Abstract

Thalidomide monotherapy in relapsed/refractory multiple myeloma (MM) has a response rate of 30%. The combination of thalidomide with dexamethasone (Thal/Dex) is expected to improve responses, but it is unknown if the combination increases the rate of adverse events. Here, we conducted a systematic review of studies evaluating Thal/Dex in relapsed/refractory MM. Twelve studies were included, comprising 451 patients. The response rate (CR and PR) was 46% (95% CI 42–51%). Therapy-related toxicity was comparable to thalidomide monotherapy and included somnolence (26%, 95% CI 22–31%), constipation (37%, 95% CI 32–42%) and peripheral neuropathy (27%, 95% CI 23–32%). Only venous thromboembolism appeared to occur more often with Thal/Dex (5%, 95% CI 3–8%). Thus, using Thal/Dex results in an improved response rate in relapsed/refractory MM, with a toxicity rate comparable to thalidomide monotherapy.

Highlights

  • Thalidomide as a single agent has been reported to be efficacious in relapsed or refractory multiple myeloma (MM) in 30% of patients [1, 2]

  • The pooled data of 12 studies reveal a median response rate of 46%, which is a considerable improvement when compared with thalidomide monotherapy, where the median response rate lies at around 30% [1, 2]

  • Despite the increase in clinical efficacy, the toxicity profile of the combination is very comparable to monotherapy

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Summary

Introduction

Thalidomide as a single agent has been reported to be efficacious in relapsed or refractory multiple myeloma (MM) in 30% of patients [1, 2]. The combination with dexamethasone (Thal ⁄ Dex) has been reported to increase the response rate [3,4,5], but there have been several reports evaluating efficacy and toxicity of the combination therapy, the number of patients in the individual studies is often small and outcomes sometimes obscured by further addition of other agents like doxorubicine [6]. Small sizes of individual studies make the extraction of additional information like survival outcome and rate and severity of adverse events unreliable. We have conducted a review of published studies in a systematic fashion in order to give an overview of the existing studies and to determine the pooled response rate of Thal ⁄ Dex. We extracted information on survival and the toxicity profile, which might aid clinicians in their application of Thal ⁄ Dex in the setting of relapsed ⁄ refractory MM

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