NEW YORK (Reuters Health) - In patients with metastatic renal cell carcinoma, the anti-epidermal growth factor receptor antibody ABX-EGF shows favorable safety and pharmacokinetics, but little antitumor activity, according to a report in the August 1st issue of the Journal of Clinical Oncology.
However, lead investigator Dr. Eric K. Rowinsky told Reuters Health, “after analysis, it was found that the study population was a very high-risk population.”
Dr. Rowinsky from the Institute for Drug Development, San Antonio, Texas and colleagues examined the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ABX-EGF in 88 patients with metastatic renal cancer carcinoma.
They had either failed to respond to treatment with interleukin-2 and interferon-alfa or such therapy had been medically contraindicated.
Only 3 of the 88 patients experienced partial or complete responses to ABX-EGF treatment, the authors report. Two additional patients had objective tumor regression that did not meet the criteria for partial response, and 44 patients had stable disease as their best response.
Treatment with ABX-EGF was well tolerated, but the researchers estimated that a dose of 1.5 mg/kg would cause skin rash in 90% of patients.
Progression-free survival was significantly longer among the 43 patients with moderate or severe skin toxicity (128 days) than it was among the 34 patients with mild skin toxicity (76 days) or the 11 patients with no skin toxicity (56 days).
Dr. Rowinsky concluded that this was “primarily a feasibility study that showed a very well behaved therapeutic profile with little interindividual variability in toxicity and pharmacokinetics.”
In a related editorial, Dr. Janet E. Dancey from National Cancer Institute, Rockville, Maryland notes that the rationale for testing epidermal growth factor receptor inhibitors in patients with advanced renal cell carcinoma “is compelling.” Nevertheless, “results from clinical trials evaluating these agents to date have been unimpressive.”
Source: J Clin Oncol 2004;22:3003-3015,2975-2977. [ Google search on this article ]
MeSH Headings:Human Activities: Membrane Proteins: Receptors, Cell Surface: Receptor, Epidermal Growth Factor: Receptors, Gastrointestinal Hormone: Survival: Receptors, Growth Factor: Receptors, Peptide: Anthropology, Education, Sociology and Social PhenomenaCopyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
