|
a b s t r a c t
Purpose: This study tested whether infliximab, a chimeric IgG1kappa monoclonal antibody that blocks
tumor necrosis factor (TNF) alpha, improves/stabilizes weight loss in elderly and/or poor performance
status patients with metastatic non-small cell lung cancer (NSCLC).
Methods: This double-blind trial randomly assigned patients to infliximab/docetaxel (n = 32) versus
placebo/docetaxel ( n = 29). The primary endpoint was ≥10% weight gain.
Results: Groups were balanced with respect to age, number of prior chemotherapy regimens, baseline
weight loss, and performance status. No patient gained ≥10% baseline weight, and early evidence of
the lack of efficacy prompted early trial closure. Appetite improvement was negligible in both arms.
However, infliximab-/docetaxel-treated patients developed greater fatigue and worse global quality of
life scores. Other outcomes, such as tumor response rate (<10% in both groups) and overall survival, were
not statistically different between groups. There were no statistically significant differences in adverse
events, although one death was attributed to infliximab. Genotyping for the TNF alpha −238 and −308
polymorphisms revealed no clinical significance of these genotypes, as relevant to the loss of weight or
appetite.
Conclusions: This trial closed early because infliximab did not prevent or palliate cancer-associatedweight
loss. Infliximab was associated with increased fatigue and inferior global quality of life.
| 
