SCIENTIFIC ADVANCES

Low-dose Steroid Combined with Lenalidomide Prolongs Survival Compared with High-dose Steroid for Multiple Myeloma Treatment

High-dose steroids have been a standard component of multiple myeloma therapy for decades. Although the use of high-dose steroids was recognized as toxic, the assumption was that the high doses of steroids were required for clinical efficacy. However, the results of a recent phase III trial conducted by ECOG, E4A03, in patients with newly diagnosed multiple myeloma compared standard high-dose steroids to low-dose steroids in patients receiving lenalidomide. A total of 445 patients were enrolled in this study between 2004 and 2006. Patients were randomized to one of two treatment arms. One patient group received lenalidomide and dexamethasone given at standard doses. The second group received standard-dose lenalidomide and low-dose dexamethasone. Patients in the study who received low-dose dexamethasone and lenalidomide had a one-year survival of 96 percent compared to 86 percent for patients treated with the standard doses of dexamethasone and lenalidomide. In addition, there were fewer side effects associated with the low-dose dexamethasone and lenalidomide. The shorter survival in those receiving the standard high-dose steroid therapy was due both to more myeloma deaths and adverse events. This study has defined a new standard of care in multiple myeloma.

Rajkumar SV, Jacobus S, Callander N, Fonseca R, Vesole D, Williams M, Abonour R, Siegel D, Greipp P. Phase III trial of lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone in newly diagnosed multiple myeloma (E4A03): A trial coordinated by the Eastern Cooperative Oncology Group.J Clin Oncol2007: ASCO Annual Meeting Proceedings (Post-Meeting Edition) 25;LBA8025.