Thalidomide Plus Dexamethasone: Improved Primary Myeloma Therapy

NEW YORK MAY 21, 2008 (Reuters Health) - For initial therapy of multiple myeloma, combination treatment with thalidomide and dexamethasone, provides better results than those obtained with dexamethasone alone, researchers report in the May 1st issue of the Journal of Clinical oncology.

As lead investigator Dr. S. Vincent Rajkumar told Reuters Health, "this study confirms the superior efficacy of thalidomide plus dexamethasone in newly diagnosed myeloma."

Dr. Rajkumar of the Mayo Clinic, Rochester, Minnesota and colleagues compared the long-term effects of these treatments in 470 patients randomized to therapy with thalidomide and dexamethasone or to dexamethasone and placebo. Median treatment duration was between 6.4 and 6.9 months in both groups.

Time to progression was 22.6 months in the combination group and 6.5 months in the dexamethasone plus placebo group. The combination therapy was also associated with a longer progression-free survival (14.9 versus 6.5 months) (p < 0.001 for both). The overall response rate in the combination group was 63%, significantly higher than 46% seen in the dexamethasone group.

Grade 4 adverse events were more frequent in the combination patients (30.3%) than in dexamethasone patients (22.8%) and more of these patients discontinued therapy because of toxicity. However, disease progression was the most common reason for discontinuation in the dexamethasone group.

Summing up, Dr. Rajkumar said that as well as showing the superiority of combination therapy in these patients, "this trial also highlights the serious inadequacies of single agent dexamethasone in the initial treatment of myeloma."

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