A placebo-controlled, double-blind trial of infliximab for cancer-associated weight loss in elderly and/or poor performance non-small cell lung cancer patients (N01C9).
OBJECTIVE
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 > or = 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 > or = 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-associated weight loss. Infliximab was associated with increased fatigue and inferior global quality of life.
Jatoi
Aminah
A
Mayo Clinic Rochester, 200 First Street SW, Rochester, MN 55905, USA. jatoi.aminah@mayo.edu
Ritter
Howard L
HL
Dueck
Amylou
A
Nguyen
Phuong L
PL
Nikcevich
Daniel A
DA
Luyun
Ronnie F
RF
Mattar
Bassam I
BI
Loprinzi
Charles L
CL
D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000503:physiopathology*; D000077143:Docetaxel; D004311:Double-Blind Method; D005221:Fatigue / Q000209:etiology; D005260:Female; D056726:Genetic Association Studies; D005838:Genotype; D006801:Humans; D000069285:Infliximab; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D011110:Polymorphism, Genetic; D011788:Quality of Life; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D014409:Tumor Necrosis Factor-alpha / Q000235:genetics / Q000276:immunology; D015431:Weight Loss / Q000187:drug effects*
D000911:Antibodies, Monoclonal; D043823:Taxoids; D014409:Tumor Necrosis Factor-alpha; D000077143:Docetaxel; D000069285:Infliximab