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Drug Combination Shows Benefit in Relapsed/Refractory Multiple Myeloma Adapted from the NCI Cancer Bulletin, vol. 4/no. 24, August 21, 2007 (see the current issue). Interim results from a phase III clinical trial suggest a new combination treatment should be another standard of care for patients with relapsed or refractory multiple myeloma, according to the trial's leaders. In the most recent survival analysis from the 646-patient trial, the combination of pegylated liposomal doxorubicin (Doxil®) and bortezomib (Velcade®) improved the median time to disease progression compared with bortezomib alone (9.3 months vs. 6.5 months) and yielded a superior 15-month overall survival rate (76 percent of patients in the combination group were alive at 15 months compared with 65 percent in the bortezomib-only group). The report, to be published in the Sept. 1, 2007, Journal of Clinical Oncology, was released early online Aug. 6, 2007 (see the journal abstract).
The results come two years after a phase III trial (see related story) that showed bortezomib alone was superior to dexamethasone, another drug commonly used to treat all stages of multiple myeloma, and one year after a trial demonstrated that the combination of lenalidomide (Revlimid®) and dexamethasone was superior to dexamethasone alone in patients with refractory or relapsed disease (see related story).
The bortezomib/Doxil combination also increased the duration of response, reported the study's principal investigator, Dr. Robert Z. Orlowski from the University of Texas M.D. Anderson Cancer Center, and colleagues. However, the combination's benefits came at the expense of an increased risk of adverse events, including high-grade hematologic (e.g., neutropenia) and gastrointestinal (e.g., diarrhea, nausea) toxicities.
Based on the results of this trial, also known as the DOXIL-MMY-3001 study (see the protocol summary), the U.S. Food and Drug Administration recently approved the use of this combination for treating patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.
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