Gefitinib Use Plummets Following ISEL Trial Results
More than 85 percent of clinical oncologists who treat lung cancer patients have modified their care patterns based on the results of a clinical trial that showed the targeted agent gefitinib (Iressa) failed to improve survival compared with placebo. At a meeting of the Food and Drug Administration (FDA) Oncology Drugs Advisory Committee last week, officials from the drug's manufacturer, AstraZeneca PLC, reported the data, along with additional market research on gefitinib use since the company issued a "Dear Doctor" letter on Dec. 17, 2004 and other communications describing the trial's overall survival results.
"Physicians are aware of the [trial] results and are no longer selecting Iressa as their EGFR inhibitor of choice," said Carolyn Fitzsimons, an executive director with AstraZeneca. "They are choosing erlotinib (Tarceva)."
In the Iressa Survival Evaluation in Lung cancer (ISEL) trial, gefitinib was tested as a second- or third-line therapy in nearly 1,700 patients with advanced non-small-cell lung cancer (NSCLC). AstraZeneca officials presented further data from ISEL during the advisory committee meeting, including subset analyses revealing a significant survival advantage with gefitinib in never smokers and patients of "Asian ethnicity." Read more
Clinical Proteomics: Developing Standardized Tools
for Cancer Research
Diagnosing cancer as early in its course as possible and developing targeted drugs for treatment result in better clinical outcomes for patients. However, the development of effective tools that enable early diagnosis and targeted therapies has been an elusive endgame. Using proteins as biomarkers has long been considered a promising clinical diagnostics approach for drug discovery and development. Some biomarkers, such as prostate-specific antigen, have been in use for many years. Many other potential biomarkers are being reported in the literature almost weekly, although few have been translated into the diagnostic arena.
In short, our progress has not been as rapid as we would like, especially given the advances in our understanding of the process by which cancer develops and becomes lethal. I believe this is about to change. This morning, in fact, during a meeting of the NCI Board of Scientific Advisors (BSA), there was rich discussion about improving both the efficiency and effectiveness of proteomic biomarker research in the United States. Specifically discussed were the need to develop animal correlates, to integrate and align existing resources such as biorepositories, and to leverage knowledge gained from work with tumors where the biology is known and apply this to the complex proteomics of serum and other body fluids. Read more