A clinical study assessing the tolerability and biological effects of infliximab, a TNF-α inhibitor, in patients with advanced cancer
| Autor: | U. Prabhakar, R. Vora, M. Nakada, M. DeWitte, R. E. Corringham, C. Sturgeon, Duncan I. Jodrell, S. A. Hoare, Ewan Brown, John F. Smyth, David Propper, Frances R. Balkwill, Rhona Aird, Kellie A. Charles, R. L. Rye |
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| Rok vydání: | 2008 |
| Předmět: |
Adult
Male musculoskeletal diseases medicine.medical_specialty medicine.medical_treatment Population Sensitivity and Specificity Gastroenterology Drug Administration Schedule Drug Hypersensitivity Neoplasms Internal medicine medicine Humans Hypersensitivity Delayed Infusions Intravenous skin and connective tissue diseases education Chemokine CCL2 Aged Stomatitis education.field_of_study Dose-Response Relationship Drug Interleukin-6 Tumor Necrosis Factor-alpha business.industry Antibodies Monoclonal Cancer Hematology Middle Aged medicine.disease Infliximab Clinical trial stomatognathic diseases C-Reactive Protein Treatment Outcome Cytokine Oncology Tolerability Toxicity Immunology Linear Models Female Tumor necrosis factor alpha business medicine.drug |
| Zdroj: | Annals of Oncology. 19:1340-1346 |
| ISSN: | 0923-7534 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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