Fatigue in patients with advanced cancer: a pilot study of an intervention with infliximab.

Goals Of Work: The objective of this study was to determine the effect of infliximab, an antitumor necrosis factor alpha (TNFalpha) antibody, on fatigue in patients with advanced cancer.

Materials And Methods: This was a pilot study undertaken in a specialist palliative care unit. Seventeen eligible outpatients were enrolled in this study. Infliximab 5 mg/kg was administered intravenously at baseline and if there was observable clinical benefit, every 4 weeks thereafter until clinical benefit was lost. The primary outcome measure assessing subjective functional improvement was the change in fatigue severity scale (FSS) score at 4 weeks following an infliximab infusion. Secondary outcome measures of subjective functional improvement that were assessed 4 weeks after each infliximab infusion included changes in Karnofsky performance status (KPS), hospital anxiety and depression scale (HADS) score, anxiety and depression subscores, and appetite visual analogue scale. Clinical laboratory assessments were C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), TNFalpha, interleukin-6, and leptin concentrations.

Main Results: At week 4, 9 of 14 patients improved in FSS, 3 of 15 improved in KPS, 7 of 15 improved in total HADS and the majority had modest improvements in serum CRP, ESR, or leptin concentrations. Case studies of six patients with overall improvement are described in detail. Five serious adverse events occurred; two were serious infections possibly related to treatment.

Conclusions: A subgroup of patients in this small pilot study demonstrated uniform subjective/clinical benefit. We were not able to identify any predictors of this response; a larger, controlled study may reveal more information.