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)

Aminah Jatoi, Howard L. Ritter, Amylou Dueck, Phuong L. Nguyen, Daniel A Nikcevich, Ronnie F. Luyun, Bassam I. Mattar, Charles L. Loprinzi

Research output: Contribution to journalArticle

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Abstract

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-associated weight loss. Infliximab was associated with increased fatigue and inferior global quality of life.

Original languageEnglish (US)
Pages (from-to)234-239
Number of pages6
JournalLung Cancer
Volume68
Issue number2
DOIs
StatePublished - May 1 2010

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docetaxel
Non-Small Cell Lung Carcinoma
Weight Loss
Placebos
Neoplasms
Appetite
Fatigue
Tumor Necrosis Factor-alpha
Quality of Life
Double-Blind Method
Weight Gain
Infliximab
Genotype
Monoclonal Antibodies
Weights and Measures
Drug Therapy
Survival

Keywords

  • Cancer-associated weight loss
  • Double-blind trial
  • Elderly patients
  • Infliximab
  • Non-small cell lung cancer

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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). / Jatoi, Aminah; Ritter, Howard L.; Dueck, Amylou; Nguyen, Phuong L.; Nikcevich, Daniel A; Luyun, Ronnie F.; Mattar, Bassam I.; Loprinzi, Charles L.

In: Lung Cancer, Vol. 68, No. 2, 01.05.2010, p. 234-239.

Research output: Contribution to journalArticle

Jatoi, Aminah ; Ritter, Howard L. ; Dueck, Amylou ; Nguyen, Phuong L. ; Nikcevich, Daniel A ; Luyun, Ronnie F. ; Mattar, Bassam I. ; Loprinzi, Charles L. / 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). In: Lung Cancer. 2010 ; Vol. 68, No. 2. pp. 234-239.
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abstract = "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-associated weight loss. Infliximab was associated with increased fatigue and inferior global quality of life.",
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