A Clinical Study Assessing the Tolerability and Biological Effects of Infliximab, a TNF-alpha Inhibitor, in Patients With Advanced Cancer

Ann Oncol. 2008 Jul;19(7):1340-6. doi: 10.1093/annonc/mdn054. Epub 2008 Mar 5.


Background: Tumour necrosis factor-alpha (TNF-alpha) is an important regulator of the chronic inflammation contributing to tumour progression. Infliximab, an anti-TNF-alpha monoclonal antibody was investigated in this trial of patients with advanced cancer. The primary objectives were to determine the safety profile and biological response of infliximab in a cancer population. Clinical response was a secondary objective.

Patients and methods: Forty-one patients received infliximab at 5 mg/kg (n = 21) or 10 mg/kg (n = 20) i.v. at 0 and 2 weeks and then every 4 weeks. Post-treatment samples were measured for changes in plasma and serum TNF-alpha, CCL2, IL-6 and C-reactive protein (CRP).

Results: Infliximab was well tolerated with no dose-limiting toxic effects. At both doses of infliximab, neutralisation of serum TNF-alpha was observed after 1 h while plasma CCL2, IL-6 and serum CRP were decreased 24 and 48 h following infliximab administration. Seven patients experienced disease stablisation (range 10-50+ weeks). There was no evidence of disease acceleration in any patient.

Conclusions: Infliximab treatment was safe and well tolerated in patients with advanced cancer. There was evidence of biological activity with baseline TNF-alpha and CCL2 being correlated with infliximab response.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / therapeutic use*
  • C-Reactive Protein / analysis
  • Chemokine CCL2 / blood
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Hypersensitivity*
  • Female
  • Humans
  • Hypersensitivity, Delayed* / chemically induced
  • Infliximab
  • Infusions, Intravenous
  • Interleukin-6 / blood
  • Linear Models
  • Male
  • Middle Aged
  • Neoplasms / blood
  • Neoplasms / drug therapy*
  • Neoplasms / pathology
  • Sensitivity and Specificity
  • Stomatitis / chemically induced
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*
  • Tumor Necrosis Factor-alpha / blood


  • Antibodies, Monoclonal
  • CCL2 protein, human
  • Chemokine CCL2
  • Interleukin-6
  • Tumor Necrosis Factor-alpha
  • C-Reactive Protein
  • Infliximab