Clinical Trial Reports from ASCO
In an oral presentation, Jeffrey A. Zonder, MD, Division of Hematology-Oncology, Karmanos Cancer Center, Wayne State University School of Medicine, Detroit, Michigan, reported updated results of SWOG 0232, a study of lenalidomide (Revlimid) plus dexamethasone compared with dexamethasone alone in patients with newly diagnosed multiple myeloma (MM).
Highlighted in the presentation was a combined complete response (CR) rate plus very good partial response (VGPR) rate of 62% for lenalidomide plus dexamethasone, compared with 19% for dexamethasone alone (P
<.002). In addition, patients in the lenalidomide plus dexamethasone arm of the study had a progression-free survival rate of 77% after one year, compared with 55% for dexamethasone alone (P
= .002). At one year, overall survival for patients in the lenalidomide plus dexamethasone arm was 93%, compared with 91% for dexamethasone alone. These data were confounded by the fact that patients in the dexamethasone-alone arm were given the option to cross over into the lenalidomide plus dexamethasone- arm after the study was halted early.
Grade 3/4 adverse events were more frequent in patients with MM who received the combination of lenalidomide-plus dexamethasone compared with dexamethasone alone. Neutropenia (13.8% vs 2.4%) and infections (18.9% vs 9.8%) were the most frequently reported adverse events. Deep vein thrombosis occurred in 27% of patients receiving lenalidomide plus dexamethasone, compared with 14.6% in those receiving dexamethasone alone.