Clinical Study of Thalidomide Combined with Dexamethasone for the Treatment of Elderly Patients with Newly Diagnosed Multiple Myeloma

Objective: To investigate the relationship between the efficacy and safety of different doses of thalidomide(Thal) plus dexamethasone (Dex) as the initial therapy in elderly patients with newly diagnosed multiplemyeloma (MM).
Methods: Clinical data of 28 elderly patients with newly diagnosed MM who underwent theTD regimen as the initial therapy were analyzed retrospectively. The patients were divided into two groupsaccording to the maximal sustained dose of Thal: lower dose (group A) and higher dose (group B). The overallresponse rate (ORR), progression free survival (PFS), overall survival (OS), and adverse events (AES) werecompared between the two groups.
Results: A total of 28 patients were followed up with a median of 18 months.The ORR was 60.1%. The median response time and PFS were 2.0 and 17.0 months, respectively. The meansustained dose of Thal in group B was significantly higher than group A (292.9 mg v 180.4 mg, P=0.01). Therewas no significantly difference in ORR (57.1% v 64.3%, P=1.00) and PFS (9.63months v 17.66 months, P=0.73)between groups A and B. During the follow up, only five patients died (<40%) and, therefore, median OS valueswere not available. It is estimated, however, that the mean survival time in the two groups was 35.6 and 33.4months (P>0.05), respectively. All of the patients tolerated the treatment well. The incidence of AES in patientswith a grading above 3 in group B was significantly higher than in group A (P=0.033).
Conclusions: The TDregimen results in a high response rate and manageable AES as the initial therapy in elderly patients with MM.TD should be considered as the front line regimen for the treatment of elderly patients with MM in areas withfinancial constraints. The clinical response can be achieved at a low dose Thal with minimal toxicity.