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Seràgnoli Institute of Hematology and Medical Oncology
Bologna University School of Medicine
NOTE: The IMF did not receive permission to post either the audio or the slides of this presentation. So we are bringing you a summary by our medical writer, Lynne Lederman, PhD.
SUMMARY: Results of clinical trials of thalidomide with dexamethasone or in doxorubicin-based regimens as primary treatment before autologous stem cell transplantation (ASCT) have shown a significant increase in response rates when compared with conventional regimens in use in the 1990s. Although the rate of deep vein thrombosis (DVT) is high, the overall risk of mortality is 5% or less. Limited thalidomide exposure in these up-front regimens has resulted in a low rate of grade 3 or 4 neurotoxicity. An open issue is whether regimens including thalidomide result in a better overall outcome. Although there is an increase in the complete response (CR) or very good partial response (VGPR) rates as well as in event-free survival (EFS), overall survival (OS) may not be increased. Data currently are limited and conflicting. Dr. Cavo suggested, however, that OS may not be the best marker post-ASCT outcome. He also suggested the need for randomized trials comparing regimens containing thalidomide and melphalan with bortezomib- or lenalidomide plus dexamethasone-based regimens. The ongoing phase 3 trial (GEMENA Bologna 2006), comparing bortezomib plus thalidomide and dexamethasone to thalidomide plus dexamethasone as induction therapy prior to double ASCT has enrolled 250 patients. Preliminary results should be available at the American Society of Hematology meeting this December.