NEW ORLEANS (Reuters Health) - The combination of two targeted drugs -- bevacizumab (Avastin) and erlotinib (Tarceva) -- appears to be “one of the most active and best tolerated regimens yet tested” in patients with metastatic renal cell carcinoma (RCC), according to a researcher who presented phase II results at the 40th annual meeting of the American Society of Clinical Oncology.
At a press briefing with reporters on Sunday, Dr. John D. Hainsworth of the Sarah Cannon Cancer Center in Nashville, Tennessee said: “Combining these two drugs seems to have more activity than has previously been reported using either agent alone. This study gives further credence to using combinations of targeted therapies successfully in kidney cancer and other cancers.”
Bevacizumab, approved recently by the Food and Drug Administration for treating metastatic colorectal cancer, is a humanized monoclonal antibody that inhibits vascular endothelial growth factor (VEGF). The investigational agent erlotinib, selectively inhibits epidermal growth factor receptor (EGFR) tyrosine kinase.
In this phase II trial, researchers confirmed their theory that combined VEGF and EGFR inhibition boosts the biological and clinical effects over either one alone.
They treated a total of 63 patients with recurrent metastatic clear cell RCC after nephrectomy with bevacizumab (10 mg/kg IV q 2 weeks) and erlotinib (150 mg PO daily) for 12 months or until tumor progression. “Originally we had planned to continue treatment only for 12 months, but we modified that plan as we saw many of the patients arriving at 12 months and still benefiting from treatment,” Dr. Hainsworth said.
Of 58 evaulable patients, 21% had a partial response and 66% had disease stabilization or a minor response -- that is, shrinkage of tumor but by less than the criteria for partial response. Only 13% had progression and halted treatment. At 12 months, 81% of patients were still alive. These are “good numbers” compared with other therapies, Dr. Hainsworth noted.
Toxicity with the two-drug combination is “manageable,” he also noted, and includes hypertension, diarrhea, ras, and nausea/vomiting.
Based on this study, a comparison of bevacizumab plus erlotinib to standard regimens for advanced RCC is warranted, Dr. Hainsworth said.
MeSH Headings:Antineoplastic Agents, Combined: Clinical Trials: Congresses: Health Care Economics and Organizations: Environment and Public Health: Epidemiologic Methods: Evaluation Studies: Health: Health Occupations: Health Services Administration: Medicine: Investigative Techniques: Organizations: Population Characteristics: Preventive Medicine: Public Health: Quality of Health Care: Specialties, Medical: Drugs, Investigational: Epidemiologic Study Characteristics: Clinical Trials, Phase II: Health Care Quality, Access, and Evaluation: Health Care Evaluation Mechanisms: Analytical, Diagnostic and Therapeutic Techniques and Equipment: Biological Sciences: Health CareCopyright © 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.