Introduction: The anorexia-cachexia syndrome is the leading cause of cancer death. Thalidomide (TH) may increase appetite (Ap) and weight (W) by lowering TNF-a. We studied TH safety and efficacy in cancer anorexia. W, performance status (PS), bioimpedance (BEI), early satiety, insomnia, sweating, and quality of life (QOL) were assessed.
Methods: Patients with cancer were screened using an appetite numerical analogue scale (Ap-NAS, 0: worst -10: normal). Patients on current antianorexia or anti-tumor therapy were excluded. Patients with an Ap-NAS/8 were eligible. TH 50 mg/d was the starting dose. Both patients and staff complied with the System for TH Education and Prescribing Safety STEPS (Celgene Corporation)=2-point increase in Ap-NAS was a response. Evaluable patients must complete 2 weeks of TH 50 mg/d. Non-responders were titrated to 100 mg. QOL was measured using a categorical scale. Other symptoms were assessed by a NAS (0: None, 10: the worst).
Results: Fifteen patients enrolled. There were seven males and eight females; median age 66 (R 53-80). Lung cancer was the commonest diagnosis (n=3). Five were withdrawn early (non-evaluable); severe drowsiness (n=3), death (n=1), and refusal (n=1). Ten were evaluable for efficacy. Nine patients had an AP response (7 at 50 mg, 2 at 100 mg). The median/range Ap-NAS was 2 (1-6) baseline, 5 (3 -8) day 7, 6 (4 - 9) day 14. The QOL at baseline was okay (n=6) and bad (n=3). This improved to good (n=6) after three days.Most (n=8) noted improved sleep. Early satiety (n=5) also improved (n=3).Wand BEI results are available in six. Of those, five gained W. W (median/range Kg) was 48.4 (42.4 -61.6) day 1; 54.9 (43.9 -63.8) day 21. W gain was both fat and LBM (n=2), LBM alone (n=2), and fat alone (n=1). Two had sweating which improved after 3 days.
Conclusion: 1) Most had sustained improved Ap 2) Sweating and early satiety improved 3) Some gained significant W 4) QOL improved first.