title: Clinical study of thalidomide combined with dexamethasone for the treatment of elderly patients with newly diagnosed multiple myeloma.
abstract: 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 multiple myeloma (MM).
  
  
  METHODS
  Clinical data of 28 elderly patients with newly diagnosed MM who underwent the TD regimen as the initial therapy were analyzed retrospectively. The patients were divided into two groups according to the maximal sustained dose of Thal: lower dose (group A) and higher dose (group B). The overall response rate (ORR), progression free survival (PFS), overall survival (OS), and adverse events (AES) were compared 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 mean sustained dose of Thal in group B was significantly higher than group A (292.9 mg v 180.4 mg, P=0.01). There was 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 values were not available. It is estimated, however, that the mean survival time in the two groups was 35.6 and 33.4 months (P>0.05), respectively. All of the patients tolerated the treatment well. The incidence of AES in patients with a grading above 3 in group B was significantly higher than in group A (P=0.033).
  
  
  CONCLUSIONS
  The TD regimen 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 with financial constraints. The clinical response can be achieved at a low dose Thal with minimal toxicity.
authors.affiliation: Department of Hematology, 100th Hospital of PLA, Medical Centre of Hematology and Oncology of Nanjing Military Command, China.
authors.forename: Hai-Fei
authors.initials: HF
authors.lastname: Chen
authors.forename: Zheng-Yang
authors.initials: ZY
authors.lastname: Li
authors.forename: Jie-Qing
authors.initials: JQ
authors.lastname: Tang
authors.forename: Hong-Shi
authors.initials: HS
authors.lastname: Shen
authors.forename: Qing-Ya
authors.initials: QY
authors.lastname: Cui
authors.forename: Yong-Ya
authors.initials: YY
authors.lastname: Ren
authors.forename: Long-Mei
authors.initials: LM
authors.lastname: Qin
authors.forename: Ling-Juan
authors.initials: LJ
authors.lastname: Jin
authors.forename: Jing-Jing
authors.initials: JJ
authors.lastname: Zhu
authors.forename: Jing
authors.initials: J
authors.lastname: Wang
authors.forename: Jie
authors.initials: J
authors.lastname: Ding
authors.forename: Ke-Yuan
authors.initials: KY
authors.lastname: Wang
authors.forename: Zi-Qiang
authors.initials: ZQ
authors.lastname: Yu
authors.forename: Zhao-Yue
authors.initials: ZY
authors.lastname: Wang
authors.forename: Tian-Qin
authors.initials: TQ
authors.lastname: Wu
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D012189:Retrospective Studies; D013792:Thalidomide / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D003907:Dexamethasone