.
The phase III trial included 646 patients from 18 countries with relapsed or refractory multiple myeloma, a condition in which cancerous cells continue to multiply despite treatment. Patients in the trial were randomly assigned to receive the drug bortezomib (Velcade), standard therapy for relapsed multiple myeloma, or a combination of Velcade and Doxil, a chemotherapy drug (doxorubicin) delivered via liposomes, or microscopic fat bubbles.
An interim analysis of study participants who received the combination treatment showed a better response in the combination group than in participants who received standard treatment. The combination group's median time to progression - the time interval between the response to treatment and the time the disease starts to show evidence of growing or recurring - was 9.3 months, while those on Velcade alone progressed after 6.5 months.
The three-month improvement is an important step forward in treatment for multiple myeloma, said Dr. Robert Orlowski, Lenvel Lee Rothrock associate professor in the department of hematology/oncology at the School of Medicine, and a member of the UNC Lineberger Comprehensive Cancer Center.
Orlowski presented the trial's early results on Monday (Dec. 11), at the meeting of the American Society of Hematology in Orlando, Fla. The study was supported by Johnson & Johnson, which owns Ortho Biotech, the maker of Doxil, and also has a financial interest in Velcade.
"The data for time to progression were so positive and encouraging that we decided to announce this information earlier than anticipated so more people could be aware of the benefits of this combination,
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Contact: L. H. Lang
llang@med.unc.edu
919-843-9687
University of North Carolina School of Medicine
12-Dec-2006