In the study, Dr. Ramalingam, assistant professor of medicine at the University of Pittsburgh School of Medicine, examined the effects of three different doses of the drug, vorinostat, on patients with advanced non-small cell lung cancer (NSCLC). The drug was administered in 200, 300 and 400 mg doses in combination with a standard chemotherapy for NSCLC that included carboplatin and paclitaxel. Vorinostat, one of a class of drugs called histone deacetylases, is thought to stop the growth of tumor cells by altering the expression of genes necessary for cancer cell growth.
"Non-small cell lung cancer is an extremely difficult disease to treat effectively over time," said Dr. Ramalingam. "Current approaches typically result in average survival of only eight to 11 months for patients with advanced disease. The purpose of our study was to see how safely we could add vorinostat, a novel anti-cancer agent, to standard chemotherapy. This is the first step in our efforts to determine whether the addition of this agent will improve survival for patients."
The study included 28 patients with NSCLC, head and neck cancer, bladder cancer and mesothelioma. Eleven of these patients had a partial response to treatment and the disease was stabilized in an additional seven patients. The dose of 400 mg of vorinostat daily for two weeks was well-tolerated by most of the patients in the study and is the recommended dose for a subsequent study to further determine the efficacy of the drug. "A larger clinical trial for patients with advanced non-small cell lung cancer with this treatment regimen will soon be initiated at UPCI, based on these promising results," noted Dr. Ramalingam.
A difficult cancer to treat due to its advanced stage at diagnosis, lung cancer is newly-diagnosed in more than 174,000 people in the United States each year. More than 163,000 people are expected to die of the disease in 2006.
Co-investigators of the study include Robert Parise, Merrill Egorin, M.D., Athanassios Argiris, M.D., Ronald Stoller, M.D, Lynette Beattie and Chandra Belani, M.D., from the University of Pittsburgh School of Medicine; Ana Aparicio, M.D, and Edward Newman, M.D, from the California Cancer Consortium; and James Zweibel, M.D., from the National Cancer Institute. Support for the study was provided by a grant from the National Cancer Institute.
The study is abstract number 2077 in the 2006 ASCO Annual Meeting Proceedings.