title: A systematic review of phase II trials of thalidomide/dexamethasone combination therapy in patients with relapsed or refractory multiple myeloma.
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.
authors.affiliation: Medizinische Klinik und Poliklinik III, Rheinische Friedrich Wilhelms Universität, Bonn, Germany. m.lilienfeld.toal@uni-bonn.de
authors.forename: Marie
authors.initials: M
authors.lastname: von Lilienfeld-Toal
authors.forename: Corinna
authors.initials: C
authors.lastname: Hahn-Ast
authors.forename: Kerstin
authors.initials: K
authors.lastname: Furkert
authors.forename: Florian
authors.initials: F
authors.lastname: Hoffmann
authors.forename: Ralph
authors.initials: R
authors.lastname: Naumann
authors.forename: Ralf
authors.initials: R
authors.lastname: Bargou
authors.forename: Gordon
authors.initials: G
authors.lastname: Cook
authors.forename: Axel
authors.initials: A
authors.lastname: Glasmacher
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D017322:Clinical Trials, Phase II as Topic; D003248:Constipation / Q000139:chemically induced; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D006970:Disorders of Excessive Somnolence / Q000139:chemically induced; D006801:Humans; D015201:Meta-Analysis as Topic; D009101:Multiple Myeloma / Q000188:drug therapy*; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D012008:Recurrence; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects; D054556:Venous Thromboembolism / Q000139:chemically induced
chemical_list: D013792:Thalidomide; D003907:Dexamethasone