RT Journal Article
SR Electronic
T1 Thalidomide in the treatment of cancer cachexia: a randomised placebo controlled trial
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 540
OP 545
DO 10.1136/gut.2004.047563
VO 54
IS 4
A1 J N Gordon
A1 T M Trebble
A1 R D Ellis
A1 H D Duncan
A1 T Johns
A1 P M Goggin
YR 2005
UL http://gut.bmj.com/content/54/4/540.abstract
AB Background: Proinflammatory cytokines, especially tumour necrosis factor α (TNF-α), play a prominent role in the pathogenesis of cancer cachexia. Thalidomide, which is an inhibitor of TNF-α synthesis, may represent a novel and rational approach to the treatment of cancer cachexia. Aims: To assess the safety and efficacy of thalidomide in attenuating weight loss in patients with cachexia secondary to advanced pancreatic cancer. Methods: Fifty patients with advanced pancreatic cancer who had lost at least 10% of their body weight were randomised to receive thalidomide 200 mg daily or placebo for 24 weeks in a single centre, double blind, randomised controlled trial. The primary outcome was change in weight and nutritional status. Results: Thirty three patients (16 control, 17 thalidomide) were evaluated at four weeks, and 20 patients (eight control, 12 thalidomide) at eight weeks. At four weeks, patients who received thalidomide had gained on average 0.37 kg in weight and 1.0 cm3 in arm muscle mass (AMA) compared with a loss of 2.21 kg (absolute difference −2.59 kg (95% confidence interval (CI) −4.3 to −0.8); p = 0.005) and 4.46 cm3 (absolute difference −5.6 cm3 (95% CI −8.9 to −2.2); p = 0.002) in the placebo group. At eight weeks, patients in the thalidomide group had lost 0.06 kg in weight and 0.5 cm3 in AMA compared with a loss of 3.62 kg (absolute difference −3.57 kg (95% CI −6.8 to −0.3); p = 0.034) and 8.4 cm3 (absolute difference −7.9 cm3 (95% CI −14.0 to −1.8); p = 0.014) in the placebo group. Improvement in physical functioning correlated positively with weight gain (r = 0.56, p = 0.001). Conclusion: Thalidomide was well tolerated and effective at attenuating loss of weight and lean body mass in patients with cachexia due to advanced pancreatic cancer.