Posted on March 8th, 2009 by
The four-drug combination of chemotherapy agents Paraplatin® (carboplatin) and Taxol® (paclitaxel) plus targeted therapies Avastin® (bevacizumab) and Erbitux® (cetuximab) is safe and may improve survival in patients with advanced non–small cell lung cancer (NSCLC), according to the results of a study presented at the 2008 Chicago Multidisciplinary Symposium in Thoracic Oncology.
Non–small cell lung cancer (NSCLC) accounts for roughly 85% of all lung cancer. In advanced NSCLC, cancer has spread outside the lung; standard therapy for this stage of disease includes chemotherapy. Because of suboptimal survival rates for advanced NSCLC, researchers continue to evaluate novel ways to improve outcomes for patients with this disease.
Treatment for NSCLC often includes different combinations of different types of chemotherapy agents-for example, platinum-based drugs (such as Paraplatin) in combination with taxanes (such as Taxol). More recently, researchers have been evaluating the addition of targeted agents, such as Avastin and Erbitux, to chemotherapy regimens.
Avastin is a drug that blocks a protein known as vascular endothelial growth factor (VEGF). VEGF stimulates the growth of new blood vessels. Drugs that interfere with VEGF can slow or stop the growth of cancer cells. In addition, drugs that interfere with VEGF may improve the delivery of chemotherapy to cancer cells by normalizing blood supply.
Erbitux is a drug that inhibits growth of the cancer by binding to a portion of the epidermal growth factor receptor (EGFR), a protein located on the surface of many cancer cells, including NSCLC.
The Southwest Oncology Group conducted a Phase II trial to evaluate the addition of Avastin to their standard regimen of Paraplatin, Taxol, and Erbitux in order to determine if they could improve efficacy without compromising safety. The study included 110 patients with Stage IIIB or IV NSCLC. Patients received six cycles of the four-drug regimen and then continued receiving both Avastin and Erbitux as maintenance.
The primary endpoint of the study was safety, specifically defined by the frequency and severity of bleeding (pulmonary hemorrhage), which has been a concern related to Avastin. There were four treatment-related deaths, two of which were due to bleeding. Grade 4 side effects occurred in 40 patients. (Grade 4 side effects are defined as those that are life-threatening or disabling.) The estimated rate of grade 4 or worse bleeding is 2%. There were no unexpected toxicities.
The secondary endpoints of the study were related to efficacy and included response rate, progression-free survival, and overall survival. The results indicated that 53% of patients experienced shrinkage of their tumors and 24% had stable disease. The median progression-free survival rate was seven months, and overall survival was 14 months.
The researchers concluded that this four-drug regimen appears safe and effective for the treatment of advanced NSCLC. To follow up on this study, the researchers are analyzing the tissue to identify biomarkers for the disease. This analysis is ongoing and in addition, a Phase III study is planned for 2009.
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