The cachexia of malignancy is considered mediated through excess production of tumor necrosis factoralpha and other cytokines. Thalidomide(Drug information on thalidomide) (Thalomid), a sedative/hypnotic, has been shown to inhibit tumor necrosis factoralpha production. We report the results of 15 cachectic patients in an ongoing study who have completed a 6-week trial of thalidomide.
All patients had stage IV disease, an Eastern Cooperative Oncology Group performance status of 02, at least a 5% loss of body weight within the prior 6 months, and no surgical procedures within a 6-week period. Body weight assessment, Bioelectric Impedance Analysis, the Mini Mental State Exam, the FAACT (version 4) with additional concerns (cachexia), and a sleep and pain questionnaire were administered 2 weeks prior to initiating thalidomide and subsequently at 2-week intervals. The initial thalidomide dose was 100 mg at bedtime and escalated to 200 mg at bedtime after 2 weeks. The median weight change in the 2 weeks prior to treatment was minus 2.51 lb.
With treatment, cessation of weight loss, increased extracellular fluid, and decreased nocturnal awakenings achieved significance at alpha = 0.05 by the Wilcoxon sign-rank test. Increased percent body fat, increased sleep time, and decreased nocturnal awakenings achieved significance at alpha = 0.05 by the Mantel-Haenszel method. There was no statistically significant change in the Mini Mental Status Exam, the FAACT, and the sleep and pain questionnaire. Thalidomide was generally well tolerated. Toxicity data will be reported.
CONCLUSION: Despite a small sample size, thalidomide was shown, over a short time period, to curtail weight loss and improve sleep in advanced cancer patients with cachexia. Blood and urine samples have been obtained for cytokine analysis.