FDA Warns Claims for Pharmacy-Made “Bio-identical” Hormones Are Misleading

Abstract

tolerated—plus high-dose dexamethasone is indicated for the treatment of patients with multiple myeloma who have received at least one prior therapy. “We’ve been using high-dose corticosteroids for myeloma just because that’s the way it’s always been done,” said first author S. Vincent Rajkumar, MD, of the Mayo Clinic in Rochester, Minn. “This is the first randomized study that looked at steroid dose.” The study revealed that lenalidomide plus low-dose dexamethasone is associated with longer survival and less toxicity than lenalidomide plus highdose dexamethasone. For patients given lenalidomide plus low-dose dexamethasone, the 1-year survival rate was 96% compared with 87% in the group receiving high-dose dexamethasone. The 18-month survival rate was 91% vs 80%, respectively. To date, 42 deaths have occurred in the high-dose group and 16 in the low-dose group. The increased mortality in the former group was due to disease progression as well as increased toxicity. The investigators reported that the superiority of the lower dose of steroid in this trial reflected not only greater safety, but also fewer adverse effects, which allowed patients to continue treatment at effective doses for a longer period. “Either regimen is excellent. However, lenalidomide and low-dose dexamethasone is safer and more effective in terms of overall survival,” said Rajkumar. “We believe our study has major implications for the continued use of high-dose dexamethasone in multiple myeloma, including in regimens that use high-dose dexamethasone in combination with other chemotherapy drugs or novel agents,” he added. Rajkumar and colleagues concluded that lenalidomide and lowdose dexamethasone should be considered for first-line therapy because the 1-year survival rate in this study is better than the rate reported in two phase 3 trials with thalidomide plus dexamethasone, an FDA-approved regimen (Rajkumar SV et al. J Clin Oncol. 2006;24[3]:431-436; Rajkumar SV et al. J Clin Oncol. In press).