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by Lynne Lederman, PhD
Although myeloma is a disease primarily of older patients, the elderly remain a less-well studied population, particularly those over the age of 75 years. The addition of thalidomide to melphalan plus prednisone for elderly patients who are not SCT candidates is more popular in Europe, whereas thalidomide plus dexamethasone is used more in the U.S. However, high dose dexamethasone can be more toxic in elderly patients, and Dr. Facon feels that melphalan plus prednisone is the best choice for these patients. The addition of thalidomide to melphalan plus prednisone in patients over 75 years in the IFM 01-01 trial has shown an increase in PFS and OS at interim analysis at 24 months of follow-up. The addition of lenalidomide to melphalan plus prednisone to treat a small number of patients (n=54) with a median age of 71 years has shown an increased response rate, EFS, and OS when compared with historic controls treated with thalidomide and melphalan plus prednisone, and provides the rationale for the phase 3 MM-015 study. The addition of bortezomib to melphalan plus prednisone has also increased time to progression, PFS, and OS, and is the basis of the phase 3 VISTA study. Dr. Facon noted that the addition of either bortezomib, lenalidomide, or thalidomide to melphalan plus prednisone resulted in similar OS, RR, and EFS. The types of adverse events associated with lenalidomide (DVT, neutropenia), bortezomib (neuropathy), thalidomide (DVT and neuropathy), should be taken into consideration. The IFM 2007-01 study will compare thalidomide plus melphalan plus prednisone with lenalidomide plus low dose dexamethasone (with and without lenalidomide maintenance, which was added after the initial trial planning) in newly diagnosed patients over the age of 65 years with no upper age limit. He noted that most maintenance trials were post-SCT in younger patients. The primary objective, PFS, was questioned by Dr. Bergsagel, who suggested that OS should be looked at. Dr. Facon responded that it is difficult to decide what the best primary objective is, and that it might not be OS.