Thalidomide improves the response to dexamethasone in multiple myeloma

An ECOG study finds that four months of thalidomide and dexamethasone produce a superior response rate, but increased toxicity, compared to dexamethasone alone in the initial treatment of multiple myeloma.The authors discussed the progress in the treatment of multiple myeloma and especially the rationale for a simple oral induction regime which would allow for subsequent efficient stem cell harvest and autologous transplantation. Three phase II studies had shown that thalidomide and dexamethasone had similar efficacy to standard therapy with VAD (vincristine, doxorubicin and dexamethasone) or dexamethasone alone. In this clinical trial, patients with previously untreated myeloma were randomly assigned to thalidomide 200 mg orally for four weeks and dexamethasone 40 mg orally on days 1 to 4, 9 to 12, and 17 to 20 (Arm A, n=103) or to the same dose of dexamethasone alone (Arm B, n=104). This was given every four weeks. The addition of thalidomide increased the response rate from 63% to 41% (p = 0.0017). Of the 79% of patients that had details of a stem-cell harvest available, 37% of Arm A and 38% of Arm B went on to harvest and this was successful in 90% of patients in each group. Grade 3 or higher nonhaematological toxicities were seen in 67% of Arm A and 43% of Arm B (pThe authors concluded that thalidomide and dexamethasone produced a significantly better response rate in newly diagnosed myeloma than did treatment with dexamethasone alone. However, the combination also caused more serious side effects. Other drugs such as lenalidomide, an analogue of thalidomide, or the use of prophylactic anticoagulation may improve the safety of combination treatment.Reference...