TY - JOUR
T1 - Nutritional parameters observed during 28-day infusion of recombinant human tumor necrosis factor-α
AU - Hardin, T. C.
AU - Koeller, J. M.
AU - Kuhn, J. G.
AU - Roodman, G. D.
AU - Von Hoff, D. D.
PY - 1993/1/1
Y1 - 1993/1/1
N2 - In conjunction with a Phase I investigation of the antineoplastic activity of recombinant human tumor necrosis factor-α (TNF-α), administered as a 28- day continuous infusion, selected nutritional parameters were evaluated to identify any effect that might be attributed to the TNF infusion. Seven clinically stable men with a variety of tumor types were studied. None had clinical or laboratory evidence of significant malnutrition before entry into the study. Five patients received 10 μg of recombinant human TNF-α per square meter per day and two patients received 25 μg/m2 per day. Indirect calorimetry assessment of resting energy expenditure, body weight, serum TNF concentration, and laboratory analysis of common nutritional markers (albumin, prealbumin, and triglycerides) were performed at baseline, day 14, day 28, and 2 weeks (day 42) after completion of the infusion. There were no statistically significant differences by analysis of variance observed in any parameter during the study period compared with baseline values and values on day 42. Also, there were no differences between any parameters when stratified by dose administered, although the number of patients studied was small. Measured serum TNF concentrations ranged from 0.02 to 1.56 ng/mL and did not correlate with study day or dose of TNF infused. No correlation was observed between serum TNF concentrations and resting energy expenditure. Although others have reported significant metabolic changes associated with acute administration of TNF in humans and animals, our experience does not support a hypermetabolic state in patients receiving low daily dose, long- term (28-day) continuous infusion of recombinant human TNF-α, a state that may be consistent with many neoplastic conditions.
AB - In conjunction with a Phase I investigation of the antineoplastic activity of recombinant human tumor necrosis factor-α (TNF-α), administered as a 28- day continuous infusion, selected nutritional parameters were evaluated to identify any effect that might be attributed to the TNF infusion. Seven clinically stable men with a variety of tumor types were studied. None had clinical or laboratory evidence of significant malnutrition before entry into the study. Five patients received 10 μg of recombinant human TNF-α per square meter per day and two patients received 25 μg/m2 per day. Indirect calorimetry assessment of resting energy expenditure, body weight, serum TNF concentration, and laboratory analysis of common nutritional markers (albumin, prealbumin, and triglycerides) were performed at baseline, day 14, day 28, and 2 weeks (day 42) after completion of the infusion. There were no statistically significant differences by analysis of variance observed in any parameter during the study period compared with baseline values and values on day 42. Also, there were no differences between any parameters when stratified by dose administered, although the number of patients studied was small. Measured serum TNF concentrations ranged from 0.02 to 1.56 ng/mL and did not correlate with study day or dose of TNF infused. No correlation was observed between serum TNF concentrations and resting energy expenditure. Although others have reported significant metabolic changes associated with acute administration of TNF in humans and animals, our experience does not support a hypermetabolic state in patients receiving low daily dose, long- term (28-day) continuous infusion of recombinant human TNF-α, a state that may be consistent with many neoplastic conditions.
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U2 - 10.1177/0148607193017006541
DO - 10.1177/0148607193017006541
M3 - Article
C2 - 8301809
AN - SCOPUS:0027438768
VL - 17
SP - 541
EP - 545
JO - Journal of Parenteral and Enteral Nutrition
JF - Journal of Parenteral and Enteral Nutrition
SN - 0148-6071
IS - 6
ER -