title: Clinical studies on the treatment of cancer cachexia with megestrol acetate plus thalidomide.
abstract: BACKGROUND
  The management of cancer-related anorexia/cachexia syndrome (CACS) is a great challenge in clinical practice. To date, practice guidelines for the prevention and treatment of CACS are lacking. The authors conducted a randomized study to confirm the effectiveness and safety of treatment of CACS utilizing megestrol acetate (MA) plus thalidomide.
  
  
  METHODS
  One hundred and two candidates with CACS were randomly assigned to two treatment groups (trial group and control group): the trial group received MA (160 mg po, bid) plus thalidomide (50 mg po, bid), while the control group received MA (160 mg po, bid) alone. Treatment duration was 8 weeks.
  
  
  RESULTS
  Analysis of the trial group demonstrated a significant increase from baseline in body weight (<0.01), quality of life (p = 0.02), appetite (p = 0.01), and grip strength (p = 0.01), and a significant decrease in fatigue, Glasgow Prognostic Score (p = 0.05), Eastern Cooperative Oncology Group performance status (p = 0.03), IL-6 (p < 0.01), and tumor necrosis factor-α (p = 0.02). In contrast, in the control group, endpoints with a significant improvement from baseline included body weight (p < 0.02) and appetite (p = 0.02). The mean changes in the endpoints from baseline in the trial group were significantly greater compared with the control group: in the primary endpoints, body weight (p = 0.05), fatigue (p < 0.01) and quality of life (p = 0.01), and in the secondary endpoints, grip strength (p = 0.05), Glasgow Prognostic Score (p = 0.02), Eastern Cooperative Oncology Group performance status (p = 0.02), IL-6 (p < 0.01) and tumor necrosis factor-α (p = 0.01). Toxicity was found to be relatively negligible in both groups.
  
  
  CONCLUSIONS
  A combination regimen of MA and thalidomide is more effective than MA alone in the treatment of CACS.
authors: Oncology Department, Ningbo Development Zone Center Hospital, Ningbo 315800, PR China. whsjl@163.com
authors: Hong-Sheng
authors: HS
authors: Wen
authors: Xu
authors: X
authors: Li
authors: Yu-Zhu
authors: YZ
authors: Cao
authors: Cui-Cui
authors: CC
authors: Zhang
authors: Fang
authors: F
authors: Yang
authors: Yu-Ming
authors: YM
authors: Shi
authors: Li-Ming
authors: LM
authors: Peng
mesh_terms: D000368:Aged; D019167:Appetite Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001835:Body Weight / Q000187:drug effects; D002100:Cachexia / Q000188:drug therapy* / Q000209:etiology; D004359:Drug Therapy, Combination; D005221:Fatigue / Q000188:drug therapy / Q000209:etiology; D005260:Female; D018737:Hand Strength; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015850:Interleukin-6 / Q000378:metabolism; D008297:Male; D019290:Megestrol Acetate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications* / Q000473:pathology; D011379:Prognosis; D011788:Quality of Life; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000378:metabolism
chemical_list: D019167:Appetite Stimulants; D007166:Immunosuppressive Agents; D015850:Interleukin-6; D014409:Tumor Necrosis Factor-alpha; D013792:Thalidomide; D019290:Megestrol Acetate