A phase II study is the first to show that adding two targeted therapy drugs to the standard chemotherapy regimen is safe and effective as first-line treatment of advanced non-small-cell lung cancer (NSCLC). The researchers found that the safety of the drugs compared well with the safety reported in studies of the targeted drugs used alone with chemotherapy. The drug combination was also found to be effective, with a good overall response rate, progression-free survival, and overall survival.
For advanced NSCLC, a platinum-based doublet has been standard chemotherapy for several years. The discovery of signaling pathways involved in the growth of NSCLC and the development of new drugs to target those pathways led to studies to evaluate the addition of a targeted therapy drug to standard chemotherapy. Researchers now believe that more than one signaling pathway may be involved in tumor growth, providing a rationale for evaluating combinations of targeted therapy drugs.
The study, which will be published in the December issue of the International Association for the Study of Lung Cancer's journal, the Journal of Thoracic Oncology (JTO), showed that the addition of cetuximab and bevacizumab to standard chemotherapy was safe. The combination treatment was associated with a low rate of serious adverse events, especially serious bleeding, an adverse event known to be associated with bevacizumab. Overall, the rate of adverse events was acceptable and comparable to the rates found in other studies. The most common adverse events were aceniform rash, neutropenia, infection, neuropathy, and fatigue.
"The combination regimen showed promising efficacy and was tolerable for patients with advanced lung cancer. Dual antibody approaches may better inhibit cell signals that feed the cancer," says Edward S. Kim, Chair, Solid Tumor Oncology and Investigational Therapeutics at Levine Cancer Institute, Charlotte, NC. "Our ongoing phase III study - SWOG 0819 - will address this regimen in a more definitive manner."
Dr. Kim and coauthors conducted the study through Southwest Oncology Group (SWOG), a National Cancer Institute-supported organization that conducts clinical trials. Dr. Kim is a member of IASLC, as are several of his coauthors, including Roy S. Herbst, MD, PhD; Mary W. Redman; Fred R. Hirsch, MD, PhD; Philip C. Mack, PhD; Karen Kelly, MD; John V. Heymach, MD, PhD; and David R. Gandara, MD.