[HTML][HTML] A clinical study assessing the tolerability and biological effects of infliximab, a TNF-α inhibitor, in patients with advanced cancer
ER Brown, KA Charles, SA Hoare, RL Rye, DI Jodrell… - Annals of oncology, 2008 - Elsevier
ER Brown, KA Charles, SA Hoare, RL Rye, DI Jodrell, RE Aird, R Vora, U Prabhakar…
Annals of oncology, 2008•ElsevierBackground Tumour necrosis factor-α (TNF-α) is an important regulator of the chronic
inflammation contributing to tumour progression. Infliximab, an anti-TNF-α 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) iv at 0 and 2 weeks …
inflammation contributing to tumour progression. Infliximab, an anti-TNF-α 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) iv at 0 and 2 weeks …
Background
Tumour necrosis factor-α (TNF-α) is an important regulator of the chronic inflammation contributing to tumour progression. Infliximab, an anti-TNF-α 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-α, 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-α 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-α and CCL2 being correlated with infliximab response.
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